Pesticide Registration Improvement Extension Act of 2018
PL 116-8 (S.483), enacted 03/08/2019

[116th Congress Public Law 8]
[From the U.S. Government Publishing Office]



[[Page 483]]

        PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2018

[[Page 133 STAT. 484]]

Public Law 116-8
116th Congress

                                 An Act


 
   To enact into law a bill by reference. <<NOTE: Mar. 8, 2019 -  [S. 
                                 483]>> 

    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 2018.>> 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title <<NOTE: 7 USC 136 note.>> .--This Act may be cited 
as the ``Pesticide Registration Improvement Extension Act of 2018''.

    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Extension and modification of maintenance fee authority.
Sec. 3. Reregistration and Expedited Processing Fund.
Sec. 4. Experimental use permits for pesticides.
Sec. 5. Pesticide registration service fees.
Sec. 6. Revision of tables regarding covered pesticide registration 
           applications and other covered actions and their 
           corresponding registration service fees.
Sec. 7. Agricultural worker protection standard; certification of 
           pesticide applicators.

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

    (a) Maintenance Fee.--Section 4(i)(1) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(1)) is amended--
            (1) in subparagraph (C), by striking ``an aggregate amount 
        of $27,800,000 for each of fiscal years 2013 through 2017'' and 
        inserting ``an average amount of $31,000,000 for each of fiscal 
        years 2019 through 2023'';
            (2) in subparagraph (D)--
                    (A) in clause (i), by striking ``$115,500 for each 
                of fiscal years 2013 through 2017'' and inserting 
                ``$129,400 for each of fiscal years 2019 through 2023''; 
                and
                    (B) in clause (ii), by striking ``$184,800 for each 
                of fiscal years 2013 through 2017'' and inserting 
                ``$207,000 for each of fiscal years 2019 through 2023'';
            (3) in subparagraph (E)(i)--
                    (A) in subclause (I), by striking ``$70,600 for each 
                of fiscal years 2013 through 2017'' and inserting 
                ``$79,100 for each of fiscal years 2019 through 2023''; 
                and
                    (B) in subclause (II), by striking ``$122,100 for 
                each of fiscal years 2013 through 2017'' and inserting 
                ``$136,800 for each of fiscal years 2019 through 2023''; 
                and
            (4) in subparagraph (I), by striking ``2017..'' and 
        inserting ``2023.''.

[[Page 133 STAT. 485]]

    (b) Prohibition on Other Fees.--Section 4(i)(2) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(2)) is 
amended--
            (1) by striking ``the date of enactment of this section and 
        ending on September 30, 2019'' and inserting ``the effective 
        date of the Pesticide Registration Improvement Extension Act of 
        2018 and ending on September 30, 2025''; and
            (2) by inserting after ``registration of a pesticide under 
        this Act'' the following: ``or any other action covered under a 
        table specified in section 33(b)(3),''.

    (c) Extension of Prohibition on Tolerance Fees.--Section 408(m)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is 
amended by striking ``2017'' and inserting ``2023''.
SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.

    (a) Authorized Use of Fund.--Section 4(k)(2)(A) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) 
is amended--
            (1) in the first sentence, by striking ``the fund'' and 
        inserting ``the Reregistration and Expedited Processing Fund'';
            (2) by striking ``paragraph (3),'' in the first sentence and 
        all that follows through the period at the end of the second 
        sentence and inserting the following: ``paragraph (3), to offset 
        the costs of registration review under section 3(g), including 
        the costs associated with any review under the Endangered 
        Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part of 
        the registration review, to offset the costs associated with 
        tracking and implementing registration review decisions, 
        including registration review decisions designed to reduce risk, 
        for the purposes specified in paragraphs (4) and (5), and to 
        enhance the information systems capabilities to improve the 
        tracking of pesticide registration decisions.'';
            (3) in clause (i), by striking ``are allocated solely'' and 
        all that follows through ``3(g);'' and inserting the following: 
        ``are allocated solely for the purposes specified in the first 
        sentence of this subparagraph;''; and
            (4) in clause (ii), by striking ``necessary to achieve'' and 
        all that follows through ``3(g);'' and inserting the following: 
        ``necessary to achieve the purposes specified in the first 
        sentence of this subparagraph;''.

    (b) Set-Aside for Review of Inert Ingredients and Expedited 
Processing of Similar Applications.--Section 4(k)(3)(A) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) 
is amended, in the matter preceding clause (i), by striking ``The 
Administrator shall use'' and all that follows through ``personnel and 
resources--'' and inserting the following: ``For each of fiscal years 
2018 through 2023, the Administrator shall use between \1/9\ and \1/8\ 
of the maintenance fees collected in such fiscal year to obtain 
sufficient personnel and resources--''.
    (c) Set-Aside for Expedited Rulemaking and Guidance Development for 
Certain Purposes.--Paragraph (4) of section 4(k) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is 
amended to read as follows:
            ``(4) Expedited rulemaking and guidance development for 
        certain product performance data requirements.--

[[Page 133 STAT. 486]]

