Text: S.3552 — 112th Congress (2011-2012)All Information (Except Text)

Text available as:

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Public Law No: 112-177 (09/28/2012)

 
[112th Congress Public Law 177]
[From the U.S. Government Printing Office]



[[Page 126 STAT. 1327]]

Public Law 112-177
112th Congress

                                 An Act


 
   To reauthorize the Federal Insecticide, Fungicide, and Rodenticide 
               Act. <<NOTE: Sept. 28, 2012 -  [S. 3552]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Pesticide 
Registration Improvement Extension Act of 2012. 7 USC 136 note.>> 
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pesticide Registration Improvement 
Extension Act of 2012''.
SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT.

    (a) Maintenance Fees.--
            (1) Fees.--Section 4(i) of the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is amended--
                    (A) in paragraph (5)--
                          (i) in subparagraph (C), by striking 
                      ``aggregate amount of'' and all that follows 
                      through the end of the subparagraph and inserting 
                      ``aggregate amount of $27,800,000 for each of 
                      fiscal years 2013 through 2017.'';
                          (ii) in subparagraph (D)--
                                    (I) in clause (i), by striking 
                                ``shall be'' and all that follows 
                                through the semicolon and inserting 
                                ``shall be $115,500 for each of fiscal 
                                years 2013 through 2017;''; and
                                    (II) in clause (ii), by striking 
                                ``shall be'' and all that follows 
                                through the period and inserting ``shall 
                                be $184,800 for each of fiscal years 
                                2013 through 2017.'';
                          (iii) in subparagraph (E)(i)--
                                    (I) in subclause (I), by striking 
                                ``shall be'' and all that follows 
                                through the semicolon and inserting 
                                ``shall be $70,600 for each of fiscal 
                                years 2013 through 2017;''; and
                                    (II) in subclause (II), by striking 
                                ``shall be'' and all that follows 
                                through the period and inserting ``shall 
                                be $122,100 for each of fiscal years 
                                2013 through 2017.'';
                          (iv) in subparagraph (F)--
                                    (I) by striking ``paragraph (3)'' 
                                and inserting ``this paragraph''; and
                                    (II) by striking ``Humans'' and 
                                inserting ``Human'';
                          (v) by redesignating subparagraphs (F) through 
                      (H) as subparagraphs (G) through (I), 
                      respectively;

[[Page 126 STAT. 1328]]

                          (vi) by inserting after subparagraph (E) the 
                      following:
                    ``(F) Fee reduction for certain small businesses.--
                          ``(i) Definition.--In this subparagraph, the 
                      term `qualified small business entity' means a 
                      corporation, partnership, or unincorporated 
                      business that--
                                    ``(I) has 500 or fewer employees;
                                    ``(II) during the 3-year period 
                                prior to the most recent maintenance fee 
                                billing cycle, had an average annual 
                                global gross revenue from all sources 
                                that did not exceed $10,000,000; and
                                    ``(III) holds not more than 5 
                                pesticide registrations under this 
                                paragraph.
                          ``(ii) Waiver.--Except as provided in clause 
                      (iii), the Administrator shall waive 25 percent of 
                      the fee under this paragraph applicable to the 
                      first registration of any qualified small business 
                      entity under this paragraph.
                          ``(iii) Limitation.--The Administrator shall 
                      not grant a waiver under clause (ii) to a 
                      qualified small business entity if the 
                      Administrator determines that the entity has been 
                      formed or manipulated primarily for the purpose of 
                      qualifying for the waiver.''; and
                          (vii) in subparagraph (I) (as redesignated by 
                      clause (v)), by striking ``2012'' and inserting 
                      ``2017'';
                    (B) in paragraph (6)--
                          (i) by striking ``2014'' and inserting 
                      ``2019''; and
                          (ii) by striking ``paragraphs (1) through 
                      (5)'' and inserting ``paragraph (1)'';
                    (C) by striking paragraphs (1), (2), (3), (4), and 
                (7); and
                    (D) by redesignating paragraphs (5) and (6) as 
                paragraphs (1) and (2), respectively.
            (2) Conforming amendments.--
                    (A) Section 4 of the Federal Insecticide, Fungicide, 
                and Rodenticide Act (7 U.S.C. 136a-1) is amended--
                          (i) in subsection (d)(5)(B)(ii)(III), by 
                      striking ``subsection (i)(1)'' and inserting 
                      ``this section'';
                          (ii) in subsection (j), by striking 
                      ``subsection (i)(5)'' and inserting ``subsection 
                      (i)(1)''; and
                          (iii) in subsection (k)(5)--
                                    (I) in the first sentence, by 
                                striking ``subsection (i)(5)(C)(ii)'' 
                                and inserting ``subsection 
                                (i)(1)(C)(ii)''; and
                                    (II) in the third and sixth 
                                sentences, by striking ``subsection 
                                (i)(5)(C)'' each place it appears and 
                                inserting ``subsection (i)(1)(C)''.
                    (B) Section 33(b)(7)(F) of the Federal Insecticide, 
                Fungicide, and Rodenticide Act (7 U.S.C. 136w-
                8(b)(7)(F)) is amended--
                          (i) by striking ``section 4(i)(5)(E)(ii)'' 
                      each place it appears in clauses (i), (ii)(I), and 
                      (iv)(I) and inserting ``section 4(i)(1)(E)(ii)'';
                          (ii) by striking ``section 
                      4(i)(5)(E)(ii)(I)(bb)'' each place it appears in 
                      clauses (ii)(II) and (iv)(II) and inserting 
                      ``section 4(i)(1)(E)(ii)(I)(bb)''; and
                          (iii) in clause (iv)(II)--

[[Page 126 STAT. 1329]]

                                    (I) by striking ``applicable.'' and 
                                inserting ``applicable''; and
                                    (II) by striking ``revenues'' and 
                                inserting ``revenue''.
            (3) 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 ``September 30, 2012'' and 
        inserting ``September 30, 2017''.
            (4) Reregistration and expedited processing fund.--
                    (A) Source and use.--Section 4(k)(2)(A) of the 
                Federal Insecticide, Fungicide, and Rodenticide Act (7 
                U.S.C. 136a-1(k)(2)(A)) is amended--
                          (i) by inserting ``, to enhance the 
                      information systems capabilities to improve the 
                      tracking of pesticide registration decisions,'' 
                      after ``paragraph (3)'' each place it appears; and
                          (ii) in clause (i)--
                                    (I) by inserting ``offset'' before 
                                ``the costs of reregistration''; and
                                    (II) by striking ``in the same 
                                portion as appropriated funds''.
                    (B) 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--
                          (i) in the matter preceding clause (i), by 
                      striking ``2008 through 2012, between \1/8\ and 
                      \1/7\'' and inserting ``2013 through 2017, between 
                      \1/9\ and \1/8\'';
                          (ii) in clause (i), by striking ``new''; and
                          (iii) in clause (ii), by striking ``any 
                      application'' and all that follows through 
                      ``that--'' and inserting ``any application that--
                      ''.
                    (C) Enhancements of information technology systems 
                for improvement in review of pesticide applications.--
                Section 4(k) of the Federal Insecticide, Fungicide, and 
                Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
                          (i) by redesignating paragraphs (4) and (5) as 
                      paragraphs (5) and (6), respectively;
                          (ii) by inserting after paragraph (3) the 
                      following:
            ``(4) Enhancements of information technology systems for 
        improvement in review of pesticide applications.--
                    ``(A) In general.--For each of fiscal years 2013 
                through 2017, the Administrator shall use not more than 
                $800,000 of the amounts made available to the 
                Administrator in the Reregistration and Expedited 
                Processing Fund for the activities described in 
                subparagraph (B).
                    ``(B) Activities.--The Administrator shall use 
                amounts made available from the Reregistration and 
                Expedited Processing Fund to improve the information 
                systems capabilities for the Office of Pesticide 
                Programs to enhance tracking of pesticide registration 
                decisions, which shall include--
                          ``(i) the electronic tracking of--
                                    ``(I) registration submissions; and
                                    ``(II) the status of conditional 
                                registrations;
                          ``(ii) enhancing the database for information 
                      regarding endangered species assessments for 
                      registration review;

