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115th Congress    }                                      {  Rept. 115-49
                         HOUSE OF REPRESENTATIVES
 1st Session      }                                      {   Part 1

======================================================================



 
             PESTICIDE REGISTRATION ENHANCEMENT ACT OF 2017

                                _______
                                

 March 20, 2017.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mr. Conaway, from the Committee on Agriculture, submitted the following

                              R E P O R T

                        [To accompany H.R. 1029]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Agriculture, to whom was referred the bill 
(H.R. 1029) to amend the Federal Insecticide, Fungicide, and 
Rodenticide Act to improve pesticide registration and other 
activities under the Act, to extend and modify fee authorities, 
and for other purposes, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.
    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Pesticide 
Registration Enhancement Act of 2017''.
  (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Extension and modification of maintenance fee authority.
Sec. 3. Reregistration and Expedited Processing Fund.
Sec. 4. Experimental use permits for pesticides.
Sec. 5. Pesticide registration service fees.
Sec. 6. Revision of tables regarding covered pesticide registration 
applications and other covered actions and their corresponding 
registration service fees.

SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE FEE AUTHORITY.

  (a) Maintenance Fee.--Section 4(i)(1) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(1)) is amended--
          (1) in subparagraph (C), by striking ``an aggregate amount of 
        $27,800,000 for each of fiscal years 2013 through 2017'' and 
        inserting ``an average amount of $31,000,000 for each of fiscal 
        years 2017 through 2023'';
          (2) in subparagraph (D)--
                  (A) in clause (i), by striking ``$115,500 for each of 
                fiscal years 2013 through 2017'' and inserting 
                ``$129,400 for each of fiscal years 2017 through 
                2023''; and
                  (B) in clause (ii), by striking ``$184,800 for each 
                of fiscal years 2013 through 2017'' and inserting 
                ``$207,000 for each of fiscal years 2017 through 
                2023'';
          (3) in subparagraph (E)(i)--
                  (A) in subclause (I), by striking ``$70,600 for each 
                of fiscal years 2013 through 2017'' and inserting 
                ``$79,100 for each of fiscal years 2017 through 2023''; 
                and
                  (B) in subclause (II), by striking ``$122,100 for 
                each of fiscal years 2013 through 2017'' and inserting 
                ``$136,800 for each of fiscal years 2017 through 
                2023''; and
          (4) in subparagraph (I), by striking ``2017'' and inserting 
        ``2023''.
  (b) Prohibition on Other Fees.--Section 4(i)(2) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(2)) is 
amended--
          (1) by striking ``during the period beginning on the date of 
        enactment of this section and ending on September 30, 2019'' 
        and inserting ``until September 30, 2025''; and
          (2) by inserting after ``registration of a pesticide under 
        this Act'' the following: ``or any other action covered under a 
        table specified in section 33(b)(3),''.
  (c) Extension of Prohibition on Tolerance Fees.--Section 408(m)(3) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is 
amended by striking ``2017'' and inserting ``2023''.

SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.

  (a) Authorized Use of Fund.--Section 4(k)(2)(A) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) 
is amended--
          (1) in the first sentence, by striking ``the fund'' and 
        inserting ``the Reregistration and Expedited Processing Fund'';
          (2) by striking ``paragraph (3),'' in the first sentence and 
        all that follows through the second sentence and inserting the 
        following: ``paragraph (3), to offset the costs of registration 
        review under section 3(g), including the costs associated with 
        any review under the Endangered Species Act of 1973 (16 U.S.C. 
        1531 et. seq.) required as part of the registration review, to 
        offset the costs associated with tracking and implementing 
        registration review decisions, including registration review 
        decisions designed to reduce risk, for the purposes specified 
        in paragraphs (4) and (5), and to enhance the information 
        systems capabilities to improve the tracking of pesticide 
        registration decisions.'';
          (3) in clause (i), by striking ``are allocated solely'' and 
        all that follows through ``3(g);'' and inserting the following: 
        ``are allocated solely for the purposes specified in the first 
        sentence of this subparagraph;''; and
          (4) in clause (ii), by striking ``necessary to achieve'' and 
        all that follows through ``3(g);'' and inserting the following: 
        ``necessary to achieve the purposes specified in the first 
        sentence of this subparagraph;''.
  (b) Set-aside for Review of Inert Ingredients and Expedited 
Processing of Similar Applications.--Section 4(k)(3)(A) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) 
is amended, in the matter preceding clause (i), by striking ``The 
Administrator shall use'' and all that follows through ``personnel and 
resources--'' and inserting the following: ``For each of fiscal years 
2017 through 2023, the Administrator shall use between \1/9\ and \1/8\ 
of the maintenance fees collected in such fiscal year to obtain 
sufficient personnel and resources--''.
  (c) Set-aside for Expedited Rulemaking and Guidance Development for 
Certain Purposes.--Paragraph (4) of section 4(k) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is 
amended to read as follows:
          ``(4) Expedited rulemaking and guidance development for 
        certain product performance data requirements.--
                  ``(A) Set-aside.--For each of fiscal years 2017 
                through 2021, the Administrator shall use not more than 
                $500,000 of the amounts made available to the 
                Administrator in the Reregistration and Expedited 
                Processing Fund for the activities described in 
                subparagraph (B).
                  ``(B) Products claiming efficacy against invertebrate 
                pests of significant public health or economic 
                importance.--The Administrator shall use amounts made 
                available under subparagraph (A) to develop, receive 
                comments with respect to, finalize, and implement the 
                necessary rulemaking and guidance for product 
                performance data requirements to evaluate products 
                claiming efficacy against the following invertebrate 
                pests of significant public health or economic 
                importance (in order of importance):
                          ``(i) Bed bugs.
                          ``(ii) Premise (including crawling insects, 
                        flying insects, and baits).
                          ``(iii) Pests of pets (including pet pests 
                        controlled by spot-ons, collars, shampoos, 
                        powders, dips).
                          ``(iv) Fire ants.
                  ``(C) Deadlines for guidance.--The Administrator 
                shall develop, and publish guidance required by 
                subparagraph (B) with respect to claims of efficacy 
                against pests described in such subparagraph as 
                follows:
                          ``(i) With respect to bed bugs, issue final 
                        guidance not later than June 30, 2017.
                          ``(ii) With respect to pests specified in 
                        clause (ii) of such subparagraph--
                                  ``(I) submit draft guidance to the 
                                Scientific Advisory Panel and for 
                                public comment not later than June 30, 
                                2018; and
                                  ``(II) complete any response to 
                                comments received with respect to such 
                                draft guidance and finalize the 
                                guidance not later than September 30, 
                                2020.
                          ``(iii) With respect to pests specified in 
                        clauses (iii) and (iv) of such subparagraph--
                                  ``(I) submit to the Scientific 
                                Advisory Panel and for public comment 
                                draft guidance not later than June 30, 
                                2019; and
                                  ``(II) complete any response to 
                                comments received with respect to such 
                                draft guidance and finalize the 
                                guidance not later than March 31, 2021.
                  ``(D) Revision.--The Administrator shall revise the 
                guidance required by subparagraph (B) from time-to-
                time, but shall permit applicants and registrants 
                sufficient time to obtain data that meet the 
                requirements specified in such revised guidance.
                  ``(E) Deadline for product performance data 
                requirements.--The Administrator shall, not later than 
                September 30, 2021, issue regulations prescribing 
                product performance data requirements for any pesticide 
                intended for preventing, destroying, repelling, or 
                mitigating any invertebrate pest of significant public 
                health or economic importance specified in clauses (i) 
                through (iv) of subparagraph (B).''.
  (d) Set-aside for Good Laboratory Practices Inspections.--Section 
4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136a-1(k)) is amended--
          (1) by redesignating paragraphs (5) and (6) as paragraphs (6) 
        and (7), respectively;
          (2) by inserting after paragraph (4) the following new 
        paragraph:
          ``(5) Good laboratory practices inspections.--
                  ``(A) Set-aside.--For each of fiscal years 2017 
                through 2023, the Administrator shall use not more than 
                $500,000 of the amounts made available to the 
                Administrator in the Reregistration and Expedited 
                Processing Fund for the activities described in 
                subparagraph (B).
                  ``(B) Activities.--The Administrator shall use 
                amounts made available under subparagraph (A) for 
                enhancements to the good laboratory practices standards 
                compliance monitoring program established under part 
                160 of title 40 of the Code of Federal Regulations (or 
                successor regulations), with respect to laboratory 
                inspections and data audits conducted in support of 
                pesticide product registrations under this Act. As part 
                of such monitoring program, the Administrator shall 
                make available to each laboratory inspected under such 
                program in support of such registrations a preliminary 
                summary of inspection observations not later than 60 
                days after the date on which such an inspection is 
                completed.''; and
          (3) in paragraph (7), as so redesignated, by striking 
        ``paragraphs (2), (3), and (4)'' and inserting ``paragraphs 
        (2), (3), (4), and (5)''.

SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.

  Subsection (a) of section 5 of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136c) is amended to read as follows:
  ``(a) Application and Issuance.--
          ``(1) Application.--Any person may apply to the Administrator 
        for an experimental use permit for a pesticide. An application 
        for an experimental use permit may be filed at any time.
          ``(2) Requirements.--An application for an experimental use 
        permit shall conform with the requirements of section 33(b).
          ``(3) Issuance.--The decision whether to grant an 
        experimental use permit shall be made within the time-frame 
        specified in the applicable covered application category 
        specified in section 33(b)(3).''.

SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.

  (a) Extension and Modification of Fee Authority.--Section 33(b) of 
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(b)) is amended--
          (1) in paragraph (2)--
                  (A) in the heading, by striking ``pesticide 
                registration''; and
                  (B) in subparagraph (A), by inserting ``or for any 
                other action covered by a table specified in paragraph 
                (3)'' after ``covered by this Act that is received by 
                the Administrator on or after the effective date of the 
                Pesticide Registration Improvement Act of 2003'';
          (2) in paragraph (5)--
                  (A) in the heading, by striking ``pesticide 
                registration applications'' and inserting ``covered 
                application''; and
                  (B) by striking ``pesticide registration 
                application'' both places it appears and inserting 
                ``covered application'';
          (3) in paragraph (6)--
                  (A) in subparagraph (A)--
                          (i) by striking ``pesticide registration''; 
                        and
                          (ii) by striking ``October 1, 2013, and 
                        ending on September 30, 2015'' and inserting 
                        ``October 1, 2019, and ending on September 30, 
                        2021'';
                  (B) in subparagraph (B)--
                          (i) by striking ``pesticide registration''; 
                        and
                          (ii) by striking ``2015'' both places it 
                        appears, and inserting ``2021''; and
                  (C) in subparagraph (C), by striking ``revised 
                registration service fee schedules'' and inserting 
                ``service fee schedules revised pursuant to this 
                paragraph'';
          (4) in paragraph (7)--
                  (A) in subparagraph (A)--
                          (i) by striking ``covered pesticide 
                        registration'' and inserting ``covered 
                        application''; and
                          (ii) by inserting before the period at the 
                        end the following: ``, except that no waiver or 
                        fee reduction shall be provided in connection 
                        with a request for a letter of certification 
                        (commonly referred to as a Gold Seal letter)''; 
                        and
                  (B) in subparagraph (F)(i), by striking ``pesticide 
                registration''; and
          (5) in paragraph (8)--
                  (A) in subparagraph (A), by striking ``pesticide 
                registration'';
                  (B) in subparagraph (B)(i), by striking ``pesticide 
                registration''; and
                  (C) in subparagraph (C)--
                          (i) in clause (i), by striking ``pesticide 
                        registration'' and inserting ``covered''; and
                          (ii) in clause (ii)(I), by striking 
                        ``pesticide registration'' and inserting 
                        ``covered''.
  (b) Pesticide Registration Fund Set-asides for Worker Protection, 
Partnership Grants, and Pesticide Safety Education.--Section 
33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136w-8(c)(3)(B)) is amended--
          (1) in the heading, by inserting ``, partnership grants, and 
        pesticide safety education'' after ``Worker protection'';
          (2) in clause (i)--
                  (A) by striking ``2017'' and inserting ``2023''; and
                  (B) by inserting before the period at the end the 
                following: ``, with an emphasis on field-worker 
                populations in the United States'';
          (3) in clause (ii), by striking ``2017'' and inserting 
        ``2023''; and
          (4) in clause (iii), by striking ``2017'' and inserting 
        ``2023''.
  (c) Reforms to Reduce Decision Time Review Periods.--Section 33(e) of 
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(e)) is amended--
          (1) by striking ``Pesticide Registration Improvement 
        Extension Act of 2012'' and inserting ``Pesticide Registration 
        Enhancement Act of 2017''; and
          (2) by inserting at the end the following new sentence: 
        ``Such reforms shall include identifying opportunities for 
        streamlining review processes for applications for a new active 
        ingredient or a new use and providing prompt feedback to 
        applicants during such review process.''.
  (d) Decision Time Review Periods.--Section 33(f) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)(1)) is 
amended--
          (1) in paragraph (1)--
                  (A) by striking ``Pesticide Registration Improvement 
                Extension Act of 2012'' and inserting ``Pesticide 
                Registration Enhancement Act of 2017''; and
                  (B) by inserting after ``covered pesticide 
                registration actions'' the following: ``or for any 
                other action covered by a table specified in subsection 
                (b)(3)'';
          (2) in paragraph (3), by striking subparagraph (C) and 
        inserting the following new subparagraph:
                  ``(C) applications for any other action covered by a 
                table specified in subsection (b)(3).''; and
          (3) in paragraph (4)(A)--
                  (A) by striking ``a pesticide registration 
                application'' and inserting ``a covered application''; 
                and
                  (B) by striking ``covered pesticide registration 
                application'' and inserting ``covered application''.
  (e) Reporting Requirements.--Section 33(k) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is 
amended--
          (1) in paragraph (1) by striking ``2017'' and inserting 
        ``2023''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (D), by striking clause (i) and 
                inserting the following new clause:
                          ``(i) the number of pesticides or pesticide 
                        cases reviewed and the number of registration 
                        review decisions completed, including--
                                  ``(I) the number of cases cancelled;
                                  ``(II) the number of cases requiring 
                                risk mitigation measures;
                                  ``(III) the number of cases removing 
                                risk mitigation measures;
                                  ``(IV) the number of cases with no 
                                risk mitigation needed; and
                                  ``(V) the number of cases in which 
                                risk mitigation has been fully 
                                implemented;'';
                  (B) in subparagraph (G)--
                          (i) in clause (i)--
                                  (I) by striking ``section 4(k)(4)'' 
                                and inserting ``paragraphs (4) and (5) 
                                of section 4(k)''; and
                                  (II) by striking ``that section'' and 
                                inserting ``such paragraphs'';
                          (ii) by striking clauses (ii), (iii), (iv), 
                        (v), and (vi);
                          (iii) by inserting after clause (i) the 
                        following new clause:
                          ``(ii) implementing enhancements to--
                                  ``(I) the electronic tracking of 
                                covered applications;
                                  ``(II) the electronic tracking of 
                                conditional registrations;
                                  ``(III) the endangered species 
                                database;
                                  ``(IV) the electronic review of 
                                labels submitted with covered 
                                applications; and
                                  ``(V) the electronic review and 
                                assessment of confidential statements 
                                of formula submitted with covered 
                                applications; and''; and
                          (iv) by redesignating clause (vii) as clause 
                        (iii);
                  (C) in subparagraph (I), by striking ``and'' at the 
                end;
                  (D) in subparagraph (J), by striking the period at 
                the end and inserting a semicolon; and
                  (E) by adding at the end the following new 
                subparagraphs:
                  ``(K) a review of the progress made in developing, 
                updating, and implementing product performance test 
                guidelines for pesticide products that are intended to 
                control invertebrate pests of significant public health 
                importance and, by regulation, prescribing product 
                performance data requirements for such pesticide 
                products registered under section 3;
                  ``(L) a review of the progress made in the priority 
                review and approval of new pesticides to control 
                vector-born public health pests for use in the United 
                States, including each territory or possession of the 
                United States, and United States military installations 
                globally;
                  ``(M) a review of the progress made in implementing 
                enhancements to the good laboratory practices standards 
                compliance monitoring program established under part 
                160 of title 40 of the Code of Federal Regulations (or 
                successor regulations);
                  ``(N) the number of approvals for active ingredients, 
                new uses, and pesticide end use products granted in 
                connection with the Design for the Environment program 
                (or any successor program) of the Environmental 
                Protection Agency; and
                  ``(O) with respect to funds in the Pesticide 
                Registration Fund reserved under subsection (c)(3), a 
                review that includes--
                          ``(i) a description of the amount and use of 
                        such funds--
                                  ``(I) to carry out activities 
                                relating to worker protection under 
                                clause (i) of subsection (c)(3)(B);
                                  ``(II) to award partnership grants 
                                under clause (ii) of such subsection; 
                                and
                                  ``(III) to carry out the pesticide 
                                safety education program under clause 
                                (iii) of such subsection;
                          ``(ii) an evaluation of the appropriateness 
                        and effectiveness of the activities, grants, 
                        and program described in clause (i);
                          ``(iii) a description of how stakeholders are 
                        engaged in the decision to fund such 
                        activities, grants, and program; and
                          ``(iv) with respect to activities relating to 
                        worker protection carried out under 
                        subparagraph (B)(i) of such subsection, a 
                        summary of the analyses from stakeholders, 
                        including from worker community-based 
                        organizations, on the appropriateness and 
                        effectiveness of such activities.''.
  (f) Termination of Effectiveness.--Section 33(m) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is 
amended--
          (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2023''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (A)--
                          (i) by striking ``Fiscal year 2018.--During 
                        fiscal year 2018'' and inserting ``Fiscal year 
                        2024.--During fiscal year 2024''; and
                          (ii) by striking ``2017'' and inserting 
                        ``2023'';
                  (B) in subparagraph (B)--
                          (i) by striking ``Fiscal year 2019.--During 
                        fiscal year 2019'' and inserting ``Fiscal year 
                        2025.--During fiscal year 2025''; and
                          (ii) by striking ``2017'' and inserting 
                        ``2023'';
                  (C) in subparagraph (C), by striking ``September 30, 
                2019.--Effective September 30, 2019'' and inserting 
                ``September 30, 2025.--Effective September 30, 2025''; 
                and
                  (D) in subparagraph (D), by striking ``2017'' both 
                places it appears and inserting ``2023''.

SEC. 6. REVISION OF TABLES REGARDING COVERED PESTICIDE REGISTRATION 
                    APPLICATIONS AND OTHER COVERED ACTIONS AND THEIR 
                    CORRESPONDING REGISTRATION SERVICE FEES.

  Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended to read as follows:
          ``(3) Schedule of covered applications and other actions and 
        their registration service fees.--Subject to paragraph (6), the 
        schedule of registration applications and other covered actions 
        and their corresponding registration service fees shall be as 
        follows:

                          ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      R010           1   New Active Ingredient, Food use.        24                                     753,082
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R020           2   New Active Ingredient, Food use;        18                                     627,568
                          reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R040           3   New Active Ingredient, Food use;        18                                     462,502
                          Experimental Use Permit application;
                          establish temporary tolerance;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
      R060           4   New Active Ingredient, Non-food use;    21                                     523,205
                          outdoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R070           5   New Active Ingredient, Non-food use;    16                                     436,004
                          outdoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R090           6   New Active Ingredient, Non-food use;    16                                     323,690
                          outdoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R110           7   New Active Ingredient, Non-food use;    20                                     290,994
                          indoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R120           8   New Active Ingredient, Non-food use;    14                                     242,495
                          indoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R121           9   New Active Ingredient, Non-food use;    18                                     182,327
                          indoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R122          10   Enriched isomer(s) of registered mixed- 18                                     317,128
                          isomer active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R123          11   New Active Ingredient, Seed treatment   18                                     471,861
                          only; includes agricultural and non-
                          agricultural seeds; residues not
                          expected in raw agricultural
                          commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R125          12   New Active Ingredient, Seed treatment;  16                                    323,690
                          Experimental Use Permit application;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      R130          13   First food use; indoor; food/food       21                                     191,444
                          handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R140          14   Additional food use; Indoor; food/food  15                                      44,672
                          handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R150          15   First food use. (2)(3)                  21                                     317,104
----------------------------------------------------------------------------------------------------------------
      R155    16 (new)   First food use, Experimental Use        21                                     264,253
                          Permit application; a.i. registered
                          for non-food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R160          17   First food use; reduced risk. (2)(3)    16                                     264,253
----------------------------------------------------------------------------------------------------------------
      R170          18   Additional food use. (3) (4)            15                                      79,349
----------------------------------------------------------------------------------------------------------------
      R175          19   Additional food uses covered within a   10                                      66,124
                          crop group resulting from the
                          conversion of existing approved crop
                          group(s) to one or more revised crop
                          groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R180          20   Additional food use; reduced risk.      10                                      66,124
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      R190          21   Additional food uses; 6 or more         15                                     476,090
                          submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R200          22   Additional Food Use; 6 or more          10                                     396,742
                          submitted in one application; Reduced
                          Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R210          23   Additional food use; Experimental Use   12                                      48,986
                          Permit application; establish
                          temporary tolerance; no credit toward
                          new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R220          24   Additional food use; Experimental Use   6                                       19,838
                          Permit application; crop destruct
                          basis; no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R230          25   Additional use; non-food; outdoor. (3)  15                                      31,713
                          (4)
----------------------------------------------------------------------------------------------------------------
      R240          26   Additional use; non-food; outdoor;      10                                      26,427
                          reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R250          27   Additional use; non-food; outdoor;      6                                       19,838
                          Experimental Use Permit application;
                          no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R251          28   Experimental Use Permit application     8                                       19,838
                          which requires no changes to the
                          tolerance(s); non-crop destruct
                          basis. (3)
----------------------------------------------------------------------------------------------------------------
      R260          29   New use; non-food; indoor. (3) (4)      12                                      15,317
----------------------------------------------------------------------------------------------------------------
      R270          30   New use; non-food; indoor; reduced      9                                       12,764
                          risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R271          31   New use; non-food; indoor;              6                                        9,725
                          Experimental Use Permit application;
                          no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R273          32   Additional use; seed treatment;         12                                      50,445
                          limited uptake into Raw Agricultural
                          Commodities; includes crops with
                          established tolerances (e.g., for
                          soil or foliar application); includes
                          food and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R274          33   Additional uses; seed treatment only;   12                                    302,663
                          6 or more submitted in one
                          application; limited uptake into raw
                          agricultural commodities; includes
                          crops with established tolerances
                          (e.g., for soil or foliar
                          application); includes food and/or
                          non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


                       ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      R280          34   Establish import tolerance; new active  21                                     319,072
                          ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
      R290          35   Establish Import tolerance; Additional  15                                      63,816
                          new food use.
----------------------------------------------------------------------------------------------------------------
      R291          36   Establish import tolerances;            15                                     382,886
                          additional food uses; 6 or more crops
                          submitted in one petition.
----------------------------------------------------------------------------------------------------------------
      R292          37   Amend an established tolerance (e.g.,   11                                      45,341
                          decrease or increase) and/or
                          harmonize established tolerances with
                          Codex MRLs; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R293          38   Establish tolerance(s) for inadvertent  12                                      53,483
                          residues in one crop; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R294          39   Establish tolerances for inadvertent    12                                     320,894
                          residues; 6 or more crops submitted
                          in one application; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R295          40   Establish tolerance(s) for residues in  15                                      66,124
                          one rotational crop in response to a
                          specific rotational crop application;
                          submission of corresponding label
                          amendments which specify the
                          necessary plant-back restrictions;
                          applicant-initiated. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R296          41   Establish tolerances for residues in    15                                     396,742
                          rotational crops in response to a
                          specific rotational crop petition; 6
                          or more crops submitted in one
                          application; submission of
                          corresponding label amendments which
                          specify the necessary plant-back
                          restrictions; applicant-initiated.
                          (3) (4)
----------------------------------------------------------------------------------------------------------------
      R297          42   Amend 6 or more established tolerances  11                                     272,037
                          (e.g., decrease or increase) in one
                          petition; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R298          43   Amend an established tolerance (e.g.,   13                                      58,565
                          decrease or increase); domestic or
                          import; submission of corresponding
                          amended labels (requiring science
                          review). (3) (4)
----------------------------------------------------------------------------------------------------------------
      R299          44   Amend 6 or more established tolerances  13                                    285,261
                          (e.g., decrease or increase);
                          domestic or import; submission of
                          corresponding amended labels
                          (requiring science review). (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
  base fee for the category. All items in the covered application must be submitted together in one package.
  Each application for an additional new product registration and new inert approval(s) that is submitted in the
  amendment application package is subject to the registration service fee for a new product or a new inert
  approval. However, if an amendment application only proposes to register the amendment for a new product and
  there are no amendments in the application, then review of one new product application is covered by the base
  fee. All such associated applications that are submitted together will be subject to the category decision
  review time.


                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
            New  CR                                        Decision  Review Time     FY'17 & FY'18 Registration
 EPA  No.     No.                   Action                      (Months)(1)               Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
    R300         45   New product; or similar            4                         1,582
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient; no
                       data review on acute toxicity,
                       efficacy or CRP - only product
                       chemistry data; cite-all data
                       citation, or selective data
                       citation where applicant owns
                       all required data, or applicant
                       submits specific authorization
                       letter from data owner. Category
                       also includes 100% re-package of
                       registered end-use or
                       manufacturing-use product that
                       requires no data submission nor
                       data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R301         46   New product; or similar            4                         1,897
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient;
                       selective data citation only for
                       data on product chemistry and/or
                       acute toxicity and/or public
                       health pest efficacy (identical
                       data citation and claims to
                       cited product(s)), where
                       applicant does not own all
                       required data and does not have
                       a specific authorization letter
                       from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R310         47   New end-use or manufacturing-use   7                         7,301
                       product with registered
                       source(s) of active
                       ingredient(s); includes products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R314         48   New end use product containing up  8                         8,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R319         49   New end use product containing up  10                        12,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R318   50 (new)   New end use product containing     9                         13,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R321   51 (new)   New end use product containing     11                        17,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R315         52   New end-use, on-animal product,    9                         9,820
                       registered source of active
                       ingredient(s), with the
                       submission of data and/or
                       waivers for only:
                       animal safety and
                       pest(s) requiring
                       efficacy (4) and/or
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------
    R316   53 (new)   New end-use or manufacturing       9                         11,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; and
                       requires review of data and/or
                       waivers for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for greater than
                       3 and up to 7 target pests.
                       (2)(3)
----------------------------------------------------------------------------------------------------------------
    R317   54 (new)   New end-use or manufacturing       10                        15,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing 2 or more registered
                       active ingredients previously
                       combined in other registered
                       products; excludes products
                       requiring or citing an animal
                       safety study; and requires
                       review of data and/or waivers
                       for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for greater than
                       7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R320         55   New product; new physical form;    12                        13,226
                       requires data review in science
                       divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R331         56   New product; repack of identical   3                         2,530
                       registered end-use product as a
                       manufacturing-use product, or
                       identical registered
                       manufacturing-use product as an
                       end use product; same registered
                       uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R332         57   New manufacturing-use product;     24                        283,215
                       registered active ingredient;
                       unregistered source of active
                       ingredient; submission of
                       completely new generic data
                       package; registered uses only;
                       requires review in RD and
                       science divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R333         58   New product; MUP or End use        10                        19,838
                       product with unregistered source
                       of active ingredient; requires
                       science data review; new
                       physical form; etc. Cite-all or
                       selective data citation where
                       applicant owns all required
                       data. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R334         59   New product; MUP or End use        11                        23,100
                       product with unregistered source
                       of the active ingredient;
                       requires science data review;
                       new physical form; etc.
                       Selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


                                ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
            New  CR                                                   Decision Review  Time        Registration
 EPA  No.     No.                       Action                             (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
    R340        60   Amendment requiring data review within RD    4                                       4,988
                      (e.g., changes to precautionary label
                      statements); includes adding/modifying
                      pest(s) claims for up to 2 target pests,
                      excludes products requiring or citing an
                      animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R341   61 (New)  Amendment requiring data review within RD    6                                       5,988
                      (e.g., changes to precautionary label
                      statements), includes adding/modifying
                      pest(s) claims for greater than 2 target
                      pests, excludes products requiring or
                      citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R345        62   Amending on-animal products previously       7                                       8,820
                      registered, with the submission of data
                      and/or waivers for only:
                      animal safety and
                      pest(s) requiring efficacy (4) and/
                      or
                      product chemistry and/or
                      acute toxicity and/or
                       child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R350        63   Amendment requiring data review in science   9                                      13,226
                      divisions (e.g., changes to REI, or PPE,
                      or PHI, or use rate, or number of
                      applications; or add aerial application;
                      or modify GW/SW advisory statement).
                      (2)(3)
----------------------------------------------------------------------------------------------------------------
    R351        64   Amendment adding a new unregistered source   8                                      13,226
                      of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R352        65   Amendment adding already approved uses;      8                                      13,226
                      selective method of support; does not
                      apply if the applicant owns all cited
                      data. (2) (3)
----------------------------------------------------------------------------------------------------------------
    R371        66   Amendment to Experimental Use Permit; (does  6                                     10,090
                      not include extending a permit's time
                      period). (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


                              ``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                 Decision Review  Time        Registration
 EPA  No.       No.                      Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
     R124          67   Conditional Ruling on Pre-application    6                                        2,530
                         Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
     R272          68   Review of Study Protocol applicant-      3                                        2,530
                         initiated; excludes DART, pre-
                         registration conference, Rapid
                         Response review, DNT protocol review,
                         protocol needing HSRB review.
----------------------------------------------------------------------------------------------------------------
     R275          69   Rebuttal of agency reviewed protocol,    3                                        2,530
                         applicant initiated.
----------------------------------------------------------------------------------------------------------------
     R370          70   Cancer reassessment; applicant-          18                                    198,250
                         initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
  EPA  No.      No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A380         71   New Active Ingredient; Indirect Food use;  24                                   137,841
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A390         72   New Active Ingredient; Direct Food use;    24                                   229,733
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A410         73   New Active Ingredient Non-food use.(2)(3)  21                                   229,733
----------------------------------------------------------------------------------------------------------------
      A431         74   New Active Ingredient, Non-food use; low-  12                                   80,225
                         risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                ``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
                             New  CR                                     Decision  Review Time     Registration
         EPA  No.              No.                  Action                    (Months)(1)          Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
A440                               75   New Use, Indirect Food Use,    21                                31,910
                                         establish tolerance or
                                         tolerance exemption.
                                         (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A441                               76   Additional Indirect food       21                               114,870
                                         uses; establish tolerances
                                         or tolerance exemptions if
                                         required; 6 or more
                                         submitted in one
                                         application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A450                               77   New use, Direct food use,      21                                95,724
                                         establish tolerance or
                                         tolerance exemption.
                                         (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A451                               78   Additional Direct food uses;   21                               182,335
                                         establish tolerances or
                                         tolerance exemptions if
                                         required; 6 or more
                                         submitted in one
                                         application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A500                               79   New use, non-food. (4)(5)      12                                31,910
----------------------------------------------------------------------------------------------------------------
A501                               80   New use, non-food; 6 or more   15                               76,583
                                         submitted in one
                                         application. (4)(5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


                      ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A530          81    New product, identical or              4                                        1,278
                          substantially similar in composition
                          and use to a registered product; no
                          data review or only product chemistry
                          data; cite all data citation or
                          selective data citation where
                          applicant owns all required data; or
                          applicant submits specific
                          authorization letter from data owner.
                          Category also includes 100% re-
                          package of registered end-use or
                          manufacturing use product that
                          requires no data submission nor data
                          matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A531          82    New product; identical or              4                                        1,824
                          substantially similar in composition
                          and use to a registered product;
                          registered source of active
                          ingredient: selective data citation
                          only for data on product chemistry
                          and/or acute toxicity and/or public
                          health pest efficacy, where applicant
                          does not own all required data and
                          does not have a specific
                          authorization letter from data owner.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      A532          83   New product; identical or               5                                        5,107
                          substantially similar in composition
                          and use to a registered product;
                          registered active ingredient;
                          unregistered source of active
                          ingredient; cite-all data citation
                          except for product chemistry; product
                          chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A540          84    New end use product; FIFRA Sec. 2(mm)  5                                        5,107
                          uses only; up to 25 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A541    85 (new)    New end use product; FIFRA Sec. 2(mm)  7                                        8,500
                          uses only; 26-50 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A542    86 (new)    New end use product; FIFRA Sec. 2(mm)  10                                      15,000
                          uses only; = 51 public health
                          organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A550          87    New end-use product; uses other than   9                                       13,226
                          FIFRA Sec. 2(mm); non-FQPA product.
                          (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A560          88    New manufacturing use product;         6                                       12,596
                          registered active ingredient;
                          selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A565    89 (new)    New manufacturing-use product;         12                                      18,234
                          registered active ingredient;
                          unregistered source of active
                          ingredient; submission of new generic
                          data package; registered uses only;
                          requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A570          90    Label amendment requiring data         4                                        3,831
                          review; up to 25 public health
                          organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A573    91 (new)    Label amendment requiring data         6                                        6,350
                          review; 26-50 public health
                          organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A574    92 (new)    Label amendment requiring data         9                                       11,000
                          review; = 51 public health organisms.
                          (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A572          93   New Product or amendment requiring      9                                      13,226
                          data review for risk assessment by
                          Science Branch (e.g., changes to REI,
                          or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
  method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number or organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number or organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.


              ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A520          94    Experimental Use Permit application,   9                                        6,383
                          non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      A521          95   Review of public health efficacy study  4                                        4,726
                          protocol within AD, per AD Internal
                          Guidance for the Efficacy Protocol
                          Review Process; Code will also
                          include review of public health
                          efficacy study protocol and data
                          review for devices making pesticidal
                          claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
      A522          96    Review of public health efficacy       12                                      12,156
                          study protocol outside AD by members
                          of AD Efficacy Protocol Review Expert
                          Panel; Code will also include review
                          of public health efficacy study
                          protocol and data review for devices
                          making pesticidal claims; applicant-
                          initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
      A537    97 (new)    New Active Ingredient/New Use,         18                                     153,156
                          Experimental Use Permit application;
                          Direct food use; Establish tolerance
                          or tolerance exemption if required.
                          Credit 45% of fee toward new active
                          ingredient/new use application that
                          follows.
----------------------------------------------------------------------------------------------------------------
      A538    98 (new)    New Active Ingredient/New Use,         18                                      95,724
                          Experimental Use Permit application;
                          Indirect food use; Establish
                          tolerance or tolerance exemption if
                          required Credit 45% of fee toward new
                          active ingredient/new use application
                          that follows.
----------------------------------------------------------------------------------------------------------------
      A539    99 (new)    New Active Ingredient/New Use,         15                                      92,163
                          Experimental Use Permit application;
                          Nonfood use. Credit 45% of fee toward
                          new active ingredient/new use
                          application that follows.
----------------------------------------------------------------------------------------------------------------
      A529         100    Amendment to Experimental Use Permit;  9                                       11,429
                          requires data review or risk
                          assessment. (2)
----------------------------------------------------------------------------------------------------------------
      A523         101    Review of protocol other than a        9                                       12,156
                          public health efficacy study (i.e.,
                          Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
      A571         102    Science reassessment: Cancer risk,     18                                      95,724
                          refined ecological risk, and/or
                          endangered species; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      A533   103 (new)   Exemption from the requirement of an    4                                        2,482
                          Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------
      A534   104 (new)    Rebuttal of agency reviewed protocol,  4                                        4,726
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      A535   105 (new)    Conditional Ruling on Pre-application  6                                        2,409
                          Study Waiver or Data Bridging
                          Argument; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      A536   106 (new)   Conditional Ruling on Pre-application   4                                       2,482
                          Direct Food, Indirect Food, Nonfood
                          use determination; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                         ``TABLE 11. -- BIOPESTICIDES DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B580         107   New active ingredient; food use;        20                                      51,053
                          petition to establish a tolerance.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B590         108    New active ingredient; food use;       18                                      31,910
                          petition to establish a tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B600         109    New active ingredient; non-food use.   13                                      19,146
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B610         110    New active ingredient; Experimental    10                                      12,764
                          Use Permit application; petition to
                          establish a temporary tolerance or
                          temporary tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B611         111    New active ingredient; Experimental    12                                      12,764
                          Use Permit application; petition to
                          establish permanent tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B612         112    New active ingredient; no change to a  10                                      17,550
                          permanent tolerance exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B613         113    New active ingredient; petition to     11                                      17,550
                          convert a temporary tolerance or a
                          temporary tolerance exemption to a
                          permanent tolerance or tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B620         114    New active ingredient; Experimental    7                                       6,383
                          Use Permit application; non-food use
                          including crop destruct. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                ``TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B630         115    First food use; petition to establish  13                                      12,764
                          a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B631         116    New food use; petition to amend an     12                                      12,764
                          established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
      B640         117   First food use; petition to establish   19                                      19,146
                          a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B643         118   New Food use; petition to amend an      10                                      12,764
                          established tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B642         119   First food use; indoor; food/food       12                                      31,910
                          handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B644         120   New use, no change to an established    8                                       12,764
                          tolerance or tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B650         121   New use; non-food. (3)(4)               7                                        6,383
----------------------------------------------------------------------------------------------------------------
      B645   122 (new)    New food use; Experimental Use Permit  12                                      12,764
                          application; petition to amend or add
                          a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
      B646   123 (new)   New use; non-food use including crop    7                                       6,383
                          destruct; Experimental Use Permit
                          application. (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                              ``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
 EPA  No.       No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
     B652         124   New product; registered source of active   13                                    12,764
                         ingredient; requires petition to amend
                         established tolerance or tolerance
                         exemption; requires 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of scientifically-
                         sound rationale based on publicly
                         available literature or other relevant
                         information that addresses the data
                         requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B660         125    New product; registered source of active  4                                      1,278
                         ingredient(s); identical or
                         substantially similar in composition and
                         use to a registered product. No data
                         review, or only product chemistry data;
                         cite-all data citation, or selective
                         data citation where applicant owns all
                         required data or authorization from data
                         owner is demonstrated. Category includes
                         100% re-package of registered end-use or
                         manufacturing-use product that requires
                         no data submission or data matrix. For
                         microbial pesticides, the active
                         ingredient(s) must not be re-isolated.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------
     B670         126    New product; registered source of active  7                                      5,107
                         ingredient(s); requires: 1) submission
                         of product specific data; or 2) citation
                         of previously reviewed and accepted
                         data; or 3) submission or citation of
                         data generated at government expense; or
                         4) submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B671         127    New product; unregistered source of       17                                    12,764
                         active ingredient(s); requires a
                         petition to amend an established
                         tolerance or tolerance exemption;
                         requires: 1) submission of product
                         specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B672         128    New product; unregistered source of       13                                     9,118
                         active ingredient(s); non-food use or
                         food use requires: 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B673         129    New product MUP/EP; unregistered source   10                                     5,107
                         of active ingredient(s); citation of
                         Technical Grade Active Ingredient (TGAI)
                         data previously reviewed and accepted by
                         the Agency. Requires an Agency
                         determination that the cited data
                         supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B674         130    New product MUP; Repack of identical      4                                      1,278
                         registered end-use product as a
                         manufacturing-use product; same
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B675         131    New Product MUP; registered source of     10                                     9,118
                         active ingredient; submission of
                         completely new generic data package;
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B676         132    New product; more than one active         13                                     9,118
                         ingredient where one active ingredient
                         is an unregistered source; product
                         chemistry data must be submitted;
                         requires: 1) submission of product
                         specific data, and 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B677         133   New end-use non-food animal product with   10                                    8,820
                         submission of two or more target animal
                         safety studies; includes data and/or
                         waivers of data for only:
                         product chemistry and/or
                         acute toxicity and/or
                         public health pest efficacy and/
                         or
                         animal safety studies and/or
                         child resistant packaging.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                               ``TABLE 14. -- BIOPESTICIDES DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                 Decision  Review Time       Registration
  EPA  No.       No.                       Action                           (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B621         134   Amendment; Experimental Use Permit; no     7                                     5,107
                          change to an established temporary
                          tolerance or tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B622         135   Amendment; Experimental Use Permit;        11                                   12,764
                          petition to amend an established or
                          temporary tolerance or tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B641         136   Amendment of an established tolerance or   13                                   12,764
                          tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B680         137    Amendment; registered sources of active   5                                     5,107
                          ingredient(s); no new use(s); no changes
                          to an established tolerance or tolerance
                          exemption. Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B681         138    Amendment; unregistered source of active  7                                     6,079
                          ingredient(s). Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B683         139    Label amendment; requires review/update   6                                     5,107
                          of previous risk assessment(s) without
                          data submission (e.g., labeling changes
                          to REI, PPE, PHI). (2)(3)
----------------------------------------------------------------------------------------------------------------
      B684         140    Amending non-food animal product that     8                                     8,820
                          includes submission of target animal
                          safety data; previously registered.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B685   141 (new)    Amendment; add a new biochemical          5                                    5,107
                          unregistered source of active ingredient
                          or a new microbial production site.
                          Requires submission of analysis of
                          samples data and source/production site-
                          specific manufacturing process
                          description. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                  ``TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B690         142   New active ingredient; food or non-     7                                        2,554
                          food use. (2)(6)
----------------------------------------------------------------------------------------------------------------
      B700         143    Experimental Use Permit application;   7                                        1,278
                          new active ingredient or new use. (6)
----------------------------------------------------------------------------------------------------------------
      B701         144    Extend or amend Experimental Use       4                                        1,278
                          Permit. (6)
----------------------------------------------------------------------------------------------------------------
      B710         145    New product; registered source of      4                                        1,278
                          active ingredient(s); identical or
                          substantially similar in composition
                          and use to a registered product; no
                          change in an established tolerance or
                          tolerance exemption. No data review,
                          or only product chemistry data; cite-
                          all data citation, or selective data
                          citation where applicant owns all
                          required data or authorization from
                          data owner is demonstrated. Category
                          includes 100% re-package of
                          registered end-use or manufacturing-
                          use product that requires no data
                          submission or data matrix. (3)(6)
----------------------------------------------------------------------------------------------------------------
      B720         146    New product; registered source of      5                                        1,278
                          active ingredient(s); requires: 1)
                          submission of product specific data;
                          or 2) citation of previously reviewed
                          and accepted data; or 3) submission
                          or citation of data generated at
                          government expense; or 4) submission
                          or citation of a scientifically-sound
                          rationale based on publicly available
                          literature or other relevant
                          information that addresses the data
                          requirement; or 5) submission of a
                          request for a data requirement to be
                          waived supported by a scientifically-
                          sound rationale explaining why the
                          data requirement does not apply.
                          (3)(6)
----------------------------------------------------------------------------------------------------------------
      B721         147    New product; unregistered source of    7                                        2,676
                          active ingredient. (3)(6)
----------------------------------------------------------------------------------------------------------------
      B722         148   New use and/or amendment; petition to   7                                        2,477
                          establish a tolerance or tolerance
                          exemption. (4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      B730         149   Label amendment requiring data          5                                       1,278
                          submission. (4)(6)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                             ``TABLE 16. -- BIOPESTICIDES DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B614         150   Pre-application; Conditional Ruling on  3                                        2,530
                          rationales for addressing a data
                          requirement in lieu of data;
                          applicant-initiated; applies to one
                          rationale at a time.
----------------------------------------------------------------------------------------------------------------
      B615         151   Rebuttal of agency reviewed protocol,   3                                        2,530
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      B682         152   Protocol review; applicant initiated;   3                                       2,432
                          excludes time for HSRB review.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


                                  ``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
             New  CR                                                   Decision  Review Time       Registration
  EPA  No.      No.                      Action                             (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B740      153   Experimental Use Permit application; no      6                                     95,724
                       petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP (12);
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct (12);
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
      B741      154   Experimental Use Permit application; no      12                                   159,538
              (new)    petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP;
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct;
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s);
                      SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
      B750      155   Experimental Use Permit application; with a  9                                    127,630
                       petition to establish a temporary or
                       permanent tolerance/tolerance exemption
                       for the active ingredient. Includes new
                       food/feed use for a registered (3) PIP.
                       (4)(12)
----------------------------------------------------------------------------------------------------------------
      B770      156   Experimental Use Permit application; new     15                                   191,444
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows;
                       SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B771      157   Experimental Use Permit application; new     10                                   127,630
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows.
                       (12)
----------------------------------------------------------------------------------------------------------------
      B772      158   Application to amend or extend an            3                                     12,764
                       Experimental Use Permit; no petition since
                       the established tolerance/tolerance
                       exemption for the active ingredient is
                       unaffected. (12)
----------------------------------------------------------------------------------------------------------------
      B773      159   Application to amend or extend an            5                                     31,910
                       Experimental Use Permit; with petition to
                       extend a temporary tolerance/tolerance
                       exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B780      160   Registration application; new (2) PIP; non-  12                                   159,537
                       food/feed. (12)
----------------------------------------------------------------------------------------------------------------
      B790      161   Registration application; new (2) PIP; non-  18                                   223,351
                       food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B800      162   Registration application; new (2) PIP; with  13                                   172,300
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------
      B810      163   Registration application; new (2) PIP; with  19                                   236,114
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. SAP review.
                       (5)(12)
----------------------------------------------------------------------------------------------------------------
      B820      164   Registration application; new (2) PIP; with  15                                   204,208
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B840      165   Registration application; new (2) PIP; with  21                                   268,022
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B851      166   Registration application; new event of a     9                                    127,630
                       previously registered PIP active
                       ingredient(s); no petition since permanent
                       tolerance/tolerance exemption is already
                       established for the active ingredient(s).
                       (12)
----------------------------------------------------------------------------------------------------------------
      B870      167   Registration application; registered (3)     9                                     38,290
                       PIP; new product; new use; no petition
                       since a permanent tolerance/tolerance
                       exemption is already established for the
                       active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
      B880      168   Registration application; registered (3)     9                                     31,910
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
      B881      169   Registration application; registered (3)     15                                    95,724
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). SAP review.
                       (5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
      B882      170   Registration application; new (2) PIP, seed  15                                   191,444
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption; SAP Review.
                       (8)(12)
----------------------------------------------------------------------------------------------------------------
      B883      171   Registration application; new (2) PIP, seed  9                                    127,630
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B884      172   Registration application; new (2) PIP, seed  12                                   159,537
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B885      173   Registration application; registered (3)     6                                     31,910
                       PIP, seed increase; breeding stack of
                       previously approved PIPs, same crop; no
                       petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
      B886      174   Registration application; new (2) PIP, seed  18                                   223,351
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B890      175   Application to amend a seed increase         9                                     63,816
                       registration; converts registration to
                       commercial registration; no petition since
                       permanent tolerance/tolerance exemption is
                       already established for the active
                       ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B891      176   Application to amend a seed increase         15                                   127,630
                       registration; converts registration to a
                       commercial registration; no petition since
                       a permanent tolerance/tolerance exemption
                       already established for the active
                       ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B900      177   Application to amend a registration,         6                                     12,764
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled.
                       (10)(11)(12)
----------------------------------------------------------------------------------------------------------------
      B901      178   Application to amend a registration,         12                                    76,578
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled. SAP
                       review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
      B902      179   PIP Protocol review.                         3                                      6,383
----------------------------------------------------------------------------------------------------------------
      B903      180   Inert ingredient tolerance exemption; e.g.,  6                                     63,816
                       a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
      B904      181   Import tolerance or tolerance exemption;     9                                    127,630
                       processed commodities/food only (inert or
                       active ingredient).
----------------------------------------------------------------------------------------------------------------
      B905      182   SAP Review.                                  6                                     63,816
              (new)
----------------------------------------------------------------------------------------------------------------
      B906      183   Petition to establish a temporary tolerance/ 3                                     31,907
              (new)    tolerance exemption for one or more active
                       ingredients.
----------------------------------------------------------------------------------------------------------------
      B907      184   Petition to establish a temporary tolerance/ 3                                     12,764
              (new)    tolerance exemption for one or more active
                       ingredients based on an existing temporary
                       tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B908      185   Petition to establish a temporary tolerance/ 3                                    44,671
              (new)    tolerance exemption for one or more active
                       ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                        ``TABLE 18. -- INERT INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
  EPA  No.      No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      I001        186   Approval of new food use inert             13                                    27,000
                         ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      I002        187   Amend currently approved inert ingredient  11                                     7,500
                         tolerance or exemption from tolerance;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I003        188   Amend currently approved inert ingredient  9                                      3,308
                         tolerance or exemption from tolerance;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I004        189   Approval of new non-food use inert         6                                     11,025
                         ingredient. (2)
----------------------------------------------------------------------------------------------------------------
      I005        190   Amend currently approved non-food use      6                                      5,513
                         inert ingredient with new use pattern;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I006        191   Amend currently approved non-food use      3                                      3,308
                         inert ingredient with new use pattern;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I007        192   Approval of substantially similar non-     4                                      1,654
                         food use inert ingredients when original
                         inert is compositionally similar with
                         similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
      I008        193   Approval of new or amended polymer inert   5                                      3,749
                         ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
      I009        194   Approval of new or amended polymer inert   4                                      3,087
                         ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      I010        195   Petition to amend a single tolerance       6                                      1,654
                         exemption descriptor, or single non-food
                         use descriptor, to add = 10 CASRNs; no
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I011   196 (new)  Approval of new food use safener with      24                                   597,683
                         tolerance or exemption from tolerance.
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I012   197 (new)  Approval of new non-food use safener.      21                                   415,241
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I013   198 (new)  Approval of additional food use for        15                                    62,975
                         previously approved safener with
                         tolerance or exemption from tolerance.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I014   199 (new)  Approval of additional non-food use for    15                                    25,168
                         previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
      I015   200 (new)  Approval of new generic data for           24                                   269,728
                         previously approved food use safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I016   201 (new)  Approval of amendment(s) to tolerance and  13                                   55,776
                         label for previously approved safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.


                            ``TABLE 19. -- EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      M001         202   Study protocol requiring Human Studies  9                                        7,938
                          Review Board review as defined in 40
                          CFR Part 26 in support of an active
                          ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M002         203   Completed study requiring Human         9                                        7,938
                          Studies Review Board review as
                          defined in 40 CFR Part 26 in support
                          of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M003         204   External technical peer review of new   12                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of less than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M004         205   External technical peer review of new   18                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of greater than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M005         206   New Product: Combination, Contains a    9                                       22,050
                          combination of active ingredients
                          from a registered and/or unregistered
                          source; conventional, antimicrobial
                          and/or biopesticide. Requires
                          coordination with other regulatory
                          divisions to conduct review of data,
                          label and/or verify the validity of
                          existing data as cited. Only existing
                          uses for each active ingredient in
                          the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
      M006         207   Request for up to 5 letters of          1                                          277
                          certification (Gold Seal) for one
                          actively registered product (excludes
                          distributor products). (8)
----------------------------------------------------------------------------------------------------------------
      M007         208   Request to extend Exclusive Use of      12                                       5,513
                          data as provided by FIFRA Section
                          3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------
      M008         209   Request to grant Exclusive Use of data  15                                       1,654
                          as provided by FIFRA Section
                          3(c)(1)(F)(vi) for a minor use, when
                          a FIFRA Section 2(ll)(2)
                          determination is required.
----------------------------------------------------------------------------------------------------------------
      M009   210 (new)   Non-FIFRA Regulated Determination:      4                                        2,363
                          Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
      M010   211 (new)   Conditional ruling on pre-application,  4                                        2,363
                          product substantial similarity.
----------------------------------------------------------------------------------------------------------------
      M011   212 (new)   Label amendment to add the DfE logo;    4                                       3,648
                          requires data review; no other label
                          changes. (9)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
  applies to one registered product.
(9) This category includes amendments the sole purpose of which is to add DfE (or equivalent terms that do not
  use ``safe'' or derivatives of ``safe'') logos to a label. DfE is a voluntary program. A label bearing a DfE
  logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet
  objective, scientific criteria established and widely publicized by EPA.''.

                           Brief Explanation

    The Pesticide Registration Enhancement Act of 2017, H.R. 
1029, reauthorizes provisions in the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) that couple the 
collection of fees with specific decision review periods for 
pesticide registrations and maintenance activities.

                    Purpose and Need for Legislation

    The first derivation of this program, known as PRIA, was 
passed in 2003 to provide predictable timelines in the 
pesticide registration process and increase transparency 
between EPA and the registrant community.
    The original PRIA legislation updated the process for 
collecting maintenance fees and required EPA to conduct 
pesticide reviews in a specific timeframe. It also authorized a 
new type of fee--registration service fees--to defray costs 
associated with EPA review of applications for registering new 
pesticide active ingredients and products, adding new uses to 
existing pesticide registrations, establishing and amending 
tolerances, and amending pesticide labels. PRIA established a 
schedule outlining the fee amounts associated with each 
specific activity. It also promoted shorter decision review 
periods for reduced-risk applications.
    The current PRIA legislation expires on September 30, 2017. 
H.R. 1029 extends the Act with minor adjustments. It 
reauthorizes existing provisions for seven years, as opposed to 
the five year extensions in previous iterations of PRIA. The 
legislation provides two increases of 5% each on registration 
fees over the seven years. H.R. 1029 also provides a $500,000 
set aside for EPA to meet deadlines for efficacy guidelines for 
pesticides to combat bed bugs (which have shut down schools, 
hotels, dorms, and movie theaters), and crawling and flying 
insects, which will inform industry what efficacy tests are 
required. The bill increases maintenance fees to $31 million 
annually from 2017-2023 and provides increased funding for 
grant programs, promoting Good Laboratory Practices, and farm 
worker protection education. This iteration also sets the 
appropriations trigger level at 2012 budget levels of $128 
million ensuring that the industry fee supplements 
appropriations.
    The committee believes that after many years as a 
successful program, PRIA continues to provide predictable 
timelines for over 200 product categories allowing industry to 
grow and innovate, adding jobs to the U.S. economy and 
providing additional options for consumers.

               Section-by-Section Analysis of Legislation


Section I. Short title; Table of Contents

    Section 1 of the bill designates the title of the bill as 
the ``Pesticide Registration Enhancement Act of 2017'' and 
enumerates the table of contents.

Section 2. Extension and modification of maintenance fee authority

    Section 2 of the bill amends section 4(i) of FIFRA (7 
U.S.C. 136a-1(i)(1)).
    Subsection (a) extends the maintenance fee provision until 
2023 as well as increasing the total amount of maintenance fees 
to $31 million. The section does the same for the fees for 
small businesses.
    Subsection (b) extends the prohibition on levying 
registration fees not otherwise authorized under PRIA, 
including a prohibition on tolerance fees.
    Subsection (c) is a conforming amendment to the Federal 
Food, Drug, and Cosmetic Act to extend the prohibition on 
collection of tolerance fees.

Section 3. Registration and Expedited Processing Fund

    Section 3 amends section 4(k) of FIFRA (7 U.S.C. 136a-
1(k)(2)(A)).
    Subsection (a) includes additional uses for the fees 
collected such as defraying the costs of registration review, 
including the cost associated with Endangered Species Act 
review, as well as offsetting the costs associated with 
tracking and implementing registration review decisions.
    Subsection (b) updates the date for review of inert 
ingredients through fiscal year 2023.
    Subsection (c) provides funds for EPA to develop and 
finalize guidance for product performance data requirements for 
certain invertebrate pests of significance public importance. 
The subsection further establishes a timeline for the 
development of such guidance.
    Subsection (d) creates a new set-aside for good laboratory 
practices inspections.

Section 4. Experimental use permits for pesticides

    Section 4 amends section 5 of FIFRA to codify timeframes 
for experimental use permits consistent with the categories in 
section 33(b).

Section 5. Pesticide registration service fees

    Section 5 amends section 33 of FIFRA (7 U.S.C. 136w-8).
    Subsection (a) clarifies that applications for inert 
ingredients, Gold Seal letters, and any other actions that are 
not specifically pesticide activities are subject to a 
registration service fee.
    The subsection further extends two existing 5 percent 
increases to the registration service fees. This subsection 
also includes the small business waiver, except for requests 
for the Gold Seal letter of certification, which are low cost 
fees.
    Subsection (b) extends the set-aside for worker protection, 
partnership grants, and pesticide safety education until 2023. 
It further emphasizes that activities relating to worker 
protection shall focus on field worker populations in the 
United States.
    Subsection (c) directs EPA to look for streamlining 
opportunities for review process applications.
    Subsection (d) provides several clarifying and conforming 
amendments.
    Subsection (e) extends the annual reporting requirements 
until 2023 and amends the required content of the reports to 
encourage greater transparency in pesticide registrations. It 
also requires reporting on the implementation of the product 
performing test guidelines, a review of the good laboratory 
practices standards compliance monitoring program, a reporting 
on the current ``Safer Choice'' program.
    Subsection (f) extends the termination of effectiveness 
section until September 30, 2023, including the current two 
year phase out period.

Section 6. Revision of tables regarding covered pesticide registration 
        applications and other covered actions and their corresponding 
        registration service fees

    Section 6 codifies the necessary changes to the schedule of 
registration applications and the corresponding tables included 
in the statute.

                        Committee Consideration


                              I. HEARINGS

    The Committee held a round table discussion on February 14, 
2017 to review reauthorization of the Pesticide Registration 
Improvement Act (PRIA).
    Members of the Committee heard presentations and discussed 
reauthorization of the Pesticide Registration Improvement Act 
(PRIA). PRIA first passed Congress in 2003 with the full 
support of the registrant community (comprised of large and 
small companies ranging from pesticide and biopesticide 
manufacturers to antimicrobial companies, to biotech firms), as 
well as labor and environmental advocates. The nature of PRIA 
is very technical, but the widespread benefits across 
industries has gained it consistent bipartisan support. PRIA 
has been authorized three times, with most recent 
reauthorization due to expire on September 30, 2017. During the 
round table discussion, the following participants gave 
presentations on the reauthorization of PRIA:
     Beau Greenwood, CropLife America, Washington, DC
     Steve Goldberg, CropLife America, Washington, DC
     Steve Christenson, Ecolab, St. Paul, MN
     Virginia Ruiz, Farmworker Justice, Washington, DC

                           II. FULL COMMITTEE

    The Committee on Agriculture met, pursuant to notice, with 
a quorum present, on February 16, 2017, to consider H.R. 1029, 
Pesticide Registration Enhancement Act of 2017.
    H.R. 1029 was placed before the Committee for 
consideration. Without objection, a first reading of the bill 
was waived and it was open for amendment at any point.
    Chairman Conaway and Mr. Peterson were recognized for 
statements. Chairman Conaway recognized Mr. Davis for a 
technical amendment, which passed by a voice vote. Mr. Peterson 
was recognized to offer a motion that the bill H.R. 1029 be 
reported, as amended, favorably to the House with the 
recommendation that it do pass. The motion was subsequently 
approved by voice vote.
    At the conclusion of the meeting, Chairman Conaway advised 
Members that pursuant to the rules of the House of 
Representatives Members had until February 21, 2017, to file 
any supplemental, minority, additional, or dissenting views 
with the Committee.
    Without objection, staff was given permission to make any 
necessary clerical, technical or conforming changes to reflect 
the intent of the Committee. Chairman Conaway thanked all the 
Members and adjourned the meeting.

                            Committee Votes

    In compliance with clause 3(b) of rule XIII of the House of 
Representatives, H.R. 1029 was reported by voice vote with a 
majority quorum present. There was no request for a recorded 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee on Agriculture's 
oversight findings and recommendations are reflected in the 
body of this report.

           Budget Act Compliance (Sections 308, 402, and 423)

    The provisions of clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives and section 308(a)(1) of the 
Congressional Budget Act of 1974 (relating to estimates of new 
budget authority, new spending authority, new credit authority, 
or increased or decreased revenues or tax expenditures) are not 
considered applicable. The estimate and comparison required to 
be prepared by the Director of the Congressional Budget Office 
under clause 3(c)(3) of rule XIII of the Rules of the House of 
Representatives and sections 402 and 423 of the Congressional 
Budget Act of 1974 submitted to the Committee prior to the 
filing of this report are as follows:

                                     U.S. Congress,
                               Congressional Budget Office,
                                    Washington, DC, March 20, 2017.
Hon. K. Michael Conaway,
Chairman, Committee on Agriculture,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1029, the 
Pesticide Registration Enhancement Act of 2017.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Jon Sperl.
            Sincerely,
                                             Mark P. Hadley
                                                  (For Keith Hall).
    Enclosure.

H.R. 1029--Pesticide Registration Enhancement Act of 2017

    Summary: H.R. 1029 would modify the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), the law that regulates 
the distribution, sale, and use of pesticides, with the aim of 
strengthening the Environmental Protection Agency's (EPA's) 
ability to evaluate and regulate pesticides. Under FIFRA, the 
EPA is required to evaluate the safety of new pesticides 
entering the market by conducting risk assessments and must 
periodically reevaluate the health and environmental effects of 
pesticides. The EPA charges fees to pesticide manufacturers and 
distributors to cover the agency's costs of performing those 
registration and reregistration activities.
    The legislation would extend the agency's authority to 
charge those fees--currently set to expire in 2018--and also 
would increase the total amount of fees that the agency is 
allowed to charge. Additional fees would lead to a net 
reduction in spending over the next five years of $1 million 
for related activities; such spending is subject to 
appropriation. CBO estimates that enacting the bill would 
reduce direct spending by $24 million over the 2018-2022 
period, but would have no significant net effect on direct 
spending over the 2018-2027 period.
    Because enacting the bill would affect direct spending, 
pay-as-you-go procedures apply. Enacting the bill would not 
affect revenues. CBO estimates that enacting H.R. 1029 would 
not increase net direct spending or on-budget deficits in any 
of the four consecutive 10-year periods beginning in 2028.
    The bill would impose intergovernmental and private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA). 
CBO estimates that the cost of those mandates would fall below 
the annual thresholds for intergovernmental and private-sector 
mandates established in UMRA ($78 million and $156 million in 
2017, respectively, adjusted annually for inflation).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 1029 is shown in the following table. 
The costs of this legislation fall within budget function 300 
(natural resources and environment).

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    By fiscal year, in millions of dollars--
                                                      --------------------------------------------------------------------------------------------------
                                                        2017   2018   2019   2020   2021   2022   2023   2024   2025   2026   2027  2017-2022  2017-2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     INCREASES OR DECREASES (-) IN DIRECT SPENDINGa
 
Estimated Budget Authority...........................      0      0      0      0      0      0      0      0      0      0      0         0          0
Estimated Outlays....................................      0      0     -6     -6     -5     -4     -2     26      0      0      0       -24          0
--------------------------------------------------------------------------------------------------------------------------------------------------------
aIn addition CBO estimates that spending subject to appropriation would be reduced by about $1 million over the 2017-2022 period.

    Basis of estimate: For this estimate, CBO assumes that the 
legislation will be enacted late in fiscal year 2017 and that 
the necessary amounts will be appropriated each year beginning 
in 2018.
    Some of EPA's activities under FIFRA--those related to 
registering pesticides--are funded with fees that may only be 
collected if allowed for in appropriation acts. Other EPA 
activities--those related to the reregistration of pesticides--
are funded with fees that are authorized to be collected and 
spent without further appropriation.

Changes in spending subject to appropriation

    H.R. 1029 would extend the authority for the EPA to collect 
fees for registering new pesticides entering the market through 
2025 and also would increase the level of those fees.
    In 2016, the EPA collected $17 million in pesticide 
registration fees and spent approximately $19 million including 
some fees collected in previous years.
    Based on information from the EPA about the number and type 
of pesticides that the agency expects to review in future years 
and assuming appropriation action consistent with the bill, CBO 
estimates that under H.R. 1029 the EPA would collect $17 
million in registration fees in 2018, with those collections 
increasing to $19 million per year by 2023. In total, CBO 
estimates that the agency would collect about $92 million in 
pesticide registration fees over the 2018-2022 period and spend 
slightly less over that period, resulting in a net collection 
of around $1 million.

Changes in direct spending

    The EPA also periodically reviews and reregisters 
pesticides that are already on the market. Under FIFRA, the EPA 
is authorized to collect up to $28 million per year in fees to 
offset the costs of those activities through 2018. The agency 
is authorized to spend those fees, which are recorded in the 
budget as reductions in direct spending, without further 
appropriation.
    H.R. 1029 would extend the agency's authority to collect 
those fees through 2023 and would raise the statutory cap to 
$31 million per year. In 2016, the EPA collected $28 million in 
reregistration fees and spent $16 million on related 
activities.
    Under H.R. 1029, CBO estimates that the EPA would collect 
and spend $186 million in reregistration fees over the 2018-
2027 period. CBO expects that the EPA's collection of fees 
would continue to exceed spending in most years, resulting in a 
reduction in direct spending of $24 million over the 2018-2022 
period. However, under the bill the agency's authority to 
collect receipts would expire after 2023. CBO estimates that 
the EPA would spend the accumulated balances of fees for 
reregistration activities in 2024.
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending; 
therefore, pay-as-you-go procedures apply. The net changes in 
outlays that are subject to those pay-as-you-go procedures are 
shown in the following table.

           CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 1029, AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON AGRICULTURE ON FEBRUARY 16, 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    By fiscal year, in millions of dollars--
                                                      --------------------------------------------------------------------------------------------------
                                                        2017   2018   2019   2020   2021   2022   2023   2024   2025   2026   2027  2017-2022  2017-2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       NET INCREASE OR DECREASE (-) IN THE DEFICIT
 
Statutory Pay-As-You-Go Impact.......................      0      0     -6     -6     -5     -4     -2     26      0      0      0       -24          0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 1029 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2028.
    Intergovernmental and private-sector impact: The bill would 
impose intergovernmental and private-sector mandates as defined 
in UMRA by extending reregistration fees for the use of 
pesticides through 2023. CBO estimates that those fees would 
total $31 million annually and that most of the amount 
collected would be borne by private entities. (Public entities 
usually receive waivers from reregistration fees for minor uses 
or public health purposes.) The bill would impose an additional 
private-sector mandate by extending pesticide registration fees 
through 2025. CBO estimates that those fees would total $18 
million annually, on average, during the first five years that 
the mandate is in effect. In aggregate, CBO estimates that the 
cost of mandates in the bill would fall below the annual 
thresholds for intergovernmental and private-sector mandates 
established in UMRA ($78 million and $156 million in 2017, 
respectively, adjusted annually for inflation).
    Estimate prepared by: Federal costs: Jon Sperl; Impact on 
state, local, and tribal governments: Zach Byrum; Impact on the 
private sector: Amy Petz.
    Estimate approved by: H. Samuel Papenfuss, Deputy Assistant 
Director for Budget Analysis.

                    Performance Goals and Objectives

    H.R. 1029 does not authorize funding, therefore, clause 
3(c)(4) of rule XIII of the Rules of the House of 
Representatives is inapplicable.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(2) of rule XIII of the Rules of the 
House of Representatives, the Committee report incorporates the 
cost estimate prepared by the Director of the Congressional 
Budget Office pursuant to sections 402 and 423 of the 
Congressional Budget Act of 1974.

                      Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                Applicability to the Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act (Public Law 
104-1).

                       Federal Mandates Statement

    The Committee adopted as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act (Public Law 104-4).

  Earmark Statement Required by Clause 9 of Rule XXI of the Rules of 
                        House of Representatives

    H.R. 1029 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9(e), 9(f), or 9(g) of rule XXI of the Rules of the 
House Representatives.

                    Duplication of Federal Programs

    This bill does not establish or reauthorize a program of 
the Federal Government known to be duplicative of another 
Federal program, a program that was included in any report from 
the Government Accountability Office to Congress pursuant to 
section 21 of Public Law 111-139, or a program related to a 
program identified in the most recent Catalog of Federal 
Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee does not believe that the legislation directs 
an executive branch official to conduct any specific rule 
making proceedings within the meaning of 5 U.S.C. 551.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

          FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT




           *       *       *       *       *       *       *
SEC. 4. REREGISTRATION OF REGISTERED PESTICIDES.