                    ``(A) Set-aside.--For each of fiscal years 2018 
                through 2023, the Administrator shall use not more than 
                $500,000 of the amounts made available to the 
                Administrator in the Reregistration and Expedited 
                Processing Fund for the activities described in 
                subparagraph (B).
                    ``(B) Products claiming efficacy against 
                invertebrate pests of significant public health or 
                economic importance <<NOTE: Evaluation.>> .--The 
                Administrator shall use amounts made available under 
                subparagraph (A) to develop, receive comments with 
                respect to, finalize, and implement the necessary 
                rulemaking and guidance for product performance data 
                requirements to evaluate products claiming efficacy 
                against the following invertebrate pests of significant 
                public health or economic importance (in order of 
                importance):
                          ``(i) Bed bugs.
                          ``(ii) Premise (including crawling insects, 
                      flying insects, and baits).
                          ``(iii) Pests of pets (including pet pests 
                      controlled by spot-ons, collars, shampoos, 
                      powders, or dips).
                          ``(iv) Fire ants.
                    ``(C) Deadlines for 
                guidance <<NOTE: Publication.>> .--The Administrator 
                shall develop, and publish guidance required by 
                subparagraph (B), with respect to claims of efficacy 
                against pests described in such subparagraph as follows:
                          ``(i) With respect to bed bugs, issue final 
                      guidance not later than 30 days after the 
                      effective date of the Pesticide Registration 
                      Improvement Extension Act of 2018.
                          ``(ii) With respect to pests specified in 
                      clause (ii) of such subparagraph--
                                    ``(I) submit draft guidance to the 
                                Scientific Advisory Panel and for public 
                                comment not later than June 30, 2018; 
                                and
                                    ``(II) complete any response to 
                                comments received with respect to such 
                                draft guidance and finalize the guidance 
                                not later than September 30, 2019.
                          ``(iii) With respect to pests specified in 
                      clauses (iii) and (iv) of such subparagraph--
                                    ``(I) submit draft guidance to the 
                                Scientific Advisory Panel and for public 
                                comment not later than June 30, 2019; 
                                and
                                    ``(II) complete any response to 
                                comments received with respect to such 
                                draft guidance and finalize the guidance 
                                not later than March 31, 2021.
                    ``(D) Revision.--The Administrator shall revise the 
                guidance required by subparagraph (B) from time to time, 
                but shall permit applicants and registrants sufficient 
                time to obtain data that meet the requirements specified 
                in such revised guidance.
                    ``(E) Deadline for product performance data 
                requirements.--The Administrator shall, not later than 
                September 30, 2021, issue regulations prescribing 
                product performance data requirements for any pesticide 
                intended for preventing, destroying, repelling, or 
                mitigating any invertebrate pest of significant public 
                health or economic

[[Page 133 STAT. 487]]

                importance specified in clauses (i) through (iv) of 
                subparagraph (B).''.

    (d) Set-Aside for Good Laboratory Practices Inspections.--Section 
4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136a-1(k)) is amended--
            (1) by redesignating paragraphs (5) and (6) as paragraphs 
        (6) and (7), respectively;
            (2) by inserting after paragraph (4) the following new 
        paragraph:
            ``(5) Good laboratory practices inspections.--
                    ``(A) Set-aside.--For each of fiscal years 2018 
                through 2023, the Administrator shall use not more than 
                $500,000 of the amounts made available to the 
                Administrator in the Reregistration and Expedited 
                Processing Fund for the activities described in 
                subparagraph (B).
                    ``(B) Activities.--The Administrator shall use 
                amounts made available under subparagraph (A) for 
                enhancements to the good laboratory practices standards 
                compliance monitoring program established under part 160 
                of title 40 of the Code of Federal Regulations (or 
                successor regulations), with respect to laboratory 
                inspections and data audits conducted in support of 
                pesticide product registrations under this 
                Act. <<NOTE: Deadline.>>  As part of such monitoring 
                program, the Administrator shall make available to each 
                laboratory inspected under such program in support of 
                such registrations a preliminary summary of inspection 
                observations not later than 60 days after the date on 
                which such an inspection is completed.''; and
            (3) in paragraph (7), as so redesignated, by striking 
        ``paragraphs (2), (3), and (4)'' and inserting ``paragraphs (2), 
        (3), (4), and (5)''.
SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.

    Section 5(a) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (7 U.S.C. 136c(a)) is amended--
            (1) by striking ``permit for a pesticide.'' and inserting 
        ``permit for a pesticide. An application for an experimental use 
        permit for a covered application under section 33(b) shall 
        conform with the requirements of that section.''; and
            (2) by inserting ``(or in the case of an application for an 
        experimental use permit for a covered application under section 
        33(b), not later than the last day of the applicable timeframe 
        for such application specified in such section)'' after ``all 
        required supporting data''.
SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.