[[Page 126 STAT. 1330]]

                          ``(iii) implementing the capability to 
                      electronically review labels submitted with 
                      registration actions; and
                          ``(iv) acquiring and implementing the 
                      capability to electronically assess and evaluate 
                      confidential statements of formula submitted with 
                      registration actions.''; and
                          (iii) in the first sentence of paragraph (6) 
                      (as redesignated by clause (i)), by striking ``to 
                      carry out the goals established under subsection 
                      (l)'' and inserting ``for the purposes described 
                      in paragraphs (2), (3), and (4) and to carry out 
                      the goals established under subsection (l)''.

    (b) Pesticide Registration Service Fees.--
            (1) Amount of fees.--Section 33(b) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) 
        is amended--
                    (A) by striking paragraph (3) and inserting the 
                following:
            ``(3) Schedule of covered applications and registration 
        service fees.--Subject to paragraph (6), the schedule of covered 
        pesticide registration applications and corresponding 
        registration service fees shall be as follows:

                          ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R010              1                New Active Ingredient, Food use (2) (3)     24                        569,221
----------------------------------------------------------------------------------------------------------------
R020              2                New Active Ingredient, Food use; reduced    18                        569,221
                                    risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R040              3                New Active Ingredient, Food use;            18                        419,502
                                    Experimental Use Permit application;
                                    establish temporary tolerance; submitted
                                    before application for registration;
                                    credit 45% of fee toward new active
                                    ingredient application that follows (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1331]]

 
R060              4                New Active Ingredient, Non-food use;        21                        395,467
                                    outdoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R070              5                New Active Ingredient, Non-food use;        16                        395,467
                                    outdoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R090              6                New Active Ingredient, Non-food use;        16                        293,596
                                    outdoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient (3)
----------------------------------------------------------------------------------------------------------------
R110              7                New Active Ingredient, Non-food use;        20                        219,949
                                    indoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R120              8                New Active Ingredient, Non-food use;        14                        219,949
                                    indoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R121              9                New Active Ingredient, Non-food use;        18                        165,375
                                    indoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient application
                                    that follows (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1332]]

 
R122              10               Enriched isomer(s) of registered mixed-     18                        287,643
                                    isomer active ingredient (2) (3)
----------------------------------------------------------------------------------------------------------------
R123              11               New Active Ingredient, Seed treatment       18                        427,991
                                    only; includes agricultural and non-
                                    agricultural seeds; residues not expected
                                    in raw agricultural commodities (2) (3)
----------------------------------------------------------------------------------------------------------------
R125              12               New Active Ingredient, Seed treatment;      16                        293,596
New                                 Experimental Use Permit application;
                                    submitted before application for
                                    registration; credit 45% of fee toward
                                    new active ingredient application that
                                    follows (3)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1333]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant 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) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1334]]



                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R130              13               First food use; indoor; food/food handling  21                        173,644
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
R140              14               Additional food use; Indoor; food/food      15                         40,518
                                    handling (3) (4)
----------------------------------------------------------------------------------------------------------------
R150              15               First food use (2) (3)                      21                        239,684
----------------------------------------------------------------------------------------------------------------
R160              16               First food use; reduced risk (2) (3)        16                        239,684
----------------------------------------------------------------------------------------------------------------
R170              17               Additional food use (3) (4)                 15                         59,976
----------------------------------------------------------------------------------------------------------------
R175              18               Additional food uses covered within a crop  10                         59,976
New                                 group resulting from the conversion of
                                    existing approved crop group(s) to one or
                                    more revised crop groups. (3) (4)
----------------------------------------------------------------------------------------------------------------
R180              19               Additional food use; reduced risk (3) (4)   10                         59,976
----------------------------------------------------------------------------------------------------------------
R190              20               Additional food uses; 6 or more submitted   15                        359,856
                                    in one application (3) (4)
----------------------------------------------------------------------------------------------------------------
R200              21               Additional food uses; 6 or more submitted   10                        359,856
                                    in one application; reduced risk (3) (4)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1335]]

 
R210              22               Additional food use; Experimental Use       12                         44,431
                                    Permit application; establish temporary
                                    tolerance; no credit toward new use
                                    registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R220              23               Additional food use; Experimental Use       6                          17,993
                                    Permit application; crop destruct basis;
                                    no credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R230              24               Additional use; non-food; outdoor (3) (4)   15                         23,969
----------------------------------------------------------------------------------------------------------------
R240              25               Additional use; non-food; outdoor; reduced  10                         23,969
                                    risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R250              26               Additional use; non-food; outdoor;          6                          17,993
                                    Experimental Use Permit application; no
                                    credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R251              27               Experimental Use Permit application which   8                          17,993
New                                 requires no changes to the tolerance(s);
                                    non-crop destruct basis (3)
----------------------------------------------------------------------------------------------------------------
R260              28               New use; non-food; indoor (3) (4)           12                         11,577
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1336]]

 
R270              29               New use; non-food; indoor; reduced risk     9                          11,577
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
R271              30               New use; non-food; indoor; Experimental     6                           8,820
                                    Use Permit application; no credit toward
                                    new use registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R273              31               Additional use; seed treatment; limited     12                         45,754
                                    uptake into raw agricultural commodities;
                                    includes crops with established
                                    tolerances (e.g., for soil or foliar
                                    application); includes food or non-food
                                    uses (3) (4)
----------------------------------------------------------------------------------------------------------------
R274              32               Additional uses; seed treatment only; 6 or  12                        274,523
                                    more submitted in one application;
                                    limited uptake into raw agricultural
                                    commodities; includes crops with
                                    established tolerances (e.g., for soil or
                                    foliar application); includes food and/or
                                    non-food uses (3) (4)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1337]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant 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) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1338]]

  (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 registra- 
tion and new inert approval(s) that is submitted in the new use ap- 
plication 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 associ- 
ated 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 sepa- 
rate 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 ini- 
tiative to support the application after completion of the technical 
deficiency screen, and (c) is not itself a covered registration applica- 
tion, must be assessed 25% of the full registration service fee for the 
new use application.