  (a) General Rule.--The Administrator shall reregister, in 
accordance with this section, each registered pesticide 
containing any active ingredient contained in any pesticide 
first registered before November 1, 1984, except for any 
pesticide as to which the Administrator has determined, after 
November 1, 1984, and before the effective date of this 
section, that--
          (1) there are no outstanding data requirements; and
          (2) the requirements of section 3(c)(5) have been 
        satisfied.
  (b) Reregistration Phases.--Reregistrations of pesticides 
under this section shall be carried out in the following 
phases:
          (1) The first phase shall include the listing under 
        subsection (c) of the active ingredients of the 
        pesticides that will be reregistered.
          (2) The second phase shall include the submission to 
        the Administrator under subsection (d) of notices by 
        registrants respecting their intention to seek 
        reregistration, identification by registrants of 
        missing and inadequate data for such pesticides, and 
        commitments by registrants to replace such missing or 
        inadequate data within the applicable time period.
          (3) The third phase shall include submission to the 
        Administrator by registrants of the information 
        required under subsection (e).
          (4) The fourth phase shall include an independent, 
        initial review by the Administrator under subsection 
        (f) of submissions under phases two and three, 
        identification of outstanding data requirements, and 
        the issuance, as necessary, of requests for additional 
        data.
          (5) The fifth phase shall include the review by the 
        Administrator under subsection (g) of data submitted 
        for reregistration and appropriate regulatory action by 
        the Administrator.
  (c) Phase One.--
          (1) Priority for reregistration.--For purposes of the 
        reregistration of the pesticides described in 
        subsection (a), the Administrator shall list the active 
        ingredients of pesticides and shall give priority to, 
        among others, active ingredients (other than active 
        ingredients for which registration standards have been 
        issued before the effective date of this section ) 
        that--
                  (A) are in use on or in food or feed and may 
                result in postharvest residues;
                  (B) may result in residues of potential 
                toxicological concern in potable ground water, 
                edible fish, or shellfish;
                  (C) have been determined by the Administrator 
                before the effective date of this section to 
                have significant outstanding data requirements; 
                or
                  (D) are used on crops, including in 
                greenhouses and nurseries, where worker 
                exposure is most likely to occur.
          (2) Reregistration lists.--For purposes of 
        reregistration under this section, the Administrator 
        shall by order--
                  (A) not later than 70 days after the 
                effective date of this section, list pesticide 
                active ingredients for which registration 
                standards have been issued before such 
                effective date;
                  (B) not later than 4 months after such 
                effective date, list the first 150 pesticide 
                active ingredients, as determined under 
                paragraph (1);
                  (C) not later than 7 months after such 
                effective date, list the second 150 pesticide 
                active ingredients, as determined under 
                paragraph (1); and
                  (D) not later than 10 months after such 
                effective date, list the remainder of the 
                pesticide active ingredients, as determined 
                under paragraph (1).
        Each list shall be published in the Federal Register.
          (3) Judicial review.--The content of a list issued by 
        the Administrator under paragraph (2) shall not be 
        subject to judicial review.
          (4) Notice to registrants.--On the publication of a 
        list of pesticide active ingredients under paragraph 
        (2), the Administrator shall send by certified mail to 
        the registrants of the pesticides containing such 
        active ingredients a notice of the time by which the 
        registrants are to notify the Administrator under 
        subsection (d) whether the registrants intend to seek 
        or not to seek reregistration of such pesticides.
  (d) Phase Two.--
          (1) In general.--The registrant of a pesticide that 
        contains an active ingredient listed under subparagraph 
        (B), (C), or (D) of subsection (c)(2) shall submit to 
        the Administrator, within the time period prescribed by 
        paragraph (4), the notice described in paragraph (2) 
        and any information, commitment, or offer described in 
        paragraph (3).
          (2) Notice of intent to seek or not to seek 
        reregistration.--
                  (A) The registrant of a pesticide containing 
                an active ingredient listed under subparagraph 
                (B), (C), or (D) of subsection (c)(2) shall 
                notify the Administrator by certified mail 
                whether the registrant intends to seek or does 
                not intend to seek reregistration of the 
                pesticide.
                  (B) If a registrant submits a notice under 
                subparagraph (A) of an intention not to seek 
                reregistration of a pesticide, the 
                Administrator shall publish a notice in the 
                Federal Register stating that such a notice has 
                been submitted.
          (3) Missing or inadequate data.--Each registrant of a 
        pesticide that contains an active ingredient listed 
        under subparagraph (B), (C), or (D) of subsection 
        (c)(2) and for which the registrant submitted a notice 
        under paragraph (2) of an intention to seek 
        reregistration of such pesticide shall submit to the 
        Administrator--
                  (A) in accordance with regulations issued by 
                the Administrator under section 3, an 
                identification of--
                          (i) all data that are required by 
                        regulation to support the registration 
                        of the pesticide with respect to such 
                        active ingredient;
                          (ii) data that were submitted by the 
                        registrant previously in support of the 
                        registration of the pesticide that are 
                        inadequate to meet such regulations; 
                        and
                          (iii) data identified under clause 
                        (i) that have not been submitted to the 
                        Administrator; and
                  (B) either--
                          (i) a commitment to replace the data 
                        identified under subparagraph (A)(ii) 
                        and submit the data identified under 
                        subparagraph (A)(iii) within the 
                        applicable time period prescribed by 
                        paragraph (4)(B); or
                          (ii) an offer to share in the cost to 
                        be incurred by a person who has made a 
                        commitment under clause (i) to replace 
                        or submit the data and an offer to 
                        submit to arbitration as described by 
                        section 3(c)(2)(B) with regard to such 
                        cost sharing.
        For purposes of a submission by a registrant under 
        subparagraph (A)(ii), data are inadequate if the data 
        are derived from a study with respect to which the 
        registrant is unable to make the certification 
        prescribed by subsection (e)(1)(G) that the registrant 
        possesses or has access to the raw data used in or 
        generated by such study. For purposes of a submission 
        by a registrant under such subparagraph, data shall be 
        considered to be inadequate if the data are derived 
        from a study submitted before January 1, 1970, unless 
        it is demonstrated to the satisfaction of the 
        Administrator that such data should be considered to 
        support the registration of the pesticide that is to be 
        reregistered.
          (4) Time periods.--
                  (A) A submission under paragraph (2) or (3) 
                shall be made--
                          (i) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(B), not later 
                        than 3 months after the date of 
                        publication of the listing of such 
                        active ingredient;
                          (ii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(C), not later 
                        than 3 months after the date of 
                        publication of the listing of such 
                        active ingredient; and
                          (iii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(D), not later 
                        than 3 months after the date of 
                        publication of the listing of such 
                        active ingredient.
                On application, the Administrator may extend a 
                time period prescribed by this subparagraph if 
                the Administrator determines that factors 
                beyond the control of the registrant prevent 
                the registrant from complying with such period.
                  (B) A registrant shall submit data in 
                accordance with a commitment entered into under 
                paragraph (3)(B) within a reasonable period of 
                time, as determined by the Administrator, but 
                not more than 48 months after the date the 
                registrant submitted the commitment. The 
                Administrator, on application of a registrant, 
                may extend the period prescribed by the 
                preceding sentence by no more than 2 years if 
                extraordinary circumstances beyond the control 
                of the registrant prevent the registrant from 
                submitting data within such prescribed period. 
                Upon application of a registrant, the 
                Administrator shall, in the case of a minor 
                use, extend the deadline for the production of 
                residue chemistry data under this subparagraph 
                for data required solely to support that minor 
                use until the final deadline for submission of 
                data under this section for the other uses of 
                the pesticide established as of the date of 
                enactment of the Food Quality Protection Act of 
                1996 if--
                          (i) the data to support other uses of 
                        the pesticide on a food are being 
                        provided;
                          (ii) the registrant, in submitting a 
                        request for such an extension provides 
                        a schedule, including interim dates to 
                        measure progress, to assure that the 
                        data production will be completed 
                        before the expiration of the extension 
                        period;
                          (iii) the Administrator has 
                        determined that such extension will not 
                        significantly delay the Administrator's 
                        schedule for issuing a reregistration 
                        eligibility determination required 
                        under this section; and
                          (iv) the Administrator has determined 
                        that based on existing data, such 
                        extension would not significantly 
                        increase the risk of any unreasonable 
                        adverse effect on the environment. If 
                        the Administrator grants an extension 
                        under this subparagraph, the 
                        Administrator shall monitor the 
                        development of the data and shall 
                        ensure that the registrant is meeting 
                        the schedule for the production of the 
                        data. If the Administrator determines 
                        that the registrant is not meeting or 
                        has not met the schedule for the 
                        production of such data, the 
                        Administrator may proceed in accordance 
                        with clause (iv) of section 3(c)(2)(B) 
                        or other provisions of this section, as 
                        appropriate, regarding the continued 
                        registration of the affected products 
                        with the minor use and shall inform the 
                        public of such action. Notwithstanding 
                        the provisions of this subparagraph, 
                        the Administrator may take action to 
                        modify or revoke the extension under 
                        this subparagraph if the Administrator 
                        determines that the extension for the 
                        minor use may cause an unreasonable 
                        adverse effect on the environment. In 
                        such circumstance, the Administrator 
                        shall provide written notice to the 
                        registrant revoking the extension of 
                        time for submission of data. Such data 
                        shall instead be due in accordance with 
                        the date then established by the 
                        Administrator for submission of the 
                        data.
          (5) Cancellation and removal.--
                  (A) If the registrant of a pesticide does not 
                submit a notice under paragraph (2) or (3) 
                within the time prescribed by paragraph (4)(A), 
                the Administrator shall issue a notice of 
                intent to cancel the registration of such 
                registrant for such pesticide and shall publish 
                the notice in the Federal Register and allow 60 
                days for the submission of comments on the 
                notice. On expiration of such 60 days, the 
                Administrator, by order and without a hearing, 
                may cancel the registration or take such other 
                action, including extension of applicable time 
                periods, as may be necessary to enable 
                reregistration of such pesticide by another 
                person.
                  (B)(i) If--
                          (I) no registrant of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2) notifies the 
                        Administrator under paragraph (2) that 
                        the registrant intends to seek 
                        reregistration of any pesticide 
                        containing that active ingredient;
                          (II) no such registrant complies with 
                        paragraph (3)(A); or
                          (III) no such registrant makes a 
                        commitment under paragraph (3)(B) to 
                        replace or submit all data described in 
                        clauses (ii) and (iii) of paragraph 
                        (3)(A);
                the Administrator shall publish in the Federal 
                Register a notice of intent to remove the 
                active ingredient from the list established 
                under subsection (c)(2) and a notice of intent 
                to cancel the registrations of all pesticides 
                containing such active ingredient and shall 
                provide 60 days for comment on such notice.
                  (ii) After the 60-day period has expired, the 
                Administrator, by order, may cancel any such 
                registration without hearing, except that the 
                Administrator shall not cancel a registration 
                under this subparagraph if--
                          (I) during the comment period a 
                        person acquires the rights of the 
                        registrant in that registration;
                          (II) during the comment period that 
                        person furnishes a notice of intent to 
                        reregister the pesticide in accordance 
                        with paragraph (2); and
                          (III) not later than 120 days after 
                        the publication of the notice under 
                        this subparagraph, that person has 
                        complied with paragraph (3) and the fee 
                        prescribed by this section has been 
                        paid.
          (6) Suspensions and penalties.--The Administrator 
        shall issue a notice of intent to suspend the 
        registration of a pesticide in accordance with the 
        procedures prescribed by section 3(c)(2)(B)(iv) if the 
        Administrator determines that (A) progress is 
        insufficient to ensure the submission of the data 
        required for such pesticide under a commitment made 
        under paragraph (3)(B) within the time period 
        prescribed by paragraph (4)(B) or (B) the registrant 
        has not submitted such data to the Administrator within 
        such time period. If the registrant does not commit to 
        support a specific minor use of the pesticide, but is 
        supporting and providing data in a timely and adequate 
        fashion to support uses of the pesticide on a food, or 
        if all uses of the pesticide are nonfood uses and the 
        registrant does not commit to support a specific minor 
        use of the pesticide but is supporting and providing 
        data in a timely and adequate fashion to support other 
        nonfood uses of the pesticide, the Administrator, at 
        the written request of the registrant, shall not take 
        any action pursuant to this paragraph in regard to such 
        unsupported minor use until the final deadline 
        established as of the date of enactment of the Food 
        Quality Protection Act of 1996, for the submission of 
        data under this section for the supported uses 
        identified pursuant to this paragraph unless the 
        Administrator determines that the absence of the data 
        is significant enough to cause human health or 
        environmental concerns. On such a determination the 
        Administrator may refuse the request for extension by 
        the registrant. Upon receipt of the request from the 
        registrant, the Administrator shall publish in the 
        Federal Register a notice of the receipt of the request 
        and the effective date upon which the uses not being 
        supported will be voluntarily deleted from the 
        registration pursuant to section 6(f)(1). If the 
        Administrator grants an extension under this paragraph, 
        the Administrator shall monitor the development of the 
        data for the uses being supported and shall ensure that 
        the registrant is meeting the schedule for the 
        production of such data. If the Administrator 
        determines that the registrant is not meeting or has 
        not met the schedule for the production of such data, 
        the Administrator may proceed in accordance with 
        section 3(c)(2)(B)(iv) regarding the continued 
        registration of the affected products with the minor 
        and other uses and shall inform the public of such 
        action in accordance with section 6(f)(2). 
        Notwithstanding this subparagraph, the Administrator 
        may deny, modify, or revoke the temporary extension 
        under this paragraph if the Administrator determines 
        that the continuation of the minor use may cause an 
        unreasonable adverse effect on the environment. In the 
        event of modification or revocation, the Administrator 
        shall provide, in writing, to the registrant a notice 
        revoking the temporary extension and establish a new 
        effective date by which the minor use shall be deleted 
        from the registration.
  (e) Phase Three.--
          (1) Information about studies.--Each registrant of a 
        pesticide that contains an active ingredient listed 
        under subparagraph (B), (C), or (D) of subsection 
        (c)(2) who has submitted a notice under subsection 
        (d)(2) of an intent to seek the reregistration of such 
        pesticide shall submit, in accordance with the 
        guidelines issued under paragraph (4), to the 
        Administrator--
                  (A) a summary of each study concerning the 
                active ingredient previously submitted by the 
                registrant in support of the registration of a 
                pesticide containing such active ingredient and 
                considered by the registrant to be adequate to 
                meet the requirements of section 3 and the 
                regulations issued under such section;
                  (B) a summary of each study concerning the 
                active ingredient previously submitted by the 
                registrant in support of the registration of a 
                pesticide containing such active ingredient 
                that may not comply with the requirements of 
                section 3 and the regulations issued under such 
                section but which the registrant asserts should 
                be deemed to comply with such requirements and 
                regulations;
                  (C) a reformat of the data from each study 
                summarized under subparagraph (A) or (B) by the 
                registrant concerning chronic dosing, 
                oncogenicity, reproductive effects, 
                mutagenicity, neurotoxicity, teratogenicity, or 
                residue chemistry of the active ingredient that 
                were submitted to the Administrator before 
                January 1, 1982;
                  (D) where data described in subparagraph (C) 
                are not required for the active ingredient by 
                regulations issued under section 3, a reformat 
                of acute and subchronic dosing data submitted 
                by the registrant to the Administrator before 
                January 1, 1982, that the registrant considers 
                to be adequate to meet the requirements of 
                section 3 and the regulations issued under such 
                section;
                  (E) an identification of data that are 
                required to be submitted to the Administrator 
                under section 6(a)(2) indicating an adverse 
                effect of the pesticide;
                  (F) an identification of any other 
                information available that in the view of the 
                registrant supports the registration;
                  (G) a certification that the registrant or 
                the Administrator possesses or has access to 
                the raw data used in or generated by the 
                studies that the registrant summarized under 
                subparagraph (A) or (B);
                  (H) either--
                          (i) a commitment to submit data to 
                        fill each outstanding data requirement 
                        identified by the registrant; or
                          (ii) an offer to share in the cost of 
                        developing such data to be incurred by 
                        a person who has made a commitment 
                        under clause (i) to submit such data, 
                        and an offer to submit to arbitration 
                        as described by section 3(c)(2)(B) with 
                        regard to such cost sharing; and
                  (I) evidence of compliance with section 
                3(c)(1)(D)(ii) and regulations issued 
                thereunder with regard to previously submitted 
                data as if the registrant were now seeking the 
                original registration of the pesticide.
        A registrant who submits a certification under 
        subparagraph (G) that is false shall be considered to 
        have violated this Act and shall be subject to the 
        penalties prescribed by section 14.
          (2) Time periods.--
                  (A) The information required by paragraph (1) 
                shall be submitted to the Administrator--
                          (i) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(B), not later 
                        than 12 months after the date of 
                        publication of the listing of such 
                        active ingredient;
                          (ii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(C), not later 
                        than 12 months after the date of 
                        publication of the listing of such 
                        active ingredient; and
                          (iii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(D), not later 
                        than 12 months after the date of 
                        publication of the listing of such 
                        active ingredient.
                  (B) A registrant shall submit data in 
                accordance with a commitment entered into under 
                paragraph (1)(H) within a reasonable period of 
                time, as determined by the Administrator, but 
                not more than 48 months after the date the 
                registrant submitted the commitment under such 
                paragraph. The Administrator, on application of 
                a registrant, may extend the period prescribed 
                by the preceding sentence by no more than 2 
                years if extraordinary circumstances beyond the 
                control of the registrant prevent the 
                registrant from submitting data within such 
                prescribed period. Upon application of a 
                registrant, the Administrator shall, in the 
                case of a minor use, extend the deadline for 
                the production of residue chemistry data under 
                this subparagraph for data required solely to 
                support that minor use until the final deadline 
                for submission of data under this section for 
                the other uses of the pesticide established as 
                of the date of enactment of the Food Quality 
                Protection Act of 1996 if--
                          (i) the data to support other uses of 
                        the pesticide on a food are being 
                        provided;
                          (ii) the registrant, in submitting a 
                        request for such an extension provides 
                        a schedule, including interim dates to 
                        measure progress, to assure that the 
                        data production will be completed 
                        before the expiration of the extension 
                        period;
                          (iii) the Administrator has 
                        determined that such extension will not 
                        significantly delay the Administrator's 
                        schedule for issuing a reregistration 
                        eligibility determination required 
                        under this section; and
                          (iv) the Administrator has determined 
                        that based on existing data, such 
                        extension would not significantly 
                        increase the risk of any unreasonable 
                        adverse effect on the environment. If 
                        the Administrator grants an extension 
                        under this subparagraph, the 
                        Administrator shall monitor the 
                        development of the data and shall 
                        ensure that the registrant is meeting 
                        the schedule for the production of the 
                        data. If the Administrator determines 
                        that the registrant is not meeting or 
                        has not met the schedule for the 
                        production of such data, the 
                        Administrator may proceed in accordance 
                        with clause (iv) of section 3(c)(2)(B) 
                        or other provisions of this section, as 
                        appropriate, regarding the continued 
                        registration of the affected products 
                        with the minor use and shall inform the 
                        public of such action. Notwithstanding 
                        the provisions of this subparagraph, 
                        the Administrator may take action to 
                        modify or revoke the extension under 
                        this subparagraph if the Administrator 
                        determines that the extension for the 
                        minor use may cause an unreasonable 
                        adverse effect on the environment. In 
                        such circumstance, the Administrator 
                        shall provide written notice to the 
                        registrant revoking the extension of 
                        time for submission of data. Such data 
                        shall instead be due in accordance with 
                        the date then established by the 
                        Administrator for submission of the 
                        data.
          (3) Cancellation.--
                  (A) If the registrant of a pesticide fails to 
                submit the information required by paragraph 
                (1) within the time prescribed by paragraph 
                (2), the Administrator, by order and without 
                hearing, shall cancel the registration of such 
                pesticide. If the registrant does not commit to 
                support a specific minor use of the pesticide, 
                but is supporting and providing data in a 
                timely and adequate fashion to support uses of 
                the pesticide on a food, or if all uses of the 
                pesticide are nonfood uses and the registrant 
                does not commit to support a specific minor use 
                of the pesticide but is supporting and 
                providing data in a timely and adequate fashion 
                to support other nonfood uses of the pesticide, 
                the Administrator, at the written request of 
                the registrant, shall not take any action 
                pursuant to this subparagraph in regard to such 
                unsupported minor use until the final deadline 
                established as of the date of enactment of the 
                Food Quality Protection Act of 1996, for the 
                submission of data under this section for the 
                supported uses identified pursuant to this 
                subparagraph unless the Administrator 
                determines that the absence of the data is 
                significant enough to cause human health or 
                environmental concerns. On the basis of such 
                determination, the Administrator may refuse the 
                request for extension by the registrant. Upon 
                receipt of the request from the registrant, the 
                Administrator shall publish in the Federal 
                Register a notice of the receipt of the request 
                and the effective date upon which the uses not 
                being supported will be voluntarily deleted 
                from the registration pursuant to section 
                6(f)(1). If the Administrator grants an 
                extension under this subparagraph, the 
                Administrator shall monitor the development of 
                the data for the uses being supported and shall 
                ensure that the registrant is meeting the 
                schedule for the production of such data. If 
                the Administrator determines that the 
                registrant is not meeting or has not met the 
                schedule for the production of such data, the 
                Administrator may proceed in accordance with 
                section 3(c)(2)(B)(iv) regarding the continued 
                registration of the affected products with the 
                minor and other uses and shall inform the 
                public of such action in accordance with 
                section 6(f)(2). Notwithstanding this 
                subparagraph, the Administrator may deny, 
                modify, or revoke the temporary extension under 
                this subparagraph if the Administrator 
                determines that the continuation of the minor 
                use may cause an unreasonable adverse effect on 
                the environment. In the event of modification 
                or revocation, the Administrator shall provide, 
                in writing, to the registrant a notice revoking 
                the temporary extension and establish a new 
                effective date by which the minor use shall be 
                deleted from the registration.
                  (B)(i) If the registrant of a pesticide 
                submits the information required by paragraph 
                (1) within the time prescribed by paragraph (2) 
                and such information does not conform to the 
                guidelines for submissions established by the 
                Administrator, the Administrator shall 
                determine whether the registrant made a good 
                faith attempt to conform its submission to such 
                guidelines.
                  (ii) If the Administrator determines that the 
                registrant made a good faith attempt to conform 
                its submission to such guidelines, the 
                Administrator shall provide the registrant a 
                reasonable period of time to make any necessary 
                changes or corrections.
                  (iii)(I) If the Administrator determines that 
                the registrant did not make a good faith 
                attempt to conform its submission to such 
                guidelines, the Administrator may issue a 
                notice of intent to cancel the registration. 
                Such a notice shall be sent to the registrant 
                by certified mail.
                  (II) The registration shall be canceled 
                without a hearing or further notice at the end 
                of 30 days after receipt by the registrant of 
                the notice unless during that time a request 
                for a hearing is made by the registrant.
                  (III) If a hearing is requested, a hearing 
                shall be conducted under section 6(d), except 
                that the only matter for resolution at the 
                hearing shall be whether the registrant made a 
                good faith attempt to conform its submission to 
                such guidelines. The hearing shall be held and 
                a determination made within 75 days after 
                receipt of a request for hearing.
          (4) Guidelines.--
                  (A) Not later than 1 year after the effective 
                date of this section, the Administrator, by 
                order, shall issue guidelines to be followed by 
                registrants in--
                          (i) summarizing studies;
                          (ii) reformatting studies;
                          (iii) identifying adverse 
                        information; and
                          (iv) identifying studies that have 
                        been submitted previously that may not 
                        meet the requirements of section 3 or 
                        regulations issued under such section,
                under paragraph (1).
                  (B) Guidelines issued under subparagraph (A) 
                shall not be subject to judicial review.
          (5) Monitoring.--The Administrator shall monitor the 
        progress of registrants in acquiring and submitting the 
        data required under paragraph (1).
  (f) Phase Four.--
          (1) Independent review and identification of 
        outstanding data requirements.--
                  (A) The Administrator shall review the 
                submissions of all registrants of pesticides 
                containing a particular active ingredient under 
                subsections (d)(3) and (e)(1) to determine if 
                such submissions identified all the data that 
                are missing or inadequate for such active 
                ingredient. To assist the review of the 
                Administrator under this subparagraph, the 
                Administrator may require a registrant seeking 
                reregistration to submit complete copies of 
                studies summarized under subsection (e)(1).
                  (B) The Administrator shall independently 
                identify and publish in the Federal Register 
                the outstanding data requirements for each 
                active ingredient that is listed under 
                subparagraph (B), (C), or (D) of subsection 
                (c)(2) and that is contained in a pesticide to 
                be reregistered under this section. The 
                Administrator, at the same time, shall issue a 
                notice under section 3(c)(2)(B) for the 
                submission of the additional data that are 
                required to meet such requirements.
          (2) Time periods.--
                  (A) The Administrator shall take the action 
                required by paragraph (1)--
                          (i) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(B), not later 
                        than 18 months after the date of the 
                        listing of such active ingredient;
                          (ii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(C), not later 
                        than 24 months after the date of the 
                        listing of such active ingredient; and
                          (iii) in the case of a pesticide 
                        containing an active ingredient listed 
                        under subsection (c)(2)(D), not later 
                        than 33 months after the date of the 
                        listing of such active ingredient.
                  (B) If the Administrator issues a notice to a 
                registrant under paragraph (1)(B) for the 
                submission of additional data, the registrant 
                shall submit such data within a reasonable 
                period of time, as determined by the 
                Administrator, but not to exceed 48 months 
                after the issuance of such notice. The 
                Administrator, on application of a registrant, 
                may extend the period prescribed by the 
                preceding sentence by no more than 2 years if 
                extraordinary circumstances beyond the control 
                of the registrant prevent the registrant from 
                submitting data within such prescribed period. 
                Upon application of a registrant, the 
                Administrator shall, in the case of a minor 
                use, extend the deadline for the production of 
                residue chemistry data under this subparagraph 
                for data required solely to support that minor 
                use until the final deadline for submission of 
                data under this section for the other uses of 
                the pesticide established as of the date of 
                enactment of the Food Quality Protection Act of 
                1996 if--
                          (i) the data to support other uses of 
                        the pesticide on a food are being 
                        provided;
                          (ii) the registrant, in submitting a 
                        request for such an extension provides 
                        a schedule, including interim dates to 
                        measure progress, to assure that the 
                        data production will be completed 
                        before the expiration of the extension 
                        period;
                          (iii) the Administrator has 
                        determined that such extension will not 
                        significantly delay the Administrator's 
                        schedule for issuing a reregistration 
                        eligibility determination required 
                        under this section; and
                          (iv) the Administrator has determined 
                        that based on existing data, such 
                        extension would not significantly 
                        increase the risk of any unreasonable 
                        adverse effect on the environment. If 
                        the Administrator grants an extension 
                        under this subparagraph, the 
                        Administrator shall monitor the 
                        development of the data and shall 
                        ensure that the registrant is meeting 
                        the schedule for the production of the 
                        data. If the Administrator determines 
                        that the registrant is not meeting or 
                        has not met the schedule for the 
                        production of such data, the 
                        Administrator may proceed in accordance 
                        with clause (iv) of section 3(c)(2)(B) 
                        or other provisions of this section, as 
                        appropriate, regarding the continued 
                        registration of the affected products 
                        with the minor use and shall inform the 
                        public of such action. Notwithstanding 
                        the provisions of this subparagraph, 
                        the Administrator may take action to 
                        modify or revoke the extension under 
                        this subparagraph if the Administrator 
                        determines that the extension for the 
                        minor use may cause an unreasonable 
                        adverse effect on the environment. In 
                        such circumstance, the Administrator 
                        shall provide written notice to the 
                        registrant revoking the extension of 
                        time for submission of data. Such data 
                        shall instead be due in accordance with 
                        the date then established by the 
                        Administrator for submission of the 
                        data.
          (3) Suspensions and penalties.--The Administrator 
        shall issue a notice of intent to suspend the 
        registration of a pesticide in accordance with the 
        procedures prescribed by section 3(c)(2)(B)(iv) if the 
        Administrator determines that (A) tests necessary to 
        fill an outstanding data requirement for such pesticide 
        have not been initiated within 1 year after the 
        issuance of a notice under paragraph (1)(B), or (B) 
        progress is insufficient to ensure submission of the 
        data referred to in clause (A) within the time period 
        prescribed by paragraph (2)(B) or the required data 
        have not been submitted to the Administrator within 
        such time period. If the registrant does not commit to 
        support a specific minor use of the pesticide, but is 
        supporting and providing data in a timely and adequate 
        fashion to support uses of the pesticide on a food, or 
        if all uses of the pesticide are nonfood uses and the 
        registrant does not commit to support a specific minor 
        use of the pesticide but is supporting and providing 
        data in a timely and adequate fashion to support other 
        nonfood uses of the pesticide, the Administrator, at 
        the written request of the registrant, shall not take 
        any action pursuant to this paragraph in regard to such 
        unsupported minor use until the final deadline 
        established as of the date of enactment of the Food 
        Quality Protection Act of 1996, for the submission of 
        data under this section for the supported uses 
        identified pursuant to this paragraph unless the 
        Administrator determines that the absence of the data 
        is significant enough to cause human health or 
        environmental concerns. On such a determination the 
        Administrator may refuse the request for extension by 
        the registrant. Upon receipt of the request from the 
        registrant, the Administrator shall publish in the 
        Federal Register a notice of the receipt of the request 
        and the effective date upon which the uses not being 
        supported will be voluntarily deleted from the 
        registration pursuant to section 6(f)(1). If the 
        Administrator grants an extension under this paragraph, 
        the Administrator shall monitor the development of the 
        data for the uses being supported and shall ensure that 
        the registrant is meeting the schedule for the 
        production of such data. If the Administrator 
        determines that the registrant is not meeting or has 
        not met the schedule for the production of such data, 
        the Administrator may proceed in accordance with 
        section 3(c)(2)(B)(iv) regarding the continued 
        registration of the affected products with the minor 
        and other uses and shall inform the public of such 
        action in accordance with section 6(f)(2). 
        Notwithstanding this subparagraph, the Administrator 
        may deny, modify, or revoke the temporary extension 
        under this paragraph if the Administrator determines 
        that the continuation of the minor use may cause an 
        unreasonable adverse effect on the environment. In the 
        event of modification or revocation, the Administrator 
        shall provide, in writing, to the registrant a notice 
        revoking the temporary extension and establish a new 
        effective date by which the minor use shall be deleted 
        from the registration.
  (g) Phase Five.--
          (1) Data review.--The Administrator shall conduct a 
        thorough examination of all data submitted under this 
        section concerning an active ingredient listed under 
        subsection (c)(2) and of all other available data found 
        by the Administrator to be relevant.
          (2) Reregistration and other actions.--
                  (A) In general.--The Administrator shall make 
                a determination as to eligibility for 
                reregistration--
                          (i) for all active ingredients 
                        subject to reregistration under this 
                        section for which tolerances or 
                        exemptions from tolerances are required 
                        under the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 301 et seq.), 
                        not later than the last date for 
                        tolerance reassessment established 
                        under section 408(q)(1)(C) of that Act 
                        (21 U.S.C. 346a(q)(1)(C)); and
                          (ii) for all other active ingredients 
                        subject to reregistration under this 
                        section, not later than October 3, 
                        2008.
                  (B) Product-specific data.--
                          (i) In general.--Before reregistering 
                        a pesticide, the Administrator shall 
                        obtain any needed product-specific data 
                        regarding the pesticide by use of 
                        section 3(c)(2)(B) and shall review 
                        such data within 90 days after its 
                        submission.
                          (ii) Timing.--
                                  (I) In general.--Subject to 
                                subclause (II), the 
                                Administrator shall require 
                                that data under this 
                                subparagraph be submitted to 
                                the Administrator not later 
                                than 8 months after a 
                                determination of eligibility 
                                under subparagraph (A) has been 
                                made for each active ingredient 
                                of the pesticide, unless the 
                                Administrator determines that a 
                                longer period is required for 
                                the generation of the data.
                                  (II) Extraordinary 
                                circumstances.--In the case of 
                                extraordinary circumstances, 
                                the Administrator may provide 
                                such a longer period, of not 
                                more than 2 additional years, 
                                for submission of data to the 
                                Administrator under this 
                                subparagraph.
                  (C) After conducting the review required by 
                paragraph (1) for each active ingredient of a 
                pesticide and the review required by 
                subparagraph (B) of this paragraph, the 
                Administrator shall determine whether to 
                reregister a pesticide by determining whether 
                such pesticide meets the requirements of 
                section 3(c)(5). If the Administrator 
                determines that a pesticide is eligible to be 
                reregistered, the Administrator shall 
                reregister such pesticide within 6 months after 
                the submission of the data concerning such 
                pesticide under subparagraph (B).
                  (D) Determination to not reregister.--
                          (i) In general.--If after conducting 
                        a review under paragraph (1) or 
                        subparagraph (B) of this paragraph the 
                        Administrator determines that a 
                        pesticide should not be reregistered, 
                        the Administrator shall take 
                        appropriate regulatory action.
                          (ii) Timing for regulatory action.--
                        Regulatory action under clause (i) 
                        shall be completed as expeditiously as 
                        possible.
                  (E) As soon as the Administrator has 
                sufficient information with respect to the 
                dietary risk of a particular active ingredient, 
                but in any event no later than the time the 
                Administrator makes a determination under 
                subparagraph (C) or (D) with respect to 
                pesticides containing a particular active 
                ingredient, the Administrator shall--
                          (i) reassess each associated 
                        tolerance and exemption from the 
                        requirement for a tolerance issued 
                        under section 408 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 
                        346a);
                          (ii) determine whether such tolerance 
                        or exemption meets the requirements of 
                        that Act;
                          (iii) determine whether additional 
                        tolerances or exemptions should be 
                        issued;
                          (iv) publish in the Federal Register 
                        a notice setting forth the 
                        determinations made under this 
                        subparagraph; and
                          (v) commence promptly such 
                        proceedings under this Act and section 
                        408 of the Federal Food, Drug, and 
                        Cosmetic Act as are warranted by such 
                        determinations.
  (h) Compensation of Data Submitter.--If data that are 
submitted by a registrant under subsection (d), (e), (f), or 
(g) are used to support the application of another person under 
section 3, the registrant who submitted such data shall be 
entitled to compensation for the use of such data as prescribed 
by section 3(c)(1)(D). In determining the amount of such 
compensation, the fees paid by the registrant under this 
section shall be taken into account.
  (i) Fees.--
          (1) Maintenance fee.--
                  (A) In general.--Subject to other provisions 
                of this paragraph, each registrant of a 
                pesticide shall pay an annual fee by January 15 
                of each year for each registration, except that 
                no fee shall be charged for more than 200 
                registrations held by any registrant.
                  (B) In the case of a pesticide that is 
                registered for a minor agricultural use, the 
                Administrator may reduce or waive the payment 
                of the fee imposed under this paragraph if the 
                Administrator determines that the fee would 
                significantly reduce the availability of the 
                pesticide for the use.
                  (C) Total amount of fees.--The amount of each 
                fee prescribed under subparagraph (A) shall be 
                adjusted by the Administrator to a level that 
                will result in the collection under this 
                paragraph of, to the extent practicable, [an 
                aggregate amount of $27,800,000 for each of 
                fiscal years 2013 through 2017] an average 
                amount of $31,000,000 for each of fiscal years 
                2017 through 2023.
                  (D) Maximum amount of fees for registrants.--
                The maximum annual fee payable under this 
                paragraph by--
                          (i) a registrant holding not more 
                        than 50 pesticide registrations shall 
                        be [$115,500 for each of fiscal years 
                        2013 through 2017] $129,400 for each of 
                        fiscal years 2017 through 2023; and
                          (ii) a registrant holding over 50 
                        registrations shall be [$184,800 for 
                        each of fiscal years 2013 through 2017] 
                        $207,000 for each of fiscal years 2017 
                        through 2023.
                  (E) Maximum amount of fees for small 
                businesses.--
                          (i) In general.--For a small 
                        business, the maximum annual fee 
                        payable under this paragraph by--
                                  (I) a registrant holding not 
                                more than 50 pesticide 
                                registrations shall be [$70,600 
                                for each of fiscal years 2013 
                                through 2017] $79,100 for each 
                                of fiscal years 2017 through 
                                2023; and
                                  (II) a registrant holding 
                                over 50 pesticide registrations 
                                shall be [$122,100 for each of 
                                fiscal years 2013 through 2017] 
                                $136,800 for each of fiscal 
                                years 2017 through 2023.
                          (ii) Definition of small business.--
                                  (I) In general.--In clause 
                                (i), the term ``small 
                                business'' means a corporation, 
                                partnership, or unincorporated 
                                business that--
                                          (aa) has 500 or fewer 
                                        employees; and
                                          (bb) during the 3-
                                        year period prior to 
                                        the most recent 
                                        maintenance fee billing 
                                        cycle, had an average 
                                        annual global gross 
                                        revenue from pesticides 
                                        that did not exceed 
                                        $60,000,000.
                                  (II) Affiliates.--
                                          (aa) In general.--In 
                                        the case of a business 
                                        entity with 1 or more 
                                        affiliates, the gross 
                                        revenue limit under 
                                        subclause (I)(bb) shall 
                                        apply to the gross 
                                        revenue for the entity 
                                        and all of the 
                                        affiliates of the 
                                        entity, including 
                                        parents and 
                                        subsidiaries, if 
                                        applicable.
                                          (bb) Affiliated 
                                        persons.--For the 
                                        purpose of item (aa), 
                                        persons are affiliates 
                                        of each other if, 
                                        directly or indirectly, 
                                        either person controls 
                                        or has the power to 
                                        control the other 
                                        person, or a third 
                                        person controls or has 
                                        the power to control 
                                        both persons.
                                          (cc) Indicia of 
                                        control.--For the 
                                        purpose of item (aa), 
                                        indicia of control 
                                        include interlocking 
                                        management or 
                                        ownership, identity of 
                                        interests among family 
                                        members, shared 
                                        facilities and 
                                        equipment, and common 
                                        use of employees.
                  (F) Fee reduction for certain small 
                businesses.--
                          (i) Definition.--In this 
                        subparagraph, the term ``qualified 
                        small business entity'' means a 
                        corporation, partnership, or 
                        unincorporated business that--
                                  (I) has 500 or fewer 
                                employees;
                                  (II) during the 3-year period 
                                prior to the most recent 
                                maintenance fee billing cycle, 
                                had an average annual global 
                                gross revenue from all sources 
                                that did not exceed 
                                $10,000,000; and
                                  (III) holds not more than 5 
                                pesticide registrations under 
                                this paragraph.
                          (ii) Waiver.--Except as provided in 
                        clause (iii), the Administrator shall 
                        waive 25 percent of the fee under this 
                        paragraph applicable to the first 
                        registration of any qualified small 
                        business entity under this paragraph.
                          (iii) Limitation.--The Administrator 
                        shall not grant a waiver under clause 
                        (ii) to a qualified small business 
                        entity if the Administrator determines 
                        that the entity has been formed or 
                        manipulated primarily for the purpose 
                        of qualifying for the waiver.
                  (G) The Administrator shall exempt any public 
                health pesticide from the payment of the fee 
                prescribed under this paragraph if, in 
                consultation with the Secretary of Health and 
                Human Services, the Administrator determines, 
                based on information supplied by the 
                registrant, that the economic return to the 
                registrant from sales of the pesticide does not 
                support the registration or reregistration of 
                the pesticide.
                  (H) If any fee prescribed by this paragraph 
                with respect to the registration of a pesticide 
                is not paid by a registrant by the time 
                prescribed, the Administrator, by order and 
                without hearing, may cancel the registration.
                  (I) The authority provided under this 
                paragraph shall terminate on September 30, 
                [2017] 2023.
          (2) Other fees.--Except as provided in section 33, 
        [during the period beginning on the date of enactment 
        of this section and ending on September 30, 2019] until 
        September 30, 2025, the Administrator may not levy any 
        other fees for the registration of a pesticide under 
        this Act or any other action covered under a table 
        specified in section 33(b)(3), except as provided in 
        paragraph (1).
  (j) Exemption of Certain Registrants.--The requirements of 
subsections (d), (e), (f), and (i) (other than subsection 
(i)(1)) regarding data concerning an active ingredient and fees 
for review of such data shall not apply to any person who is 
the registrant of a pesticide to the extent that, under section 
3(c)(2)(D), the person would not be required to submit or cite 
such data to obtain an initial registration of such pesticide.
  (k) Reregistration and Expedited Processing Fund.--
          (1) Establishment.--There shall be established in the 
        Treasury of the United States a reregistration and 
        expedited processing fund which shall be known as the 
        Reregistration and Expedited Processing Fund.
          (2) Source and use.--
                  (A) All moneys derived from fees collected by 
                the Administrator under subsection (i) shall be 
                deposited in [the fund] the Reregistration and 
                Expedited Processing Fund and shall be 
                available to the Administrator, without fiscal 
                year limitation, specifically to offset the 
                costs of reregistration and expedited 
                processing of the applications specified in 
                [paragraph (3), to enhance the information 
                systems capabilities to improve the tracking of 
                pesticide registration decisions, and to offset 
                the costs of registration review under section 
                3(g). Such moneys derived from fees may not be 
                expended in any fiscal year to the extent such 
                moneys derived from fees would exceed money 
                appropriated for use by the Administrator and 
                expended in such year for such costs of 
                reregistration and expedited processing of such 
                applications.] paragraph (3), to offset the 
                costs of registration review under section 
                3(g), including the costs associated with any 
                review under the Endangered Species Act of 1973 
                (16 U.S.C. 1531 et. seq.) required as part of 
                the registration review, to offset the costs 
                associated with tracking and implementing 
                registration review decisions, including 
                registration review decisions designed to 
                reduce risk, for the purposes specified in 
                paragraphs (4) and (5), and to enhance the 
                information systems capabilities to improve the 
                tracking of pesticide registration decisions. 
                The Administrator shall, prior to expending any 
                such moneys derived from fees--
                          (i) effective October 1, 1997, adopt 
                        specific and cost accounting rules and 
                        procedures as approved by the General 
                        Accounting Office and the Inspector 
                        General of the Environmental Protection 
                        Agency to ensure that moneys derived 
                        from fees [are allocated solely to the 
                        costs of reregistration and expedited 
                        processing of the applications 
                        specified in paragraph (3), to enhance 
                        the information systems capabilities to 
                        improve the tracking of pesticide 
                        registration decisions, and to offset 
                        the costs of registration review under 
                        section 3(g);] are allocated solely for 
                        the purposes specified in the first 
                        sentence of this subparagraph;
                          (ii) prohibit the use of such moneys 
                        derived from fees to pay for any costs 
                        other than those [necessary to achieve 
                        reregistration and expedited processing 
                        of the applications specified in 
                        paragraph (3), to enhance the 
                        information systems capabilities to 
                        improve the tracking of pesticide 
                        registration decisions, and to offset 
                        the costs of registration review under 
                        section 3(g);] necessary to achieve the 
                        purposes specified in the first 
                        sentence of this subparagraph; and
                          (iii) ensure that personnel and 
                        facility costs associated with the 
                        functions to be carried out under this 
                        paragraph do not exceed agency averages 
                        for comparable personnel and facility 
                        costs.
                  (B) The Administrator shall also--
                          (i) complete the review of unreviewed 
                        reregistration studies required to 
                        support the reregistration eligibility 
                        decisions scheduled for completion in 
                        accordance with subsection (l)(2); and
                          (ii) contract for such outside 
                        assistance as may be necessary for 
                        review of required studies, using a 
                        generally accepted competitive process 
                        for the selection of vendors of such 
                        assistance.
          (3) Review of inert ingredients; expedited processing 
        of similar applications.--
                  (A) [The Administrator shall use for each of 
                the fiscal years 2004 through 2006, 
                approximately $3,300,000, and for each of 
                fiscal years 2013 through 2017, between \1/9\ 
                and \1/8\, of the maintenance fees collected in 
                such fiscal year to obtain sufficient personnel 
                and resources--] For each of fiscal years 2017 
                through 2023, the Administrator shall use 
                between \1/9\ and \1/8\ of the maintenance fees 
                collected in such fiscal year to obtain 
                sufficient personnel and resources--
                          (i) to review and evaluate inert 
                        ingredients; and
                          (ii) to ensure the expedited 
                        processing and review of any 
                        application that--
                                  (I) proposes the initial or 
                                amended registration of an end-
                                use pesticide that, if 
                                registered as proposed, would 
                                be identical or substantially 
                                similar in composition and 
                                labeling to a currently-
                                registered pesticide identified 
                                in the application, or that 
                                would differ in composition and 
                                labeling from any such 
                                currently-registered pesticide 
                                only in ways that would not 
                                significantly increase the risk 
                                of unreasonable adverse effects 
                                on the environment;
                                  (II) proposes an amendment to 
                                the registration of a 
                                registered pesticide that does 
                                not require scientific review 
                                of data; or
                                  (III) proposes the initial or 
                                amended registration of an end 
                                use pesticide that, if 
                                registered as proposed, would 
                                be used for a public health 
                                pesticide.
                  (B) Any amounts made available under 
                subparagraph (A) shall be used to obtain 
                sufficient personnel and resources to carry out 
                the activities described in such subparagraph 
                that are in addition to the personnel and 
                resources available to carry out such 
                activities on the date of enactment of this 
                section
                  (C) So long as the Administrator has not met 
                the time frames specified in clause (ii) of 
                section 3(c)(3)(B) with respect to any 
                application subject to section 3(c)(3)(B) that 
                was received prior to the date of enactment of 
                the Food Quality Protection Act of 1996, the 
                Administrator shall use the full amount of the 
                fees specified in subparagraph (A) for the 
                purposes specified therein. Once all 
                applications subject to section 3(c)(3)(B) that 
                were received prior to such date of enactment 
                have been acted upon, no limitation shall be 
                imposed by the preceding sentence of this 
                subparagraph so long as the Administrator meets 
                the time frames specified in clause (ii) of 
                section 3(c)(3)(B) on 90 percent of affected 
                applications in a fiscal year. Should the 
                Administrator not meet such time frames in a 
                fiscal year, the limitations imposed by the 
                first sentence of this subparagraph shall apply 
                until all overdue applications subject to 
                section 3(c)(3)(B) have been acted upon.
          [(4) Enhancements of information technology systems 
        for improvement in review of pesticide applications.--
                  [(A) In general.--For each of fiscal years 
                2013 through 2017, the Administrator shall use 
                not more than $800,000 of the amounts made 
                available to the Administrator in the 
                Reregistration and Expedited Processing Fund 
                for the activities described in subparagraph 
                (B).
                  [(B) Activities.--The Administrator shall use 
                amounts made available from the Reregistration 
                and Expedited Processing Fund to improve the 
                information systems capabilities for the Office 
                of Pesticide Programs to enhance tracking of 
                pesticide registration decisions, which shall 
                include--
                          [(i) the electronic tracking of--
                                  [(I) registration 
                                submissions; and
                                  [(II) the status of 
                                conditional registrations;
                          [(ii) enhancing the database for 
                        information regarding endangered 
                        species assessments for registration 
                        review;
                          [(iii) implementing the capability to 
                        electronically review labels submitted 
                        with registration actions; and
                          [(iv) acquiring and implementing the 
                        capability to electronically assess and 
                        evaluate confidential statements of 
                        formula submitted with registration 
                        actions.]
          (4) Expedited rulemaking and guidance development for 
        certain product performance data requirements.--
                  (A) Set-aside.--For each of fiscal years 2017 
                through 2021, the Administrator shall use not 
                more than $500,000 of the amounts made 
                available to the Administrator in the 
                Reregistration and Expedited Processing Fund 
                for the activities described in subparagraph 
                (B).
                  (B) Products claiming efficacy against 
                invertebrate pests of significant public health 
                or economic importance.--The Administrator 
                shall use amounts made available under 
                subparagraph (A) to develop, receive comments 
                with respect to, finalize, and implement the 
                necessary rulemaking and guidance for product 
                performance data requirements to evaluate 
                products claiming efficacy against the 
                following invertebrate pests of significant 
                public health or economic importance (in order 
                of importance):
                          (i) Bed bugs.
                          (ii) Premise (including crawling 
                        insects, flying insects, and baits).
                          (iii) Pests of pets (including pet 
                        pests controlled by spot-ons, collars, 
                        shampoos, powders, dips).
                          (iv) Fire ants.
                  (C) Deadlines for guidance.--The 
                Administrator shall develop, and publish 
                guidance required by subparagraph (B) with 
                respect to claims of efficacy against pests 
                described in such subparagraph as follows:
                          (i) With respect to bed bugs, issue 
                        final guidance not later than June 30, 
                        2017.
                          (ii) With respect to pests specified 
                        in clause (ii) of such subparagraph--
                                  (I) submit draft guidance to 
                                the Scientific Advisory Panel 
                                and for public comment not 
                                later than June 30, 2018; and
                                  (II) complete any response to 
                                comments received with respect 
                                to such draft guidance and 
                                finalize the guidance not later 
                                than September 30, 2020.
                          (iii) With respect to pests specified 
                        in clauses (iii) and (iv) of such 
                        subparagraph--
                                  (I) submit to the Scientific 
                                Advisory Panel and for public 
                                comment draft guidance not 
                                later than June 30, 2019; and
                                  (II) complete any response to 
                                comments received with respect 
                                to such draft guidance and 
                                finalize the guidance not later 
                                than March 31, 2021.
                  (D) Revision.--The Administrator shall revise 
                the guidance required by subparagraph (B) from 
                time-to-time, but shall permit applicants and 
                registrants sufficient time to obtain data that 
                meet the requirements specified in such revised 
                guidance.
                  (E) Deadline for product performance data 
                requirements.--The Administrator shall, not 
                later than September 30, 2021, issue 
                regulations prescribing product performance 
                data requirements for any pesticide intended 
                for preventing, destroying, repelling, or 
                mitigating any invertebrate pest of significant 
                public health or economic importance specified 
                in clauses (i) through (iv) of subparagraph 
                (B).
          (5) Good laboratory practices inspections.--
                  (A) Set-aside.--For each of fiscal years 2017 
                through 2023, the Administrator shall use not 
                more than $500,000 of the amounts made 
                available to the Administrator in the 
                Reregistration and Expedited Processing Fund 
                for the activities described in subparagraph 
                (B).
                  (B) Activities.--The Administrator shall use 
                amounts made available under subparagraph (A) 
                for enhancements to the good laboratory 
                practices standards compliance monitoring 
                program established under part 160 of title 40 
                of the Code of Federal Regulations (or 
                successor regulations), with respect to 
                laboratory inspections and data audits 
                conducted in support of pesticide product 
                registrations under this Act. As part of such 
                monitoring program, the Administrator shall 
                make available to each laboratory inspected 
                under such program in support of such 
                registrations a preliminary summary of 
                inspection observations not later than 60 days 
                after the date on which such an inspection is 
                completed.
          [(5)] (6) Unused funds.--Money in the fund not 
        currently needed to carry out this section shall be--
                  (A) maintained on hand or on deposit;
                  (B) invested in obligations of the United 
                States or guaranteed thereby; or
                  (C) invested in obligations, participations, 
                or other instruments that are lawful 
                investments for fiduciary, trust, or public 
                funds.
          [(6)] (7) Accounting and performance.--The 
        Administrator shall take all steps necessary to ensure 
        that expenditures from fees authorized by subsection 
        (i)(1)(C)(ii) are used only for the purposes described 
        in [paragraphs (2), (3), and (4)] paragraphs (2), (3), 
        (4), and (5) and to carry out the goals established 
        under subsection (l). The Reregistration and Expedited 
        Processing Fund shall be designated as an Environmental 
        Protection Agency component for purposes of section 
        3515(c) of title 31, United States Code. The annual 
        audit required under section 3521 of such title of the 
        financial statements of activities under this Act under 
        section 3515(b) of such title shall include an audit of 
        the fees collected under subsection (i)(1)(C) and 
        disbursed, of the amount appropriated to match such 
        fees, and of the Administrator's attainment of 
        performance measures and goals established under 
        subsection (l). Such an audit shall also include a 
        review of the reasonableness of the overhead allocation 
        and adequacy of disclosures of direct and indirect 
        costs associated with carrying out the reregistration 
        and expedited processing of the applications specified 
        in paragraph (3), and the basis for and accuracy of all 
        costs paid with moneys derived from such fees. The 
        Inspector General shall conduct the annual audit and 
        report the findings and recommendations of such audit 
        to the Administrator and to the Committees on 
        Agriculture of the House of Representatives and the 
        Senate. The cost of such audit shall be paid for out of 
        the fees collected under subsection (i)(1)(C).
  (l) Performance Measures and Goal.--The Administrator shall 
establish and publish annually in the Federal Register 
performance measures and goals. Such measures and goals shall 
include--
          (1) the number of products reregistered, canceled, or 
        amended, the status of reregistration, the number and 
        type of data requests under section 3(c)(2)(B) issued 
        to support product reregistration by active ingredient, 
        the progress in reducing the number of unreviewed, 
        required reregistration studies, the aggregate status 
        of tolerances reassessed, and the number of 
        applications for registration submitted under 
        subsection (k)(3) that were approved or disapproved;
          (2) the future schedule for reregistrations, 
        including the projection for such schedules that will 
        be issued under subsection (g)(2)(A) and (B) in the 
        current fiscal year and the succeeding fiscal year; and
          (3) the projected year of completion of the 
        reregistrations under this section.
  (m) Judicial Review.--Any failure of the Administrator to 
take any action required by this section shall be subject to 
judicial review under the procedures prescribed by section 
16(b).
  (n) Authorization of Funds To Develop Public Health Data.--
          (1) Definition.--For the purposes of this section, 
        ``Secretary'' means the Secretary of Health and Human 
        Services, acting through the Public Health Service.
          (2) Consultation.--In the case of a pesticide 
        registered for use in public health programs for vector 
        control or for other uses the Administrator determines 
        to be human health protection uses, the Administrator 
        shall, upon timely request by the registrant or any 
        other interested person, or on the Administrator's own 
        initiative may, consult with the Secretary prior to 
        taking final action to suspend registration under 
        section 3(c)(2)(B)(iv), or cancel a registration under 
        section 4, 6(e), or 6(f). In consultation with the 
        Secretary, the Administrator shall prescribe the form 
        and content of requests under this section.
          (3) Benefits to support family.--The Administrator, 
        after consulting with the Secretary, shall make a 
        determination whether the potential benefits of 
        continued use of the pesticide for public health or 
        health protection purposes are of such significance as 
        to warrant a commitment by the Secretary to conduct or 
        to arrange for the conduct of the studies required by 
        the Administrator to support continued registration 
        under section 3 or reregistration under section 4.
          (4) Additional time.--If the Administrator determines 
        that such a commitment is warranted and in the public 
        interest, the Administrator shall notify the Secretary 
        and shall, to the extent necessary, amend a notice 
        issued under section 3(c)(2)(B) to specify additional 
        reasonable time periods for submission of the data.
          (5) Arrangements.--The Secretary shall make such 
        arrangements for the conduct of required studies as the 
        Secretary finds necessary and appropriate to permit 
        submission of data in accordance with the time periods 
        prescribed by the Administrator. Such arrangements may 
        include Public Health Service intramural research 
        activities, grants, contracts, or cooperative 
        agreements with academic, public health, or other 
        organizations qualified by experience and training to 
        conduct such studies.
          (6) Support.--The Secretary may provide for support 
        of the required studies using funds authorized to be 
        appropriated under this section, the Public Health 
        Service Act, or other appropriate authorities. After a 
        determination is made under subsection (d), the 
        Secretary shall notify the Committees on Appropriations 
        of the House of Representatives and the Senate of the 
        sums required to conduct the necessary studies.
          (7) Authorization of appropriations.--There is 
        authorized to be appropriated to carry out the purposes 
        of this section $12,000,000 for fiscal year 1997, and 
        such sums as may be necessary for succeeding fiscal 
        years.