    (a) Extension and Modification of Fee Authority.--Section 33(b) of 
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(b)) is amended--
            (1) in paragraph (2)--
                    (A) in the heading, by striking ``pesticide 
                registration''; and
                    (B) in subparagraph (A), by inserting ``or for any 
                other action covered by a table specified in paragraph 
                (3)'' after ``covered by this Act that is received by 
                the Administrator on or after the effective date of the 
                Pesticide Registration Improvement Act of 2003'';
            (2) in paragraph (5)--

[[Page 133 STAT. 488]]

                    (A) in the heading, by striking ``pesticide 
                registration applications'' and inserting ``covered 
                applications''; and
                    (B) by striking ``pesticide registration 
                application'' both places it appears and inserting 
                ``covered application'';
            (3) in paragraph (6)--
                    (A) in subparagraph (A)--
                          (i) by striking ``pesticide registration''; 
                      and
                          (ii) by striking ``October 1, 2013, and ending 
                      on September 30, 2015'' and inserting ``October 1, 
                      2019, and ending on September 30, 2021'';
                    (B) in subparagraph (B)--
                          (i) by striking ``pesticide registration''; 
                      and
                          (ii) by striking ``2015'' each place it 
                      appears and inserting ``2021''; and
                    (C) in subparagraph (C), by striking ``revised 
                registration service fee schedules'' and inserting 
                ``service fee schedules revised pursuant to this 
                paragraph'';
            (4) in paragraph (7)--
                    (A) in subparagraph (A)--
                          (i) by striking ``covered pesticide 
                      registration'' and inserting ``covered 
                      application''; and
                          (ii) by inserting before the period at the end 
                      the following: ``, except that no waiver or fee 
                      reduction shall be provided in connection with a 
                      request for a letter of certification (commonly 
                      referred to as a Gold Seal letter)''; and
                    (B) in subparagraph (F)(i), by striking ``pesticide 
                registration''; and
            (5) in paragraph (8)--
                    (A) in subparagraph (A), by striking ``pesticide 
                registration'';
                    (B) in subparagraph (B)(i), by striking ``pesticide 
                registration''; and
                    (C) in subparagraph (C)--
                          (i) in clause (i), by striking ``pesticide 
                      registration'' and inserting ``covered''; and
                          (ii) in clause (ii)(I), by striking 
                      ``pesticide registration'' and inserting 
                      ``covered''.

    (b) Pesticide Registration Fund Set-Asides for Worker Protection, 
Partnership Grants, and Pesticide Safety Education.--Section 33(c)(3)(B) 
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
136w-8(c)(3)(B)) is amended--
            (1) in the heading, by inserting ``, partnership grants, and 
        pesticide safety education'' after ``Worker protection'';
            (2) in clause (i)--
                    (A) by striking ``2017'' and inserting ``2023''; and
                    (B) by inserting before the period at the end the 
                following:``, with an emphasis on field-worker 
                populations in the United States'';
            (3) in clause (ii), by striking ``2017'' and inserting 
        ``2023''; and
            (4) in clause (iii), by striking ``2017'' and inserting 
        ``2023''.

    (c) Reforms To Reduce Decision Time Review Periods.--Section 33(e) 
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
136w-8(e)) is amended--

[[Page 133 STAT. 489]]

            (1) by striking ``Pesticide Registration Improvement 
        Extension Act of 2012'' and inserting ``Pesticide Registration 
        Improvement Extension Act of 2018''; and
            (2) by inserting at the end the following new sentence: 
        ``Such reforms shall include identifying opportunities for 
        streamlining review processes for applications for a new active 
        ingredient or a new use and providing prompt feedback to 
        applicants during such review process.''.

    (d) Decision Time Review Periods.--Section 33(f) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is 
amended--
            (1) in paragraph (1)--
                    (A) by striking ``Pesticide Registration Improvement 
                Extension Act of 2012'' and inserting ``Pesticide 
                Registration Improvement Extension Act of 2018''; and
                    (B) by inserting after ``covered pesticide 
                registration actions'' the following: ``or for any other 
                action covered by a table specified in subsection 
                (b)(3)'';
            (2) in paragraph (3), by striking subparagraph (C) and 
        inserting the following new subparagraph:
                    ``(C) applications for any other action covered by a 
                table specified in subsection (b)(3).''; and
            (3) in paragraph (4)(A)--
                    (A) by striking ``a pesticide registration 
                application'' and inserting ``a covered application''; 
                and
                    (B) by striking ``covered pesticide registration 
                application'' and inserting ``covered application''.

    (e) Reporting Requirements.--Section 33(k) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is 
amended--
            (1) in paragraph (1) by striking ``2017'' and inserting 
        ``2023''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (D), by striking clause (i) and 
                inserting the following new clause:
                          ``(i) the number of pesticides or pesticide 
                      cases reviewed and the number of registration 
                      review decisions completed, including--
                                    ``(I) the number of cases cancelled;
                                    ``(II) the number of cases requiring 
                                risk mitigation measures;
                                    ``(III) the number of cases removing 
                                risk mitigation measures;
                                    ``(IV) the number of cases with no 
                                risk mitigation needed; and
                                    ``(V) the number of cases in which 
                                risk mitigation has been fully 
                                implemented;'';
                    (B) in subparagraph (G)--
                          (i) in clause (i)--
                                    (I) by striking ``section 4(k)(4)'' 
                                and inserting ``paragraphs (4) and (5) 
                                of section 4(k)''; and
                                    (II) by striking ``that section'' 
                                and inserting ``such paragraphs'';
                          (ii) by striking clauses (ii), (iii), (iv), 
                      (v), and (vi);
                          (iii) by inserting after clause (i) the 
                      following new clause:
                          ``(ii) implementing enhancements to--