                       ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R280              33               Establish import tolerance; new active      21                        289,407
                                    ingredient or first food use (2)
----------------------------------------------------------------------------------------------------------------
R290              34               Establish import tolerance; additional      15                         57,882
                                    food use
----------------------------------------------------------------------------------------------------------------
R291              35               Establish import tolerances; additional     15                        347,288
                                    food uses; 6 or more crops submitted in
                                    one petition
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1339]]

 
R292              36               Amend an established tolerance (e.g.,       11                         41,124
                                    decrease or increase); domestic or
                                    import; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293              37               Establish tolerance(s) for inadvertent      12                         48,510
                                    residues in one crop; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R294              38               Establish tolerances for inadvertent        12                        291,060
                                    residues; 6 or more crops submitted in
                                    one application; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R295              39               Establish tolerance(s) for residues in one  15                         59,976
                                    rotational crop in response to a specific
                                    rotational crop application; applicant-
                                    initiated
----------------------------------------------------------------------------------------------------------------
R296              40               Establish tolerances for residues in        15                        359,856
                                    rotational crops in response to a
                                    specific rotational crop petition; 6 or
                                    more crops submitted in one application;
                                    applicant-initiated
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1340]]

 
R297              41               Amend 6 or more established tolerances      11                        246,744
New                                 (e.g., decrease or increase) in one
                                    petition; domestic or import; applicant-
                                    initiated
----------------------------------------------------------------------------------------------------------------
R298              42               Amend an established tolerance (e.g.,       13                         53,120
New                                 decrease or increase); domestic or
                                    import; submission of amended labels
                                    (requiring science review) in addition to
                                    those associated with the amended
                                    tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------
R299              43               Amend 6 or more established tolerances      13                        258,740
New                                 (e.g., decrease or increase); domestic or
                                    import; submission of amended labels
                                    (requiring science review) in addition to
                                    those associated with the amended
                                    tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1341]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant 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) <<NOTE: Labeling. Deadlines.>> 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, includ- ing 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 ei- ther 
(a) agrees to all of the terms associated with the draft accept- ed 
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 dif- ference(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 reso- lution 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 126 STAT. 1342]]



                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R300              44               New product; or similar combination         4                           1,434
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; no data review on acute
                                    toxicity, efficacy or CRP - only product
                                    chemistry data; cite-all data citation,
                                    or selective data citation where
                                    applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter from data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1343]]

 
R301              45               New product; or similar combination         4                           1,720
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; selective data citation only
                                    for data on product chemistry and/or
                                    acute toxicity and/or public health pest
                                    efficacy, where applicant does not own
                                    all required data and does not have a
                                    specific authorization letter from data
                                    owner. (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1344]]

 
R310              46               New end-use or manufacturing-use product    7                           4,807
                                    with registered source(s) of active
                                    ingredient(s); includes products
                                    containing two or more registered active
                                    ingredients previously combined in other
                                    registered products; requires review of
                                    data package within RD only; includes
                                    data and/or waivers of data for only:
                                   <bullet> product chemistry and/or
                                    <bullet> acute toxicity and/or
                                   <bullet> public health pest efficacy and/
                                    or
                                   <bullet> child resistant packaging. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1345]]

 
R314              47               New end use product containing two or more  8                           6,009
New                                 registered active ingredients never
                                    before registered as this combination in
                                    a formulated product; new product label
                                    is identical or substantially similar to
                                    the labels of currently registered
                                    products which separately contain the
                                    respective component active ingredients;
                                    requires review of data package within RD
                                    only; includes data and/or waivers of
                                    data for only:
                                   <bullet> product chemistry and/or
                                   <bullet> acute toxicity and/or
                                   <bullet> public health pest efficacy and/
                                    or
                                   <bullet> child resistant packaging. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1346]]

 
R315              48               New end-use non-food animal product with    9                           8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                   <bullet> product chemistry and/or
                                   <bullet> acute toxicity and/or
                                   <bullet> public health pest efficacy and/
                                    or
                                   <bullet> animal safety studies and/or
                                   <bullet> child resistant packaging (2) (3)
----------------------------------------------------------------------------------------------------------------
R320              49               New product; new physical form; requires    12                         11,996
                                    data review in science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R331              50               New product; repack of identical            3                           2,294
                                    registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1347]]

 
R332              51               New manufacturing-use product; registered   24                        256,883
                                    active ingredient; unregistered source of
                                    active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only; requires review in
                                    RD and science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R333              52               New product; MUP or End use product with    10                         17,993
New                                 unregistered source of active ingredient;
                                    requires science data review; new
                                    physical form; etc. Cite-all or selective
                                    data citation where applicant owns all
                                    required data. (2) (3)
----------------------------------------------------------------------------------------------------------------
 
 
 

[[Page 126 STAT. 1348]]

 
R334              53               New product; MUP or End use product with    11                         17,993
New                                 unregistered source of the active
                                    ingredient; requires science data review;
                                    new physical form; etc. Selective data
                                    citation. (2) (3)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, 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 ac- 
tive ingredient that (a) is not yet registered but (b) has an applica- 
tion pending with the Agency for review, will be considered an ap- 
plication for a new product with an unregistered source of active 
ingredient.
  (3) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1349]]



                        ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R340              54               Amendment requiring data review within RD   4                           3,617
                                    (e.g., changes to precautionary label
                                    statements) (2) (3)
----------------------------------------------------------------------------------------------------------------
R345              55               Amending non-food animal product that       7                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R350              56               Amendment requiring data review in science  9                          11,996
                                    divisions (e.g., changes to REI, or PPE,
                                    or PHI, or use rate, or number of
                                    applications; or add aerial application;
                                    or modify GW/SW advisory statement) (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R351              57               Amendment adding a new unregistered source  8                          11,996
New                                 of active ingredient. (2) (3)
----------------------------------------------------------------------------------------------------------------
R352              58               Amendment adding already approved uses;     8                          11,996
New                                 selective method of support; does not
                                    apply if the applicant owns all cited
                                    data (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1350]]

 
R371              59               Amendment to Experimental Use Permit;       6                           9,151
                                    (does not include extending a permit's
                                    time period) (3)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

  (2) (a) EPA-initiated amendments shall not be charged registra- tion 
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 no- tification under PR Notices, such as PR 
Notice 98-10, continue under PR Notice timelines and are not subject to 
registration serv- ice fees. (e) Submissions with data and requiring 
data review are subject to registration service fees.
  (3) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1351]]



                              ``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R124              60               Conditional Ruling on Preapplication Study  6                           2,294
                                    Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R272              61               Review of Study Protocol applicant-         3                           2,294
                                    initiated; excludes DART, pre-
                                    registration conference, Rapid Response
                                    review, DNT protocol review, protocol
                                    needing HSRB review
----------------------------------------------------------------------------------------------------------------
R275              62               Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
R370              63               Cancer reassessment; applicant-initiated    18                        179,818
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.


