February 25, 2019 - Issue: Vol. 165, No. 34 — Daily Edition116th Congress (2019 - 2020) - 1st Session
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ENACTING INTO LAW A BILL BY REFERENCE; Congressional Record Vol. 165, No. 34
(House of Representatives - February 25, 2019)
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[Pages H2068-H2087] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov] ENACTING INTO LAW A BILL BY REFERENCE Mr. PETERSON. Mr. Speaker, I ask unanimous consent to take from the Speaker's table the bill (S. 483) to enact into law a bill by reference, and ask for its immediate consideration in the House. The Clerk read the title of the bill. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Minnesota? There was no objection. The text of the bill is as follows: S. 483 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Section 1. (a) H.R. 1029 of the 115th Congress, as passed by the Senate on June 28, 2018, is enacted into law. (b) In publishing this Act in slip form and in the United States Statutes at Large pursuant to section 112 of title 1, United States Code, the Archivist of the United States shall include after the date of approval at the end an appendix setting forth the text of the bill referred to in subsection (a). Amendment Offered by Mr. Peterson Mr. PETERSON. Mr. Speaker, I have an amendment at the desk. The Clerk read as follows: Amendment offered by Mr. Peterson: 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 Improvement Extension Act of 2018''. (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. 7. Agricultural worker protection standard; certification of pesticide applicators. 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 2019 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 2019 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 2019 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 2019 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 2019 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 ``the date of enactment of this section and ending on September 30, 2019'' and inserting ``the effective date of the Pesticide Registration Improvement Extension Act of 2018 and ending on 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 period at the end of 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 2018 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 2018 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) 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, or 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 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2018. ``(ii) With respect to pests specified in clause (ii) of such subparagraph-- [[Page H2069]] ``(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, 2019. ``(iii) With respect to pests specified in clauses (iii) and (iv) of such subparagraph-- ``(I) submit draft guidance to the Scientific Advisory Panel and for public comment 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 2018 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. Section 5(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136c(a)) is amended-- (1) by striking ``permit for a pesticide.'' and inserting ``permit for a pesticide. An application for an experimental use permit for a covered application under section 33(b) shall conform with the requirements of that section.''; and (2) by inserting ``(or in the case of an application for an experimental use permit for a covered application under section 33(b), not later than the last day of the applicable timeframe for such application specified in such section)'' after ``all required supporting data''. 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 applications''; 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'' each place 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 Improvement Extension Act of 2018''; 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)) is amended-- (1) in paragraph (1)-- (A) by striking ``Pesticide Registration Improvement Extension Act of 2012'' and inserting ``Pesticide Registration Improvement Extension Act of 2018''; 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: [[Page H2070]] ``(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 invertebrate public health pests that may transmit vector-borne disease 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 ---------------------------------------------------------------------------------------------------------------- Decision EPA No. New CR Action Review Time Registration No. (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- R010 1 New Active Ingredient, Food use. (2)(3) 24 753,082 ---------------------------------------------------------------------------------------------------------------- R020 2 New Active Ingredient, Food use; reduced risk. 18 627,568 (2)(3) ---------------------------------------------------------------------------------------------------------------- R040 3 New Active Ingredient, Food use; Experimental Use 18 462,502 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; outdoor. 21 523,205 (2)(3) ---------------------------------------------------------------------------------------------------------------- R070 5 New Active Ingredient, Non-food use; outdoor; 16 436,004 reduced risk. (2)(3) ---------------------------------------------------------------------------------------------------------------- R090 6 New Active Ingredient, Non-food use; outdoor; 16 323,690 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; indoor. (2)(3) 20 290,994 ---------------------------------------------------------------------------------------------------------------- R120 8 New Active Ingredient, Non-food use; indoor; 14 242,495 reduced risk. (2)(3) ---------------------------------------------------------------------------------------------------------------- R121 9 New Active Ingredient, Non-food use; indoor; 18 182,327 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-isomer 18 317,128 active ingredient. (2)(3) ---------------------------------------------------------------------------------------------------------------- R123 11 New Active Ingredient, Seed treatment only; 18 471,861 includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities. (2)(3) ---------------------------------------------------------------------------------------------------------------- R125 12 New Active Ingredient, Seed treatment; Experimental 16 323,690 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. [[Page H2071]] (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 ---------------------------------------------------------------------------------------------------------------- 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 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. [[Page H2072]] (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 ---------------------------------------------------------------------------------------------------------------- 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; additional 15 382,886 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. [[Page H2073]] (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 Registration Service EPA No. No. Action (Months)(1) Fee ($) ---------------------------------------------------------------------------------------------------------------- R300 45 New product; or similar combination 4 1,582 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 combination 4 1,897 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 to 8 8,626 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 to 10 12,626 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 four 9 13,252 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 four 11 17,252 