SEC. 5. EXPERIMENTAL USE PERMITS.

  [(a) Issuance.--Any person may apply to the Administrator for 
an experimental use permit for a pesticide. The Administrator 
shall review the application. After completion of the review, 
but not later than one hundred and twenty days after receipt of 
the application and all required supporting data, the 
Administrator shall either issue the permit or notify the 
applicant of the Administrator's determination not to issue the 
permit and the reasons therefor. The applicant may correct the 
application or request a waiver of the conditions for such 
permit within thirty days of receipt by the applicant of such 
notification. The Administrator may issue an experimental use 
permit only if the Administrator determines that the applicant 
needs such permit in order to accumulate information necessary 
to register a pesticide under section 3 of this Act. An 
application for an experimental use permit may be filed at any 
time.]
  (a) Application and Issuance.--
          (1) Application.--Any person may apply to the 
        Administrator for an experimental use permit for a 
        pesticide. An application for an experimental use 
        permit may be filed at any time.
          (2) Requirements.--An application for an experimental 
        use permit shall conform with the requirements of 
        section 33(b).
          (3) Issuance.--The decision whether to grant an 
        experimental use permit shall be made within the time-
        frame specified in the applicable covered application 
        category specified in section 33(b)(3).
  (b) Temporary Tolerance Level.--If the Administrator 
determines that the use of a pesticide may reasonably be 
expected to result in any residue on or in food or feed, the 
Administrator may establish a temporary tolerance level for the 
residue of the pesticide before issuing the experimental use 
permit.
  (c) Use Under Permit.--Use of a pesticide under an 
experimental use permit shall be under the supervision of the 
Administrator, and shall be subject to such terms and 
conditions and be for such period of time as the Administrator 
may prescribe in the permit.
  (d) Studies.--When any experimental use permit is issued for 
a pesticide containing any chemical or combination of chemicals 
which has not been included in any previously registered 
pesticide, the Administrator may specify that studies be 
conducted to detect whether the use of the pesticide under the 
permit may cause unreasonable adverse effects on the 
environment. All results of such studies shall be reported to 
the Administrator before such pesticide may be registered under 
section 3.
  (e) Revocation.--The Administrator may revoke any 
experimental use permit, at any time, if the Administrator 
finds that its terms or conditions are being violated, or that 
its terms and conditions are inadequate to avoid unreasonable 
adverse effects on the environment.
  (f) State Issuance of Permits.--Notwithstanding the foregoing 
provisions of this section, the Administrator shall, under such 
terms and conditions as the Administrator may by regulations 
prescribe, authorize any State to issue an experimental use 
permit for a pesticide. All provisions of section 11 relating 
to State plans shall apply with equal force to a State plan for 
the issuance of experimental use permits under this section.
  (g) Exemption for Agricultural Research Agencies.--
Notwithstanding the foregoing provisions of this section, the 
Administrator may issue an experimental use permit for a 
pesticide to any public or private agricultural research agency 
or educational institution which applies for such permit. Each 
permit shall not exceed more than a one-year period or such 
other specific time as the Administrator may prescribe. Such 
permit shall be issued under such terms and conditions 
restricting the use of the pesticide as the Administrator may 
require. Such pesticide may be used only by such research 
agency or educational institution for purposes of 
experimentation.

           *       *       *       *       *       *       *


SEC. 33. PESTICIDE REGISTRATION SERVICE FEES.

  (a) Definition of Costs.--In this section, the term 
``costs'', when used with respect to review and decisionmaking 
pertaining to an application for which registration service 
fees are paid under this section, means--
          (1) costs to the extent that--
                  (A) officers and employees provide direct 
                support for the review and decisionmaking for 
                covered pesticide applications, associated 
                tolerances, and corresponding risk and benefits 
                information and analyses;
                  (B) persons and organizations under contract 
                with the Administrator engage in the review of 
                the applications, and corresponding risk and 
                benefits information and assessments; and
                  (C) advisory committees and other accredited 
                persons or organizations, on the request of the 
                Administrator, engage in the peer review of 
                risk or benefits information associated with 
                covered pesticide applications;
          (2) costs of management of information, and the 
        acquisition, maintenance, and repair of computer and 
        telecommunication resources (including software), used 
        to support review of pesticide applications, associated 
        tolerances, and corresponding risk and benefits 
        information and analyses; and
          (3) costs of collecting registration service fees 
        under subsections (b) and (c) and reporting, auditing, 
        and accounting under this section.
  (b) Fees.--
          (1) In general.--Effective beginning on the effective 
        date of the Pesticide Registration Improvement Act of 
        2003, the Administrator shall assess and collect 
        covered pesticide registration service fees in 
        accordance with this section.
          (2) Covered [pesticide registration] applications.--
                  (A) In general.--An application for the 
                registration of a pesticide covered by this Act 
                that is received by the Administrator on or 
                after the effective date of the Pesticide 
                Registration Improvement Act of 2003 or for any 
                other action covered by a table specified in 
                paragraph (3) shall be subject to a 
                registration service fee under this section.
                  (B) Existing applications.--
                          (i) In general.--Subject to clause 
                        (ii), an application for the 
                        registration of a pesticide that was 
                        submitted to the Administrator before 
                        the effective date of the Pesticide 
                        Registration Improvement Act of 2003 
                        and is pending on that effective date 
                        shall be subject to a service fee under 
                        this section if the application is for 
                        the registration of a new active 
                        ingredient that is not listed in the 
                        Registration Division 2003 Work Plan of 
                        the Office of Pesticide Programs of the 
                        Environmental Protection Agency.
                          (ii) Tolerance or exemption fees.--
                        The amount of any fee otherwise payable 
                        for an application described in clause 
                        (i) under this section shall be reduced 
                        by the amount of any fees paid to 
                        support the related petition for a 
                        pesticide tolerance or exemption under 
                        the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 301 et seq.).
                  (C) Documentation.--An application subject to 
                a registration service fee under this section 
                shall be submitted with documentation 
                certifying--
                          (i) payment of the registration 
                        service fee; or
                          (ii) payment of at least 25 percent 
                        of the registration service fee and a 
                        request for a waiver from or reduction 
                        of the remaining amount of the 
                        registration service fee.
                  (D) Payment.--The registration service fee 
                required under this subsection shall be due 
                upon submission of the application.
                  (E) Applications subject to additional 
                fees.--An application may be subject to 
                additional fees if--
                          (i) the applicant identified the 
                        incorrect registration service fee and 
                        decision review period;
                          (ii) after review of a waiver 
                        request, the Administrator denies the 
                        waiver request; or
                          (iii) after review of the 
                        application, the Administrator 
                        determines that a different 
                        registration service fee and decision 
                        review period apply to the application.
                  (F) Effect of failure to pay fees.--The 
                Administrator shall reject any application 
                submitted without the required registration 
                service fee.
                  (G) Non-refundable portion of fees.--
                          (i) In general.--The Administrator 
                        shall retain 25 percent of the 
                        applicable registration service fee.
                          (ii) Limitation.--Any waiver, refund, 
                        credit or other reduction in the 
                        registration service fee shall not 
                        exceed 75 percent of the registration 
                        service fee.
                  (H) Collection of unpaid fees.--In any case 
                in which the Administrator does not receive 
                payment of a registration service fee (or 
                applicable portion of the registration service 
                fee) by the date that is 30 days after the fee 
                is due, the fee shall be treated as a claim of 
                the United States Government subject to 
                subchapter II of chapter 37 of title 31, United 
                States Code.
          [(3) Schedule of covered applications and 
        registration service fees.--Subject to paragraph (6), 
        the schedule of covered pesticide registration 
        applications and corresponding registration service 
        fees shall be as follows:


                          [TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R010              1                New Active Ingredient, Food use (2) (3)     24                        569,221
----------------------------------------------------------------------------------------------------------------
R020              2                New Active Ingredient, Food use; reduced    18                        569,221
                                    risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R040              3                New Active Ingredient, Food use;            18                        419,502
                                    Experimental Use Permit application;
                                    establish temporary tolerance; submitted
                                    before application for registration;
                                    credit 45% of fee toward new active
                                    ingredient application that follows (3)
----------------------------------------------------------------------------------------------------------------
R060              4                New Active Ingredient, Non-food use;        21                        395,467
                                    outdoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R070              5                New Active Ingredient, Non-food use;        16                        395,467
                                    outdoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R090              6                New Active Ingredient, Non-food use;        16                        293,596
                                    outdoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient (3)
----------------------------------------------------------------------------------------------------------------
R110              7                New Active Ingredient, Non-food use;        20                        219,949
                                    indoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R120              8                New Active Ingredient, Non-food use;        14                        219,949
                                    indoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R121              9                New Active Ingredient, Non-food use;        18                        165,375
                                    indoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient application
                                    that follows (3)
----------------------------------------------------------------------------------------------------------------
R122              10               Enriched isomer(s) of registered mixed-     18                        287,643
                                    isomer active ingredient (2) (3)
----------------------------------------------------------------------------------------------------------------
R123              11               New Active Ingredient, Seed treatment       18                        427,991
                                    only; includes agricultural and non-
                                    agricultural seeds; residues not expected
                                    in raw agricultural commodities (2) (3)
----------------------------------------------------------------------------------------------------------------
R125              12               New Active Ingredient, Seed treatment;      16                        293,596
New                                 Experimental Use Permit application;
                                    submitted before application for
                                    registration; credit 45% of fee toward
                                    new active ingredient application that
                                    follows (3)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                 [TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R130              13               First food use; indoor; food/food handling  21                        173,644
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
R140              14               Additional food use; Indoor; food/food      15                         40,518
                                    handling (3) (4)
----------------------------------------------------------------------------------------------------------------
R150              15               First food use (2) (3)                      21                        239,684
----------------------------------------------------------------------------------------------------------------
R160              16               First food use; reduced risk (2) (3)        16                        239,684
----------------------------------------------------------------------------------------------------------------
R170              17               Additional food use (3) (4)                 15                         59,976
----------------------------------------------------------------------------------------------------------------
R175              18               Additional food uses covered within a crop  10                         59,976
New                                 group resulting from the conversion of
                                    existing approved crop group(s) to one or
                                    more revised crop groups. (3) (4)
----------------------------------------------------------------------------------------------------------------
R180              19               Additional food use; reduced risk (3) (4)   10                         59,976
----------------------------------------------------------------------------------------------------------------
R190              20               Additional food uses; 6 or more submitted   15                        359,856
                                    in one application (3) (4)
----------------------------------------------------------------------------------------------------------------
R200              21               Additional food uses; 6 or more submitted   10                        359,856
                                    in one application; reduced risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R210              22               Additional food use; Experimental Use       12                         44,431
                                    Permit application; establish temporary
                                    tolerance; no credit toward new use
                                    registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R220              23               Additional food use; Experimental Use       6                          17,993
                                    Permit application; crop destruct basis;
                                    no credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R230              24               Additional use; non-food; outdoor (3) (4)   15                         23,969
----------------------------------------------------------------------------------------------------------------
R240              25               Additional use; non-food; outdoor; reduced  10                         23,969
                                    risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R250              26               Additional use; non-food; outdoor;          6                          17,993
                                    Experimental Use Permit application; no
                                    credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R251              27               Experimental Use Permit application which   8                          17,993
New                                 requires no changes to the tolerance(s);
                                    non-crop destruct basis (3)
----------------------------------------------------------------------------------------------------------------
R260              28               New use; non-food; indoor (3) (4)           12                         11,577
----------------------------------------------------------------------------------------------------------------
R270              29               New use; non-food; indoor; reduced risk     9                          11,577
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
R271              30               New use; non-food; indoor; Experimental     6                           8,820
                                    Use Permit application; no credit toward
                                    new use registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R273              31               Additional use; seed treatment; limited     12                         45,754
                                    uptake into raw agricultural commodities;
                                    includes crops with established
                                    tolerances (e.g., for soil or foliar
                                    application); includes food or non-food
                                    uses (3) (4)
----------------------------------------------------------------------------------------------------------------
R274              32               Additional uses; seed treatment only; 6 or  12                        274,523
                                    more submitted in one application;
                                    limited uptake into raw agricultural
                                    commodities; includes crops with
                                    established tolerances (e.g., for soil or
                                    foliar application); includes food and/or
                                    non-food uses (3) (4)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
[(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.



                        [TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                         Decision
                                                                                       Review Time  Registration
     [EPA No.                       New CR No.                          Action           (Months)    Service Fee
                                                                                           (1)           ($)
----------------------------------------------------------------------------------------------------------------
R280               33                                            Establish import               21  289,407
                                                                  tolerance; new
                                                                  active ingredient
                                                                  or first food use
                                                                  (2)
----------------------------------------------------------------------------------------------------------------
R290               34                                            Establish import               15  57,882
                                                                  tolerance;
                                                                  additional food use
----------------------------------------------------------------------------------------------------------------
R291               35                                            Establish import               15  347,288
                                                                  tolerances;
                                                                  additional food
                                                                  uses; 6 or more
                                                                  crops submitted in
                                                                  one petition
----------------------------------------------------------------------------------------------------------------
R292               36                                            Amend an established           11  41,124
                                                                  tolerance (e.g.,
                                                                  decrease or
                                                                  increase); domestic
                                                                  or import;
                                                                  applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293               37                                            Establish                      12  48,510
                                                                  tolerance(s) for
                                                                  inadvertent
                                                                  residues in one
                                                                  crop; applicant-
                                                                  initiated
----------------------------------------------------------------------------------------------------------------
R294               38                                            Establish tolerances           12  291,060
                                                                  for inadvertent
                                                                  residues; 6 or more
                                                                  crops submitted in
                                                                  one application;
                                                                  applicant-initiated
----------------------------------------------------------------------------------------------------------------
R295               39                                            Establish                      15  59,976
                                                                  tolerance(s) for
                                                                  residues in one
                                                                  rotational crop in
                                                                  response to a
                                                                  specific rotational
                                                                  crop application;
                                                                  applicant-initiated
----------------------------------------------------------------------------------------------------------------
R296               40                                            Establish tolerances           15  359,856
                                                                  for residues in
                                                                  rotational crops in
                                                                  response to a
                                                                  specific rotational
                                                                  crop petition; 6 or
                                                                  more crops
                                                                  submitted in one
                                                                  application;
                                                                  applicant-initiated
----------------------------------------------------------------------------------------------------------------
R297               41                                            Amend 6 or more                11  246,744
New                                                               established
                                                                  tolerances (e.g.,
                                                                  decrease or
                                                                  increase) in one
                                                                  petition; domestic
                                                                  or import;
                                                                  applicant-initiated
----------------------------------------------------------------------------------------------------------------
R298               42                                            Amend an established           13  53,120
New                                                               tolerance (e.g.,
                                                                  decrease or
                                                                  increase); domestic
                                                                  or import;
                                                                  submission of
                                                                  amended labels
                                                                  (requiring science
                                                                  review) in addition
                                                                  to those associated
                                                                  with the amended
                                                                  tolerance;
                                                                  applicant-initiated
                                                                  (3)
----------------------------------------------------------------------------------------------------------------
R299               43                                            Amend 6 or more                13  258,740
New                                                               established
                                                                  tolerances (e.g.,
                                                                  decrease or
                                                                  increase); domestic
                                                                  or import;
                                                                  submission of
                                                                  amended labels
                                                                  (requiring science
                                                                  review) in addition
                                                                  to those associated
                                                                  with the amended
                                                                  tolerance;
                                                                  applicant-initiated
                                                                  (3)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                               [TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R300              44               New product; or similar combination         4                           1,434
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; no data review on acute
                                    toxicity, efficacy or CRP - only product
                                    chemistry data; cite-all data citation,
                                    or selective data citation where
                                    applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter from data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------
R301              45               New product; or similar combination         4                           1,720
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; selective data citation only
                                    for data on product chemistry and/or
                                    acute toxicity and/or public health pest
                                    efficacy, where applicant does not own
                                    all required data and does not have a
                                    specific authorization letter from data
                                    owner. (2) (3)
----------------------------------------------------------------------------------------------------------------
R310              46               New end-use or manufacturing-use product    7                           4,807
                                    with registered source(s) of active
                                    ingredient(s); includes products
                                    containing two or more registered active
                                    ingredients previously combined in other
                                    registered products; requires review of
                                    data package within RD only; includes
                                    data and/or waivers of data for only:
                                   g product chemistry and/or
                                   g acute toxicity and/or
                                   g public health pest efficacy and/or
                                   g child resistant packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------
R314              47               New end use product containing two or more  8                           6,009
New                                 registered active ingredients never
                                    before registered as this combination in
                                    a formulated product; new product label
                                    is identical or substantially similar to
                                    the labels of currently registered
                                    products which separately contain the
                                    respective component active ingredients;
                                    requires review of data package within RD
                                    only; includes data and/or waivers of
                                    data for only:
                                   g product chemistry and/or
                                   g acute toxicity and/or
                                   g public health pest efficacy and/or
                                   g child resistant packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------
R315              48               New end-use non-food animal product with    9                           8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                   g product chemistry and/or
                                   g acute toxicity and/or
                                   g public health pest efficacy and/or
                                   g animal safety studies and/or
                                   g child resistant packaging (2) (3)
----------------------------------------------------------------------------------------------------------------
R320              49               New product; new physical form; requires    12                         11,996
                                    data review in science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R331              50               New product; repack of identical            3                           2,294
                                    registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2) (3)
----------------------------------------------------------------------------------------------------------------
R332              51               New manufacturing-use product; registered   24                        256,883
                                    active ingredient; unregistered source of
                                    active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only; requires review in
                                    RD and science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R333              52               New product; MUP or End use product with    10                         17,993
New                                 unregistered source of active ingredient;
                                    requires science data review; new
                                    physical form; etc. Cite-all or selective
                                    data citation where applicant owns all
                                    required data. (2) (3)
----------------------------------------------------------------------------------------------------------------
R334              53               New product; MUP or End use product with    11                         17,993
New                                 unregistered source of the active
                                    ingredient; requires science data review;
                                    new physical form; etc. Selective data
                                    citation. (2) (3)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                        [TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R340              54               Amendment requiring data review within RD   4                           3,617
                                    (e.g., changes to precautionary label
                                    statements) (2) (3)
----------------------------------------------------------------------------------------------------------------
R345              55               Amending non-food animal product that       7                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R350              56               Amendment requiring data review in science  9                          11,996
                                    divisions (e.g., changes to REI, or PPE,
                                    or PHI, or use rate, or number of
                                    applications; or add aerial application;
                                    or modify GW/SW advisory statement) (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R351              57               Amendment adding a new unregistered source  8                          11,996
New                                 of active ingredient. (2) (3)
----------------------------------------------------------------------------------------------------------------
R352              58               Amendment adding already approved uses;     8                          11,996
New                                 selective method of support; does not
                                    apply if the applicant owns all cited
                                    data (2) (3)
----------------------------------------------------------------------------------------------------------------
R371              59               Amendment to Experimental Use Permit;       6                           9,151
                                    (does not include extending a permit's
                                    time period) (3)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                               [TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R124              60               Conditional Ruling on Preapplication Study  6                           2,294
                                    Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R272              61               Review of Study Protocol applicant-         3                           2,294
                                    initiated; excludes DART, pre-
                                    registration conference, Rapid Response
                                    review, DNT protocol review, protocol
                                    needing HSRB review
----------------------------------------------------------------------------------------------------------------
R275              62               Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
R370              63               Cancer reassessment; applicant-initiated    18                        179,818
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.



                         [TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A380              64               Food use; establish tolerance exemption     24                        104,187
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
A390              65               Food use; establish tolerance (2) (3)       24                        173,644
----------------------------------------------------------------------------------------------------------------
A400              66               Non-food use; outdoor; FIFRA Sec. 2(mm)     18                         86,823
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A410              67               Non-food use; outdoor; uses other than      21                        173,644
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A420              68               Non-food use; indoor; FIFRA Sec. 2(mm)      18                         57,882
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A430              69               Non-food use; indoor; uses other than       20                         86,823
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A431              70               Non-food use; indoor; low-risk, low-        12                         60,638
                                    toxicity food-grade active ingredient(s);
                                    efficacy testing for public health claims
                                    required under GLP and following DIS/TSS
                                    or AD-approved study protocol (2) (3)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                [TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A440              71               First food use; establish tolerance         21                         28,942
                                    exemption (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
A450              72               First food use; establish tolerance (2)     21                         86,823
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
A460              73               Additional food use; establish tolerance    15                         11,577
                                    exemption (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A470              74               Additional food use; establish tolerance    15                         28,942
                                    (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A471              75               Additional food uses; establish             15                        173,652
New                                 tolerances; 6 or more submitted in one
                                    application (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A480              76               Additional use; non-food; outdoor; FIFRA    9                          17,365
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A481              77               Additional non-food outdoor uses; FIFRA     9                         104,190
New                                 Sec. 2(mm) uses; 6 or more submitted in
                                    one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A490              78               Additional use; non-food; outdoor; uses     15                         28,942
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A491              79               Additional non-food; outdoor; uses other    15                        173,652
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A500              80               Additional use; non-food, indoor, FIFRA     9                          11,577
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A501              81               Additional non-food; indoor; FIFRA Sec.     9                          69,462
New                                 2(mm) uses; 6 or more submitted in one
                                    application (4) (5)
----------------------------------------------------------------------------------------------------------------
A510              82               Additional use; non-food; indoor; uses      12                         11,577
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A511              83               Additional non-food; indoor; uses other     12                         69,462
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient
  of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review
  of the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
[(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
[(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.