                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A380              64               Food use; establish tolerance exemption     24                        104,187
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
A390              65               Food use; establish tolerance (2) (3)       24                        173,644
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1352]]

 
A400              66               Non-food use; outdoor; FIFRA Sec. 2(mm)     18                         86,823
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A410              67               Non-food use; outdoor; uses other than      21                        173,644
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A420              68               Non-food use; indoor; FIFRA Sec. 2(mm)      18                         57,882
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A430              69               Non-food use; indoor; uses other than       20                         86,823
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A431              70               Non-food use; indoor; low-risk, low-        12                         60,638
                                    toxicity food-grade active ingredient(s);
                                    efficacy testing for public health claims
                                    required under GLP and following DIS/TSS
                                    or AD-approved study protocol (2) (3)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1353]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant 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) <<NOTE: Labeling. Deadline.>> 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, includ- ing 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 ei- ther 
(a) agrees to all of the terms associated with the draft accept- ed 
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 dif- ference(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 reso- lution 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 126 STAT. 1354]]



                                ``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A440              71               First food use; establish tolerance         21                         28,942
                                    exemption (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
A450              72               First food use; establish tolerance (2)     21                         86,823
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
A460              73               Additional food use; establish tolerance    15                         11,577
                                    exemption (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A470              74               Additional food use; establish tolerance    15                         28,942
                                    (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A471              75               Additional food uses; establish             15                        173,652
New                                 tolerances; 6 or more submitted in one
                                    application (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A480              76               Additional use; non-food; outdoor; FIFRA    9                          17,365
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A481              77               Additional non-food outdoor uses; FIFRA     9                         104,190
New                                 Sec. 2(mm) uses; 6 or more submitted in
                                    one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A490              78               Additional use; non-food; outdoor; uses     15                         28,942
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1355]]

 
A491              79               Additional non-food; outdoor; uses other    15                        173,652
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A500              80               Additional use; non-food, indoor, FIFRA     9                          11,577
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A501              81               Additional non-food; indoor; FIFRA Sec.     9                          69,462
New                                 2(mm) uses; 6 or more submitted in one
                                    application (4) (5)
----------------------------------------------------------------------------------------------------------------
A510              82               Additional use; non-food; indoor; uses      12                         11,577
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A511              83               Additional non-food; indoor; uses other     12                         69,462
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1356]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant 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) <<NOTE: Time period.>> If EPA data rules are amended to newly 
require clearance under section 408 of the FFDCA for an ingredient of an 
anti- microbial 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) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1357]]

  (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 registra- 
tion and new inert approval(s) that is submitted in the new use ap- 
plication 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 associ- 
ated 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 sepa- 
rate 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 ini- 
tiative to support the application after completion of the technical 
deficiency screen, and (c) is not itself a covered registration applica- 
tion, must be assessed 25% of the full registration service fee for the 
new use application.


[[Page 126 STAT. 1358]]



                      ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A530              84               New product; identical or substantially     4                           1,159
                                    similar in composition and use to a
                                    registered product; no data review or
                                    only product chemistry data; cite-all
                                    data citation, or selective data citation
                                    when applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter for data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1359]]

 
A531              85               New product; identical or substantially     4                           1,654
                                    similar in composition and use to a
                                    registered product; registered source of
                                    active ingredient: selective data
                                    citation only for data on product
                                    chemistry and/or acute toxicity and/or
                                    public health pest efficacy, where
                                    applicant does not own all required data
                                    and does not have a specific
                                    authorization letter from data owner. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
A532              86               New product; identical or substantially     5                           4,631
                                    similar in composition and use to a
                                    registered product; registered active
                                    ingredient; unregistered source of active
                                    ingredient; cite-all data citation except
                                    for product chemistry; product chemistry
                                    data submitted (2) (3)
----------------------------------------------------------------------------------------------------------------
A540              87               New end use product; FIFRA Sec. 2(mm) uses  5                           4,631
                                    only (2) (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1360]]

 
A550              88               New end-use product; uses other than FIFRA  7                           4,631
                                    Sec. 2(mm); non-FQPA product (2) (3)
----------------------------------------------------------------------------------------------------------------
A560              89               New manufacturing-use product; registered   12                         17,365
                                    active ingredient; selective data
                                    citation (2) (3)
----------------------------------------------------------------------------------------------------------------
A570              90               Label amendment requiring data review (3)   4                           3,474
                                    (4)
----------------------------------------------------------------------------------------------------------------
A572              91               New Product or amendment requiring data     9                          11,996
New                                 review for risk assessment by Science
                                    Branch (e.g., changes to REI, or PPE, or
                                    use rate) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, 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 ac- 
tive ingredient that (a) is not yet registered but (b) has an applica- 
tion pending with the Agency for review, will be considered an ap- 
plication for a new product with an unregistered source of active 
ingredient.

[[Page 126 STAT. 1361]]

  (3) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 registra- tion 
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 no- tification under PR Notices, such as PR 
Notice 98-10, continue under PR Notice timelines and are not subject to 
registration serv- ice fees. (e) Submissions with data and requiring 
data review are subject to registration service fees.


          ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A520              92               Experimental Use Permit application, Non-   9                           5,789
                                    Food Use (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1362]]

 
A521              93               Review of public health efficacy study      3                           2,250
                                    protocol within AD, per AD Internal
                                    Guidance for the Efficacy Protocol Review
                                    Process; Code will also include review of
                                    public health efficacy study protocol and
                                    data review for devices making pesticidal
                                    claims; applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522              94               Review of public health efficacy study      12                         11,025
                                    protocol outside AD by members of AD
                                    Efficacy Protocol Review Expert Panel;
                                    Code will also include review of public
                                    health efficacy study protocol and data
                                    review for devices making pesticidal
                                    claims; applicant-initiated; Tier 2
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1363]]

 
A524              95               New Active Ingredient, Experimental Use     18                        138,916
New                                 Permit application; Food Use Requires
                                    Tolerance. Credit 45% of fee toward new
                                    active ingredient application that
                                    follows. (2)
----------------------------------------------------------------------------------------------------------------
A525              96               New Active Ingredient, Experimental Use     18                         83,594
New                                 Permit application; Food Use Requires
                                    Tolerance Exemption. Credit 45% of fee
                                    toward new active ingredient application
                                    that follows. (2)
----------------------------------------------------------------------------------------------------------------
A526              97               New Active Ingredient, Experimental Use     15                         86,823
New                                 Permit application; Non-Food, Outdoor
                                    Use. Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A527              98               New Active Ingredient, Experimental Use     15                         58,000
New                                 Permit application; Non-Food, Indoor Use.
                                    Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1364]]

 
A528              99               Experimental Use Permit application, Food   15                         20,260
New                                 Use; Requires Tolerance or Tolerance
                                    Exemption (2)
----------------------------------------------------------------------------------------------------------------
A529              100              Amendment to Experimental Use Permit;       9                          10,365
New                                 requires data review or risk assessment
                                    (2)
----------------------------------------------------------------------------------------------------------------
A523              101              Review of protocol other than a public      9                          11,025
New                                 health efficacy study (i.e., Toxicology
                                    or Exposure Protocols)
----------------------------------------------------------------------------------------------------------------
 
 
 

[[Page 126 STAT. 1365]]

 
A571              102              Science reassessment: Cancer risk, refined  18                         86,823
New                                 ecological risk, and/or endangered
                                    species; applicant-initiated
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

  (2) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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 126 STAT. 1366]]



   ``TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                               ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B580              103              New active ingredient; food use; petition   19                         46,305
                                    to establish a tolerance (2)
----------------------------------------------------------------------------------------------------------------
B590              104              New active ingredient; food use; petition   17                         28,942
                                    to establish a tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B600              105              New active ingredient; non-food use (2)     13                         17,365
----------------------------------------------------------------------------------------------------------------
B610              106              New active ingredient; Experimental Use     10                         11,577
                                    Permit application; petition to establish
                                    a temporary tolerance or temporary
                                    tolerance exemption
----------------------------------------------------------------------------------------------------------------
B611              107              New active ingredient; Experimental Use     12                         11,577
New                                 Permit application; petition to establish
                                    permanent tolerance exemption
----------------------------------------------------------------------------------------------------------------
B612              108              New active ingredient; no change to a       10                         15,918
New                                 permanent tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1367]]