[[Page 133 STAT. 490]]

                                    ``(I) the electronic tracking of 
                                covered applications;
                                    ``(II) the electronic tracking of 
                                conditional registrations;
                                    ``(III) the endangered species 
                                database;
                                    ``(IV) the electronic review of 
                                labels submitted with covered 
                                applications; and
                                    ``(V) the electronic review and 
                                assessment of confidential statements of 
                                formula submitted with covered 
                                applications; and''; and
                          (iv) by redesignating clause (vii) as clause 
                      (iii);
                    (C) in subparagraph (I), by striking ``and'' at the 
                end;
                    (D) in subparagraph (J), by striking the period at 
                the end and inserting a semicolon; and
                    (E) <<NOTE: Reviews.>>  by adding at the end the 
                following new subparagraphs:
                    ``(K) a review of the progress made in developing, 
                updating, and implementing product performance test 
                guidelines for pesticide products that are intended to 
                control invertebrate pests of significant public health 
                importance and, by regulation, prescribing product 
                performance data requirements for such pesticide 
                products registered under section 3;
                    ``(L) a review of the progress made in the priority 
                review and approval of new pesticides to control 
                invertebrate public health pests that may transmit 
                vector-borne disease for use in the United States, 
                including each territory or possession of the United 
                States, and United States military installations 
                globally;
                    ``(M) a review of the progress made in implementing 
                enhancements to the good laboratory practices standards 
                compliance monitoring program established under part 160 
                of title 40 of the Code of Federal Regulations (or 
                successor regulations);
                    ``(N) the number of approvals for active 
                ingredients, new uses, and pesticide end use products 
                granted in connection with the Design for the 
                Environment program (or any successor program) of the 
                Environmental Protection Agency; and
                    ``(O) with respect to funds in the Pesticide 
                Registration Fund reserved under subsection (c)(3), a 
                review that includes--
                          ``(i) a description of the amount and use of 
                      such funds--
                                    ``(I) to carry out activities 
                                relating to worker protection under 
                                clause (i) of subsection (c)(3)(B);
                                    ``(II) to award partnership grants 
                                under clause (ii) of such subsection; 
                                and
                                    ``(III) to carry out the pesticide 
                                safety education program under clause 
                                (iii) of such subsection;
                          ``(ii) <<NOTE: Evaluation.>>  an evaluation of 
                      the appropriateness and effectiveness of the 
                      activities, grants, and program described in 
                      clause (i);
                          ``(iii) a description of how stakeholders are 
                      engaged in the decision to fund such activities, 
                      grants, and program; and

[[Page 133 STAT. 491]]

                          ``(iv) <<NOTE: Summary.>>  with respect to 
                      activities relating to worker protection carried 
                      out under subparagraph (B)(i) of such subsection, 
                      a summary of the analyses from stakeholders, 
                      including from worker community-based 
                      organizations, on the appropriateness and 
                      effectiveness of such activities.''.

    (f) Termination of Effectiveness.--Section 33(m) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is 
amended--
            (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2023''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                          (i) by striking ``Fiscal year 2018.--During 
                      fiscal year 2018'' and inserting ``Fiscal year 
                      2024.--During fiscal year 2024''; and
                          (ii) by striking ``2017'' and inserting 
                      ``2023'';
                    (B) in subparagraph (B)--
                          (i) by striking ``Fiscal year 2019.--During 
                      fiscal year 2019'' and inserting ``Fiscal year 
                      2025.--During fiscal year 2025''; and
                          (ii) by striking ``2017'' and inserting 
                      ``2023'';
                    (C) in subparagraph (C), by striking ``September 30, 
                2019.--Effective September 30, 2019'' and inserting 
                ``September 30, 2025.--Effective September 30, 2025''; 
                and
                    (D) in subparagraph (D), by striking ``2017'' both 
                places it appears and inserting ``2023''.
SEC. 6. <<NOTE: Extension. Notification. Time period. Deadline.>>  
                    REVISION OF TABLES REGARDING COVERED PESTICIDE 
                    REGISTRATION APPLICATIONS AND OTHER COVERED 
                    ACTIONS AND THEIR CORRESPONDING REGISTRATION 
                    SERVICE FEES.