                       [TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A530              84               New product; identical or substantially     4                           1,159
                                    similar in composition and use to a
                                    registered product; no data review or
                                    only product chemistry data; cite-all
                                    data citation, or selective data citation
                                    when applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter for data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------
A531              85               New product; identical or substantially     4                           1,654
                                    similar in composition and use to a
                                    registered product; registered source of
                                    active ingredient: selective data
                                    citation only for data on product
                                    chemistry and/or acute toxicity and/or
                                    public health pest efficacy, where
                                    applicant does not own all required data
                                    and does not have a specific
                                    authorization letter from data owner. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
A532              86               New product; identical or substantially     5                           4,631
                                    similar in composition and use to a
                                    registered product; registered active
                                    ingredient; unregistered source of active
                                    ingredient; cite-all data citation except
                                    for product chemistry; product chemistry
                                    data submitted (2) (3)
----------------------------------------------------------------------------------------------------------------
A540              87               New end use product; FIFRA Sec. 2(mm) uses  5                           4,631
                                    only (2) (3)
----------------------------------------------------------------------------------------------------------------
A550              88               New end-use product; uses other than FIFRA  7                           4,631
                                    Sec. 2(mm); non-FQPA product (2) (3)
----------------------------------------------------------------------------------------------------------------
A560              89               New manufacturing-use product; registered   12                         17,365
                                    active ingredient; selective data
                                    citation (2) (3)
----------------------------------------------------------------------------------------------------------------
A570              90               Label amendment requiring data review (3)   4                           3,474
                                    (4)
----------------------------------------------------------------------------------------------------------------
A572              91               New Product or amendment requiring data     9                          11,996
New                                 review for risk assessment by Science
                                    Branch (e.g., changes to REI, or PPE, or
                                    use rate) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
[(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
[(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.



           [TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A520              92               Experimental Use Permit application, Non-   9                           5,789
                                    Food Use (2)
----------------------------------------------------------------------------------------------------------------
A521              93               Review of public health efficacy study      3                           2,250
                                    protocol within AD, per AD Internal
                                    Guidance for the Efficacy Protocol Review
                                    Process; Code will also include review of
                                    public health efficacy study protocol and
                                    data review for devices making pesticidal
                                    claims; applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522              94               Review of public health efficacy study      12                         11,025
                                    protocol outside AD by members of AD
                                    Efficacy Protocol Review Expert Panel;
                                    Code will also include review of public
                                    health efficacy study protocol and data
                                    review for devices making pesticidal
                                    claims; applicant-initiated; Tier 2
----------------------------------------------------------------------------------------------------------------
A524              95               New Active Ingredient, Experimental Use     18                        138,916
New                                 Permit application; Food Use Requires
                                    Tolerance. Credit 45% of fee toward new
                                    active ingredient application that
                                    follows. (2)
----------------------------------------------------------------------------------------------------------------
A525              96               New Active Ingredient, Experimental Use     18                         83,594
New                                 Permit application; Food Use Requires
                                    Tolerance Exemption. Credit 45% of fee
                                    toward new active ingredient application
                                    that follows. (2)
----------------------------------------------------------------------------------------------------------------
A526              97               New Active Ingredient, Experimental Use     15                         86,823
New                                 Permit application; Non-Food, Outdoor
                                    Use. Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A527              98               New Active Ingredient, Experimental Use     15                         58,000
New                                 Permit application; Non-Food, Indoor Use.
                                    Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A528              99               Experimental Use Permit application, Food   15                         20,260
New                                 Use; Requires Tolerance or Tolerance
                                    Exemption (2)
----------------------------------------------------------------------------------------------------------------
A529              100              Amendment to Experimental Use Permit;       9                          10,365
New                                 requires data review or risk assessment
                                    (2)
----------------------------------------------------------------------------------------------------------------
A523              101              Review of protocol other than a public      9                          11,025
New                                 health efficacy study (i.e., Toxicology
                                    or Exposure Protocols)
----------------------------------------------------------------------------------------------------------------
A571              102              Science reassessment: Cancer risk, refined  18                         86,823
New                                 ecological risk, and/or endangered
                                    species; applicant-initiated
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



   [TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                               ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B580              103              New active ingredient; food use; petition   19                         46,305
                                    to establish a tolerance (2)
----------------------------------------------------------------------------------------------------------------
B590              104              New active ingredient; food use; petition   17                         28,942
                                    to establish a tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B600              105              New active ingredient; non-food use (2)     13                         17,365
----------------------------------------------------------------------------------------------------------------
B610              106              New active ingredient; Experimental Use     10                         11,577
                                    Permit application; petition to establish
                                    a temporary tolerance or temporary
                                    tolerance exemption
----------------------------------------------------------------------------------------------------------------
B611              107              New active ingredient; Experimental Use     12                         11,577
New                                 Permit application; petition to establish
                                    permanent tolerance exemption
----------------------------------------------------------------------------------------------------------------
B612              108              New active ingredient; no change to a       10                         15,918
New                                 permanent tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B613              109              New active ingredient; petition to convert  11                         15,918
New                                 a temporary tolerance or a temporary
                                    tolerance exemption to a permanent
                                    tolerance or tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B620              110              New active ingredient; Experimental Use     7                           5,789
                                    Permit application; non-food use
                                    including crop destruct
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time,
  except where the new inert approval decision review time is greater than that for the new active ingredient,
  in which case the associated new active ingredient will be subject to the new inert approval decision review
  time. In the case of a new active ingredient application, until that new active ingredient is approved, any
  subsequent application for another new product containing the same active ingredient or an amendment to the
  proposed labeling will be deemed a new active ingredient application, subject to the registration service fee
  and decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.



 [TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B630              111              First food use; petition to establish a     13                         11,577
                                    tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B631              112              New food use; petition to amend an          12                         11,577
                                    established tolerance (3)
----------------------------------------------------------------------------------------------------------------
B640              113              First food use; petition to establish a     19                         17,365
                                    tolerance (2)
----------------------------------------------------------------------------------------------------------------
B643              114              New Food use; petition to amend tolerance   10                         11,577
New                                 exemption (3)
----------------------------------------------------------------------------------------------------------------
B642              115              First food use; indoor; food/food handling  12                         28,942
New                                 (2)
----------------------------------------------------------------------------------------------------------------
B644              116              New use, no change to an established        8                          11,577
New                                 tolerance or tolerance exemption (3)
----------------------------------------------------------------------------------------------------------------
B650              117              New use; non-food (3)                       7                           5,789
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


   [TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                                    PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B652              118              New product; registered source of active    13                         11,577
New                                 ingredient; requires petition to amend
                                    established tolerance or tolerance
                                    exemption; requires 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of scientifically-
                                    sound rationale based on publicly
                                    available literature or other relevant
                                    information that addresses the data
                                    requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply (2)
----------------------------------------------------------------------------------------------------------------
B660              119              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. For
                                    microbial pesticides, the active
                                    ingredient(s) must not be re-isolated.
                                    (2)
----------------------------------------------------------------------------------------------------------------
B670              120              New product; registered source of active    7                           4,631
                                    ingredient(s); no change in an
                                    established tolerance or tolerance
                                    exemption; requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B671              121              New product; unregistered source of active  17                         11,577
                                    ingredient(s); requires a petition to
                                    amend an established tolerance or
                                    tolerance exemption; requires: 1)
                                    submission of product specific data; or
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B672              122              New product; unregistered source of active  13                          8,269
                                    ingredient(s); non-food use or food use
                                    with a tolerance or tolerance exemption
                                    previously established for the active
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B673              123              New product MUP/EP; unregistered source of  10                          4,631
New                                 active ingredient(s); citation of
                                    Technical Grade Active Ingredient (TGAI)
                                    data previously reviewed and accepted by
                                    the Agency. Requires an Agency
                                    determination that the cited data
                                    supports the new product. (2)
----------------------------------------------------------------------------------------------------------------
B674              124              New product MUP; Repack of identical        4                           1,159
New                                 registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2)
----------------------------------------------------------------------------------------------------------------
B675              125              New Product MUP; registered source of       10                          8,269
New                                 active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only. (2)
----------------------------------------------------------------------------------------------------------------
B676              126              New product; more than one active           13                          8,269
New                                 ingredient where one active ingredient is
                                    an unregistered source; product chemistry
                                    data must be submitted; requires: 1)
                                    submission of product specific data, and
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B677              127              New end-use non-food animal product with    10                          8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                   g product chemistry and/or
                                   g acute toxicity and/or
                                   g public health pest efficacy and/or
                                   g animal safety studies and/or
                                   g child resistant packaging (2)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.


     [TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES;
                                                   AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B621              128              Amendment; Experimental Use Permit; no      7                           4,631
                                    change to an established temporary
                                    tolerance or tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B622              129              Amendment; Experimental Use Permit;         11                         11,577
New                                 petition to amend an established or
                                    temporary tolerance or tolerance
                                    exemption.
----------------------------------------------------------------------------------------------------------------
B641              130              Amendment of an established tolerance or    13                         11,577
                                    tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680              131              Amendment; registered source of active      5                           4,631
                                    ingredient(s); no new use(s); no changes
                                    to an established tolerance or tolerance
                                    exemption. Requires data submission. (2)
----------------------------------------------------------------------------------------------------------------
B681              132              Amendment; unregistered source of active    7                           5,513
                                    ingredient(s). Requires data submission.
                                    (2)
----------------------------------------------------------------------------------------------------------------
B683              133              Label amendment; requires review/update of  6                           4,631
New                                 previous risk assessment(s) without data
                                    submission (e.g., labeling changes to
                                    REI, PPE, PHI). (2)
----------------------------------------------------------------------------------------------------------------
B684              134              Amending non-food animal product that       8                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.


 [TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B690              135              New active ingredient; food or non-food     7                           2,316
                                    use. (2)
----------------------------------------------------------------------------------------------------------------
B700              136              Experimental Use Permit application; new    7                           1,159
                                    active ingredient or new use.
----------------------------------------------------------------------------------------------------------------
B701              137              Extend or amend Experimental Use Permit.    4                           1,159
----------------------------------------------------------------------------------------------------------------
B710              138              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. (3)
----------------------------------------------------------------------------------------------------------------
B720              139              New product; registered source of active    5                           1,159
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (3)
----------------------------------------------------------------------------------------------------------------
B721              140              New product; unregistered source of active  7                           2,426
                                    ingredient. (3)
----------------------------------------------------------------------------------------------------------------
B722              141              New use and/or amendment; petition to       7                           2,246
                                    establish a tolerance or tolerance
                                    exemption. (4) (5)
----------------------------------------------------------------------------------------------------------------
B730              142              Label amendment requiring data submission.  5                           1,159
                                    (4)
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time,
  except where the new inert approval decision review time is greater than that for the new active ingredient,
  in which case the associated new active ingredient will be subject to the new inert approval decision review
  time. In the case of a new active ingredient application, until that new active ingredient is approved, any
  subsequent application for another new product containing the same active ingredient or an amendment to the
  proposed labeling will be deemed a new active ingredient application, subject to the registration service fee
  and decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
[(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
[(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
[(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


                   [TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B614              143              Conditional Ruling on Preapplication Study  3                           2,294
New                                 Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
B615              144              Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
B682              145              Protocol review; applicant initiated;       3                           2,205
                                    excludes time for HSRB review
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


     [TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B740              146              Experimental Use Permit application; no     6                          86,823
                                    petition for tolerance/tolerance
                                    exemption. Includes:
                                   1) non-food/feed use(s) for a new (2) or
                                    registered (3) PIP;
                                   2) food/feed use(s) for a new or
                                    registered PIP with crop destruct;
                                   3) food/feed use(s) for a new or
                                    registered PIP in which an established
                                    tolerance/tolerance exemption exists for
                                    the intended use(s). (4)
----------------------------------------------------------------------------------------------------------------
B750              147              Experimental Use Permit application; with   9                         115,763
                                    a petition to establish a temporary or
                                    permanent tolerance/tolerance exemption
                                    for the active ingredient. Includes new
                                    food/feed use for a registered (3) PIP.
                                    (4)
----------------------------------------------------------------------------------------------------------------
B770              148              Experimental Use Permit application; new    15                        173,644
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows;
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B771              149              Experimental Use Permit application; new    10                        115,763
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows.
----------------------------------------------------------------------------------------------------------------
B772              150              Application to amend or extend an           3                          11,577
                                    Experimental Use Permit; no petition
                                    since the established tolerance/tolerance
                                    exemption for the active ingredient is
                                    unaffected.
----------------------------------------------------------------------------------------------------------------
B773              151              Application to amend or extend an           5                          28,942
                                    Experimental Use Permit; with petition to
                                    extend a temporary tolerance/tolerance
                                    exemption for the active ingredient.
----------------------------------------------------------------------------------------------------------------
B780              152              Registration application; new (2) PIP; non- 12                        144,704
                                    food/feed.
----------------------------------------------------------------------------------------------------------------
B790              153              Registration application; new (2) PIP; non- 18                        202,585
                                    food/feed; SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B800              154              Registration application; new (2) PIP;      12                        231,585
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B810              155              Registration application; new (2) PIP;      18                        289,407
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B820              156              Registration application; new (2) PIP;      15                        289,407
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient.
----------------------------------------------------------------------------------------------------------------
B840              157              Registration application; new (2) PIP;      21                        347,288
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient. SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B851              158              Registration application; new event of a    9                         115,763
                                    previously registered PIP active
                                    ingredient(s); no petition since
                                    permanent tolerance/tolerance exemption
                                    is already established for the active
                                    ingredient(s).
----------------------------------------------------------------------------------------------------------------
B870              159              Registration application; registered (3)    9                          34,729
                                    PIP; new product; new use; no petition
                                    since a permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s). (4)
----------------------------------------------------------------------------------------------------------------
B880              160              Registration application; registered (3)    9                          28,942
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (6) (7)
----------------------------------------------------------------------------------------------------------------
B881              161              Registration application; registered (3)    15                         86,823
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    SAP review. (5) (6) (7)
----------------------------------------------------------------------------------------------------------------
B883              162              Registration application; new (2) PIP,      9                         115,763
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    (8)
----------------------------------------------------------------------------------------------------------------
B884              163              Registration application; new (2) PIP,      12                        144,704
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient. (8)
----------------------------------------------------------------------------------------------------------------
B885              164              Registration application; registered (3)    9                          86,823
New                                 PIP, seed increase; breeding stack of
                                    previously approved PIPs, same crop; no
                                    petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (9)
----------------------------------------------------------------------------------------------------------------
B890              165              Application to amend a seed increase        9                          57,882
                                    registration; converts registration to
                                    commercial registration; no petition
                                    since permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s).
----------------------------------------------------------------------------------------------------------------
B891              166              Application to amend a seed increase        15                        115,763
                                    registration; converts registration to a
                                    commercial registration; no petition
                                    since a permanent tolerance/tolerance
                                    exemption already established for the
                                    active ingredient(s); SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B900              167              Application to amend a registration,        6                          11,577
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled.
                                    (10) (11)
----------------------------------------------------------------------------------------------------------------
B901              168              Application to amend a registration,        12                         69,458
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled. SAP
                                    review. (10) (11)
----------------------------------------------------------------------------------------------------------------
B902              169              PIP protocol review                         3                           5,789
----------------------------------------------------------------------------------------------------------------
B903              170              Inert ingredient tolerance exemption;       6                          57,882
                                    e.g., a marker such as NPT II; reviewed
                                    in BPPD.
----------------------------------------------------------------------------------------------------------------
B904              171              Import tolerance or tolerance exemption;    9                         115,763
                                    processed commodities/food only (inert or
                                    active ingredient).
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) New PIP = a PIP with an active ingredient that has not been registered.
[(3) Registered PIP = a PIP with an active ingredient that is currently registered.
[(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
[(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
[(6) Registered PIPs stacked through conventional breeding.
[(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
[(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
[(9) Application can be submitted prior to or concurrently with an application for commercial registration.
[(10) For example, IRM plan modifications that are applicant-initiated.
[(11) EPA-initiated amendments shall not be charged fees.



                   [TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
    [EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
I001              172              Approval of new food use inert ingredient   12                         18,000
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
I002              173              Amend currently approved inert ingredient   10                          5,000
New                                 tolerance or exemption from tolerance;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I003              174              Amend currently approved inert ingredient   8                           3,000
New                                 tolerance or exemption from tolerance; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I004              175              Approval of new non-food use inert          8                          10,000
New                                 ingredient (2)
----------------------------------------------------------------------------------------------------------------
I005              176              Amend currently approved non-food use       8                           5,000
New                                 inert ingredient with new use pattern;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I006              177              Amend currently approved non-food use       6                           3,000
New                                 inert ingredient with new use pattern; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I007              178              Approval of substantially similar non-food  4                           1,500
New                                 use inert ingredients when original inert
                                    is compositionally similar with similar
                                    use pattern (2)
----------------------------------------------------------------------------------------------------------------
I008              179              Approval of new polymer inert ingredient,   5                           3,400
New                                 food use (2)
----------------------------------------------------------------------------------------------------------------
I009              180              Approval of new polymer inert ingredient,   4                           2,800
New                                 non food use (2)
----------------------------------------------------------------------------------------------------------------
I010              181              Petition to amend a tolerance exemption     6                           1,500
New                                 descriptor to add one or more CASRNs; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
M001              182              Study protocol requiring Human Studies      9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M002              183              Completed study requiring Human Studies     9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M003              184              External technical peer review of new       12                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of less than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M004              185              External technical peer review of new       18                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of greater than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M005              186              New Product: Combination, Contains a        9                          20,000
New                                 combination of active ingredients from a
                                    registered and/or unregistered source;
                                    conventional, antimicrobial and/or
                                    biopesticide. Requires coordination with
                                    other regulatory divisions to conduct
                                    review of data, label and/or verify the
                                    validity of existing data as cited. Only
                                    existing uses for each active ingredient
                                    in the combination product. (6) (7)
----------------------------------------------------------------------------------------------------------------
M006              187              Request for up to 5 letters of              1                             250
New                                 certification (Gold Seal) for one
                                    actively registered product.
----------------------------------------------------------------------------------------------------------------
M007              188              Request to extend Exclusive Use of data as  12                          5,000
New                                 provided by FIFRA Section 3(c)(1)(F)(ii)
----------------------------------------------------------------------------------------------------------------
M008              189              Request to grant Exclusive Use of data as   10                          1,500
New                                 provided by FIFRA Section 3(c)(1)(F)(vi)
                                    for a minor use, when a FIFRA Section
                                    2(ll)(2) determination is required
----------------------------------------------------------------------------------------------------------------
[(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
[(2) If another covered application is associated with and dependent upon a pending application for an inert
  ingredient action, each application will be subject to its respective registration service fee. The decision
  review time for the other associated covered application will be extended to match the PRIA due date of the
  pending inert ingredient action, unless the PRIA due date for the other associated covered action is further
  out, in which case it will be subject to its own decision review time. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
[(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient
  of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review
  of the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
[(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
[(5) Any other covered application that is associated with and dependent on the SAP review will be subject to
  its separate registration service fee. The decision review time for the associated action will be extended by
  the decision review time for the SAP review.
[(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
[(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.]

          (3) Schedule of covered applications and other 
        actions and their registration service fees.--Subject 
        to paragraph (6), the schedule of registration 
        applications and other covered actions and their 
        corresponding registration service fees shall be as 
        follows:


                           TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      R010           1   New Active Ingredient, Food use.        24                                     753,082
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R020           2   New Active Ingredient, Food use;        18                                     627,568
                          reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R040           3   New Active Ingredient, Food use;        18                                     462,502
                          Experimental Use Permit application;
                          establish temporary tolerance;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
      R060           4   New Active Ingredient, Non-food use;    21                                     523,205
                          outdoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R070           5   New Active Ingredient, Non-food use;    16                                     436,004
                          outdoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R090           6   New Active Ingredient, Non-food use;    16                                     323,690
                          outdoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R110           7   New Active Ingredient, Non-food use;    20                                     290,994
                          indoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R120           8   New Active Ingredient, Non-food use;    14                                     242,495
                          indoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R121           9   New Active Ingredient, Non-food use;    18                                     182,327
                          indoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R122          10   Enriched isomer(s) of registered mixed- 18                                     317,128
                          isomer active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R123          11   New Active Ingredient, Seed treatment   18                                     471,861
                          only; includes agricultural and non-
                          agricultural seeds; residues not
                          expected in raw agricultural
                          commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R125          12   New Active Ingredient, Seed treatment;  16                                     323,690
                          Experimental Use Permit application;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                  TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
 EPA  No.     New  CR                    Action                       Decision  Review Time        Registration
                No.                                                        (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      R130         13   First food use; indoor; food/food        21                                     191,444
                         handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R140         14   Additional food use; Indoor; food/food   15                                      44,672
                         handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R150         15   First food use. (2)(3)                   21                                     317,104
----------------------------------------------------------------------------------------------------------------
      R155   16 (new)   First food use, Experimental Use Permit  21                                     264,253
                         application; a.i. registered for non-
                         food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R160         17   First food use; reduced risk. (2)(3)     16                                     264,253
----------------------------------------------------------------------------------------------------------------
      R170         18   Additional food use. (3) (4)             15                                      79,349
----------------------------------------------------------------------------------------------------------------
      R175         19   Additional food uses covered within a    10                                      66,124
                         crop group resulting from the
                         conversion of existing approved crop
                         group(s) to one or more revised crop
                         groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R180         20   Additional food use; reduced risk.       10                                      66,124
                         (3)(4)
----------------------------------------------------------------------------------------------------------------
      R190         21   Additional food uses; 6 or more          15                                     476,090
                         submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R200         22   Additional Food Use; 6 or more           10                                     396,742
                         submitted in one application; Reduced
                         Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R210         23   Additional food use; Experimental Use    12                                      48,986
                         Permit application; establish
                         temporary tolerance; no credit toward
                         new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R220         24   Additional food use; Experimental Use    6                                       19,838
                         Permit application; crop destruct
                         basis; no credit toward new use
                         registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R230         25   Additional use; non-food; outdoor. (3)   15                                      31,713
                         (4)
----------------------------------------------------------------------------------------------------------------
      R240         26   Additional use; non-food; outdoor;       10                                      26,427
                         reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R250         27   Additional use; non-food; outdoor;       6                                       19,838
                         Experimental Use Permit application;
                         no credit toward new use registration.
                         (3)(4)
----------------------------------------------------------------------------------------------------------------
      R251         28   Experimental Use Permit application      8                                       19,838
                         which requires no changes to the
                         tolerance(s); non-crop destruct basis.
                         (3)
----------------------------------------------------------------------------------------------------------------
      R260         29   New use; non-food; indoor. (3) (4)       12                                      15,317
----------------------------------------------------------------------------------------------------------------
      R270         30   New use; non-food; indoor; reduced       9                                       12,764
                         risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R271         31   New use; non-food; indoor; Experimental  6                                        9,725
                         Use Permit application; no credit
                         toward new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R273         32   Additional use; seed treatment; limited  12                                      50,445
                         uptake into Raw Agricultural
                         Commodities; includes crops with
                         established tolerances (e.g., for soil
                         or foliar application); includes food
                         and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R274         33   Additional uses; seed treatment only; 6  12                                     302,663
                         or more submitted in one application;
                         limited uptake into raw agricultural
                         commodities; includes crops with
                         established tolerances (e.g., for soil
                         or foliar application); includes food
                         and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.



                        TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      R280          34   Establish import tolerance; new active  21                                     319,072
                          ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
      R290          35   Establish Import tolerance; Additional  15                                      63,816
                          new food use.
----------------------------------------------------------------------------------------------------------------
      R291          36   Establish import tolerances;            15                                     382,886
                          additional food uses; 6 or more crops
                          submitted in one petition.
----------------------------------------------------------------------------------------------------------------
      R292          37   Amend an established tolerance (e.g.,   11                                      45,341
                          decrease or increase) and/or
                          harmonize established tolerances with
                          Codex MRLs; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R293          38   Establish tolerance(s) for inadvertent  12                                      53,483
                          residues in one crop; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R294          39   Establish tolerances for inadvertent    12                                     320,894
                          residues; 6 or more crops submitted
                          in one application; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R295          40   Establish tolerance(s) for residues in  15                                      66,124
                          one rotational crop in response to a
                          specific rotational crop application;
                          submission of corresponding label
                          amendments which specify the
                          necessary plant-back restrictions;
                          applicant-initiated. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R296          41   Establish tolerances for residues in    15                                     396,742
                          rotational crops in response to a
                          specific rotational crop petition; 6
                          or more crops submitted in one
                          application; submission of
                          corresponding label amendments which
                          specify the necessary plant-back
                          restrictions; applicant-initiated.
                          (3) (4)
----------------------------------------------------------------------------------------------------------------
      R297          42   Amend 6 or more established tolerances  11                                     272,037
                          (e.g., decrease or increase) in one
                          petition; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R298          43   Amend an established tolerance (e.g.,   13                                      58,565
                          decrease or increase); domestic or
                          import; submission of corresponding
                          amended labels (requiring science
                          review). (3) (4)
----------------------------------------------------------------------------------------------------------------
      R299          44   Amend 6 or more established tolerances  13                                     285,261
                          (e.g., decrease or increase);
                          domestic or import; submission of
                          corresponding amended labels
                          (requiring science review). (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
  base fee for the category. All items in the covered application must be submitted together in one package.
  Each application for an additional new product registration and new inert approval(s) that is submitted in the
  amendment application package is subject to the registration service fee for a new product or a new inert
  approval. However, if an amendment application only proposes to register the amendment for a new product and
  there are no amendments in the application, then review of one new product application is covered by the base
  fee. All such associated applications that are submitted together will be subject to the category decision
  review time.



                                TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
            New  CR                                        Decision  Review Time     FY'17 & FY'18 Registration
 EPA  No.     No.                   Action                      (Months)(1)               Service Fee ($)
----------------------------------------------------------------------------------------------------------------
    R300         45   New product; or similar            4                         1,582
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient; no
                       data review on acute toxicity,
                       efficacy or CRP - only product
                       chemistry data; cite-all data
                       citation, or selective data
                       citation where applicant owns
                       all required data, or applicant
                       submits specific authorization
                       letter from data owner. Category
                       also includes 100% re-package of
                       registered end-use or
                       manufacturing-use product that
                       requires no data submission nor
                       data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R301         46   New product; or similar            4                         1,897
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient;
                       selective data citation only for
                       data on product chemistry and/or
                       acute toxicity and/or public
                       health pest efficacy (identical
                       data citation and claims to
                       cited product(s)), where
                       applicant does not own all
                       required data and does not have
                       a specific authorization letter
                       from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R310         47   New end-use or manufacturing-use   7                         7,301
                       product with registered
                       source(s) of active
                       ingredient(s); includes products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for up to 3 target pests.
                       (2)(3)
----------------------------------------------------------------------------------------------------------------
    R314         48   New end use product containing up  8                         8,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for up to 3 target pests.
                       (2)(3)
----------------------------------------------------------------------------------------------------------------
    R319         49   New end use product containing up  10                        12,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for 4 to 7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R318   50 (new)   New end use product containing     9                         13,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for up to 3 target pests.
                       (2)(3)
----------------------------------------------------------------------------------------------------------------
    R321   51 (new)   New end use product containing     11                        17,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for 4 to 7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R315         52   New end-use, on-animal product,    9                         9,820
                       registered source of active
                       ingredient(s), with the
                       submission of data and/or
                       waivers for only:
                        animal safety and
                        pest(s) requiring efficacy (4)
                       and/or
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging. (2)
                       (3)
----------------------------------------------------------------------------------------------------------------
    R316   53 (new)   New end-use or manufacturing       9                         11,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; and
                       requires review of data and/or
                       waivers for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for greater than 3 and up to 7
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R317   54 (new)   New end-use or manufacturing       10                        15,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing 2 or more registered
                       active ingredients previously
                       combined in other registered
                       products; excludes products
                       requiring or citing an animal
                       safety study; and requires
                       review of data and/or waivers
                       for only:
                        product chemistry and/or
                        acute toxicity and/or
                        child resistant packaging and/
                       or
                        pest(s) requiring efficacy (4) -
                        for greater than 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R320         55   New product; new physical form;    12                        13,226
                       requires data review in science
                       divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R331         56   New product; repack of identical   3                         2,530
                       registered end-use product as a
                       manufacturing-use product, or
                       identical registered
                       manufacturing-use product as an
                       end use product; same registered
                       uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R332         57   New manufacturing-use product;     24                        283,215
                       registered active ingredient;
                       unregistered source of active
                       ingredient; submission of
                       completely new generic data
                       package; registered uses only;
                       requires review in RD and
                       science divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R333         58   New product; MUP or End use        10                        19,838
                       product with unregistered source
                       of active ingredient; requires
                       science data review; new
                       physical form; etc. Cite-all or
                       selective data citation where
                       applicant owns all required
                       data. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R334         59   New product; MUP or End use        11                        23,100
                       product with unregistered source
                       of the active ingredient;
                       requires science data review;
                       new physical form; etc.
                       Selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.



                                 TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
 EPA  No.   New  CR                     Action                        Decision Review  Time        Registration
              No.                                                          (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
    R340        60   Amendment requiring data review within RD    4                                       4,988
                      (e.g., changes to precautionary label
                      statements); includes adding/modifying
                      pest(s) claims for up to 2 target pests,
                      excludes products requiring or citing an
                      animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R341   61 (New)  Amendment requiring data review within RD    6                                       5,988
                      (e.g., changes to precautionary label
                      statements), includes adding/modifying
                      pest(s) claims for greater than 2 target
                      pests, excludes products requiring or
                      citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R345        62   Amending on-animal products previously       7                                       8,820
                      registered, with the submission of data
                      and/or waivers for only:
                       animal safety and
                       pest(s) requiring efficacy (4) and/or
                       product chemistry and/or
                       acute toxicity and/or
                        child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R350        63   Amendment requiring data review in science   9                                      13,226
                      divisions (e.g., changes to REI, or PPE,
                      or PHI, or use rate, or number of
                      applications; or add aerial application;
                      or modify GW/SW advisory statement).
                      (2)(3)
----------------------------------------------------------------------------------------------------------------
    R351        64   Amendment adding a new unregistered source   8                                      13,226
                      of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R352        65   Amendment adding already approved uses;      8                                      13,226
                      selective method of support; does not
                      apply if the applicant owns all cited
                      data. (2) (3)
----------------------------------------------------------------------------------------------------------------
    R371        66   Amendment to Experimental Use Permit; (does  6                                      10,090
                      not include extending a permit's time
                      period). (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.



                               TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
 EPA  No.     New  CR                    Action                       Decision Review  Time        Registration
                No.                                                        (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
     R124          67   Conditional Ruling on Pre-application    6                                        2,530
                         Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
     R272          68   Review of Study Protocol applicant-      3                                        2,530
                         initiated; excludes DART, pre-
                         registration conference, Rapid
                         Response review, DNT protocol review,
                         protocol needing HSRB review.
----------------------------------------------------------------------------------------------------------------
     R275          69   Rebuttal of agency reviewed protocol,    3                                        2,530
                         applicant initiated.
----------------------------------------------------------------------------------------------------------------
     R370          70   Cancer reassessment; applicant-          18                                     198,250
                         initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.



                          TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.    New  CR                     Action                       Decision  Review Time       Registration
                No.                                                         (Months)(1)          Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      A380         71   New Active Ingredient; Indirect Food use;  24                                   137,841
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A390         72   New Active Ingredient; Direct Food use;    24                                   229,733
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A410         73   New Active Ingredient Non-food use.(2)(3)  21                                   229,733
----------------------------------------------------------------------------------------------------------------
      A431         74   New Active Ingredient, Non-food use; low-  12                                    80,225
                         risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                 TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
         EPA  No.            New  CR                Action               Decision  Review Time     Registration
                               No.                                            (Months)(1)        Service Fee ($)
----------------------------------------------------------------------------------------------------------------
A440                               75   New Use, Indirect Food Use,    21                                31,910
                                         establish tolerance or
                                         tolerance exemption.
                                         (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A441                               76   Additional Indirect food       21                               114,870
                                         uses; establish tolerances
                                         or tolerance exemptions if
                                         required; 6 or more
                                         submitted in one
                                         application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A450                               77   New use, Direct food use,      21                                95,724
                                         establish tolerance or
                                         tolerance exemption.
                                         (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A451                               78   Additional Direct food uses;   21                               182,335
                                         establish tolerances or
                                         tolerance exemptions if
                                         required; 6 or more
                                         submitted in one
                                         application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A500                               79   New use, non-food. (4)(5)      12                                31,910
----------------------------------------------------------------------------------------------------------------
A501                               80   New use, non-food; 6 or more   15                                76,583
                                         submitted in one
                                         application. (4)(5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.



                       TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      A530          81    New product, identical or              4                                        1,278
                          substantially similar in composition
                          and use to a registered product; no
                          data review or only product chemistry
                          data; cite all data citation or
                          selective data citation where
                          applicant owns all required data; or
                          applicant submits specific
                          authorization letter from data owner.
                          Category also includes 100% re-
                          package of registered end-use or
                          manufacturing use product that
                          requires no data submission nor data
                          matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A531          82    New product; identical or              4                                        1,824
                          substantially similar in composition
                          and use to a registered product;
                          registered source of active
                          ingredient: selective data citation
                          only for data on product chemistry
                          and/or acute toxicity and/or public
                          health pest efficacy, where applicant
                          does not own all required data and
                          does not have a specific
                          authorization letter from data owner.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      A532          83   New product; identical or               5                                        5,107
                          substantially similar in composition
                          and use to a registered product;
                          registered active ingredient;
                          unregistered source of active
                          ingredient; cite-all data citation
                          except for product chemistry; product
                          chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A540          84    New end use product; FIFRA Sec. 2(mm)  5                                        5,107
                          uses only; up to 25 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A541    85 (new)    New end use product; FIFRA Sec. 2(mm)  7                                        8,500
                          uses only; 26-50 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A542    86 (new)    New end use product; FIFRA Sec. 2(mm)  10                                      15,000
                          uses only; ; 51 public health
                          organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A550          87    New end-use product; uses other than   9                                       13,226
                          FIFRA Sec. 2(mm); non-FQPA product.
                          (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A560          88    New manufacturing use product;         6                                       12,596
                          registered active ingredient;
                          selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A565    89 (new)    New manufacturing-use product;         12                                      18,234
                          registered active ingredient;
                          unregistered source of active
                          ingredient; submission of new generic
                          data package; registered uses only;
                          requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A570          90    Label amendment requiring data         4                                        3,831
                          review; up to 25 public health
                          organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A573    91 (new)    Label amendment requiring data         6                                        6,350
                          review; 26-50 public health
                          organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A574    92 (new)    Label amendment requiring data         9                                       11,000
                          review; ; 51 public health organisms.
                          (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A572          93   New Product or amendment requiring      9                                       13,226
                          data review for risk assessment by
                          Science Branch (e.g., changes to REI,
                          or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
  method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number or organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number or organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.



               TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      A520          94    Experimental Use Permit application,   9                                        6,383
                          non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      A521          95   Review of public health efficacy study  4                                        4,726
                          protocol within AD, per AD Internal
                          Guidance for the Efficacy Protocol
                          Review Process; Code will also
                          include review of public health
                          efficacy study protocol and data
                          review for devices making pesticidal
                          claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
      A522          96    Review of public health efficacy       12                                      12,156
                          study protocol outside AD by members
                          of AD Efficacy Protocol Review Expert
                          Panel; Code will also include review
                          of public health efficacy study
                          protocol and data review for devices
                          making pesticidal claims; applicant-
                          initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
      A537    97 (new)    New Active Ingredient/New Use,         18                                     153,156
                          Experimental Use Permit application;
                          Direct food use; Establish tolerance
                          or tolerance exemption if required.
                          Credit 45% of fee toward new active
                          ingredient/new use application that
                          follows.
----------------------------------------------------------------------------------------------------------------
      A538    98 (new)    New Active Ingredient/New Use,         18                                      95,724
                          Experimental Use Permit application;
                          Indirect food use; Establish
                          tolerance or tolerance exemption if
                          required Credit 45% of fee toward new
                          active ingredient/new use application
                          that follows.
----------------------------------------------------------------------------------------------------------------
      A539    99 (new)    New Active Ingredient/New Use,         15                                      92,163
                          Experimental Use Permit application;
                          Nonfood use. Credit 45% of fee toward
                          new active ingredient/new use
                          application that follows.
----------------------------------------------------------------------------------------------------------------
      A529         100    Amendment to Experimental Use Permit;  9                                       11,429
                          requires data review or risk
                          assessment. (2)
----------------------------------------------------------------------------------------------------------------
      A523         101    Review of protocol other than a        9                                       12,156
                          public health efficacy study (i.e.,
                          Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
      A571         102    Science reassessment: Cancer risk,     18                                      95,724
                          refined ecological risk, and/or
                          endangered species; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      A533   103 (new)   Exemption from the requirement of an    4                                        2,482
                          Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------
      A534   104 (new)    Rebuttal of agency reviewed protocol,  4                                        4,726
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      A535   105 (new)    Conditional Ruling on Pre-application  6                                        2,409
                          Study Waiver or Data Bridging
                          Argument; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      A536   106 (new)   Conditional Ruling on Pre-application   4                                        2,482
                          Direct Food, Indirect Food, Nonfood
                          use determination; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                          TABLE 11. -- BIOPESTICIDES DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B580         107   New active ingredient; food use;        20                                      51,053
                          petition to establish a tolerance.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B590         108    New active ingredient; food use;       18                                      31,910
                          petition to establish a tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B600         109    New active ingredient; non-food use.   13                                      19,146
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B610         110    New active ingredient; Experimental    10                                      12,764
                          Use Permit application; petition to
                          establish a temporary tolerance or
                          temporary tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B611         111    New active ingredient; Experimental    12                                      12,764
                          Use Permit application; petition to
                          establish permanent tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B612         112    New active ingredient; no change to a  10                                      17,550
                          permanent tolerance exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B613         113    New active ingredient; petition to     11                                      17,550
                          convert a temporary tolerance or a
                          temporary tolerance exemption to a
                          permanent tolerance or tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B620         114    New active ingredient; Experimental    7                                        6,383
                          Use Permit application; non-food use
                          including crop destruct. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                 TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B630         115    First food use; petition to establish  13                                      12,764
                          a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B631         116    New food use; petition to amend an     12                                      12,764
                          established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
      B640         117   First food use; petition to establish   19                                      19,146
                          a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B643         118   New Food use; petition to amend an      10                                      12,764
                          established tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B642         119   First food use; indoor; food/food       12                                      31,910
                          handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B644         120   New use, no change to an established    8                                       12,764
                          tolerance or tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B650         121   New use; non-food. (3)(4)               7                                        6,383
----------------------------------------------------------------------------------------------------------------
      B645   122 (new)    New food use; Experimental Use Permit  12                                      12,764
                          application; petition to amend or add
                          a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
      B646   123 (new)   New use; non-food use including crop    7                                        6,383
                          destruct; Experimental Use Permit
                          application. (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                               TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
 EPA  No.     New  CR                     Action                       Decision  Review Time       Registration
                No.                                                         (Months)(1)          Service Fee ($)
----------------------------------------------------------------------------------------------------------------
     B652         124   New product; registered source of active   13                                    12,764
                         ingredient; requires petition to amend
                         established tolerance or tolerance
                         exemption; requires 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of scientifically-
                         sound rationale based on publicly
                         available literature or other relevant
                         information that addresses the data
                         requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B660         125    New product; registered source of active  4                                      1,278
                         ingredient(s); identical or
                         substantially similar in composition and
                         use to a registered product. No data
                         review, or only product chemistry data;
                         cite-all data citation, or selective
                         data citation where applicant owns all
                         required data or authorization from data
                         owner is demonstrated. Category includes
                         100% re-package of registered end-use or
                         manufacturing-use product that requires
                         no data submission or data matrix. For
                         microbial pesticides, the active
                         ingredient(s) must not be re-isolated.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------
     B670         126    New product; registered source of active  7                                      5,107
                         ingredient(s); requires: 1) submission
                         of product specific data; or 2) citation
                         of previously reviewed and accepted
                         data; or 3) submission or citation of
                         data generated at government expense; or
                         4) submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B671         127    New product; unregistered source of       17                                    12,764
                         active ingredient(s); requires a
                         petition to amend an established
                         tolerance or tolerance exemption;
                         requires: 1) submission of product
                         specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B672         128    New product; unregistered source of       13                                     9,118
                         active ingredient(s); non-food use or
                         food use requires: 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B673         129    New product MUP/EP; unregistered source   10                                     5,107
                         of active ingredient(s); citation of
                         Technical Grade Active Ingredient (TGAI)
                         data previously reviewed and accepted by
                         the Agency. Requires an Agency
                         determination that the cited data
                         supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B674         130    New product MUP; Repack of identical      4                                      1,278
                         registered end-use product as a
                         manufacturing-use product; same
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B675         131    New Product MUP; registered source of     10                                     9,118
                         active ingredient; submission of
                         completely new generic data package;
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B676         132    New product; more than one active         13                                     9,118
                         ingredient where one active ingredient
                         is an unregistered source; product
                         chemistry data must be submitted;
                         requires: 1) submission of product
                         specific data, and 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B677         133   New end-use non-food animal product with   10                                     8,820
                         submission of two or more target animal
                         safety studies; includes data and/or
                         waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          public health pest efficacy and/or
                          animal safety studies and/or
                          child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                TABLE 14. -- BIOPESTICIDES DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                     Action                      Decision  Review Time       Registration
                 No.                                                        (Months)(1)          Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B621         134   Amendment; Experimental Use Permit; no     7                                     5,107
                          change to an established temporary
                          tolerance or tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B622         135   Amendment; Experimental Use Permit;        11                                   12,764
                          petition to amend an established or
                          temporary tolerance or tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B641         136   Amendment of an established tolerance or   13                                   12,764
                          tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B680         137    Amendment; registered sources of active   5                                     5,107
                          ingredient(s); no new use(s); no changes
                          to an established tolerance or tolerance
                          exemption. Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B681         138    Amendment; unregistered source of active  7                                     6,079
                          ingredient(s). Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B683         139    Label amendment; requires review/update   6                                     5,107
                          of previous risk assessment(s) without
                          data submission (e.g., labeling changes
                          to REI, PPE, PHI). (2)(3)
----------------------------------------------------------------------------------------------------------------
      B684         140    Amending non-food animal product that     8                                     8,820
                          includes submission of target animal
                          safety data; previously registered.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B685   141 (new)    Amendment; add a new biochemical          5                                     5,107
                          unregistered source of active ingredient
                          or a new microbial production site.
                          Requires submission of analysis of
                          samples data and source/production site-
                          specific manufacturing process
                          description. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                   TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B690         142   New active ingredient; food or non-     7                                        2,554
                          food use. (2)(6)
----------------------------------------------------------------------------------------------------------------
      B700         143    Experimental Use Permit application;   7                                        1,278
                          new active ingredient or new use. (6)
----------------------------------------------------------------------------------------------------------------
      B701         144    Extend or amend Experimental Use       4                                        1,278
                          Permit. (6)
----------------------------------------------------------------------------------------------------------------
      B710         145    New product; registered source of      4                                        1,278
                          active ingredient(s); identical or
                          substantially similar in composition
                          and use to a registered product; no
                          change in an established tolerance or
                          tolerance exemption. No data review,
                          or only product chemistry data; cite-
                          all data citation, or selective data
                          citation where applicant owns all
                          required data or authorization from
                          data owner is demonstrated. Category
                          includes 100% re-package of
                          registered end-use or manufacturing-
                          use product that requires no data
                          submission or data matrix. (3)(6)
----------------------------------------------------------------------------------------------------------------
      B720         146    New product; registered source of      5                                        1,278
                          active ingredient(s); requires: 1)
                          submission of product specific data;
                          or 2) citation of previously reviewed
                          and accepted data; or 3) submission
                          or citation of data generated at
                          government expense; or 4) submission
                          or citation of a scientifically-sound
                          rationale based on publicly available
                          literature or other relevant
                          information that addresses the data
                          requirement; or 5) submission of a
                          request for a data requirement to be
                          waived supported by a scientifically-
                          sound rationale explaining why the
                          data requirement does not apply.
                          (3)(6)
----------------------------------------------------------------------------------------------------------------
      B721         147    New product; unregistered source of    7                                        2,676
                          active ingredient. (3)(6)
----------------------------------------------------------------------------------------------------------------
      B722         148   New use and/or amendment; petition to   7                                        2,477
                          establish a tolerance or tolerance
                          exemption. (4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      B730         149   Label amendment requiring data          5                                        1,278
                          submission. (4)(6)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                              TABLE 16. -- BIOPESTICIDES DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B614         150   Pre-application; Conditional Ruling on  3                                        2,530
                          rationales for addressing a data
                          requirement in lieu of data;
                          applicant-initiated; applies to one
                          rationale at a time.
----------------------------------------------------------------------------------------------------------------
      B615         151   Rebuttal of agency reviewed protocol,   3                                        2,530
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      B682         152   Protocol review; applicant initiated;   3                                        2,432
                          excludes time for HSRB review.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.



                                   TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.   New  CR                     Action                        Decision  Review Time       Registration
                No.                                                         (Months)(1)          Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      B740      153   Experimental Use Permit application; no      6                                     95,724
                       petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP (12);
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct (12);
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
      B741      154   Experimental Use Permit application; no      12                                   159,538
              (new)    petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP;
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct;
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s);
                      SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
      B750      155   Experimental Use Permit application; with a  9                                    127,630
                       petition to establish a temporary or
                       permanent tolerance/tolerance exemption
                       for the active ingredient. Includes new
                       food/feed use for a registered (3) PIP.
                       (4)(12)
----------------------------------------------------------------------------------------------------------------
      B770      156   Experimental Use Permit application; new     15                                   191,444
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows;
                       SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B771      157   Experimental Use Permit application; new     10                                   127,630
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows.
                       (12)
----------------------------------------------------------------------------------------------------------------
      B772      158   Application to amend or extend an            3                                     12,764
                       Experimental Use Permit; no petition since
                       the established tolerance/tolerance
                       exemption for the active ingredient is
                       unaffected. (12)
----------------------------------------------------------------------------------------------------------------
      B773      159   Application to amend or extend an            5                                     31,910
                       Experimental Use Permit; with petition to
                       extend a temporary tolerance/tolerance
                       exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B780      160   Registration application; new (2) PIP; non-  12                                   159,537
                       food/feed. (12)
----------------------------------------------------------------------------------------------------------------
      B790      161   Registration application; new (2) PIP; non-  18                                   223,351
                       food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B800      162   Registration application; new (2) PIP; with  13                                   172,300
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------
      B810      163   Registration application; new (2) PIP; with  19                                   236,114
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. SAP review.
                       (5)(12)
----------------------------------------------------------------------------------------------------------------
      B820      164   Registration application; new (2) PIP; with  15                                   204,208
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B840      165   Registration application; new (2) PIP; with  21                                   268,022
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B851      166   Registration application; new event of a     9                                    127,630
                       previously registered PIP active
                       ingredient(s); no petition since permanent
                       tolerance/tolerance exemption is already
                       established for the active ingredient(s).
                       (12)
----------------------------------------------------------------------------------------------------------------
      B870      167   Registration application; registered (3)     9                                     38,290
                       PIP; new product; new use; no petition
                       since a permanent tolerance/tolerance
                       exemption is already established for the
                       active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
      B880      168   Registration application; registered (3)     9                                     31,910
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
      B881      169   Registration application; registered (3)     15                                    95,724
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). SAP review.
                       (5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
      B882      170   Registration application; new (2) PIP, seed  15                                   191,444
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption; SAP Review.
                       (8)(12)
----------------------------------------------------------------------------------------------------------------
      B883      171   Registration application; new (2) PIP, seed  9                                    127,630
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B884      172   Registration application; new (2) PIP, seed  12                                   159,537
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B885      173   Registration application; registered (3)     6                                     31,910
                       PIP, seed increase; breeding stack of
                       previously approved PIPs, same crop; no
                       petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
      B886      174   Registration application; new (2) PIP, seed  18                                   223,351
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B890      175   Application to amend a seed increase         9                                     63,816
                       registration; converts registration to
                       commercial registration; no petition since
                       permanent tolerance/tolerance exemption is
                       already established for the active
                       ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B891      176   Application to amend a seed increase         15                                   127,630
                       registration; converts registration to a
                       commercial registration; no petition since
                       a permanent tolerance/tolerance exemption
                       already established for the active
                       ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B900      177   Application to amend a registration,         6                                     12,764
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled.
                       (10)(11)(12)
----------------------------------------------------------------------------------------------------------------
      B901      178   Application to amend a registration,         12                                    76,578
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled. SAP
                       review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
      B902      179   PIP Protocol review.                         3                                      6,383
----------------------------------------------------------------------------------------------------------------
      B903      180   Inert ingredient tolerance exemption; e.g.,  6                                     63,816
                       a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
      B904      181   Import tolerance or tolerance exemption;     9                                    127,630
                       processed commodities/food only (inert or
                       active ingredient).
----------------------------------------------------------------------------------------------------------------
      B905      182   SAP Review.                                  6                                     63,816
              (new)
----------------------------------------------------------------------------------------------------------------
      B906      183   Petition to establish a temporary tolerance/ 3                                     31,907
              (new)    tolerance exemption for one or more active
                       ingredients.
----------------------------------------------------------------------------------------------------------------
      B907      184   Petition to establish a temporary tolerance/ 3                                     12,764
              (new)    tolerance exemption for one or more active
                       ingredients based on an existing temporary
                       tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B908      185   Petition to establish a temporary tolerance/ 3                                     44,671
              (new)    tolerance exemption for one or more active
                       ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.



                                         TABLE 18. -- INERT INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.    New  CR                     Action                       Decision  Review Time       Registration
                No.                                                         (Months)(1)          Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      I001        186   Approval of new food use inert             13                                    27,000
                         ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      I002        187   Amend currently approved inert ingredient  11                                     7,500
                         tolerance or exemption from tolerance;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I003        188   Amend currently approved inert ingredient  9                                      3,308
                         tolerance or exemption from tolerance;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I004        189   Approval of new non-food use inert         6                                     11,025
                         ingredient. (2)
----------------------------------------------------------------------------------------------------------------
      I005        190   Amend currently approved non-food use      6                                      5,513
                         inert ingredient with new use pattern;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I006        191   Amend currently approved non-food use      3                                      3,308
                         inert ingredient with new use pattern;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I007        192   Approval of substantially similar non-     4                                      1,654
                         food use inert ingredients when original
                         inert is compositionally similar with
                         similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
      I008        193   Approval of new or amended polymer inert   5                                      3,749
                         ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
      I009        194   Approval of new or amended polymer inert   4                                      3,087
                         ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      I010        195   Petition to amend a single tolerance       6                                      1,654
                         exemption descriptor, or single non-food
                         use descriptor, to add : 10 CASRNs; no
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I011   196 (new)  Approval of new food use safener with      24                                   597,683
                         tolerance or exemption from tolerance.
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I012   197 (new)  Approval of new non-food use safener.      21                                   415,241
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I013   198 (new)  Approval of additional food use for        15                                    62,975
                         previously approved safener with
                         tolerance or exemption from tolerance.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I014   199 (new)  Approval of additional non-food use for    15                                    25,168
                         previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
      I015   200 (new)  Approval of new generic data for           24                                   269,728
                         previously approved food use safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I016   201 (new)  Approval of amendment(s) to tolerance and  13                                    55,776
                         label for previously approved safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.



                             TABLE 19. -- EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
  EPA  No.     New  CR                   Action                       Decision  Review Time        Registration
                 No.                                                       (Months)(1)           Service Fee ($)
----------------------------------------------------------------------------------------------------------------
      M001         202   Study protocol requiring Human Studies  9                                        7,938
                          Review Board review as defined in 40
                          CFR Part 26 in support of an active
                          ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M002         203   Completed study requiring Human         9                                        7,938
                          Studies Review Board review as
                          defined in 40 CFR Part 26 in support
                          of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M003         204   External technical peer review of new   12                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of less than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M004         205   External technical peer review of new   18                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of greater than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M005         206   New Product: Combination, Contains a    9                                       22,050
                          combination of active ingredients
                          from a registered and/or unregistered
                          source; conventional, antimicrobial
                          and/or biopesticide. Requires
                          coordination with other regulatory
                          divisions to conduct review of data,
                          label and/or verify the validity of
                          existing data as cited. Only existing
                          uses for each active ingredient in
                          the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
      M006         207   Request for up to 5 letters of          1                                          277
                          certification (Gold Seal) for one
                          actively registered product (excludes
                          distributor products). (8)
----------------------------------------------------------------------------------------------------------------
      M007         208   Request to extend Exclusive Use of      12                                       5,513
                          data as provided by FIFRA Section
                          3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------
      M008         209   Request to grant Exclusive Use of data  15                                       1,654
                          as provided by FIFRA Section
                          3(c)(1)(F)(vi) for a minor use, when
                          a FIFRA Section 2(ll)(2)
                          determination is required.
----------------------------------------------------------------------------------------------------------------
      M009   210 (new)   Non-FIFRA Regulated Determination:      4                                        2,363
                          Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
      M010   211 (new)   Conditional ruling on pre-application,  4                                        2,363
                          product substantial similarity.
----------------------------------------------------------------------------------------------------------------
      M011   212 (new)   Label amendment to add the DfE logo;    4                                        3,648
                          requires data review; no other label
                          changes. (9)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
  applies to one registered product.
(9) This category includes amendments the sole purpose of which is to add DfE (or equivalent terms that do not
  use ``safe'' or derivatives of ``safe'') logos to a label. DfE is a voluntary program. A label bearing a DfE
  logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet
  objective, scientific criteria established and widely publicized by EPA.

          (4) Pending pesticide registration applications.--
                  (A) In general.--An applicant that submitted 
                a registration application to the Administrator 
                before the effective date of the Pesticide 
                Registration Improvement Act of 2003, but that 
                is not required to pay a registration service 
                fee under paragraph (2)(B), may, on a voluntary 
                basis, pay a registration service fee in 
                accordance with paragraph (2)(B).
                  (B) Voluntary fee.--The Administrator may not 
                compel payment of a registration service fee 
                for an application described in subparagraph 
                (A).
                  (C) Documentation.--An application for which 
                a voluntary registration service fee is paid 
                under this paragraph shall be submitted with 
                documentation certifying--
                          (i) payment of the registration 
                        service fee; or
                          (ii) a request for a waiver from or 
                        reduction of the registration service 
                        fee.
          (5) Resubmission of [pesticide registration 
        applications] covered application.--If a [pesticide 
        registration application] covered application is 
        submitted by a person that paid the fee for the 
        application under paragraph (2), is determined by the 
        Administrator to be complete, and is not approved or is 
        withdrawn (without a waiver or refund), the submission 
        of the same [pesticide registration application] 
        covered application by the same person (or a licensee, 
        assignee, or successor of the person) shall not be 
        subject to a fee under paragraph (2).
          (6) Fee adjustment.--
                  (A) In general.--Effective for a covered 
                [pesticide registration] application received 
                during the period beginning on [October 1, 
                2013, and ending on September 30, 2015] October 
                1, 2019, and ending on September 30, 2021, the 
                Administrator shall increase by 5 percent the 
                registration service fee payable for the 
                application under paragraph (3).
                  (B) Additional adjustment.--Effective for a 
                covered [pesticide registration] application 
                received on or after October 1, [2015] 2021, 
                the Administrator shall increase by an 
                additional 5 percent the registration service 
                fee in effect as of September 30, [2015] 2021.
                  (C) Publication.--The Administrator shall 
                publish in the Federal Register the [revised 
                registration service fee schedules] service fee 
                schedules revised pursuant to this paragraph.
          (7) Waivers and reductions.--
                  (A) In general.--An applicant for a [covered 
                pesticide registration] covered application may 
                request the Administrator to waive or reduce 
                the amount of a registration service fee 
                payable under this section under the 
                circumstances described in subparagraphs (D) 
                through (G), except that no waiver or fee 
                reduction shall be provided in connection with 
                a request for a letter of certification 
                (commonly referred to as a Gold Seal letter).
                  (B) Documentation.--
                          (i) In general.--A request for a 
                        waiver from or reduction of the 
                        registration service fee shall be 
                        accompanied by appropriate 
                        documentation demonstrating the basis 
                        for the waiver or reduction.
                          (ii) Certification.--The applicant 
                        shall provide to the Administrator a 
                        written certification, signed by a 
                        responsible officer, that the 
                        documentation submitted to support the 
                        waiver or reduction request is 
                        accurate.
                          (iii) Inaccurate documentation.--An 
                        application shall be subject to the 
                        applicable registration service fee 
                        payable under paragraph (3) if, at any 
                        time, the Administrator determines 
                        that--
                                  (I) the documentation 
                                supporting the waiver or 
                                reduction request is not 
                                accurate; or
                                  (II) based on the 
                                documentation or any other 
                                information, the waiver or 
                                reduction should not have been 
                                granted or should not be 
                                granted.
                  (C) Determination to grant or deny request.--
                As soon as practicable, but not later than 60 
                days, after the date on which the Administrator 
                receives a request for a waiver or reduction of 
                a registration service fee under this 
                paragraph, the Administrator shall--
                          (i) determine whether to grant or 
                        deny the request; and
                          (ii) notify the applicant of the 
                        determination.
                  (D) Minor uses.--
                          (i) In general.--The Administrator 
                        may exempt from, or waive a portion of, 
                        the registration service fee for an 
                        application for minor uses for a 
                        pesticide.
                          (ii) Supporting documentation.--An 
                        applicant requesting a waiver or 
                        exemption under this subparagraph shall 
                        provide supporting documentation that 
                        demonstrates, to the satisfaction of 
                        the Administrator, that anticipated 
                        revenues from the uses that are the 
                        subject of the application would be 
                        insufficient to justify imposition of 
                        the full application fee.
                  (E) IR-4 exemption.--The Administrator shall 
                exempt an application from the registration 
                service fee if the Administrator determines 
                that--
                          (i) the application is solely 
                        associated with a tolerance petition 
                        submitted in connection with the Inter-
                        Regional Project Number 4 (IR-4) as 
                        described in section 2 of Public Law 
                        89-106 (7 U.S.C. 450i(e)); and
                          (ii) the exemption is in the public 
                        interest.
                  (F) Small businesses.--
                          (i) In general.--The Administrator 
                        shall waive 50 percent of the 
                        registration service fees payable by an 
                        entity for a covered [pesticide 
                        registration] application under this 
                        section if the entity is a small 
                        business (as defined in section 
                        4(i)(1)(E)(ii)) at the time of 
                        application.
                          (ii) Waiver of fees.--The 
                        Administrator shall waive 75 percent of 
                        the registration service fees payable 
                        by an entity under this section if the 
                        entity--
                                  (I) is a small business (as 
                                defined in section 
                                4(i)(1)(E)(ii)) at the time of 
                                application; and
                                  (II) has average annual 
                                global gross revenues described 
                                in section 
                                4(i)(1)(E)(ii)(I)(bb) that does 
                                not exceed $10,000,000, at the 
                                time of application.
                          (iii) Formation for waiver.--The 
                        Administrator shall not grant a waiver 
                        under this subparagraph if the 
                        Administrator determines that the 
                        entity submitting the application has 
                        been formed or manipulated primarily 
                        for the purpose of qualifying for the 
                        waiver.
                          (iv) Documentation.--An entity 
                        requesting a waiver under this 
                        subparagraph shall provide to the 
                        Administrator--
                                  (I) documentation 
                                demonstrating that the entity 
                                is a small business (as defined 
                                in section 4(i)(1)(E)(ii)) at 
                                the time of application; and
                                  (II) if the entity is 
                                requesting a waiver of 75 
                                percent of the applicable 
                                registration service fees 
                                payable under this section, 
                                documentation demonstrating 
                                that the entity has an average 
                                annual global gross revenue 
                                described in section 
                                4(i)(1)(E)(ii)(I)(bb) that does 
                                not exceed $10,000,000, at the 
                                time of application.
                  (G) Federal and state agency exemptions.--An 
                agency of the Federal Government or a State 
                government shall be exempt from covered 
                registration service fees under this section.
          (8) Refunds.--
                  (A) Early withdrawals.--If, during the first 
                60 days after the beginning of the applicable 
                decision time review period under subsection 
                (f)(3), a covered [pesticide registration] 
                application is withdrawn by the applicant, the 
                Administrator shall refund all but 25 percent 
                of the total registration service fee payable 
                under paragraph (3) for the application.
                  (B) Withdrawals after the first 60 days of 
                decision review time period.--
                          (i) In general.--If a covered 
                        [pesticide registration] application is 
                        withdrawn after the first 60 days of 
                        the applicable decision time review 
                        period, the Administrator shall 
                        determine what portion, if any, of the 
                        total registration service fee payable 
                        under paragraph (3) for the application 
                        may be refunded based on the proportion 
                        of the work completed at the time of 
                        withdrawal.
                          (ii) Timing.--The Administrator 
                        shall--
                                  (I) make the determination 
                                described in clause (i) not 
                                later than 90 days after the 
                                date the application is 
                                withdrawn; and
                                  (II) provide any refund as 
                                soon as practicable after the 
                                determination.
                  (C) Discretionary refunds.--
                          (i) In general.--In the case of a 
                        [pesticide registration] covered 
                        application that has been filed with 
                        the Administrator and has not been 
                        withdrawn by the applicant, but for 
                        which the Administrator has not yet 
                        made a final determination, the 
                        Administrator may refund a portion of a 
                        covered registration service fee if the 
                        Administrator determines that the 
                        refund is justified.
                          (ii) Basis.--The Administrator may 
                        provide a refund for an application 
                        under this subparagraph--
                                  (I) on the basis that, in 
                                reviewing the application, the 
                                Administrator has considered 
                                data submitted in support of 
                                another [pesticide 
                                registration] covered 
                                application;
                                  (II) on the basis that the 
                                Administrator completed 
                                portions of the review of the 
                                application before the 
                                effective date of this section; 
                                or
                                  (III) on the basis that the 
                                Administrator rejected the 
                                application under subsection 
                                (f)(4)(B).
                  (D) Credited fees.--In determining whether to 
                grant a refund under this paragraph, the 
                Administrator shall take into account any 
                portion of the registration service fees 
                credited under paragraph (2) or (4).
  (c) Pesticide Registration Fund.--
          (1) Establishment.--There is established in the 
        Treasury of the United States a Pesticide Registration 
        Fund to be used in carrying out this section (referred 
        to in this section as the ``Fund''), consisting of--
                  (A) such amounts as are deposited in the Fund 
                under paragraph (2);
                  (B) any interest earned on investment of 
                amounts in the Fund under paragraph (5); and
                  (C) any proceeds from the sale or redemption 
                of investments held in the Fund.
          (2) Deposits in fund.--Subject to paragraph (4), the 
        Administrator shall deposit fees collected under this 
        section in the Fund.
          (3) Expenditures from fund.--
                  (A) In general.--Subject to subparagraphs (B) 
                and (C) and paragraph (4), the Administrator 
                may make expenditures from the Fund--
                          (i) to cover the costs associated 
                        with the review and decisionmaking 
                        pertaining to all applications for 
                        which registration service fees have 
                        been paid under this section; and
                          (ii) to otherwise carry out this 
                        section.
                  (B) Worker protection, partnership grants, 
                and pesticide safety education.--
                          (i) In general.--For each of fiscal 
                        years 2013 through [2017] 2023, the 
                        Administrator shall use approximately 
                        \1/17\ of the amount in the Fund (but 
                        not less than $1,000,000) to enhance 
                        scientific and regulatory activities 
                        relating to worker protection, with an 
                        emphasis on field-worker populations in 
                        the United States.
                          (ii) Partnership grants.--Of the 
                        amounts in the Fund, the Administrator 
                        shall use for partnership grants, for 
                        each of fiscal years 2013 through 
                        [2017] 2023, $500,000.
                          (iii) Pesticide safety education 
                        program.--Of the amounts in the Fund, 
                        the Administrator shall use $500,000 
                        for each of fiscal years 2013 through 
                        [2017] 2023 to carry out the pesticide 
                        safety education program.
          (4) Collections and appropriations acts.--The fees 
        authorized by this section and amounts deposited in the 
        Fund--
                  (A) shall be collected and made available for 
                obligation only to the extent provided in 
                advance in appropriations Acts; and
                  (B) shall be available without fiscal year 
                limitation.
          (5) Unused funds.--
                  (A) In general.--Amounts in the Fund not 
                currently needed to carry out this section 
                shall be--
                  (i) maintained readily available or on 
                deposit;
                  (ii) invested in obligations of the United 
                States or guaranteed by the United States; or
                  (iii) invested in obligations, 
                participations, or other instruments that are 
                lawful investments for fiduciary, trust, or 
                public funds.
                  (B) Use of investment income.--After 
                consultation with the Secretary of the 
                Treasury, the Administrator may use income from 
                investments described in clauses (ii) and (iii) 
                of subparagraph (A) to carry out this section.
  (d) Assessment of Fees.--
          (1) Definition of covered functions.--In this 
        subsection, the term ``covered functions'' means 
        functions of the Office of Pesticide Programs of the 
        Environmental Protection Agency, as identified in key 
        programs and projects of the final operating plan for 
        the Environmental Protection Agency submitted as part 
        of the budget process for fiscal year 2002, regardless 
        of any subsequent transfer of 1 or more of the 
        functions to another office or agency or the subsequent 
        transfer of a new function to the Office of Pesticide 
        Programs.
          (2) Minimum amount of appropriations.--Registration 
        service fees may not be assessed for a fiscal year 
        under this section unless the amount of appropriations 
        for salaries, contracts, and expenses for the functions 
        (as in existence in fiscal year 2012) of the Office of 
        Pesticide Programs of the Environmental Protection 
        Agency for the fiscal year (excluding the amount of any 
        fees appropriated for the fiscal year) are equal to or 
        greater than the amount of appropriations for covered 
        functions for fiscal year 2012 (excluding the amount of 
        any fees appropriated for the fiscal year).
          (3) Use of fees.--Registration service fees 
        authorized by this section shall be available, in the 
        aggregate, only to defray increases in the costs 
        associated with the review and decisionmaking for the 
        review of pesticide registration applications and 
        associated tolerances (including increases in the 
        number of full-time equivalent positions in the 
        Environmental Protection Agency engaged in those 
        activities) over the costs for fiscal year 2002, 
        excluding costs paid from fees appropriated for the 
        fiscal year.
          (4) Subsequent authority.--If the Administrator does 
        not assess registration service fees under subsection 
        (b) during any portion of a fiscal year as the result 
        of paragraph (2) and is subsequently permitted to 
        assess the fees under subsection (b) during the fiscal 
        year, the Administrator shall assess and collect the 
        fees, without any modification in rate, at any time 
        during the fiscal year, notwithstanding any provisions 
        of subsection (b) relating to the date fees are to be 
        paid.
  (e) Reforms to Reduce Decision Time Review Periods.--To the 
maximum extent practicable consistent with the degrees of risk 
presented by pesticides and the type of review appropriate to 
evaluate risks, the Administrator shall identify and evaluate 
reforms to the pesticide registration process under this Act 
with the goal of reducing decision review periods in effect on 
the effective date of the [Pesticide Registration Improvement 
Extension Act of 2012] Pesticide Registration Enhancement Act 
of 2017 for pesticide registration actions for covered 
pesticide registration applications (including reduced risk 
applications). Such reforms shall include identifying 
opportunities for streamlining review processes for 
applications for a new active ingredient or a new use and 
providing prompt feedback to applicants during such review 
process.
  (f) Decision Time Review Periods.--
          (1) In general.--Not later than 30 days after the 
        effective date of the [Pesticide Registration 
        Improvement Extension Act of 2012] Pesticide 
        Registration Enhancement Act of 2017, the Administrator 
        shall make publicly available a schedule of decision 
        review periods for covered pesticide registration 
        actions or for any other action covered by a table 
        specified in subsection (b)(3) and corresponding 
        registration service fees under this Act.
          (2) Report.--The schedule shall be the same as the 
        applicable schedule provided under subsection (b)(3).
          (3) Applications subject to decision time review 
        periods.--The decision time review periods specified in 
        paragraph (1) shall apply to--
                  (A) covered pesticide registration 
                applications subject to registration service 
                fees under subsection (b)(2);
                  (B) covered pesticide registration 
                applications for which an applicant has 
                voluntarily paid registration service fees 
                under subsection (b)(4); and
                  [(C) covered pesticide registration 
                applications listed in the Registration 
                Division 2003 Work Plan of the Office of 
                Pesticide Programs of the Environmental 
                Protection Agency.]
                  (C) applications for any other action covered 
                by a table specified in subsection (b)(3).
          (4) Start of decision time review period.--
                  (A) In general.--Except as provided in 
                subparagraphs (C), (D), and (E), in the case of 
                [a pesticide registration application] a 
                covered application accompanied by the 
                registration service fee required under this 
                section, the decision time review period begins 
                21 days after the date on which the 
                Administrator receives the [covered pesticide 
                registration application] covered application 
                and fee.
                  (B) Initial content and preliminary technical 
                screenings.--
                          (i) Screenings.--
                                  (I) Initial content.--Not 
                                later than 21 days after 
                                receiving an application and 
                                the required registration 
                                service fee, the Administrator 
                                shall conduct an initial 
                                screening of the contents of 
                                the application in accordance 
                                with clause (iii).
                                  (II) Preliminary technical 
                                screening.--After conducting 
                                the initial content screening 
                                described in subclause (I) and 
                                in accordance with clause (iv), 
                                the Administrator shall conduct 
                                a preliminary technical 
                                screening--
                                          (aa) not later than 
                                        45 days after the date 
                                        on which the decision 
                                        time review period 
                                        begins (for 
                                        applications with 
                                        decision time review 
                                        periods of not more 
                                        than 180 days); and
                                          (bb) not later than 
                                        90 days after the date 
                                        on which the decision 
                                        time review period 
                                        begins (for 
                                        applications with 
                                        decision time review 
                                        periods greater than 
                                        180 days).
                          (ii) Rejection.--
                                  (I) In general.--If the 
                                Administrator determines at any 
                                time before the Administrator 
                                completes the preliminary 
                                technical screening under 
                                clause (i)(II) that the 
                                application failed the initial 
                                content or preliminary 
                                technical screening and the 
                                applicant does not correct the 
                                failure before the date that is 
                                10 business days after the 
                                applicant receives a 
                                notification of the failure, 
                                the Administrator shall reject 
                                the application.
                                  (II) Written notification.--
                                The Administrator shall make 
                                every effort to provide a 
                                written notification of a 
                                rejection under subclause (I) 
                                during the 10-day period that 
                                begins on the date the 
                                Administrator completes the 
                                preliminary technical 
                                screening.
                          (iii) Requirements of initial content 
                        screening.--In conducting an initial 
                        content screening of an application, 
                        the Administrator shall determine 
                        whether--
                                  (I)(aa) the applicable 
                                registration service fee has 
                                been paid; or
                                  (bb) at least 25 percent of 
                                the applicable registration 
                                service fee has been paid and 
                                the application contains a 
                                waiver or refund request for 
                                the outstanding amount and 
                                documentation establishing the 
                                basis for the waiver request; 
                                and
                                  (II) the application appears 
                                to contain all the necessary 
                                forms, data, and draft 
                                labeling, formatted in 
                                accordance with guidance 
                                published by the Administrator.
                          (iv) Requirements of preliminary 
                        technical screening.--In conducting a 
                        preliminary technical screening of an 
                        application, the Administrator shall 
                        determine if--
                                  (I) the application and the 
                                data and information submitted 
                                with the application are 
                                accurate and complete; and
                                  (II) the application, data, 
                                and information are consistent 
                                with the proposed labeling and 
                                any proposal for a tolerance or 
                                exemption from the requirement 
                                for a tolerance under section 
                                408 of the Federal Food, Drug, 
                                and Cosmetic Act (21 U.S.C. 
                                346a), and are such that, 
                                subject to full review under 
                                the standards of this Act, 
                                could result in the granting of 
                                the application.
                  (C) Applications with waiver or reduction 
                requests.--
                          (i) In general.--In the case of an 
                        application submitted with a request 
                        for a waiver or reduction of 
                        registration service fees under 
                        subsection (b)(7), the decision time 
                        review period shall be determined in 
                        accordance with this subparagraph.
                          (ii) Request granted with no 
                        additional fees required.--If the 
                        Administrator grants the waiver or 
                        reduction request and no additional fee 
                        is required, the decision time review 
                        period begins on the earlier of--
                                  (I) the date on which the 
                                Administrator grants the 
                                request; or
                                  (II) the date that is 60 days 
                                after the date of receipt of 
                                the application.
                          (iii) Request granted with additional 
                        fees required.--If the Administrator 
                        grants the waiver or reduction request, 
                        in whole or in part, but an additional 
                        registration service fee is required, 
                        the decision time review period begins 
                        on the date on which the Administrator 
                        receives certification of payment of 
                        the applicable registration service 
                        fee.
                          (iv) Request denied.--If the 
                        Administrator denies the waiver or 
                        reduction request, the decision time 
                        review period begins on the date on 
                        which the Administrator receives 
                        certification of payment of the 
                        applicable registration service fee.
                  (D) Pending applications.--
                          (i) In general.--The start of the 
                        decision time review period for 
                        applications described in clause (ii) 
                        shall be the date on which the 
                        Administrator receives certification of 
                        payment of the applicable registration 
                        service fee.
                          (ii) Applications.--Clause (i) 
                        applies to--
                                  (I) covered pesticide 
                                registration applications for 
                                which voluntary fees have been 
                                paid under subsection (b)(4); 
                                and
                                  (II) covered pesticide 
                                registration applications 
                                received on or after the 
                                effective date of the Pesticide 
                                Registration Improvement Act of 
                                2003 but submitted without the 
                                applicable registration service 
                                fee required under this section 
                                due to the inability of the 
                                Administrator to assess fees 
                                under subsection (d)(1).
                  (E)  2003 work plan.--In the case of a 
                covered pesticide registration application 
                listed in the Registration Division 2003 Work 
                Plan of the Office of Pesticide Programs of the 
                Environmental Protection Agency, the decision 
                time review period begins on the date that is 
                30 days after the effective date of the 
                Pesticide Registration Improvement Act of 2003.
          (5) Extension of decision time review period.--The 
        Administrator and the applicant may mutually agree in 
        writing to extend a decision time review period under 
        this subsection.
  (g) Judicial Review.--
          (1) In general.--Any applicant adversely affected by 
        the failure of the Administrator to make a 
        determination on the application of the applicant for 
        registration of a new active ingredient or new use for 
        which a registration service fee is paid under this 
        section may obtain judicial review of the failure 
        solely under this section.
          (2) Scope.--
                  (A) In general.--In an action brought under 
                this subsection, the only issue on review is 
                whether the Administrator failed to make a 
                determination on the application specified in 
                paragraph (1) by the end of the applicable 
                decision time review period required under 
                subsection (f) for the application.
                  (B) Other actions.--No other action 
                authorized or required under this section shall 
                be judicially reviewable by a Federal or State 
                court.
          (3) Timing.--
                  (A) In general.--A person may not obtain 
                judicial review of the failure of the 
                Administrator to make a determination on the 
                application specified in paragraph (1) before 
                the expiration of the 2-year period that begins 
                on the date on which the decision time review 
                period for the application ends.
                  (B) Meeting with administrator.--To be 
                eligible to seek judicial review under this 
                subsection, a person seeking the review shall 
                first request in writing, at least 120 days 
                before filing the complaint for judicial 
                review, a decision review meeting with the 
                Administrator.
          (4) Remedies.--The Administrator may not be required 
        or permitted to refund any portion of a registration 
        service fee paid in response to a complaint that the 
        Administrator has failed to make a determination on the 
        covered pesticide registration application specified in 
        paragraph (1) by the end of the applicable decision 
        review period.
  (h) Accounting.--The Administrator shall--
          (1) provide an annual accounting of the registration 
        service fees paid to the Administrator and disbursed 
        from the Fund, by providing financial statements in 
        accordance with--
                  (A) the Chief Financial Officers Act of 1990 
                (Public Law 101-576; 104 Stat. 2838) and 
                amendments made by that Act; and
                  (B) the Government Management Reform Act of 
                1994 (Public Law 103-356; 108 Stat. 3410) and 
                amendments made by that Act;
          (2) provide an accounting describing expenditures 
        from the Fund authorized under subsection (c); and
          (3) provide an annual accounting describing 
        collections and expenditures authorized under 
        subsection (d).
  (i) Auditing.--
          (1) Financial statements of agencies.--For the 
        purpose of section 3515(c) of title 31, United States 
        Code, the Fund shall be considered a component of an 
        executive agency.
          (2) Components.--The annual audit required under 
        sections 3515(b) and 3521 of that title of the 
        financial statements of activities under this section 
        shall include an analysis of--
                  (A) the fees collected under subsection (b) 
                and disbursed;
                  (B) compliance with subsection (f);
                  (C) the amount appropriated to meet the 
                requirements of subsection (d)(1); and
                  (D) the reasonableness of the allocation of 
                the overhead allocation of costs associated 
                with the review and decisionmaking pertaining 
                to applications under this section.
          (3) Inspector general.--The Inspector General of the 
        Environmental Protection Agency shall--
                  (A) conduct the annual audit required under 
                this subsection; and
                  (B) report the findings and recommendations 
                of the audit to the Administrator and to the 
                appropriate committees of Congress.
  (j) Personnel Levels.--All full-time equivalent positions 
supported by fees authorized and collected under this section 
shall not be counted against the agency-wide personnel level 
goals of the Environmental Protection Agency.
  (k) Reports.--
          (1) In general.--Not later than March 1, 2005, and 
        each March 1 thereafter through March 1, [2017] 2023, 
        the Administrator shall publish an annual report 
        describing actions taken under this section.
          (2) Contents.--The report shall include--
                  (A) a review of the progress made in carrying 
                out each requirement of subsections (e) and 
                (f), including--
                          (i) the number of applications 
                        reviewed, including the decision times 
                        for each application specified in 
                        subsection (f);
                          (ii) the number of label amendments 
                        that have been reviewed using 
                        electronic means;
                          (iii) the amount of money from the 
                        Reregistration and Expedited Processing 
                        Fund used to carry out inert ingredient 
                        review and review of similar 
                        applications under section 4(k)(3);
                          (iv) the number of applications 
                        completed for identical or 
                        substantially similar applications 
                        under section 3(c)(3)(B), including the 
                        number of such applications completed 
                        within 90 days pursuant to that 
                        section;
                          (v) the number of actions pending in 
                        each category of actions described in 
                        subsection (f)(3), as well as the 
                        number of inert ingredients;
                          (vi) to the extent determined 
                        appropriate by the Administrator and 
                        consistent with the authorities of the 
                        Administrator and limitations on 
                        delegation of functions by the 
                        Administrator, recommendations for--
                                  (I) expanding the use of 
                                self-certification in all 
                                appropriate areas of the 
                                registration process;
                                  (II) providing for 
                                accreditation of outside 
                                reviewers and the use of 
                                outside reviewers to conduct 
                                the review of major portions of 
                                applications;
                                  (III) reviewing the scope of 
                                use of the notification process 
                                to cover broader categories of 
                                registration actions;
                                  (IV) providing for electronic 
                                submission and review of 
                                labels, including process 
                                improvements to further enhance 
                                the procedures used in 
                                electronic label review; and
                                  (V) the allowance and use of 
                                summaries of acute toxicity 
                                studies;
                          (vii) the use of performance-based 
                        contracts, other contracts, and 
                        procurement to ensure that--
                                  (I) the goals of this Act for 
                                the timely review of 
                                applications for registration 
                                are met; and
                                  (II) the registration program 
                                is administered in the most 
                                productive and cost effective 
                                manner practicable; and
                          (viii) the number of extensions of 
                        decision time review periods agreed to 
                        under subsection (f)(5) along with a 
                        description of the reason that the 
                        Administrator was unable to make a 
                        decision within the initial decision 
                        time review period;
                  (B) a description of the staffing and 
                resources relating to the costs associated with 
                the review and decisionmaking pertaining to 
                applications;
                  (C) a review of the progress in meeting the 
                timeline requirements of section 4(g);
                  (D) a review of the progress in carrying out 
                section 3(g), including--
                          [(i) the number of pesticides or 
                        pesticide cases reviewed;]
                          (i) the number of pesticides or 
                        pesticide cases reviewed and the number 
                        of registration review decisions 
                        completed, including--
                                  (I) the number of cases 
                                cancelled;
                                  (II) the number of cases 
                                requiring risk mitigation 
                                measures;
                                  (III) the number of cases 
                                removing risk mitigation 
                                measures;
                                  (IV) the number of cases with 
                                no risk mitigation needed; and
                                  (V) the number of cases in 
                                which risk mitigation has been 
                                fully implemented;
                          (ii) a description of the staffing 
                        and resources relating to the costs 
                        associated with the review and decision 
                        making relating to reregistration and 
                        registration review for compliance with 
                        the deadlines specified in this Act;
                          (iii) to the extent determined 
                        appropriate by the Administrator and 
                        consistent with the authorities of the 
                        Administrator and limitations on 
                        delegation of functions by the 
                        Administrator, recommendations for--
                                  (I) process improvements in 
                                the handling of registration 
                                review under section 3(g);
                                  (II) providing for 
                                accreditation of outside 
                                reviewers and the use of 
                                outside reviewers in the 
                                registration review process; 
                                and
                                  (III) streamlining the 
                                registration review process, 
                                consistent with section 3(g);
                  (E) a review of the progress in meeting the 
                timeline requirements for the review of 
                antimicrobial pesticide products under section 
                3(h);
                  (F) a review of the progress in carrying out 
                the review of inert ingredients, including the 
                number of applications pending, the number of 
                new applications, the number of applications 
                reviewed, staffing, and resources devoted to 
                the review of inert ingredients and 
                recommendations to improve the timeliness of 
                review of inert ingredients;
                  (G) a review of the progress made toward--
                          (i) carrying out [section 4(k)(4)] 
                        paragraphs (4) and (5) of section 4(k) 
                        and the amounts from the Reregistration 
                        and Expedited Processing Fund used for 
                        the purposes described in [that 
                        section] such paragraphs;
                          [(ii) implementing systems for the 
                        electronic tracking of registration 
                        submissions by December 31, 2013;
                          [(iii) implementing a system for 
                        tracking the status of conditional 
                        registrations, including making 
                        nonconfidential information related to 
                        the conditional registrations publicly 
                        available by December 31, 2013;
                          [(iv) implementing enhancements to 
                        the endangered species knowledge 
                        database, including making 
                        nonconfidential information related to 
                        the database publicly available;
                          [(v) implementing the capability to 
                        electronically submit and review labels 
                        submitted with registration actions;
                          [(vi) acquiring and implementing the 
                        capability to electronically assess and 
                        evaluate confidential statements of 
                        formula submitted with registration 
                        actions by December 31, 2014; and]
                          (ii) implementing enhancements to--
                                  (I) the electronic tracking 
                                of covered applications;
                                  (II) the electronic tracking 
                                of conditional registrations;
                                  (III) the endangered species 
                                database;
                                  (IV) the electronic review of 
                                labels submitted with covered 
                                applications; and
                                  (V) the electronic review and 
                                assessment of confidential 
                                statements of formula submitted 
                                with covered applications; and
                          [(vii)] (iii) facilitating public 
                        participation in certain registration 
                        actions and the registration review 
                        process by providing electronic 
                        notification to interested parties of 
                        additions to the public docket;
                  (H) the number of applications rejected by 
                the Administrator under the initial content and 
                preliminary technical screening conducted under 
                subsection (f)(4);
                  (I) a review of the progress made in updating 
                the Pesticide Incident Data System, including 
                progress toward making the information 
                contained in the System available to the public 
                (as the Administrator determines is 
                appropriate); [and]
                  (J) an assessment of the public availability 
                of summary pesticide usage data[.];
                  (K) a review of the progress made in 
                developing, updating, and implementing product 
                performance test guidelines for pesticide 
                products that are intended to control 
                invertebrate pests of significant public health 
                importance and, by regulation, prescribing 
                product performance data requirements for such 
                pesticide products registered under section 3;
                  (L) a review of the progress made in the 
                priority review and approval of new pesticides 
                to control vector-born public health pests for 
                use in the United States, including each 
                territory or possession of the United States, 
                and United States military installations 
                globally;
                  (M) a review of the progress made in 
                implementing enhancements to the good 
                laboratory practices standards compliance 
                monitoring program established under part 160 
                of title 40 of the Code of Federal Regulations 
                (or successor regulations);
                  (N) the number of approvals for active 
                ingredients, new uses, and pesticide end use 
                products granted in connection with the Design 
                for the Environment program (or any successor 
                program) of the Environmental Protection 
                Agency; and
                  (O) with respect to funds in the Pesticide 
                Registration Fund reserved under subsection 
                (c)(3), a review that includes--
                          (i) a description of the amount and 
                        use of such funds--
                                  (I) to carry out activities 
                                relating to worker protection 
                                under clause (i) of subsection 
                                (c)(3)(B);
                                  (II) to award partnership 
                                grants under clause (ii) of 
                                such subsection; and
                                  (III) to carry out the 
                                pesticide safety education 
                                program under clause (iii) of 
                                such subsection;
                          (ii) an evaluation of the 
                        appropriateness and effectiveness of 
                        the activities, grants, and program 
                        described in clause (i);
                          (iii) a description of how 
                        stakeholders are engaged in the 
                        decision to fund such activities, 
                        grants, and program; and
                          (iv) with respect to activities 
                        relating to worker protection carried 
                        out under subparagraph (B)(i) of such 
                        subsection, a summary of the analyses 
                        from stakeholders, including from 
                        worker community-based organizations, 
                        on the appropriateness and 
                        effectiveness of such activities.
          (3) Method.--The Administrator shall publish a report 
        required by this subsection by such method as the 
        Administrator determines to be the most effective for 
        efficiently disseminating the report, including 
        publication of the report on the Internet site of the 
        Environmental Protection Agency.
          (4) Other report.--
                  (A) Scope.--In addition to the annual report 
                described in paragraph (1), not later than 
                October 1, 2016, the Administrator shall submit 
                to the Committee on Agriculture of the House of 
                Representatives and the Committee on 
                Agriculture, Nutrition, and Forestry of the 
                Senate a report that includes an analysis of 
                the impact of maintenance fees on small 
                businesses that have--
                          (i) 10 or fewer employees; and
                          (ii) annual global gross revenue that 
                        does not exceed $2,000,000.
                  (B) Information required.--In conducting the 
                analysis described in subparagraph (A), the 
                Administrator shall collect, and include in the 
                report under that subparagraph, information 
                on--
                          (i) the number of small businesses 
                        described in subparagraph (A) that are 
                        paying maintenance fees; and
                          (ii) the number of registrations each 
                        company holds.
  (l) Savings Clause.--Nothing in this section affects any 
other duties, obligations, or authorities established by any 
other section of this Act, including the right to judicial 
review of duties, obligations, or authorities established by 
any other section of this Act.
  (m) Termination of Effectiveness.--
          (1) In general.--Except as provided in paragraph (2), 
        the authority provided by this section terminates on 
        September 30, [2017] 2023.
          (2) Phase out.--
                  (A)  [Fiscal year 2018.--] Fiscal year 2024._ 
                [During fiscal year 2018] During fiscal year 
                2024, the requirement to pay and collect 
                registration service fees applies, except that 
                the level of registration service fees payable 
                under this section shall be reduced 40 percent 
                below the level in effect on September 30, 
                [2017] 2023.
                  (B)  [Fiscal year 2019.--] Fiscal year 2025._ 
                [During fiscal year 2019] During fiscal year 
                2025, the requirement to pay and collect 
                registration service fees applies, except that 
                the level of registration service fees payable 
                under this section shall be reduced 70 percent 
                below the level in effect on September 30, 
                [2017] 2023.
                  (C)  [September 30, 2019.--] September 30, 
                2025._ [Effective September 30, 2019] Effective 
                September 30, 2025, the requirement to pay and 
                collect registration service fees terminates.
                  (D) Decision review periods.--
                          (i) Pending applications.--In the 
                        case of an application received under 
                        this section before September 30, 
                        [2017] 2023, the application shall be 
                        reviewed in accordance with subsection 
                        (f).
                          (ii) New applications.--In the case 
                        of an application received under this 
                        section on or after September 30, 
                        [2017] 2023, subsection (f) shall not 
                        apply to the application.