 
B613              109              New active ingredient; petition to convert  11                         15,918
New                                 a temporary tolerance or a temporary
                                    tolerance exemption to a permanent
                                    tolerance or tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
 
 
 

[[Page 126 STAT. 1368]]

 
B620              110              New active ingredient; Experimental Use     7                           5,789
                                    Permit application; non-food use
                                    including crop destruct
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, 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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view time, except where the new inert 
approval decision review time is greater than that for the new active 
ingredient, in which case the associated new active ingredient will be 
subject to the new inert approval decision review time. In the case of a 
new active in- gredient 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 addi- 
tional new food use or uses will be subject to the registration serv- 
ice fee and decision review time for a first food use. Any informa- 
tion 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 126 STAT. 1369]]



``TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B630              111              First food use; petition to establish a     13                         11,577
                                    tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B631              112              New food use; petition to amend an          12                         11,577
                                    established tolerance (3)
----------------------------------------------------------------------------------------------------------------
B640              113              First food use; petition to establish a     19                         17,365
                                    tolerance (2)
----------------------------------------------------------------------------------------------------------------
B643              114              New Food use; petition to amend tolerance   10                         11,577
New                                 exemption (3)
----------------------------------------------------------------------------------------------------------------
B642              115              First food use; indoor; food/food handling  12                         28,942
New                                 (2)
----------------------------------------------------------------------------------------------------------------
B644              116              New use, no change to an established        8                          11,577
New                                 tolerance or tolerance exemption (3)
----------------------------------------------------------------------------------------------------------------
B650              117              New use; non-food (3)                       7                           5,789
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1370]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view 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 ac- tive 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 re- quested nor required by the Agency, and (b) is submitted by 
the ap- plicant at the applicant's initiative to support the application 
after completion of the technical deficiency screening, and (c) is 
not itself a covered registration application, must be assessed 25% of 
the full registration service fee for the new active ingredient or first 
food use application.
  (3) Amendment applications to add the new use(s) to registered 
product labels are covered by the base fee for the new use(s). All 
items in the covered application must be submitted together in one 
package. Each application for an additional new product registra- 
tion and new inert approval(s) that is submitted in the new use ap- 
plication 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 associ- 
ated 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 sepa- 
rate 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 ini- 
tiative to support the application after completion of the technical 
deficiency screen, and (c) is not itself a covered registration applica- 
tion, must be assessed 25% of the full registration service fee for the 
new use application.


[[Page 126 STAT. 1371]]



   ``TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                                    PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B652              118              New product; registered source of active    13                         11,577
New                                 ingredient; requires petition to amend
                                    established tolerance or tolerance
                                    exemption; requires 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of scientifically-
                                    sound rationale based on publicly
                                    available literature or other relevant
                                    information that addresses the data
                                    requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1372]]

 
B660              119              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. For
                                    microbial pesticides, the active
                                    ingredient(s) must not be re-isolated.
                                    (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1373]]

 
B670              120              New product; registered source of active    7                           4,631
                                    ingredient(s); no change in an
                                    established tolerance or tolerance
                                    exemption; requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1374]]

 
B671              121              New product; unregistered source of active  17                         11,577
                                    ingredient(s); requires a petition to
                                    amend an established tolerance or
                                    tolerance exemption; requires: 1)
                                    submission of product specific data; or
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1375]]

 
B672              122              New product; unregistered source of active  13                          8,269
                                    ingredient(s); non-food use or food use
                                    with a tolerance or tolerance exemption
                                    previously established for the active
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1376]]

 
B673              123              New product MUP/EP; unregistered source of  10                          4,631
New                                 active ingredient(s); citation of
                                    Technical Grade Active Ingredient (TGAI)
                                    data previously reviewed and accepted by
                                    the Agency. Requires an Agency
                                    determination that the cited data
                                    supports the new product. (2)
----------------------------------------------------------------------------------------------------------------
B674              124              New product MUP; Repack of identical        4                           1,159
New                                 registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2)
----------------------------------------------------------------------------------------------------------------
B675              125              New Product MUP; registered source of       10                          8,269
New                                 active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1377]]

 
B676              126              New product; more than one active           13                          8,269
New                                 ingredient where one active ingredient is
                                    an unregistered source; product chemistry
                                    data must be submitted; requires: 1)
                                    submission of product specific data, and
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1378]]

 
B677              127              New end-use non-food animal product with    10                          8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                   <bullet> product chemistry and/or
                                   <bullet> acute toxicity and/or
                                   <bullet> public health pest efficacy and/
                                    or
                                   <bullet> animal safety studies and/or
                                   <bullet> child resistant packaging (2)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, 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 ac- 
tive ingredient that (a) is not yet registered but (b) has an applica- 
tion pending with the Agency for review, will be considered an ap- 
plication for a new product with an unregistered source of active 
ingredient.


[[Page 126 STAT. 1379]]



     ``TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES;
                                                   AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B621              128              Amendment; Experimental Use Permit; no      7                           4,631
                                    change to an established temporary
                                    tolerance or tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B622              129              Amendment; Experimental Use Permit;         11                         11,577
New                                 petition to amend an established or
                                    temporary tolerance or tolerance
                                    exemption.
----------------------------------------------------------------------------------------------------------------
B641              130              Amendment of an established tolerance or    13                         11,577
                                    tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680              131              Amendment; registered source of active      5                           4,631
                                    ingredient(s); no new use(s); no changes
                                    to an established tolerance or tolerance
                                    exemption. Requires data submission. (2)
----------------------------------------------------------------------------------------------------------------
B681              132              Amendment; unregistered source of active    7                           5,513
                                    ingredient(s). Requires data submission.
                                    (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1380]]

 
B683              133              Label amendment; requires review/update of  6                           4,631
New                                 previous risk assessment(s) without data
                                    submission (e.g., labeling changes to
                                    REI, PPE, PHI). (2)
----------------------------------------------------------------------------------------------------------------
B684              134              Amending non-food animal product that       8                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

  (2) (a) EPA-initiated amendments shall not be charged registra- tion 
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 no- tification under PR Notices, such as PR 
Notice 98-10, continue under PR Notice timelines and are not subject to 
registration serv- ice fees. (e) Submissions with data and requiring 
data review are subject to registration service fees.


[[Page 126 STAT. 1381]]



 ``TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B690              135              New active ingredient; food or non-food     7                           2,316
                                    use. (2)
----------------------------------------------------------------------------------------------------------------
B700              136              Experimental Use Permit application; new    7                           1,159
                                    active ingredient or new use.
----------------------------------------------------------------------------------------------------------------
B701              137              Extend or amend Experimental Use Permit.    4                           1,159
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1382]]

 
B710              138              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1383]]

 
B720              139              New product; registered source of active    5                           1,159
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (3)
----------------------------------------------------------------------------------------------------------------
B721              140              New product; unregistered source of active  7                           2,426
                                    ingredient. (3)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1384]]

 
B722              141              New use and/or amendment; petition to       7                           2,246
                                    establish a tolerance or tolerance
                                    exemption. (4) (5)
----------------------------------------------------------------------------------------------------------------
B730              142              Label amendment requiring data submission.  5                           1,159
                                    (4)
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

[[Page 126 STAT. 1385]]

  (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 applica- 
tion must be received by the agency in one package. The base fee for the 
category covers a maximum of five new products. Each ap- plication 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 reg- istration 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 re- view time, except where the new inert 
approval decision review time is greater than that for the new active 
ingredient, in which case the associated new active ingredient will be 
subject to the new inert approval decision review time. In the case of a 
new active in- gredient 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 addi- 
tional new food use or uses will be subject to the registration serv- 
ice fee and decision review time for a first food use. Any informa- 
tion 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 ac- 
tive ingredient that (a) is not yet registered but (b) has an applica- 
tion pending with the Agency for review, will be considered an ap- 
plication for a new product with an unregistered source of active 
ingredient.
  (4) (a) EPA-initiated amendments shall not be charged registra- tion 
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 no- tification under PR Notices, such as PR 
Notice 98-10, continue under PR Notice timelines and are not subject to 
registration serv- ice fees. (e) Submissions with data and requiring 
data review are subject to registration service fees.