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


                          ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      R010           1   New Active Ingredient, Food use.        24                                     753,082
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R020           2   New Active Ingredient, Food use;        18                                     627,568
                          reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 492]]

 
      R040           3   New Active Ingredient, Food use;        18                                     462,502
                          Experimental Use Permit application;
                          establish temporary tolerance;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
      R060           4   New Active Ingredient, Non-food use;    21                                     523,205
                          outdoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R070           5   New Active Ingredient, Non-food use;    16                                     436,004
                          outdoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R090           6   New Active Ingredient, Non-food use;    16                                     323,690
                          outdoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 493]]

 
      R110           7   New Active Ingredient, Non-food use;    20                                     290,994
                          indoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R120           8   New Active Ingredient, Non-food use;    14                                     242,495
                          indoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R121           9   New Active Ingredient, Non-food use;    18                                     182,327
                          indoor; Experimental Use Permit
                          application; submitted before
                          application for registration; credit
                          45% of fee toward new active
                          ingredient application that follows.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R122          10   Enriched isomer(s) of registered mixed- 18                                     317,128
                          isomer active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R123          11   New Active Ingredient, Seed treatment   18                                     471,861
                          only; includes agricultural and non-
                          agricultural seeds; residues not
                          expected in raw agricultural
                          commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 494]]

 
      R125          12   New Active Ingredient, Seed treatment;  16                                     323,690
                          Experimental Use Permit application;
                          submitted before application for
                          registration; credit 45% of fee
                          toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 133 STAT. 495]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      R130          13   First food use; indoor; food/food       21                                     191,444
                          handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R140          14   Additional food use; Indoor; food/food  15                                      44,672
                          handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R150          15   First food use. (2)(3)                  21                                     317,104
----------------------------------------------------------------------------------------------------------------
      R155    16 (new)   First food use, Experimental Use        21                                     264,253
                          Permit application; a.i. registered
                          for non-food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R160          17   First food use; reduced risk. (2)(3)    16                                     264,253
----------------------------------------------------------------------------------------------------------------
      R170          18   Additional food use. (3) (4)            15                                      79,349
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 496]]

 
      R175          19   Additional food uses covered within a   10                                      66,124
                          crop group resulting from the
                          conversion of existing approved crop
                          group(s) to one or more revised crop
                          groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R180          20   Additional food use; reduced risk.      10                                      66,124
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      R190          21   Additional food uses; 6 or more         15                                     476,090
                          submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R200          22   Additional Food Use; 6 or more          10                                     396,742
                          submitted in one application; Reduced
                          Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R210          23   Additional food use; Experimental Use   12                                      48,986
                          Permit application; establish
                          temporary tolerance; no credit toward
                          new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 497]]

 
      R220          24   Additional food use; Experimental Use   6                                       19,838
                          Permit application; crop destruct
                          basis; no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R230          25   Additional use; non-food; outdoor. (3)  15                                      31,713
                          (4)
----------------------------------------------------------------------------------------------------------------
      R240          26   Additional use; non-food; outdoor;      10                                      26,427
                          reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R250          27   Additional use; non-food; outdoor;      6                                       19,838
                          Experimental Use Permit application;
                          no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R251          28   Experimental Use Permit application     8                                       19,838
                          which requires no changes to the
                          tolerance(s); non-crop destruct
                          basis. (3)
----------------------------------------------------------------------------------------------------------------
      R260          29   New use; non-food; indoor. (3) (4)      12                                      15,317
----------------------------------------------------------------------------------------------------------------
      R270          30   New use; non-food; indoor; reduced      9                                       12,764
                          risk. (3)(4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 498]]

 
      R271          31   New use; non-food; indoor;              6                                        9,725
                          Experimental Use Permit application;
                          no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R273          32   Additional use; seed treatment;         12                                      50,445
                          limited uptake into Raw Agricultural
                          Commodities; includes crops with
                          established tolerances (e.g., for
                          soil or foliar application); includes
                          food and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R274          33   Additional uses; seed treatment only;   12                                     302,663
                          6 or more submitted in one
                          application; limited uptake into raw
                          agricultural commodities; includes
                          crops with established tolerances
                          (e.g., for soil or foliar
                          application); includes food and/or
                          non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.

[[Page 133 STAT. 499]]

 
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

[[Page 133 STAT. 500]]

 
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.




                       ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      R280          34   Establish import tolerance; new active  21                                     319,072
                          ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
      R290          35   Establish Import tolerance; Additional  15                                      63,816
                          new food use.
----------------------------------------------------------------------------------------------------------------
      R291          36   Establish import tolerances;            15                                     382,886
                          additional food uses; 6 or more crops
                          submitted in one petition.
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 501]]

 
      R292          37   Amend an established tolerance (e.g.,   11                                      45,341
                          decrease or increase) and/or
                          harmonize established tolerances with
                          Codex MRLs; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R293          38   Establish tolerance(s) for inadvertent  12                                      53,483
                          residues in one crop; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R294          39   Establish tolerances for inadvertent    12                                     320,894
                          residues; 6 or more crops submitted
                          in one application; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      R295          40   Establish tolerance(s) for residues in  15                                      66,124
                          one rotational crop in response to a
                          specific rotational crop application;
                          submission of corresponding label
                          amendments which specify the
                          necessary plant-back restrictions;
                          applicant-initiated. (3) (4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 502]]