           *       *       *       *       *       *       *

                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
CHAPTER IV--FOOD

           *       *       *       *       *       *       *


       tolerances and exemptions for pesticide chemical residues

  Sec. 408. (a) Requirement for Tolerance or Exemption.--
          (1) General rule.--Except as provided in paragraph 
        (2) or (3), any pesticide chemical residue in or on a 
        food shall be deemed unsafe for the purpose of section 
        402(a)(2)(B) unless--
                  (A) a tolerance for such pesticide chemical 
                residue in or on such food is in effect under 
                this section and the quantity of the residue is 
                within the limits of the tolerance; or
                  (B) an exemption from the requirement of a 
                tolerance is in effect under this section for 
                the pesticide chemical residue.
        For the purposes of this section, the term ``food'', 
        when used as a noun without modification, shall mean a 
        raw agricultural commodity or processed food.
          (2) Processed food.--Notwithstanding paragraph (1)--
                  (A) if a tolerance is in effect under this 
                section for a pesticide chemical residue in or 
                on a raw agricultural commodity, a pesticide 
                chemical residue that is present in or on a 
                processed food because the food is made from 
                that raw agricultural commodity shall not be 
                considered unsafe within the meaning of section 
                402(a)(2)(B) despite the lack of a tolerance 
                for the pesticide chemical residue in or on the 
                processed food if the pesticide chemical has 
                been used in or on the raw agricultural 
                commodity in conformity with a tolerance under 
                this section, such residue in or on the raw 
                agricultural commodity has been removed to the 
                extent possible in good manufacturing practice, 
                and the concentration of the pesticide chemical 
                residue in the processed food is not greater 
                than the tolerance prescribed for the pesticide 
                chemical residue in the raw agricultural 
                commodity; or
                  (B) if an exemption for the requirement for a 
                tolerance is in effect under this section for a 
                pesticide chemical residue in or on a raw 
                agricultural commodity, a pesticide chemical 
                residue that is present in or on a processed 
                food because the food is made from that raw 
                agricultural commodity shall not be considered 
                unsafe within the meaning of section 
                402(a)(2)(B).
          (3) Residues of degradation products.--If a pesticide 
        chemical residue is present in or on a food because it 
        is a metabolite or other degradation product of a 
        precursor substance that itself is a pesticide chemical 
        or pesticide chemical residue, such a residue shall not 
        be considered to be unsafe within the meaning of 
        section 402(a)(2)(B) despite the lack of a tolerance or 
        exemption from the need for a tolerance for such 
        residue in or on such food if--
                  (A) the Administrator has not determined that 
                the degradation product is likely to pose any 
                potential health risk from dietary exposure 
                that is of a different type than, or of a 
                greater significance than, any risk posed by 
                dietary exposure to the precursor substance;
                  (B) either--
                          (i) a tolerance is in effect under 
                        this section for residues of the 
                        precursor substance in or on the food, 
                        and the combined level of residues of 
                        the degradation product and the 
                        precursor substance in or on the food 
                        is at or below the stoichiometrically 
                        equivalent level that would be 
                        permitted by the tolerance if the 
                        residue consisted only of the precursor 
                        substance rather than the degradation 
                        product; or
                          (ii) an exemption from the need for a 
                        tolerance is in effect under this 
                        section for residues of the precursor 
                        substance in or on the food; and
                  (C) the tolerance or exemption for residues 
                of the precursor substance does not state that 
                it applies only to particular named substances 
                and does not state that it does not apply to 
                residues of the degradation product.
          (4) Effect of tolerance or exemption.--While a 
        tolerance or exemption from the requirement for a 
        tolerance is in effect under this section for a 
        pesticide chemical residue with respect to any food, 
        the food shall not by reason of bearing or containing 
        any amount of such a residue be considered to be 
        adulterated within the meaning of section 402(a)(1).
  (b) Authority and Standard for Tolerance.--
          (1) Authority.--The Administrator may issue 
        regulations establishing, modifying, or revoking a 
        tolerance for a pesticide chemical residue in or on a 
        food--
                  (A) in response to a petition filed under 
                subsection (d); or
                  (B) on the Administrator's own initiative 
                under subsection (e).
        As used in this section, the term ``modify'' shall not 
        mean expanding the tolerance to cover additional foods.
          (2) Standard.--
                  (A) General rule.--
                          (i) Standard.--The Administrator may 
                        establish or leave in effect a 
                        tolerance for a pesticide chemical 
                        residue in or on a food only if the 
                        Administrator determines that the 
                        tolerance is safe. The Administrator 
                        shall modify or revoke a tolerance if 
                        the Administrator determines it is not 
                        safe.
                          (ii) Determination of safety.--As 
                        used in this section, the term 
                        ``safe'', with respect to a tolerance 
                        for a pesticide chemical residue, means 
                        that the Administrator has determined 
                        that there is a reasonable certainty 
                        that no harm will result from aggregate 
                        exposure to the pesticide chemical 
                        residue, including all anticipated 
                        dietary exposures and all other 
                        exposures for which there is reliable 
                        information.
                          (iii) Rule of construction.--With 
                        respect to a tolerance, a pesticide 
                        chemical residue meeting the standard 
                        under clause (i) is not an eligible 
                        pesticide chemical residue for purposes 
                        of subparagraph (B).
                  (B) Tolerances for eligible pesticide 
                chemical residues.--
                          (i) Definition.--As used in this 
                        subparagraph, the term ``eligible 
                        pesticide chemical residue'' means a 
                        pesticide chemical residue as to 
                        which--
                                  (I) the Administrator is not 
                                able to identify a level of 
                                exposure to the residue at 
                                which the residue will not 
                                cause or contribute to a known 
                                or anticipated harm to human 
                                health (referred to in this 
                                section as a ``nonthreshold 
                                effect'');
                                  (II) the lifetime risk of 
                                experiencing the nonthreshold 
                                effect is appropriately 
                                assessed by quantitative risk 
                                assessment; and
                                  (III) with regard to any 
                                known or anticipated harm to 
                                human health for which the 
                                Administrator is able to 
                                identify a level at which the 
                                residue will not cause such 
                                harm (referred to in this 
                                section as a ``threshold 
                                effect''), the Administrator 
                                determines that the level of 
                                aggregate exposure is safe.
                          (ii) Determination of tolerance.--
                        Notwithstanding subparagraph (A)(i), a 
                        tolerance for an eligible pesticide 
                        chemical residue may be left in effect 
                        or modified under this subparagraph 
                        if--
                                  (I) at least one of the 
                                conditions described in clause 
                                (iii) is met; and
                                  (II) both of the conditions 
                                described in clause (iv) are 
                                met.
                          (iii) Conditions regarding use.--For 
                        purposes of clause (ii), the conditions 
                        described in this clause with respect 
                        to a tolerance for an eligible 
                        pesticide chemical residue are the 
                        following:
                                  (I) Use of the pesticide 
                                chemical that produces the 
                                residue protects consumers from 
                                adverse effects on health that 
                                would pose a greater risk than 
                                the dietary risk from the 
                                residue.
                                  (II) Use of the pesticide 
                                chemical that produces the 
                                residue is necessary to avoid a 
                                significant disruption in 
                                domestic production of an 
                                adequate, wholesome, and 
                                economical food supply.
                          (iv) Conditions regarding risk.--For 
                        purposes of clause (ii), the conditions 
                        described in this clause with respect 
                        to a tolerance for an eligible 
                        pesticide chemical residue are the 
                        following:
                                  (I) The yearly risk 
                                associated with the 
                                nonthreshold effect from 
                                aggregate exposure to the 
                                residue does not exceed 10 
                                times the yearly risk that 
                                would be allowed under 
                                subparagraph (A) for such 
                                effect.
                                  (II) The tolerance is limited 
                                so as to ensure that the risk 
                                over a lifetime associated with 
                                the nonthreshold effect from 
                                aggregate exposure to the 
                                residue is not greater than 
                                twice the lifetime risk that 
                                would be allowed under 
                                subparagraph (A) for such 
                                effect.
                          (v) Review.--Five years after the 
                        date on which the Administrator makes a 
                        determination to leave in effect or 
                        modify a tolerance under this 
                        subparagraph, and thereafter as the 
                        Administrator deems appropriate, the 
                        Administrator shall determine, after 
                        notice and opportunity for comment, 
                        whether it has been demonstrated to the 
                        Administrator that a condition 
                        described in clause (iii)(I) or clause 
                        (iii)(II) continues to exist with 
                        respect to the tolerance and that the 
                        yearly and lifetime risks from 
                        aggregate exposure to such residue 
                        continue to comply with the limits 
                        specified in clause (iv). If the 
                        Administrator determines by such date 
                        that such demonstration has not been 
                        made, the Administrator shall, not 
                        later than 180 days after the date of 
                        such determination, issue a regulation 
                        under subsection (e)(1) to modify or 
                        revoke the tolerance.
                          (vi) Infants and children.--Any 
                        tolerance under this subparagraph shall 
                        meet the requirements of subparagraph 
                        (C).
                  (C) Exposure of infants and children.--In 
                establishing, modifying, leaving in effect, or 
                revoking a tolerance or exemption for a 
                pesticide chemical residue, the Administrator--
                          (i) shall assess the risk of the 
                        pesticide chemical residue based on--
                                  (I) available information 
                                about consumption patterns 
                                among infants and children that 
                                are likely to result in 
                                disproportionately high 
                                consumption of foods containing 
                                or bearing such residue among 
                                infants and children in 
                                comparison to the general 
                                population;
                                  (II) available information 
                                concerning the special 
                                susceptibility of infants and 
                                children to the pesticide 
                                chemical residues, including 
                                neurological differences 
                                between infants and children 
                                and adults, and effects of in 
                                utero exposure to pesticide 
                                chemicals; and
                                  (III) available information 
                                concerning the cumulative 
                                effects on infants and children 
                                of such residues and other 
                                substances that have a common 
                                mechanism of toxicity; and
                          (ii) shall--
                                  (I) ensure that there is a 
                                reasonable certainty that no 
                                harm will result to infants and 
                                children from aggregate 
                                exposure to the pesticide 
                                chemical residue; and
                                  (II) publish a specific 
                                determination regarding the 
                                safety of the pesticide 
                                chemical residue for infants 
                                and children.
                The Secretary of Health and Human Services and 
                the Secretary of Agriculture, in consultation 
                with the Administrator, shall conduct surveys 
                to document dietary exposure to pesticides 
                among infants and children. In the case of 
                threshold effects, for purposes of clause 
                (ii)(I) an additional tenfold margin of safety 
                for the pesticide chemical residue and other 
                sources of exposure shall be applied for 
                infants and children to take into account 
                potential pre- and post-natal toxicity and 
                completeness of the data with respect to 
                exposure and toxicity to infants and children. 
                Notwithstanding such requirement for an 
                additional margin of safety, the Administrator 
                may use a different margin of safety for the 
                pesticide chemical residue only if, on the 
                basis of reliable data, such margin will be 
                safe for infants and children.
                  (D) Factors.--In establishing, modifying, 
                leaving in effect, or revoking a tolerance or 
                exemption for a pesticide chemical residue, the 
                Administrator shall consider, among other 
                relevant factors--
                          (i) the validity, completeness, and 
                        reliability of the available data from 
                        studies of the pesticide chemical and 
                        pesticide chemical residue;
                          (ii) the nature of any toxic effect 
                        shown to be caused by the pesticide 
                        chemical or pesticide chemical residue 
                        in such studies;
                          (iii) available information 
                        concerning the relationship of the 
                        results of such studies to human risk;
                          (iv) available information concerning 
                        the dietary consumption patterns of 
                        consumers (and major identifiable 
                        subgroups of consumers);
                          (v) available information concerning 
                        the cumulative effects of such residues 
                        and other substances that have a common 
                        mechanism of toxicity;
                          (vi) available information concerning 
                        the aggregate exposure levels of 
                        consumers (and major identifiable 
                        subgroups of consumers) to the 
                        pesticide chemical residue and to other 
                        related substances, including dietary 
                        exposure under the tolerance and all 
                        other tolerances in effect for the 
                        pesticide chemical residue, and 
                        exposure from other non-occupational 
                        sources;
                          (vii) available information 
                        concerning the variability of the 
                        sensitivities of major identifiable 
                        subgroups of consumers;
                          (viii) such information as the 
                        Administrator may require on whether 
                        the pesticide chemical may have an 
                        effect in humans that is similar to an 
                        effect produced by a naturally 
                        occurring estrogen or other endocrine 
                        effects; and
                          (ix) safety factors which in the 
                        opinion of experts qualified by 
                        scientific training and experience to 
                        evaluate the safety of food additives 
                        are generally recognized as appropriate 
                        for the use of animal experimentation 
                        data.
                  (E) Data and information regarding 
                anticipated and actual residue levels.--
                          (i) Authority.--In establishing, 
                        modifying, leaving in effect, or 
                        revoking a tolerance for a pesticide 
                        chemical residue, the Administrator may 
                        consider available data and information 
                        on the anticipated residue levels of 
                        the pesticide chemical in or on food 
                        and the actual residue levels of the 
                        pesticide chemical that have been 
                        measured in food, including residue 
                        data collected by the Food and Drug 
                        Administration.
                          (ii) Requirement.--If the 
                        Administrator relies on anticipated or 
                        actual residue levels in establishing, 
                        modifying, or leaving in effect a 
                        tolerance, the Administrator shall 
                        pursuant to subsection (f)(1) require 
                        that data be provided five years after 
                        the date on which the tolerance is 
                        established, modified, or left in 
                        effect, and thereafter as the 
                        Administrator deems appropriate, 
                        demonstrating that such residue levels 
                        are not above the levels so relied on. 
                        If such data are not so provided, or if 
                        the data do not demonstrate that the 
                        residue levels are not above the levels 
                        so relied on, the Administrator shall, 
                        not later than 180 days after the date 
                        on which the data were required to be 
                        provided, issue a regulation under 
                        subsection (e)(1), or an order under 
                        subsection (f)(2), as appropriate, to 
                        modify or revoke the tolerance.
                  (F) Percent of food actually treated.--In 
                establishing, modifying, leaving in effect, or 
                revoking a tolerance for a pesticide chemical 
                residue, the Administrator may, when assessing 
                chronic dietary risk, consider available data 
                and information on the percent of food actually 
                treated with the pesticide chemical (including 
                aggregate pesticide use data collected by the 
                Department of Agriculture) only if the 
                Administrator--
                          (i) finds that the data are reliable 
                        and provide a valid basis to show what 
                        percentage of the food derived from 
                        such crop is likely to contain such 
                        pesticide chemical residue;
                          (ii) finds that the exposure estimate 
                        does not understate exposure for any 
                        significant subpopulation group;
                          (iii) finds that, if data are 
                        available on pesticide use and 
                        consumption of food in a particular 
                        area, the population in such area is 
                        not dietarily exposed to residues above 
                        those estimated by the Administrator; 
                        and
                          (iv) provides for the periodic 
                        reevaluation of the estimate of 
                        anticipated dietary exposure.
          (3) Detection methods.--
                  (A) General rule.--A tolerance for a 
                pesticide chemical residue in or on a food 
                shall not be established or modified by the 
                Administrator unless the Administrator 
                determines, after consultation with the 
                Secretary, that there is a practical method for 
                detecting and measuring the levels of the 
                pesticide chemical residue in or on the food.
                  (B) Detection limit.--A tolerance for a 
                pesticide chemical residue in or on a food 
                shall not be established at or modified to a 
                level lower than the limit of detection of the 
                method for detecting and measuring the 
                pesticide chemical residue specified by the 
                Administrator under subparagraph (A).
          (4) International standards.--In establishing a 
        tolerance for a pesticide chemical residue in or on a 
        food, the Administrator shall determine whether a 
        maximum residue level for the pesticide chemical has 
        been established by the Codex Alimentarius Commission. 
        If a Codex maximum residue level has been established 
        for the pesticide chemical and the Administrator does 
        not propose to adopt the Codex level, the Administrator 
        shall publish for public comment a notice explaining 
        the reasons for departing from the Codex level.
  (c) Authority and Standard for Exemptions.--
          (1) Authority.--The Administrator may issue a 
        regulation establishing, modifying, or revoking an 
        exemption from the requirement for a tolerance for a 
        pesticide chemical residue in or on food--
                  (A) in response to a petition filed under 
                subsection (d); or
                  (B) on the Administrator's initiative under 
                subsection (e).
          (2) Standard.--
                  (A) General rule.--
                          (i) Standard.--The Administrator may 
                        establish or leave in effect an 
                        exemption from the requirement for a 
                        tolerance for a pesticide chemical 
                        residue in or on food only if the 
                        Administrator determines that the 
                        exemption is safe. The Administrator 
                        shall modify or revoke an exemption if 
                        the Administrator determines it is not 
                        safe.
                          (ii) Determination of safety.--The 
                        term ``safe'', with respect to an 
                        exemption for a pesticide chemical 
                        residue, means that the Administrator 
                        has determined that there is a 
                        reasonable certainty that no harm will 
                        result from aggregate exposure to the 
                        pesticide chemical residue, including 
                        all anticipated dietary exposures and 
                        all other exposures for which there is 
                        reliable information.
                  (B) Factors.--In making a determination under 
                this paragraph, the Administrator shall take 
                into account, among other relevant 
                considerations, the considerations set forth in 
                subparagraphs (C) and (D) of subsection (b)(2).
          (3) Limitation.--An exemption from the requirement 
        for a tolerance for a pesticide chemical residue in or 
        on food shall not be established or modified by the 
        Administrator unless the Administrator determines, 
        after consultation with the Secretary--
                  (A) that there is a practical method for 
                detecting and measuring the levels of such 
                pesticide chemical residue in or on food; or
                  (B) that there is no need for such a method, 
                and states the reasons for such determination 
                in issuing the regulation establishing or 
                modifying the exemption.
  (d) Petition for Tolerance or Exemption.--
          (1) Petitions and petitioners.--Any person may file 
        with the Administrator a petition proposing the 
        issuance of a regulation--
                  (A) establishing, modifying, or revoking a 
                tolerance for a pesticide chemical residue in 
                or on a food; or
                  (B) establishing, modifying, or revoking an 
                exemption from the requirement of a tolerance 
                for such a residue.
          (2) Petition contents.--
                  (A) Establishment.--A petition under 
                paragraph (1) to establish a tolerance or 
                exemption for a pesticide chemical residue 
                shall be supported by such data and information 
                as are specified in regulations issued by the 
                Administrator, including--
                          (i)(I) an informative summary of the 
                        petition and of the data, information, 
                        and arguments submitted or cited in 
                        support of the petition; and
                          (II) a statement that the petitioner 
                        agrees that such summary or any 
                        information it contains may be 
                        published as a part of the notice of 
                        filing of the petition to be published 
                        under this subsection and as part of a 
                        proposed or final regulation issued 
                        under this section;
                          (ii) the name, chemical identity, and 
                        composition of the pesticide chemical 
                        residue and of the pesticide chemical 
                        that produces the residue;
                          (iii) data showing the recommended 
                        amount, frequency, method, and time of 
                        application of that pesticide chemical;
                          (iv) full reports of tests and 
                        investigations made with respect to the 
                        safety of the pesticide chemical, 
                        including full information as to the 
                        methods and controls used in conducting 
                        those tests and investigations;
                          (v) full reports of tests and 
                        investigations made with respect to the 
                        nature and amount of the pesticide 
                        chemical residue that is likely to 
                        remain in or on the food, including a 
                        description of the analytical methods 
                        used;
                          (vi) a practical method for detecting 
                        and measuring the levels of the 
                        pesticide chemical residue in or on the 
                        food, or for exemptions, a statement 
                        why such a method is not needed;
                          (vii) a proposed tolerance for the 
                        pesticide chemical residue, if a 
                        tolerance is proposed;
                          (viii) if the petition relates to a 
                        tolerance for a processed food, reports 
                        of investigations conducted using the 
                        processing method(s) used to produce 
                        that food;
                          (ix) such information as the 
                        Administrator may require to make the 
                        determination under subsection 
                        (b)(2)(C);
                          (x) such information as the 
                        Administrator may require on whether 
                        the pesticide chemical may have an 
                        effect in humans that is similar to an 
                        effect produced by a naturally 
                        occurring estrogen or other endocrine 
                        effects;
                          (xi) information regarding exposure 
                        to the pesticide chemical residue due 
                        to any tolerance or exemption already 
                        granted for such residue;
                          (xii) practical methods for removing 
                        any amount of the residue that would 
                        exceed any proposed tolerance; and
                          (xiii) such other data and 
                        information as the Administrator 
                        requires by regulation to support the 
                        petition.
                If information or data required by this 
                subparagraph is available to the Administrator, 
                the person submitting the petition may cite the 
                availability of the information or data in lieu 
                of submitting it. The Administrator may require 
                a petition to be accompanied by samples of the 
                pesticide chemical with respect to which the 
                petition is filed.
                  (B) Modification or revocation.--The 
                Administrator may by regulation establish the 
                requirements for information and data to 
                support a petition to modify or revoke a 
                tolerance or to modify or revoke an exemption 
                from the requirement for a tolerance.
          (3) Notice.--A notice of the filing of a petition 
        that the Administrator determines has met the 
        requirements of paragraph (2) shall be published by the 
        Administrator within 30 days after such determination. 
        The notice shall announce the availability of a 
        description of the analytical methods available to the 
        Administrator for the detection and measurement of the 
        pesticide chemical residue with respect to which the 
        petition is filed or shall set forth the petitioner's 
        statement of why such a method is not needed. The 
        notice shall include the summary required by paragraph 
        (2)(A)(i)(I).
          (4) Actions by the administrator.--
                  (A) In general.--The Administrator shall, 
                after giving due consideration to a petition 
                filed under paragraph (1) and any other 
                information available to the Administrator--
                          (i) issue a final regulation (which 
                        may vary from that sought by the 
                        petition) establishing, modifying, or 
                        revoking a tolerance for the pesticide 
                        chemical residue or an exemption of the 
                        pesticide chemical residue from the 
                        requirement of a tolerance (which final 
                        regulation shall be issued without 
                        further notice and without further 
                        period for public comment);
                          (ii) issue a proposed regulation 
                        under subsection (e), and thereafter 
                        issue a final regulation under such 
                        subsection; or
                          (iii) issue an order denying the 
                        petition.
                  (B) Priorities.--The Administrator shall give 
                priority to petitions for the establishment or 
                modification of a tolerance or exemption for a 
                pesticide chemical residue that appears to pose 
                a significantly lower risk to human health from 
                dietary exposure than pesticide chemical 
                residues that have tolerances in effect for the 
                same or similar uses.
                  (C) Expedited review of certain petitions.--
                          (i) Date certain for review.--If a 
                        person files a complete petition with 
                        the Administrator proposing the 
                        issuance of a regulation establishing a 
                        tolerance or exemption for a pesticide 
                        chemical residue that presents a lower 
                        risk to human health than a pesticide 
                        chemical residue for which a tolerance 
                        has been left in effect or modified 
                        under subsection (b)(2)(B), the 
                        Administrator shall complete action on 
                        such petition under this paragraph 
                        within 1 year.
                          (ii) Required determinations.--If the 
                        Administrator issues a final regulation 
                        establishing a tolerance or exemption 
                        for a safer pesticide chemical residue 
                        under clause (i), the Administrator 
                        shall, not later than 180 days after 
                        the date on which the regulation is 
                        issued, determine whether a condition 
                        described in subclause (I) or (II) of 
                        subsection (b)(2)(B)(iii) continues to 
                        exist with respect to a tolerance that 
                        has been left in effect or modified 
                        under subsection (b)(2)(B). If such 
                        condition does not continue to exist, 
                        the Administrator shall, not later than 
                        180 days after the date on which the 
                        determination under the preceding 
                        sentence is made, issue a regulation 
                        under subsection (e)(1) to modify or 
                        revoke the tolerance.
  (e) Action on Administrator's Own Initiative.--
          (1) General rule.--The Administrator may issue a 
        regulation--
                  (A) establishing, modifying, suspending under 
                subsection (l)(3), or revoking a tolerance for 
                a pesticide chemical or a pesticide chemical 
                residue;
                  (B) establishing, modifying, suspending under 
                subsection (l)(3), or revoking an exemption of 
                a pesticide chemical residue from the 
                requirement of a tolerance; or
                  (C) establishing general procedures and 
                requirements to implement this section.
          (2) Notice.--Before issuing a final regulation under 
        paragraph (1), the Administrator shall issue a notice 
        of proposed rulemaking and provide a period of not less 
        than 60 days for public comment on the proposed 
        regulation, except that a shorter period for comment 
        may be provided if the Administrator for good cause 
        finds that it would be in the public interest to do so 
        and states the reasons for the finding in the notice of 
        proposed rulemaking.
  (f) Special Data Requirements.--
          (1) Requiring submission of additional data.--If the 
        Administrator determines that additional data or 
        information are reasonably required to support the 
        continuation of a tolerance or exemption that is in 
        effect under this section for a pesticide chemical 
        residue on a food, the Administrator shall--
                  (A) issue a notice requiring the person 
                holding the pesticide registrations associated 
                with such tolerance or exemption to submit the 
                data or information under section 3(c)(2)(B) of 
                the Federal Insecticide, Fungicide, and 
                Rodenticide Act;
                  (B) issue a rule requiring that testing be 
                conducted on a substance or mixture under 
                section 4 of the Toxic Substances Control Act; 
                or
                  (C) publish in the Federal Register, after 
                first providing notice and an opportunity for 
                comment of not less than 60 days' duration, an 
                order--
                          (i) requiring the submission to the 
                        Administrator by one or more interested 
                        persons of a notice identifying the 
                        person or persons who will submit the 
                        required data and information;
                          (ii) describing the type of data and 
                        information required to be submitted to 
                        the Administrator and stating why the 
                        data and information could not be 
                        obtained under the authority of section 
                        3(c)(2)(B) of the Federal Insecticide, 
                        Fungicide, and Rodenticide Act or 
                        section 4 of the Toxic Substances 
                        Control Act;
                          (iii) describing the reports of the 
                        Administrator required to be prepared 
                        during and after the collection of the 
                        data and information;
                          (iv) requiring the submission to the 
                        Administrator of the data, information, 
                        and reports referred to in clauses (ii) 
                        and (iii); and
                          (v) establishing dates by which the 
                        submissions described in clauses (i) 
                        and (iv) must be made.
                The Administrator may under subparagraph (C) 
                revise any such order to correct an error. The 
                Administrator may under this paragraph require 
                data or information pertaining to whether the 
                pesticide chemical may have an effect in humans 
                that is similar to an effect produced by a 
                naturally occurring estrogen or other endocrine 
                effects.
          (2) Noncompliance.--If a submission required by a 
        notice issued in accordance with paragraph (1)(A), a 
        rule issued under paragraph (1)(B), or an order issued 