[[Page 126 STAT. 1386]]

  (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 registra- 
tion and new inert approval(s) that is submitted in the new use ap- 
plication 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 associ- 
ated 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 sepa- 
rate 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 ini- 
tiative to support the application after completion of the technical 
deficiency screen, and (c) is not itself a covered registration applica- 
tion, must be assessed 25% of the full registration service fee for the 
new use application.


                   ``TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B614              143              Conditional Ruling on Preapplication Study  3                           2,294
New                                 Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
B615              144              Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1387]]

 
B682              145              Protocol review; applicant initiated;       3                           2,205
                                    excludes time for HSRB review
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.



     ``TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B740              146              Experimental Use Permit application; no     6                          86,823
                                    petition for tolerance/tolerance
                                    exemption. Includes:
                                   1) non-food/feed use(s) for a new (2) or
                                    registered (3) PIP;
                                   2) food/feed use(s) for a new or
                                    registered PIP with crop destruct;
                                   3) food/feed use(s) for a new or
                                    registered PIP in which an established
                                    tolerance/tolerance exemption exists for
                                    the intended use(s). (4)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1388]]

 
B750              147              Experimental Use Permit application; with   9                         115,763
                                    a petition to establish a temporary or
                                    permanent tolerance/tolerance exemption
                                    for the active ingredient. Includes new
                                    food/feed use for a registered (3) PIP.
                                    (4)
----------------------------------------------------------------------------------------------------------------
B770              148              Experimental Use Permit application; new    15                        173,644
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows;
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B771              149              Experimental Use Permit application; new    10                        115,763
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows.
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1389]]

 
B772              150              Application to amend or extend an           3                          11,577
                                    Experimental Use Permit; no petition
                                    since the established tolerance/tolerance
                                    exemption for the active ingredient is
                                    unaffected.
----------------------------------------------------------------------------------------------------------------
B773              151              Application to amend or extend an           5                          28,942
                                    Experimental Use Permit; with petition to
                                    extend a temporary tolerance/tolerance
                                    exemption for the active ingredient.
----------------------------------------------------------------------------------------------------------------
B780              152              Registration application; new (2) PIP; non- 12                        144,704
                                    food/feed.
----------------------------------------------------------------------------------------------------------------
B790              153              Registration application; new (2) PIP; non- 18                        202,585
                                    food/feed; SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B800              154              Registration application; new (2) PIP;      12                        231,585
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1390]]

 
B810              155              Registration application; new (2) PIP;      18                        289,407
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B820              156              Registration application; new (2) PIP;      15                        289,407
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient.
----------------------------------------------------------------------------------------------------------------
B840              157              Registration application; new (2) PIP;      21                        347,288
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient. SAP review. (5)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1391]]

 
B851              158              Registration application; new event of a    9                         115,763
                                    previously registered PIP active
                                    ingredient(s); no petition since
                                    permanent tolerance/tolerance exemption
                                    is already established for the active
                                    ingredient(s).
----------------------------------------------------------------------------------------------------------------
B870              159              Registration application; registered (3)    9                          34,729
                                    PIP; new product; new use; no petition
                                    since a permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s). (4)
----------------------------------------------------------------------------------------------------------------
B880              160              Registration application; registered (3)    9                          28,942
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (6) (7)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1392]]

 
B881              161              Registration application; registered (3)    15                         86,823
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    SAP review. (5) (6) (7)
----------------------------------------------------------------------------------------------------------------
B883              162              Registration application; new (2) PIP,      9                         115,763
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    (8)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1393]]

 
B884              163              Registration application; new (2) PIP,      12                        144,704
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient. (8)
----------------------------------------------------------------------------------------------------------------
B885              164              Registration application; registered (3)    9                          86,823
New                                 PIP, seed increase; breeding stack of
                                    previously approved PIPs, same crop; no
                                    petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (9)
----------------------------------------------------------------------------------------------------------------
B890              165              Application to amend a seed increase        9                          57,882
                                    registration; converts registration to
                                    commercial registration; no petition
                                    since permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s).
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1394]]

 
B891              166              Application to amend a seed increase        15                        115,763
                                    registration; converts registration to a
                                    commercial registration; no petition
                                    since a permanent tolerance/tolerance
                                    exemption already established for the
                                    active ingredient(s); SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B900              167              Application to amend a registration,        6                          11,577
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled.
                                    (10) (11)
----------------------------------------------------------------------------------------------------------------
B901              168              Application to amend a registration,        12                         69,458
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled. SAP
                                    review. (10) (11)
----------------------------------------------------------------------------------------------------------------
B902              169              PIP protocol review                         3                           5,789
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1395]]

 
B903              170              Inert ingredient tolerance exemption;       6                          57,882
                                    e.g., a marker such as NPT II; reviewed
                                    in BPPD.
----------------------------------------------------------------------------------------------------------------
 
 
 

[[Page 126 STAT. 1396]]

 
B904              171              Import tolerance or tolerance exemption;    9                         115,763
                                    processed commodities/food only (inert or
                                    active ingredient).
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, 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 cur- 
rently 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 appli- 
cators, 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 envi- ronment from risks 
posed by pesticides. Due to the time it takes to schedule and prepare 
for meetings with the SAP, additional time and costs are needed.
  (6) Registered PIPs stacked through conventional breeding.
  (7) Deployment of a registered PIP with a different IRM plan (e.g., 
seed blend).
  (8) The negotiated acreage cap will depend upon EPA's deter- mination 
of the potential environmental exposure, risk(s) to non- target 
organisms, and the risk of targeted pest developing resist- ance 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-ini- 
tiated.
  (11) EPA-initiated amendments shall not be charged fees.