 
      R296          41   Establish tolerances for residues in    15                                     396,742
                          rotational crops in response to a
                          specific rotational crop petition; 6
                          or more crops submitted in one
                          application; submission of
                          corresponding label amendments which
                          specify the necessary plant-back
                          restrictions; applicant-initiated.
                          (3) (4)
----------------------------------------------------------------------------------------------------------------
      R297          42   Amend 6 or more established tolerances  11                                     272,037
                          (e.g., decrease or increase) in one
                          petition; domestic or import;
                          applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      R298          43   Amend an established tolerance (e.g.,   13                                      58,565
                          decrease or increase); domestic or
                          import; submission of corresponding
                          amended labels (requiring science
                          review). (3) (4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 503]]

 
      R299          44   Amend 6 or more established tolerances  13                                     285,261
                          (e.g., decrease or increase);
                          domestic or import; submission of
                          corresponding amended labels
                          (requiring science review). (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 133 STAT. 504]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
  base fee for the category. All items in the covered application must be submitted together in one package.
  Each application for an additional new product registration and new inert approval(s) that is submitted in the
  amendment application package is subject to the registration service fee for a new product or a new inert
  approval. However, if an amendment application only proposes to register the amendment for a new product and
  there are no amendments in the application, then review of one new product application is covered by the base
  fee. All such associated applications that are submitted together will be subject to the category decision
  review time.




[[Page 133 STAT. 505]]


                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
            New  CR                                        Decision  Review Time      Registration  Service Fee
 EPA  No.     No.                   Action                      (Months)(1)                     ($)
----------------------------------------------------------------------------------------------------------------
    R300         45   New product; or similar            4                         1,582
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient; no
                       data review on acute toxicity,
                       efficacy or CRP - only product
                       chemistry data; cite-all data
                       citation, or selective data
                       citation where applicant owns
                       all required data, or applicant
                       submits specific authorization
                       letter from data owner. Category
                       also includes 100% re-package of
                       registered end-use or
                       manufacturing-use product that
                       requires no data submission nor
                       data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 506]]

 
    R301         46   New product; or similar            4                         1,897
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient;
                       selective data citation only for
                       data on product chemistry and/or
                       acute toxicity and/or public
                       health pest efficacy (identical
                       data citation and claims to
                       cited product(s)), where
                       applicant does not own all
                       required data and does not have
                       a specific authorization letter
                       from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 507]]

 
    R310         47   New end-use or manufacturing-use   7                         7,301
                       product with registered
                       source(s) of active
                       ingredient(s); includes products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 508]]

 
    R314         48   New end use product containing up  8                         8,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 509]]

 
    R319         49   New end use product containing up  10                        12,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 510]]

 
    R318   50 (new)   New end use product containing     9                         13,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 511]]

 
    R321   51 (new)   New end use product containing     11                        17,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 512]]

 
    R315         52   New end-use, on-animal product,    9                         9,820
                       registered source of active
                       ingredient(s), with the
                       submission of data and/or
                       waivers for only:
                      <bullet> animal safety and
                      <bullet> pest(s) requiring
                       efficacy (4) and/or
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 513]]

 
    R316   53 (new)   New end-use or manufacturing       9                         11,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; and
                       requires review of data and/or
                       waivers for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for greater than
                       3 and up to 7 target pests.
                       (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 514]]

 
    R317   54 (new)   New end-use or manufacturing       10                        15,301
                       product with registered
                       source(s) of active
                       ingredient(s) including products
                       containing 2 or more registered
                       active ingredients previously
                       combined in other registered
                       products; excludes products
                       requiring or citing an animal
                       safety study; and requires
                       review of data and/or waivers
                       for only:
                      <bullet> product chemistry and/or
                      <bullet> acute toxicity and/or
                      <bullet> child resistant
                       packaging and/or
                      <bullet> pest(s) requiring
                       efficacy (4) - for greater than
                       7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R320         55   New product; new physical form;    12                        13,226
                       requires data review in science
                       divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 515]]

 
    R331         56   New product; repack of identical   3                         2,530
                       registered end-use product as a
                       manufacturing-use product, or
                       identical registered
                       manufacturing-use product as an
                       end use product; same registered
                       uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R332         57   New manufacturing-use product;     24                        283,215
                       registered active ingredient;
                       unregistered source of active
                       ingredient; submission of
                       completely new generic data
                       package; registered uses only;
                       requires review in RD and
                       science divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 516]]

 
    R333         58   New product; MUP or End use        10                        19,838
                       product with unregistered source
                       of active ingredient; requires
                       science data review; new
                       physical form; etc. Cite-all or
                       selective data citation where
                       applicant owns all required
                       data. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R334         59   New product; MUP or End use        11                        23,100
                       product with unregistered source
                       of the active ingredient;
                       requires science data review;
                       new physical form; etc.
                       Selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.

[[Page 133 STAT. 517]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.