        under paragraph (1)(C) is not made by the time 
        specified in such notice, rule, or order, the 
        Administrator may by order published in the Federal 
        Register modify or revoke the tolerance or exemption in 
        question. In any review of such an order under 
        subsection (g)(2), the only material issue shall be 
        whether a submission required under paragraph (1) was 
        not made by the time specified.
  (g) Effective Date, Objections, Hearings, and Administrative 
Review.--
          (1) Effective date.--A regulation or order issued 
        under subsection (d)(4), (e)(1), or (f)(2) shall take 
        effect upon publication unless the regulation or order 
        specifies otherwise. The Administrator may stay the 
        effectiveness of the regulation or order if, after 
        issuance of such regulation or order, objections are 
        filed with respect to such regulation or order pursuant 
        to paragraph (2).
          (2) Further proceedings.--
                  (A) Objections.--Within 60 days after a 
                regulation or order is issued under subsection 
                (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), 
                or (n)(5)(C), any person may file objections 
                thereto with the Administrator, specifying with 
                particularity the provisions of the regulation 
                or order deemed objectionable and stating 
                reasonable grounds therefor. If the regulation 
                or order was issued in response to a petition 
                under subsection (d)(1), a copy of each 
                objection filed by a person other than the 
                petitioner shall be served by the Administrator 
                on the petitioner.
                  (B) Hearing.--An objection may include a 
                request for a public evidentiary hearing upon 
                the objection. The Administrator shall, upon 
                the initiative of the Administrator or upon the 
                request of an interested person and after due 
                notice, hold a public evidentiary hearing if 
                and to the extent the Administrator determines 
                that such a public hearing is necessary to 
                receive factual evidence relevant to material 
                issues of fact raised by the objections. The 
                presiding officer in such a hearing may 
                authorize a party to obtain discovery from 
                other persons and may upon a showing of good 
                cause made by a party issue a subpoena to 
                compel testimony or production of documents 
                from any person. The presiding officer shall be 
                governed by the Federal Rules of Civil 
                Procedure in making any order for the 
                protection of the witness or the content of 
                documents produced and shall order the payment 
                of reasonable fees and expenses as a condition 
                to requiring testimony of the witness. On 
                contest, such a subpoena may be enforced by a 
                Federal district court.
                  (C) Final decision.--As soon as practicable 
                after receiving the arguments of the parties, 
                the Administrator shall issue an order stating 
                the action taken upon each such objection and 
                setting forth any revision to the regulation or 
                prior order that the Administrator has found to 
                be warranted. If a hearing was held under 
                subparagraph (B), such order and any revision 
                to the regulation or prior order shall, with 
                respect to questions of fact at issue in the 
                hearing, be based only on substantial evidence 
                of record at such hearing, and shall set forth 
                in detail the findings of facts and the 
                conclusions of law or policy upon which the 
                order or regulation is based.
  (h) Judicial Review.--
          (1) Petition.--In a case of actual controversy as to 
        the validity of any regulation issued under subsection 
        (e)(1)(C), or any order issued under subsection 
        (f)(1)(C) or (g)(2)(C), or any regulation that is the 
        subject of such an order, any person who will be 
        adversely affected by such order or regulation may 
        obtain judicial review by filing in the United States 
        Court of Appeals for the circuit wherein that person 
        resides or has its principal place of business, or in 
        the United States Court of Appeals for the District of 
        Columbia Circuit, within 60 days after publication of 
        such order or regulation, a petition praying that the 
        order or regulation be set aside in whole or in part.
          (2) Record and jurisdiction.--A copy of the petition 
        under paragraph (1) shall be forthwith transmitted by 
        the clerk of the court to the Administrator, or any 
        officer designated by the Administrator for that 
        purpose, and thereupon the Administrator shall file in 
        the court the record of the proceedings on which the 
        Administrator based the order or regulation, as 
        provided in section 2112 of title 28, United States 
        Code. Upon the filing of such a petition, the court 
        shall have exclusive jurisdiction to affirm or set 
        aside the order or regulation complained of in whole or 
        in part. As to orders issued following a public 
        evidentiary hearing, the findings of the Administrator 
        with respect to questions of fact shall be sustained 
        only if supported by substantial evidence when 
        considered on the record as a whole.
          (3) Additional evidence.--If a party applies to the 
        court for leave to adduce additional evidence and shows 
        to the satisfaction of the court that the additional 
        evidence is material and that there were reasonable 
        grounds for the failure to adduce the evidence in the 
        proceeding before the Administrator, the court may 
        order that the additional evidence (and evidence in 
        rebuttal thereof) shall be taken before the 
        Administrator in the manner and upon the terms and 
        conditions the court deems proper. The Administrator 
        may modify prior findings as to the facts by reason of 
        the additional evidence so taken and may modify the 
        order or regulation accordingly. The Administrator 
        shall file with the court any such modified finding, 
        order, or regulation.
          (4) Final judgment; supreme court review.--The 
        judgment of the court affirming or setting aside, in 
        whole or in part, any regulation or any order and any 
        regulation which is the subject of such an order shall 
        be final, subject to review by the Supreme Court of the 
        United States as provided in section 1254 of title 28 
        of the United States Code. The commencement of 
        proceedings under this subsection shall not, unless 
        specifically ordered by the court to the contrary, 
        operate as a stay of a regulation or order.
          (5) Application.--Any issue as to which review is or 
        was obtainable under this subsection shall not be the 
        subject of judicial review under any other provision of 
        law.
  (i) Confidentiality and Use of Data.--
          (1) General rule.--Data and information that are or 
        have been submitted to the Administrator under this 
        section or section 409 in support of a tolerance or an 
        exemption from a tolerance shall be entitled to 
        confidential treatment for reasons of business 
        confidentiality and to exclusive use and data 
        compensation to the same extent provided by sections 3 
        and 10 of the Federal Insecticide, Fungicide, and 
        Rodenticide Act.
          (2) Exceptions.--
                  (A) In general.--Data and information that 
                are entitled to confidential treatment under 
                paragraph (1) may be disclosed, under such 
                security requirements as the Administrator may 
                provide by regulation, to--
                          (i) employees of the United States 
                        authorized by the Administrator to 
                        examine such data and information in 
                        the carrying out of their official 
                        duties under this Act or other Federal 
                        statutes intended to protect the public 
                        health; or
                          (ii) contractors with the United 
                        States authorized by the Administrator 
                        to examine such data and information in 
                        the carrying out of contracts under 
                        this Act or such statutes.
                  (B) Congress.--This subsection does not 
                authorize the withholding of data or 
                information from either House of Congress or 
                from, to the extent of matter within its 
                jurisdiction, any committee or subcommittee of 
                such committee or any joint committee of 
                Congress or any subcommittee of such joint 
                committee.
          (3) Summaries.--Notwithstanding any provision of this 
        subsection or other law, the Administrator may publish 
        the informative summary required by subsection 
        (d)(2)(A)(i) and may, in issuing a proposed or final 
        regulation or order under this section, publish an 
        informative summary of the data relating to the 
        regulation or order.
  (j) Status of Previously Issued Regulations.--
          (1) Regulations under section 406.--Regulations 
        affecting pesticide chemical residues in or on raw 
        agricultural commodities promulgated, in accordance 
        with section 701(e), under the authority of section 
        406(a) upon the basis of public hearings instituted 
        before January 1, 1953, shall be deemed to be 
        regulations issued under this section and shall be 
        subject to modification or revocation under subsections 
        (d) and (e), and shall be subject to review under 
        subsection (q).
          (2) Regulations under section 409.--Regulations that 
        established tolerances for substances that are 
        pesticide chemical residues in or on processed food, or 
        that otherwise stated the conditions under which such 
        pesticide chemicals could be safely used, and that were 
        issued under section 409 on or before the date of the 
        enactment of this paragraph, shall be deemed to be 
        regulations issued under this section and shall be 
        subject to modification or revocation under subsection 
        (d) or (e), and shall be subject to review under 
        subsection (q).
          (3) Regulations under section 408.--Regulations that 
        established tolerances or exemptions under this section 
        that were issued on or before the date of the enactment 
        of this paragraph shall remain in effect unless 
        modified or revoked under subsection (d) or (e), and 
        shall be subject to review under subsection (q).
          (4) Certain substances.--With respect to a substance 
        that is not included in the definition of the term 
        ``pesticide chemical'' under section 201(q)(1) but was 
        so included on the day before the date of the enactment 
        of the Antimicrobial Regulation Technical Corrections 
        Act of 1998, the following applies as of such date of 
        enactment:
                  (A) Notwithstanding paragraph (2), any 
                regulation applying to the use of the substance 
                that was in effect on the day before such date, 
                and was on such day deemed in such paragraph to 
                have been issued under this section, shall be 
                considered to have been issued under section 
                409.
                  (B) Notwithstanding paragraph (3), any 
                regulation applying to the use of the substance 
                that was in effect on such day and was issued 
                under this section (including any such 
                regulation issued before the date of the 
                enactment of the Food Quality Protection Act of 
                1996) is deemed to have been issued under 
                section 409.
  (k) Transitional Provision.--If, on the day before the date 
of the enactment of this subsection, a substance that is a 
pesticide chemical was, with respect to a particular pesticidal 
use of the substance and any resulting pesticide chemical 
residue in or on a particular food--
          (1) regarded by the Administrator or the Secretary as 
        generally recognized as safe for use within the meaning 
        of the provisions of subsection (a) or section 201(s) 
        as then in effect; or
          (2) regarded by the Secretary as a substance 
        described by section 201(s)(4);
such a pesticide chemical residue shall be regarded as exempt 
from the requirement for a tolerance, as of the date of 
enactment of this subsection. The Administrator shall by 
regulation indicate which substances are described by this 
subsection. Any exemption under this subsection may be modified 
or revoked as if it had been issued under subsection (c).
  (l) Harmonization With Action Under Other Laws.--
          (1) Coordination with fifra.--To the extent 
        practicable and consistent with the review deadlines in 
        subsection (q), in issuing a final rule under this 
        subsection that suspends or revokes a tolerance or 
        exemption for a pesticide chemical residue in or on 
        food, the Administrator shall coordinate such action 
        with any related necessary action under the Federal 
        Insecticide, Fungicide, and Rodenticide Act.
          (2) Revocation of tolerance or exemption following 
        cancellation of associated registrations.--If the 
        Administrator, acting under the Federal Insecticide, 
        Fungicide, and Rodenticide Act, cancels the 
        registration of each pesticide that contains a 
        particular pesticide chemical and that is labeled for 
        use on a particular food, or requires that the 
        registration of each such pesticide be modified to 
        prohibit its use in connection with the production, 
        storage, or transportation of such food, due in whole 
        or in part to dietary risks to humans posed by residues 
        of that pesticide chemical on that food, the 
        Administrator shall revoke any tolerance or exemption 
        that allows the presence of the pesticide chemical, or 
        any pesticide chemical residue that results from its 
        use, in or on that food. Subsection (e) shall apply to 
        actions taken under this paragraph. A revocation under 
        this paragraph shall become effective not later than 
        180 days after--
                  (A) the date by which each such cancellation 
                of a registration has become effective; or
                  (B) the date on which the use of the canceled 
                pesticide becomes unlawful under the terms of 
                the cancellation, whichever is later.
          (3) Suspension of tolerance or exemption following 
        suspension of associated registrations.--
                  (A) Suspension.--If the Administrator, acting 
                under the Federal Insecticide, Fungicide, and 
                Rodenticide Act, suspends the use of each 
                registered pesticide that contains a particular 
                pesticide chemical and that is labeled for use 
                on a particular food, due in whole or in part 
                to dietary risks to humans posed by residues of 
                that pesticide chemical on that food, the 
                Administrator shall suspend any tolerance or 
                exemption that allows the presence of the 
                pesticide chemical, or any pesticide chemical 
                residue that results from its use, in or on 
                that food. Subsection (e) shall apply to 
                actions taken under this paragraph. A 
                suspension under this paragraph shall become 
                effective not later than 60 days after the date 
                by which each such suspension of use has become 
                effective.
                  (B) Effect of suspension.--The suspension of 
                a tolerance or exemption under subparagraph (A) 
                shall be effective as long as the use of each 
                associated registration of a pesticide is 
                suspended under the Federal Insecticide, 
                Fungicide, and Rodenticide Act. While a 
                suspension of a tolerance or exemption is 
                effective the tolerance or exemption shall not 
                be considered to be in effect. If the 
                suspension of use of the pesticide under that 
                Act is terminated, leaving the registration of 
                the pesticide for such use in effect under that 
                Act, the Administrator shall rescind any 
                associated suspension of tolerance or 
                exemption.
          (4) Tolerances for unavoidable residues.--In 
        connection with action taken under paragraph (2) or 
        (3), or with respect to pesticides whose registrations 
        were suspended or canceled prior to the date of the 
        enactment of this paragraph under the Federal 
        Insecticide, Fungicide, and Rodenticide Act, if the 
        Administrator determines that a residue of the canceled 
        or suspended pesticide chemical will unavoidably 
        persist in the environment and thereby be present in or 
        on a food, the Administrator may establish a tolerance 
        for the pesticide chemical residue. In establishing 
        such a tolerance, the Administrator shall take into 
        account both the factors set forth in subsection (b)(2) 
        and the unavoidability of the residue. Subsection (e) 
        shall apply to the establishment of such tolerance. The 
        Administrator shall review any such tolerance 
        periodically and modify it as necessary so that it 
        allows no greater level of the pesticide chemical 
        residue than is unavoidable.
          (5) Pesticide residues resulting from lawful 
        application of pesticide.--Notwithstanding any other 
        provision of this Act, if a tolerance or exemption for 
        a pesticide chemical residue in or on a food has been 
        revoked, suspended, or modified under this section, an 
        article of that food shall not be deemed unsafe solely 
        because of the presence of such pesticide chemical 
        residue in or on such food if it is shown to the 
        satisfaction of the Secretary that--
                  (A) the residue is present as the result of 
                an application or use of a pesticide at a time 
                and in a manner that was lawful under the 
                Federal Insecticide, Fungicide, and Rodenticide 
                Act; and
                  (B) the residue does not exceed a level that 
                was authorized at the time of that application 
                or use to be present on the food under a 
                tolerance, exemption, food additive regulation, 
                or other sanction then in effect under this 
                Act;
        unless, in the case of any tolerance or exemption 
        revoked, suspended, or modified under this subsection 
        or subsection (d) or (e), the Administrator has issued 
        a determination that consumption of the legally treated 
        food during the period of its likely availability in 
        commerce will pose an unreasonable dietary risk.
          (6) Tolerance for use of pesticides under an 
        emergency exemption.--If the Administrator grants an 
        exemption under section 18 of the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. 136p) for a 
        pesticide chemical, the Administrator shall establish a 
        tolerance or exemption from the requirement for a 
        tolerance for the pesticide chemical residue. Such a 
        tolerance or exemption from a tolerance shall have an 
        expiration date. The Administrator may establish such a 
        tolerance or exemption without providing notice or a 
        period for comment on the tolerance or exemption. The 
        Administrator shall promulgate regulations within 365 
        days after the date of the enactment of this paragraph 
        governing the establishment of tolerances and 
        exemptions under this paragraph. Such regulations shall 
        be consistent with the safety standard under 
        subsections (b)(2) and (c)(2) and with section 18 of 
        the Federal Insecticide, Fungicide, and Rodenticide 
        Act.
  (m) Fees.--
          (1) Amount.--The Administrator shall by regulation 
        require the payment of such fees as will in the 
        aggregate, in the judgment of the Administrator, be 
        sufficient over a reasonable term to provide, equip, 
        and maintain an adequate service for the performance of 
        the Administrator's functions under this section. Under 
        the regulations, the performance of the Administrator's 
        services or other functions under this section, 
        including--
                  (A) the acceptance for filing of a petition 
                submitted under subsection (d);
                  (B) establishing, modifying, leaving in 
                effect, or revoking a tolerance or 
                establishing, modifying, leaving in effect, or 
                revoking an exemption from the requirement for 
                a tolerance under this section;
                  (C) the acceptance for filing of objections 
                under subsection (g); or
                  (D) the certification and filing in court of 
                a transcript of the proceedings and the record 
                under subsection (h);
        may be conditioned upon the payment of such fees. The 
        regulations may further provide for waiver or refund of 
        fees in whole or in part when in the judgment of the 
        Administrator such a waiver or refund is equitable and 
        not contrary to the purposes of this subsection.
          (2) Deposit.--All fees collected under paragraph (1) 
        shall be deposited in the Reregistration and Expedited 
        Processing Fund created by section 4(k) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act. Such fees 
        shall be available to the Administrator, without fiscal 
        year limitation, for the performance of the 
        Administrator's services or functions as specified in 
        paragraph (1).
          (3) Prohibition.--During the period beginning on the 
        effective date of the Pesticide Registration 
        Improvement Renewal Act and ending on September 30, 
        [2017] 2023, the Administrator shall not collect any 
        tolerance fees under paragraph (1).
  (n) National Uniformity of Tolerances.--
          (1) Qualifying pesticide chemical residue.--For 
        purposes of this subsection, the term ``qualifying 
        pesticide chemical residue'' means a pesticide chemical 
        residue resulting from the use, in production, 
        processing, or storage of a food, of a pesticide 
        chemical that is an active ingredient and that--
                  (A) was first approved for such use in a 
                registration of a pesticide issued under 
                section 3(c)(5) of the Federal Insecticide, 
                Fungicide, and Rodenticide Act on or after 
                April 25, 1985, on the basis of data determined 
                by the Administrator to meet all applicable 
                requirements for data prescribed by regulations 
                in effect under that Act on April 25, 1985; or
                  (B) was approved for such use in a 
                reregistration eligibility determination issued 
                under section 4(g) of that Act on or after the 
                date of enactment of this subsection.
          (2) Qualifying federal determination.--For purposes 
        of this subsection, the term ``qualifying Federal 
        determination'' means a tolerance or exemption from the 
        requirement for a tolerance for a qualifying pesticide 
        chemical residue that--
                  (A) is issued under this section after the 
                date of the enactment of this subsection and 
                determined by the Administrator to meet the 
                standard under subsection (b)(2)(A) (in the 
                case of a tolerance) or (c)(2) (in the case of 
                an exemption); or
                  (B)(i) pursuant to subsection (j) is 
                remaining in effect or is deemed to have been 
                issued under this section, or is regarded under 
                subsection (k) as exempt from the requirement 
                for a tolerance; and
                  (ii) is determined by the Administrator to 
                meet the standard under subsection (b)(2)(A) 
                (in the case of a tolerance) or (c)(2) (in the 
                case of an exemption).
          (3) Limitation.--The Administrator may make the 
        determination described in paragraph (2)(B)(ii) only by 
        issuing a rule in accordance with the procedure set 
        forth in subsection (d) or (e) and only if the 
        Administrator issues a proposed rule and allows a 
        period of not less than 30 days for comment on the 
        proposed rule. Any such rule shall be reviewable in 
        accordance with subsections (g) and (h).
          (4) State authority.--Except as provided in 
        paragraphs (5), (6), and (8) no State or political 
        subdivision may establish or enforce any regulatory 
        limit on a qualifying pesticide chemical residue in or 
        on any food if a qualifying Federal determination 
        applies to the presence of such pesticide chemical 
        residue in or on such food, unless such State 
        regulatory limit is identical to such qualifying 
        Federal determination. A State or political subdivision 
        shall be deemed to establish or enforce a regulatory 
        limit on a pesticide chemical residue in or on a food 
        if it purports to prohibit or penalize the production, 
        processing, shipping, or other handling of a food 
        because it contains a pesticide residue (in excess of a 
        prescribed limit).
          (5) Petition procedure.--
                  (A) In general.--Any State may petition the 
                Administrator for authorization to establish in 
                such State a regulatory limit on a qualifying 
                pesticide chemical residue in or on any food 
                that is not identical to the qualifying Federal 
                determination applicable to such qualifying 
                pesticide chemical residue.
                  (B) Petition requirements.--Any petition 
                under subparagraph (A) shall--
                          (i) satisfy any requirements 
                        prescribed, by rule, by the 
                        Administrator; and
                          (ii) be supported by scientific data 
                        about the pesticide chemical residue 
                        that is the subject of the petition or 
                        about chemically related pesticide 
                        chemical residues, data on the 
                        consumption within such State of food 
                        bearing the pesticide chemical residue, 
                        and data on exposure of humans within 
                        such State to the pesticide chemical 
                        residue.
                  (C) Authorization.--The Administrator may, by 
                order, grant the authorization described in 
                subparagraph (A) if the Administrator 
                determines that the proposed State regulatory 
                limit--
                          (i) is justified by compelling local 
                        conditions; and
                          (ii) would not cause any food to be a 
                        violation of Federal law.
                  (D) Treatment.--In lieu of any action 
                authorized under subparagraph (C), the 
                Administrator may treat a petition under this 
                paragraph as a petition under subsection (d) to 
                modify or revoke a tolerance or an exemption. 
                If the Administrator determines to treat a 
                petition under this paragraph as a petition 
                under subsection (d), the Administrator shall 
                thereafter act on the petition pursuant to 
                subsection (d).
                  (E) Review.--Any order of the Administrator 
                granting or denying the authorization described 
                in subparagraph (A) shall be subject to review 
                in the manner described in subsections (g) and 
                (h).
          (6) Urgent petition procedure.--Any State petition to 
        the Administrator pursuant to paragraph (5) that 
        demonstrates that consumption of a food containing such 
        pesticide residue level during the period of the food's 
        likely availability in the State will pose a 
        significant public health threat from acute exposure 
        shall be considered an urgent petition. If an order by 
        the Administrator to grant or deny the requested 
        authorization in an urgent petition is not made within 
        30 days of receipt of the petition, the petitioning 
        State may establish and enforce a temporary regulatory 
        limit on a qualifying pesticide chemical residue in or 
        on the food. The temporary regulatory limit shall be 
        validated or terminated by the Administrator's final 
        order on the petition.
          (7) Residues from lawful application.--No State or 
        political subdivision may enforce any regulatory limit 
        on the level of a pesticide chemical residue that may 
        appear in or on any food if, at the time of the 
        application of the pesticide that resulted in such 
        residue, the sale of such food with such residue level 
        was lawful under this section and under the law of such 
        State, unless the State demonstrates that consumption 
        of the food containing such pesticide residue level 
        during the period of the food's likely availability in 
        the State will pose an unreasonable dietary risk to the 
        health of persons within such State.
          (8) Savings.--Nothing in this Act preempts the 
        authority of any State or political subdivision to 
        require that a food containing a pesticide chemical 
        residue bear or be the subject of a warning or other 
        statement relating to the presence of the pesticide 
        chemical residue in or on such food.
  (o) Consumer Right To Know.--Not later than 2 years after the 
date of the enactment of the Food Quality Protection Act of 
1996, and annually thereafter, the Administrator shall, in 
consultation with the Secretary of Agriculture and the 
Secretary of Health and Human Services, publish in a format 
understandable to a lay person, and distribute to large retail 
grocers for public display (in a manner determined by the 
grocer), the following information, at a minimum:
          (1) A discussion of the risks and benefits of 
        pesticide chemical residues in or on food purchased by 
        consumers.
          (2) A listing of actions taken under subparagraph (B) 
        of subsection (b)(2) that may result in pesticide 
        chemical residues in or on food that present a yearly 
        or lifetime risk above the risk allowed under 
        subparagraph (A) of such subsection, and the food on 
        which the pesticide chemicals producing the residues 
        are used.
          (3) Recommendations to consumers for reducing dietary 
        exposure to pesticide chemical residues in a manner 
        consistent with maintaining a healthy diet, including a 
        list of food that may reasonably substitute for food 
        listed under paragraph (2).
  Nothing in this subsection shall prevent retail grocers from 
providing additional information.
  (p) Estrogenic substances screening program.--
          (1) Development.--Not later than 2 years after the 
        date of enactment of this section, the Administrator 
        shall in consultation with the Secretary of Health and 
        Human Services develop a screening program, using 
        appropriate validated test systems and other 
        scientifically relevant information, to determine 
        whether certain substances may have an effect in humans 
        that is similar to an effect produced by a naturally 
        occurring estrogen, or such other endocrine effect as 
        the Administrator may designate.
          (2) Implementation.--Not later than 3 years after the 
        date of enactment of this section, after obtaining 
        public comment and review of the screening program 
        described in paragraph (1) by the scientific advisory 
        panel established under section 25(d) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act or the 
        science advisory board established by section 8 of the 
        Environmental Research, Development, and Demonstration 
        Act of 1978 (42 U.S.C. 4365), the Administrator shall 
        implement the program.
          (3) Substances.--In carrying out the screening 
        program described in paragraph (1), the Administrator--
                  (A) shall provide for the testing of all 
                pesticide chemicals; and
                  (B) may provide for the testing of any other 
                substance that may have an effect that is 
                cumulative to an effect of a pesticide chemical 
                if the Administrator determines that a 
                substantial population may be exposed to such 
                substance.
          (4) Exemption.--Notwithstanding paragraph (3), the 
        Administrator may, by order, exempt from the 
        requirements of this section a biologic substance or 
        other substance if the Administrator determines that 
        the substance is anticipated not to produce any effect 
        in humans similar to an effect produced by a naturally 
        occurring estrogen.
          (5) Collection of information.--
                  (A) In general.--The Administrator shall 
                issue an order to a registrant of a substance 
                for which testing is required under this 
                subsection, or to a person who manufactures or 
                imports a substance for which testing is 
                required under this subsection, to conduct 
                testing in accordance with the screening 
                program described in paragraph (1), and submit 
                information obtained from the testing to the 
                Administrator, within a reasonable time period 
                that the Administrator determines is sufficient 
                for the generation of the information.
                  (B) Procedures.--To the extent practicable 
                the Administrator shall minimize duplicative 
                testing of the same substance for the same 
                endocrine effect, develop, as appropriate, 
                procedures for fair and equitable sharing of 
                test costs, and develop, as necessary, 
                procedures for handling of confidential 
                business information.
                  (C) Failure of registrants to submit 
                information.--
                          (i) Suspension.--If a registrant of a 
                        substance referred to in paragraph 
                        (3)(A) fails to comply with an order 
                        under subparagraph (A) of this 
                        paragraph, the Administrator shall 
                        issue a notice of intent to suspend the 
                        sale or distribution of the substance 
                        by the registrant. Any suspension 
                        proposed under this paragraph shall 
                        become final at the end of the 30-day 
                        period beginning on the date that the 
                        registrant receives the notice of 
                        intent to suspend, unless during that 
                        period a person adversely affected by 
                        the notice requests a hearing or the 
                        Administrator determines that the 
                        registrant has complied fully with this 
                        paragraph.
                          (ii) Hearing.--If a person requests a 
                        hearing under clause (i), the hearing 
                        shall be conducted in accordance with 
                        section 554 of title 5, United States 
                        Code. The only matter for resolution at 
                        the hearing shall be whether the 
                        registrant has failed to comply with an 
                        order under subparagraph (A) of this 
                        paragraph. A decision by the 
                        Administrator after completion of a 
                        hearing shall be considered to be a 
                        final agency action.
                          (iii) Termination of suspensions.--
                        The Administrator shall terminate a 
                        suspension under this subparagraph 
                        issued with respect to a registrant if 
                        the Administrator determines that the 
                        registrant has complied fully with this 
                        paragraph.
                  (D) Noncompliance by other persons.--Any 
                person (other than a registrant) who fails to 
                comply with an order under subparagraph (A) 
                shall be liable for the same penalties and 
                sanctions as are provided under section 16 of 
                the Toxic Substances Control Act (15 U.S.C. 
                2601 and following) in the case of a violation 
                referred to in that section. Such penalties and 
                sanctions shall be assessed and imposed in the 
                same manner as provided in such section 16.
          (6) Agency action.--In the case of any substance that 
        is found, as a result of testing and evaluation under 
        this section, to have an endocrine effect on humans, 
        the Administrator shall, as appropriate, take action 
        under such statutory authority as is available to the 
        Administrator, including consideration under other 
        sections of this Act, as is necessary to ensure the 
        protection of public health.
          (7) Report to congress.--Not later than 4 years after 
        the date of enactment of this section, the 
        Administrator shall prepare and submit to Congress a 
        report containing--
                  (A) the findings of the Administrator 
                resulting from the screening program described 
                in paragraph (1);
                  (B) recommendations for further testing 
                needed to evaluate the impact on human health 
                of the substances tested under the screening 
                program; and
                  (C) recommendations for any further actions 
                (including any action described in paragraph 
                (6)) that the Administrator determines are 
                appropriate based on the findings.
  (q) Schedule for Review.--
          (1) In general.--The Administrator shall review 
        tolerances and exemptions for pesticide chemical 
        residues in effect on the day before the date of the 
        enactment of the Food Quality Protection Act of 1996, 
        as expeditiously as practicable, assuring that--
                  (A) 33 percent of such tolerances and 
                exemptions are reviewed within 3 years of the 
                date of enactment of such Act;
                  (B) 66 percent of such tolerances and 
                exemptions are reviewed within 6 years of the 
                date of enactment of such Act; and
                  (C) 100 percent of such tolerances and 
                exemptions are reviewed within 10 years of the 
                date of enactment of such Act.
        In conducting a review of a tolerance or exemption, the 
        Administrator shall determine whether the tolerance or 
        exemption meets the requirements of subsections (b)(2) 
        or (c)(2) and shall, by the deadline for the review of 
        the tolerance or exemption, issue a regulation under 
        subsection (d)(4) or (e)(1) to modify or revoke the 
        tolerance or exemption if the tolerance or exemption 
        does not meet such requirements.
          (2) Priorities.--In determining priorities for 
        reviewing tolerances and exemptions under paragraph 
        (1), the Administrator shall give priority to the 
        review of the tolerances or exemptions that appear to 
        pose the greatest risk to public health.
          (3) Publication of schedule.--Not later than 12 
        months after the date of the enactment of the Food 
        Quality Protection Act of 1996, the Administrator shall 
        publish a schedule for review of tolerances and 
        exemptions established prior to the date of the 
        enactment of the Food Quality Protection Act of 1996. 
        The determination of priorities for the review of 
        tolerances and exemptions pursuant to this subsection 
        is not a rulemaking and shall not be subject to 
        judicial review, except that failure to take final 
        action pursuant to the schedule established by this 
        paragraph shall be subject to judicial review.
  (r) Temporary Tolerance or Exemption.--The Administrator may, 
upon the request of any person who has obtained an experimental 
permit for a pesticide chemical under the Federal Insecticide, 
Fungicide, and Rodenticide Act or upon the Administrator's own 
initiative, establish a temporary tolerance or exemption for 
the pesticide chemical residue for the uses covered by the 
permit. Subsections (b)(2), (c)(2), (d), and (e) shall apply to 
actions taken under this subsection.
  (s) Savings Clause.--Nothing in this section shall be 
construed to amend or modify the provisions of the Toxic 
Substances Control Act or the Federal Insecticide, Fungicide, 
and Rodenticide Act.

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