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) ---------------------------------------------------------------------------------------------------------------- [[Page H2074]] 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 product 9 11,301 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 product 10 15,301 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 product 10 19,838 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 product 11 23,100 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 ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- R340 60 Amendment requiring data review within 4 4,988 RD (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) ---------------------------------------------------------------------------------------------------------------- [[Page H2075]] R341 61 (New) Amendment requiring data review within 6 5,988 RD (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 9 13,226 science 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 8 13,226 source 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; 6 10,090 (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. (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 ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- R124 67 Conditional Ruling on Pre-application 6 2,530 Study Waivers; applicant-initiated. ---------------------------------------------------------------------------------------------------------------- R272 68 Review of Study Protocol applicant- 3 2,530 initiated; excludes DART, pre- registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review. ---------------------------------------------------------------------------------------------------------------- R275 69 Rebuttal of agency reviewed protocol, 3 2,530 applicant initiated. ---------------------------------------------------------------------------------------------------------------- R370 70 Cancer reassessment; applicant- 18 198,250 initiated. ---------------------------------------------------------------------------------------------------------------- (1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- A380 71 New Active Ingredient; Indirect Food 24 137,841 use; 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) ---------------------------------------------------------------------------------------------------------------- [[Page H2076]] A410 73 New Active Ingredient Non-food 21 229,733 use.(2)(3) ---------------------------------------------------------------------------------------------------------------- A431 74 New Active Ingredient, Non-food use; 12 80,225 low-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 ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- A440 75 New Use, Indirect Food Use, establish 21 31,910 tolerance or tolerance exemption. (2)(3)(4) ---------------------------------------------------------------------------------------------------------------- A441 76 Additional Indirect food uses; 21 114,870 establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3)(4)(5) ---------------------------------------------------------------------------------------------------------------- A450 77 New use, Direct food use, establish 21 95,724 tolerance or tolerance exemption. (2)(3)(4) ---------------------------------------------------------------------------------------------------------------- A451 78 Additional Direct food uses; establish 21 182,335 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 submitted 15 76,583 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. [[Page H2077]] (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 ---------------------------------------------------------------------------------------------------------------- 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 substantially 5 5,107 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 review; 4 3,831 up to 25 public health organisms. (3)(4)(5)(6) ---------------------------------------------------------------------------------------------------------------- A573 91 (new) Label amendment requiring data review; 6 6,350 26-50 public health organisms. (2)(3)(5)(7) ---------------------------------------------------------------------------------------------------------------- A574 92 (new) Label amendment requiring data review; 9 11,000 $ 51 public health organisms. (2)(3)(5)(7) ---------------------------------------------------------------------------------------------------------------- A572 93 New Product or amendment requiring data 9 13,226 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. [[Page H2078]] (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 of 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 of 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 ---------------------------------------------------------------------------------------------------------------- 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 study 12 12,156 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 public 9 12,156 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 ---------------------------------------------------------------------------------------------------------------- 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) ---------------------------------------------------------------------------------------------------------------- [[Page H2079]] 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 ---------------------------------------------------------------------------------------------------------------- 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 a 19 19,146 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. [[Page H2080]] (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 ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- B652 124 New product; registered source of 13 12,764 active 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 4 1,278 active 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 7 5,107 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)(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 10 5,107 source 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) ---------------------------------------------------------------------------------------------------------------- [[Page H2081]] 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 10 8,820 with 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 ---------------------------------------------------------------------------------------------------------------- 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 13 12,764 or tolerance exemption. ---------------------------------------------------------------------------------------------------------------- B680 137 Amendment; registered sources of 5 5,107 active 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 7 6,079 active ingredient(s). Requires data submission. (2)(3) ---------------------------------------------------------------------------------------------------------------- B683 139 Label amendment; requires review/ 6 5,107 update 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. [[Page H2082]] ``TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- B690 142 New active ingredient; food or non-food 7 2,554 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 ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- B614 150 Pre-application; Conditional Ruling on 3 2,530 rationales for addressing a data requirement in lieu of data; applicant- initiated; applies to one rationale at a time. ---------------------------------------------------------------------------------------------------------------- [[Page H2083]] B615 151 Rebuttal of agency reviewed protocol, 3 2,530 applicant initiated. ---------------------------------------------------------------------------------------------------------------- B682 152 Protocol review; applicant