[[Page 126 STAT. 1397]]



                   ``TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
I001              172              Approval of new food use inert ingredient   12                         18,000
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
I002              173              Amend currently approved inert ingredient   10                          5,000
New                                 tolerance or exemption from tolerance;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I003              174              Amend currently approved inert ingredient   8                           3,000
New                                 tolerance or exemption from tolerance; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I004              175              Approval of new non-food use inert          8                          10,000
New                                 ingredient (2)
----------------------------------------------------------------------------------------------------------------
I005              176              Amend currently approved non-food use       8                           5,000
New                                 inert ingredient with new use pattern;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I006              177              Amend currently approved non-food use       6                           3,000
New                                 inert ingredient with new use pattern; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1398]]

 
I007              178              Approval of substantially similar non-food  4                           1,500
New                                 use inert ingredients when original inert
                                    is compositionally similar with similar
                                    use pattern (2)
----------------------------------------------------------------------------------------------------------------
I008              179              Approval of new polymer inert ingredient,   5                           3,400
New                                 food use (2)
----------------------------------------------------------------------------------------------------------------
I009              180              Approval of new polymer inert ingredient,   4                           2,800
New                                 non food use (2)
----------------------------------------------------------------------------------------------------------------
I010              181              Petition to amend a tolerance exemption     6                           1,500
New                                 descriptor to add one or more CASRNs; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
M001              182              Study protocol requiring Human Studies      9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M002              183              Completed study requiring Human Studies     9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1399]]

 
M003              184              External technical peer review of new       12                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of less than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1400]]

 
M004              185              External technical peer review of new       18                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of greater than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1401]]

 
M005              186              New Product: Combination, Contains a        9                          20,000
New                                 combination of active ingredients from a
                                    registered and/or unregistered source;
                                    conventional, antimicrobial and/or
                                    biopesticide. Requires coordination with
                                    other regulatory divisions to conduct
                                    review of data, label and/or verify the
                                    validity of existing data as cited. Only
                                    existing uses for each active ingredient
                                    in the combination product. (6) (7)
----------------------------------------------------------------------------------------------------------------
M006              187              Request for up to 5 letters of              1                             250
New                                 certification (Gold Seal) for one
                                    actively registered product.
----------------------------------------------------------------------------------------------------------------
M007              188              Request to extend Exclusive Use of data as  12                          5,000
New                                 provided by FIFRA Section 3(c)(1)(F)(ii)
----------------------------------------------------------------------------------------------------------------
 

[[Page 126 STAT. 1402]]

 
M008              189              Request to grant Exclusive Use of data as   10                          1,500
New                                 provided by FIFRA Section 3(c)(1)(F)(vi)
                                    for a minor use, when a FIFRA Section
                                    2(ll)(2) determination is required
----------------------------------------------------------------------------------------------------------------

  (1) <<NOTE: Extension.>> A decision review time that would otherwise 
end on a Satur- day, Sunday, or 
federal holiday, will be extended to end on the next business day.

  (2) If another covered application is associated with and depend- 
ent upon a pending application for an inert ingredient action, each 
application will be subject to its respective registration service fee. 
The decision review time for the other associated covered applica- tion 
will be extended to match the PRIA due date of the pending 
inert ingredient action, unless the PRIA due date for the other as- 
sociated covered action is further out, in which case it will be sub- 
ject to its own decision review time. If the application covers multiple 
ingredients grouped by EPA into one chemical class, a single 
registration service fee will be assessed for approval of those ingre- 
dients.
  (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 tol- erance action for two 
years from the effective date of the rule.      
  (4) Any other covered application that is associated with and de- 
pendent on the HSRB review will be subject to its separate reg- 
istration service fee. The decision review times for the associated 
actions run concurrently, but will end at the date of the latest re- 
view time.
  (5) Any other covered application that is associated with and de- 
pendent 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 ac- 
tive ingredient that (a) is not yet registered but (b) has an applica- 
tion pending with the Agency for review, will be considered an ap- 
plication for a new product with an unregistered source of active 
ingredient.

[[Page 126 STAT. 1403]]

  (7) <<NOTE: Labeling. Deadlines.>> 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, includ- ing any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the 
Agency. The <<NOTE: Notification.>> applicant will notify the Agency 
that the applicant ei- ther (a) agrees to all of the terms associated 
with the draft accept- ed 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 dif- ference(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 reso- lution 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.'';

                    (B) in paragraph (6)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``October 1, 2008'' 
                                and inserting ``October 1, 2013''; and
                                    (II) by striking ``September 30, 
                                2010'' and inserting ``September 30, 
                                2015''; and
                          (ii) in subparagraph (B)--
                                    (I) by striking ``October 1, 2010'' 
                                and inserting ``October 1, 2015''; and
                                    (II) by striking ``September 30, 
                                2010'' and inserting ``September 30, 
                                2015''; and
                    (C) in paragraph (8)(C)(ii)--
                          (i) in subclause (I), by striking ``or'' at 
                      the end;
                          (ii) in subclause (II), by striking the period 
                      at the end and inserting ``; or''; and
                          (iii) by adding at the end the following:
                                    ``(III) on the basis that the 
                                Administrator rejected the application 
                                under subsection (f)(4)(B).''.
            (2) Pesticide registration fund.--Section 33(c)(3)(B) of the 
        Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
        136w-8(c)(3)(B)) is amended--
                    (A) in clause (i), by striking ``2008 through 2012'' 
                and inserting ``2013 through 2017'';
                    (B) in clause (ii), by striking ``grants'' and all 
                that follows through the end of the clause and inserting 
                ``grants, for each of fiscal years 2013 through 2017, 
                $500,000.''; and
                    (C) in clause (iii), by striking ``2008 through 
                2012'' and inserting ``2013 through 2017''.
            (3) Assessment of fees.--Section 33(d) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d)) 
        is amended--
                    (A) in paragraph (2), by striking ``2002'' each 
                place it appears and inserting ``2012'';

[[Page 126 STAT. 1404]]

                    (B) by striking paragraph (4); and
                    (C) by redesignating paragraph (5) as paragraph (4).
            (4) 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 by striking ``Pesticide 
        Registration Improvement Act of 2003'' and inserting ``Pesticide 
        Registration Improvement Extension Act of 2012''.
            (5) Decision time review periods.--Section 33(f) of the 
        Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
        136w-8(f)) is amended--
                    (A) in paragraph (1), by striking ``Pesticide 
                Registration Improvement Renewal Act, the Administrator 
                shall publish in the Federal Register'' and inserting 
                ``Pesticide Registration Improvement Extension Act of 
                2012, the Administrator shall make publicly available'';
                    (B) in paragraph (2), by striking ``appearing in the 
                Congressional Record on pages S10409'' and all that 
                follows through the period and inserting ``provided 
                under subsection (b)(3).''; and
                    (C) in paragraph (4)--
                          (i) in subparagraph (A), by inserting ``and 
                      fee'' before the period; and
                          (ii) in subparagraph (B)--
                                    (I) by striking ``(B) Completeness 
                                of application'' and all that follows 
                                through ``Not later'' in clause (i) and 
                                inserting the following:
                    ``(B) Initial content and preliminary technical 
                screenings.--
                          ``(i) Screenings.--
                                    ``(I) Initial content.--Not later'';
                                    (II) in clause (i) (as so 
                                designated) by adding at the end the 
                                following:
                                    ``(II) <<NOTE: Deadlines.>>  
                                Preliminary technical screening.--After 
                                conducting the initial content screening 
                                described in subclause (I) and in 
                                accordance with clause (iv), the 
                                Administrator shall conduct a 
                                preliminary technical screening--
                                            ``(aa) not later than 45 
                                        days after the date on which the 
                                        decision time review period 
                                        begins (for applications with 
                                        decision time review periods of 
                                        not more than 180 days); and
                                            ``(bb) not later than 90 
                                        days after the date on which the 
                                        decision time review period 
                                        begins (for applications with 
                                        decision time review periods 
                                        greater than 180 days).'';
                                    (III) by striking clause (ii) and 
                                inserting the following:
                          ``(ii) Rejection.--
                                    ``(I) <<NOTE: Determination.>>  In 
                                general.--If the Administrator 
                                determines at any time before the 
                                Administrator completes the preliminary 
                                technical screening under clause (i)(II) 
                                that the application failed the initial 
                                content or preliminary technical 
                                screening and the applicant does not 
                                correct the failure before the date that 
                                is 10 business days after the applicant