[[Page 133 STAT. 518]]


                                ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
 EPA  No.   New  CR                     Action                        Decision Review  Time        Service Fee
              No.                                                          (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
    R340        60   Amendment requiring data review within RD    4                                       4,988
                      (e.g., changes to precautionary label
                      statements); includes adding/modifying
                      pest(s) claims for up to 2 target pests,
                      excludes products requiring or citing an
                      animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R341   61 (New)  Amendment requiring data review within RD    6                                       5,988
                      (e.g., changes to precautionary label
                      statements), includes adding/modifying
                      pest(s) claims for greater than 2 target
                      pests, excludes products requiring or
                      citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R345        62   Amending on-animal products previously       7                                       8,820
                      registered, with the submission of data
                      and/or waivers for only:
                     <bullet> animal safety and
                     <bullet> pest(s) requiring efficacy (4) and/
                      or
                     <bullet> product chemistry and/or
                     <bullet> acute toxicity and/or
                      <bullet> child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 519]]

 
    R350        63   Amendment requiring data review in science   9                                      13,226
                      divisions (e.g., changes to REI, or PPE,
                      or PHI, or use rate, or number of
                      applications; or add aerial application;
                      or modify GW/SW advisory statement).
                      (2)(3)
----------------------------------------------------------------------------------------------------------------
    R351        64   Amendment adding a new unregistered source   8                                      13,226
                      of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R352        65   Amendment adding already approved uses;      8                                      13,226
                      selective method of support; does not
                      apply if the applicant owns all cited
                      data. (2) (3)
----------------------------------------------------------------------------------------------------------------
    R371        66   Amendment to Experimental Use Permit; (does  6                                      10,090
                      not include extending a permit's time
                      period). (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

[[Page 133 STAT. 520]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.




                              ``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
 EPA  No.     New  CR                    Action                       Decision Review  Time        Service Fee
                No.                                                        (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
     R124          67   Conditional Ruling on Pre-application    6                                        2,530
                         Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 521]]

 
     R272          68   Review of Study Protocol applicant-      3                                        2,530
                         initiated; excludes DART, pre-
                         registration conference, Rapid
                         Response review, DNT protocol review,
                         protocol needing HSRB review.
----------------------------------------------------------------------------------------------------------------
     R275          69   Rebuttal of agency reviewed protocol,    3                                        2,530
                         applicant initiated.
----------------------------------------------------------------------------------------------------------------
     R370          70   Cancer reassessment; applicant-          18                                     198,250
                         initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.




                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.    New  CR                     Action                       Decision  Review Time       Service Fee
                No.                                                         (Months)(1)                ($)
----------------------------------------------------------------------------------------------------------------
      A380         71   New Active Ingredient; Indirect Food use;  24                                   137,841
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 522]]

 
      A390         72   New Active Ingredient; Direct Food use;    24                                   229,733
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A410         73   New Active Ingredient Non-food use.(2)(3)  21                                   229,733
----------------------------------------------------------------------------------------------------------------
      A431         74   New Active Ingredient, Non-food use; low-  12                                    80,225
                         risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 133 STAT. 523]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




                                ``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
    EPA  No.        New  CR                  Action                    Decision  Review Time       Service Fee
                      No.                                                   (Months)(1)                ($)
----------------------------------------------------------------------------------------------------------------
A440                      75   New Use, Indirect Food Use,         21                                    31,910
                                establish tolerance or tolerance
                                exemption. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A441                      76   Additional Indirect food uses;      21                                   114,870
                                establish tolerances or tolerance
                                exemptions if required; 6 or more
                                submitted in one application.
                                (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A450                      77   New use, Direct food use,           21                                    95,724
                                establish tolerance or tolerance
                                exemption. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 524]]

 
A451                      78   Additional Direct food uses;        21                                   182,335
                                establish tolerances or tolerance
                                exemptions if required; 6 or more
                                submitted in one application.
                                (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A500                      79   New use, non-food. (4)(5)           12                                    31,910
----------------------------------------------------------------------------------------------------------------
A501                      80   New use, non-food; 6 or more        15                                    76,583
                                submitted in one application.
                                (4)(5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 133 STAT. 525]]

 
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.




[[Page 133 STAT. 526]]


                      ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      A530          81    New product, identical or              4                                        1,278
                          substantially similar in composition
                          and use to a registered product; no
                          data review or only product chemistry
                          data; cite all data citation or
                          selective data citation where
                          applicant owns all required data; or
                          applicant submits specific
                          authorization letter from data owner.
                          Category also includes 100% re-
                          package of registered end-use or
                          manufacturing use product that
                          requires no data submission nor data
                          matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 527]]

 
      A531          82    New product; identical or              4                                        1,824
                          substantially similar in composition
                          and use to a registered product;
                          registered source of active
                          ingredient: selective data citation
                          only for data on product chemistry
                          and/or acute toxicity and/or public
                          health pest efficacy, where applicant
                          does not own all required data and
                          does not have a specific
                          authorization letter from data owner.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 528]]

 
      A532          83   New product; identical or               5                                        5,107
                          substantially similar in composition
                          and use to a registered product;
                          registered active ingredient;
                          unregistered source of active
                          ingredient; cite-all data citation
                          except for product chemistry; product
                          chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A540          84    New end use product; FIFRA Sec. 2(mm)  5                                        5,107
                          uses only; up to 25 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A541    85 (new)    New end use product; FIFRA Sec. 2(mm)  7                                        8,500
                          uses only; 26-50 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A542    86 (new)    New end use product; FIFRA Sec. 2(mm)  10                                      15,000
                          uses only; $ 51 public health
                          organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 529]]