initiated; 3 2,432 excludes time for HSRB review. ---------------------------------------------------------------------------------------------------------------- (1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. ``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP ---------------------------------------------------------------------------------------------------------------- New CR Decision Review Time Registration EPA No. No. Action (Months)(1) Service Fee ($) ---------------------------------------------------------------------------------------------------------------- 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 (new) Experimental Use Permit application; no 12 159,538 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; 9 127,630 with 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)(12) ---------------------------------------------------------------------------------------------------------------- B770 156 Experimental Use Permit application; 15 191,444 new (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; 10 127,630 new (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; 12 159,537 non-food/feed. (12) ---------------------------------------------------------------------------------------------------------------- B790 161 Registration application; new (2) PIP; 18 223,351 non-food/feed; SAP review. (5)(12) ---------------------------------------------------------------------------------------------------------------- B800 162 Registration application; new (2) PIP; 13 172,300 with 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; 19 236,114 with 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; 15 204,208 with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. (12) ---------------------------------------------------------------------------------------------------------------- B840 165 Registration application; new (2) PIP; 21 268,022 with 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 9 127,630 a 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 9 38,290 (3) PIP; new product; new use; no petition since a permanent tolerance/ tolerance exemption is already established for the active ingredient(s). (4) (12) ---------------------------------------------------------------------------------------------------------------- [[Page H2084]] B880 168 Registration application; registered 9 31,910 (3) 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 15 95,724 (3) 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 (new) Registration application; new (2) PIP, 15 191,444 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; SAP Review. (8)(12) ---------------------------------------------------------------------------------------------------------------- B883 171 Registration application; new (2) PIP, 9 127,630 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) (12) ---------------------------------------------------------------------------------------------------------------- B884 172 Registration application; new (2) PIP, 12 159,537 seed 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 6 31,910 (3) 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 (new) Registration application; new (2) PIP, 18 223,351 seed 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; 6 63,816 e.g., a marker such as NPT II; reviewed in BPPD. ---------------------------------------------------------------------------------------------------------------- B904 181 Import tolerance or tolerance 9 127,630 exemption; processed commodities/food only (inert or active ingredient). ---------------------------------------------------------------------------------------------------------------- B905 182 (new) SAP Review. 6 63,816 ---------------------------------------------------------------------------------------------------------------- B906 183 (new) Petition to establish a temporary 3 31,907 tolerance/tolerance exemption for one or more active ingredients. ---------------------------------------------------------------------------------------------------------------- B907 184 (new) Petition to establish a temporary 3 12,764 tolerance/tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption. ---------------------------------------------------------------------------------------------------------------- B908 185 (new) Petition to establish a temporary 3 44,671 tolerance/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). [[Page H2085]] (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 ---------------------------------------------------------------------------------------------------------------- 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 11 7,500 ingredient tolerance or exemption from tolerance; new data. (2) ---------------------------------------------------------------------------------------------------------------- I003 188 Amend currently approved inert 9 3,308 ingredient 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 5 3,749 inert ingredient, food use. (2) ---------------------------------------------------------------------------------------------------------------- I009 194 Approval of new or amended polymer 4 3,087 inert 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 13 55,776 and 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. [[Page H2086]] (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 ---------------------------------------------------------------------------------------------------------------- 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 Studies 9 7,938 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 data 12 5,513 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.''. SEC. 7. AGRICULTURAL WORKER PROTECTION STANDARD; CERTIFICATION OF PESTICIDE APPLICATORS. (a) In General.--Except as provided in subsection (b), during the period beginning on the date of enactment of this Act and ending not earlier than October 1, 2021, the Administrator of the Environmental Protection Agency (referred to in this section as the ``Administrator'')-- (1) shall carry out-- (A) the final rule of the Administrator entitled ``Pesticides; Agricultural Worker Protection Standard Revisions'' (80 Fed. Reg. 67496 (November 2, 2015)); and (B) the final rule of the Administrator entitled ``Pesticides; Certification of Pesticide Applicators'' (82 Fed. Reg. 952 (January 4, 2017)); and [[Page H2087]] (2) shall not revise or develop revisions to the rules described in subparagraphs (A) and (B) of paragraph (1). (b) Exceptions.--Prior to October 1, 2021, the Administrator may propose, and after a notice and public comment period of not less than 90 days, promulgate revisions to the final rule described in subsection (a)(1)(A) addressing application exclusion zones under part 170 of title 40, Code of Federal Regulations, consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.). (c) GAO Report.--The Comptroller General of the United States shall-- (1) conduct a study on the use of the designated representative, including the effect of that use on the availability of pesticide application and hazard information and worker health and safety; and (2) not later than October 1, 2021, make publically available a report describing the study under paragraph (1), including any recommendations to prevent the misuse of pesticide application and hazard information, if that misuse is identified. Mr. PETERSON (during the reading). Mr. Speaker, I ask unanimous consent to dispense with the reading of the amendment. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Minnesota? There was no objection. The amendment was agreed to. The bill was ordered to be read a third time, was read the third time, and passed, and a motion to reconsider was laid on the table. ____________________
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