[[Page 126 STAT. 1405]]

                                receives a notification of the failure, 
                                the Administrator shall reject the 
                                application.
                                    ``(II) <<NOTE: Time period.>>  
                                Written notification.--The Administrator 
                                shall make every effort to provide a 
                                written notification of a rejection 
                                under subclause (I) during the 10-day 
                                period that begins on the date the 
                                Administrator completes the preliminary 
                                technical screening.'';
                                    (IV) in clause (iii)--
                                            (aa) in the heading, by 
                                        inserting ``initial content'' 
                                        before ``screening'' ;
                                            (bb) in the matter preceding 
                                        subclause (I), by inserting 
                                        ``content'' after ``initial''; 
                                        and
                                            (cc) in subclause (II), by 
                                        striking ``contains'' and 
                                        inserting ``appears to 
                                        contain''; and
                                    (V) by adding at the end the 
                                following:
                          ``(iv) Requirements of preliminary technical 
                      screening.--In <<NOTE: Determination.>> conducting 
                      a preliminary technical screening of an 
                      application, the Administrator shall determine 
                      if--
                                    ``(I) the application and the data 
                                and information submitted with the 
                                application are accurate and complete; 
                                and
                                    ``(II) the application, data, and 
                                information are consistent with the 
                                proposed labeling and any proposal for a 
                                tolerance or exemption from the 
                                requirement for a tolerance under 
                                section 408 of the Federal Food, Drug, 
                                and Cosmetic Act (21 U.S.C. 346a), and 
                                are such that, subject to full review 
                                under the standards of this Act, could 
                                result in the granting of the 
                                application.''.
            (6) Reports.--Section 33(k) of the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended--
                    (A) in paragraph (1), by striking ``March 1, 2014'' 
                and inserting ``March 1, 2017'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (A)--
                                    (I) in clause (vi)(V), by striking 
                                ``and'' at the end;
                                    (II) in clause (vii)(II), by 
                                inserting ``and'' at the end; and
                                    (III) by adding at the end the 
                                following:
                          ``(viii) the number of extensions of decision 
                      time review periods agreed to under subsection 
                      (f)(5) along with a description of the reason that 
                      the Administrator was unable to make a decision 
                      within the initial decision time review period;'';
                          (ii) in subparagraph (E), by striking ``and'' 
                      at the end;
                          (iii) in subparagraph (F), by striking the 
                      period and inserting a semicolon; and
                          (iv) by adding at the end the following:
                    ``(G) a review of the progress made toward--
                          ``(i) carrying out section 4(k)(4) and the 
                      amounts from the Reregistration and Expedited 
                      Processing Fund used for the purposes described in 
                      that section;

[[Page 126 STAT. 1406]]

                          ``(ii) implementing systems for the electronic 
                      tracking of registration submissions by December 
                      31, 2013;
                          ``(iii) <<NOTE: Public 
                      information. Deadline.>> implementing a system for 
                      tracking the status of conditional registrations, 
                      including making nonconfidential information 
                      related to the conditional registrations publicly 
                      available by December 31, 2013;
                          ``(iv) implementing enhancements to the 
                      endangered species knowledge database, including 
                      making nonconfidential information related to the 
                      database publicly available;
                          ``(v) implementing the capability to 
                      electronically submit and review labels submitted 
                      with registration actions;
                          
                      ``(vi) <<NOTE: Assessment. Evaluation. Deadline.>> 
                      acquiring and implementing the capability to 
                      electronically assess and evaluate confidential 
                      statements of formula submitted with registration 
                      actions by December 31, 2014; and
                          ``(vii) <<NOTE: Notification.>> facilitating 
                      public participation in certain registration 
                      actions and the registration review process by 
                      providing electronic notification to interested 
                      parties of additions to the public docket;
                    ``(H) the number of applications rejected by the 
                Administrator under the initial content and preliminary 
                technical screening conducted under subsection (f)(4);
                    ``(I) <<NOTE: Review.>> a review of the progress 
                made in updating the Pesticide Incident Data System, 
                including progress toward making the information 
                contained in the System available to the public (as the 
                Administrator determines is appropriate); and
                    ``(J) <<NOTE: Assessment.>> an assessment of the 
                public availability of summary pesticide usage data.''; 
                and
                    (C) by adding at the end the following:
            ``(4) Other report.--
                    ``(A) Scope.--In addition to the annual report 
                described in paragraph (1), not later than October 1, 
                2016, the Administrator shall submit to the Committee on 
                Agriculture of the House of Representatives and the 
                Committee on Agriculture, Nutrition, and Forestry of the 
                Senate a report that includes an analysis of the impact 
                of maintenance fees on small businesses that have--
                          ``(i) 10 or fewer employees; and
                          ``(ii) annual global gross revenue that does 
                      not exceed $2,000,000.
                    ``(B) Information required.--In conducting the 
                analysis described in subparagraph (A), the 
                Administrator shall collect, and include in the report 
                under that subparagraph, information on--
                          ``(i) the number of small businesses described 
                      in subparagraph (A) that are paying maintenance 
                      fees; and
                          ``(ii) the number of registrations each 
                      company holds.''.
            (7) Termination of effectiveness.--Section 33(m) of the 
        Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
        136w-8(m)) is amended--

[[Page 126 STAT. 1407]]

                    (A) in paragraph (1), by striking ``2012'' and 
                inserting ``2017''; and
                    (B) in paragraph (2)--
                          (i) in subparagraph (A)--
                                    (I) in the heading, by striking 
                                ``2013'' and inserting ``2018'';
                                    (II) by striking ``2013,'' and 
                                inserting ``2018,''; and
                                    (III) by striking ``September 30, 
                                2012'' and inserting ``September 30, 
                                2017'';
                          (ii) in subparagraph (B)--
                                    (I) in the heading, by striking 
                                ``2014'' and inserting ``2019'';
                                    (II) by striking ``2014,'' and 
                                inserting ``2019,''; and
                                    (III) by striking ``September 30, 
                                2012'' and inserting ``September 30, 
                                2017'';
                          (iii) in subparagraph (C)--
                                    (I) in the heading, by striking 
                                ``2014'' and inserting ``2019''; and
                                    (II) by striking ``September 30, 
                                2014'' and inserting ``September 30, 
                                2019''; and
                          (iv) in subparagraph (D), by striking ``2012'' 
                      each place it appears and inserting ``2017''.

    (c) <<NOTE: 7 USC 136a-1 note.>>  Effective Date.--This section and 
the amendments made by this section take effect on October 1, 2012.

    (d) <<NOTE: 7 USC 136a-1 note.>>  Relationship to Other Law.--In the 
case of any conflict between this section (including the amendments made 
by this section) and a joint resolution making continuing appropriations 
for fiscal year 2013 (including any amendments made by such a joint 
resolution), this section and the amendments made by this section shall 
control.

    Approved September 28, 2012.

LEGISLATIVE HISTORY--S. 3552:
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CONGRESSIONAL RECORD, Vol. 158 (2012):
            Sept. 13, considered and passed Senate.
            Sept. 14, considered and passed House.

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