 
      A550          87    New end-use product; uses other than   9                                       13,226
                          FIFRA Sec. 2(mm); non-FQPA product.
                          (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A560          88    New manufacturing use product;         6                                       12,596
                          registered active ingredient;
                          selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A565    89 (new)    New manufacturing-use product;         12                                      18,234
                          registered active ingredient;
                          unregistered source of active
                          ingredient; submission of new generic
                          data package; registered uses only;
                          requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A570          90    Label amendment requiring data         4                                        3,831
                          review; up to 25 public health
                          organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A573    91 (new)    Label amendment requiring data         6                                        6,350
                          review; 26-50 public health
                          organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 530]]

 
      A574    92 (new)    Label amendment requiring data         9                                       11,000
                          review; $ 51 public health organisms.
                          (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A572          93   New Product or amendment requiring      9                                       13,226
                          data review for risk assessment by
                          Science Branch (e.g., changes to REI,
                          or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

[[Page 133 STAT. 531]]

 
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
  method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number of organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number of organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.




              ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      A520          94    Experimental Use Permit application,   9                                        6,383
                          non-food use. (2)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 532]]

 
      A521          95   Review of public health efficacy study  4                                        4,726
                          protocol within AD, per AD Internal
                          Guidance for the Efficacy Protocol
                          Review Process; Code will also
                          include review of public health
                          efficacy study protocol and data
                          review for devices making pesticidal
                          claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
      A522          96    Review of public health efficacy       12                                      12,156
                          study protocol outside AD by members
                          of AD Efficacy Protocol Review Expert
                          Panel; Code will also include review
                          of public health efficacy study
                          protocol and data review for devices
                          making pesticidal claims; applicant-
                          initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 533]]

 
      A537    97 (new)    New Active Ingredient/New Use,         18                                     153,156
                          Experimental Use Permit application;
                          Direct food use; Establish tolerance
                          or tolerance exemption if required.
                          Credit 45% of fee toward new active
                          ingredient/new use application that
                          follows.
----------------------------------------------------------------------------------------------------------------
      A538    98 (new)    New Active Ingredient/New Use,         18                                      95,724
                          Experimental Use Permit application;
                          Indirect food use; Establish
                          tolerance or tolerance exemption if
                          required Credit 45% of fee toward new
                          active ingredient/new use application
                          that follows.
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 534]]

 
      A539    99 (new)    New Active Ingredient/New Use,         15                                      92,163
                          Experimental Use Permit application;
                          Nonfood use. Credit 45% of fee toward
                          new active ingredient/new use
                          application that follows.
----------------------------------------------------------------------------------------------------------------
      A529         100    Amendment to Experimental Use Permit;  9                                       11,429
                          requires data review or risk
                          assessment. (2)
----------------------------------------------------------------------------------------------------------------
      A523         101    Review of protocol other than a        9                                       12,156
                          public health efficacy study (i.e.,
                          Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
      A571         102    Science reassessment: Cancer risk,     18                                      95,724
                          refined ecological risk, and/or
                          endangered species; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      A533   103 (new)   Exemption from the requirement of an    4                                        2,482
                          Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 535]]

 
      A534   104 (new)    Rebuttal of agency reviewed protocol,  4                                        4,726
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      A535   105 (new)    Conditional Ruling on Pre-application  6                                        2,409
                          Study Waiver or Data Bridging
                          Argument; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
      A536   106 (new)   Conditional Ruling on Pre-application   4                                        2,482
                          Direct Food, Indirect Food, Nonfood
                          use determination; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




[[Page 133 STAT. 536]]


                         ``TABLE 11. -- BIOPESTICIDES DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      B580         107   New active ingredient; food use;        20                                      51,053
                          petition to establish a tolerance.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B590         108    New active ingredient; food use;       18                                      31,910
                          petition to establish a tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B600         109    New active ingredient; non-food use.   13                                      19,146
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B610         110    New active ingredient; Experimental    10                                      12,764
                          Use Permit application; petition to
                          establish a temporary tolerance or
                          temporary tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B611         111    New active ingredient; Experimental    12                                      12,764
                          Use Permit application; petition to
                          establish permanent tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B612         112    New active ingredient; no change to a  10                                      17,550
                          permanent tolerance exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 537]]

 
      B613         113    New active ingredient; petition to     11                                      17,550
                          convert a temporary tolerance or a
                          temporary tolerance exemption to a
                          permanent tolerance or tolerance
                          exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B620         114    New active ingredient; Experimental    7                                        6,383
                          Use Permit application; non-food use
                          including crop destruct. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 133 STAT. 538]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




                                ``TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      B630         115    First food use; petition to establish  13                                      12,764
                          a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B631         116    New food use; petition to amend an     12                                      12,764
                          established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
      B640         117   First food use; petition to establish   19                                      19,146
                          a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B643         118   New Food use; petition to amend an      10                                      12,764
                          established tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B642         119   First food use; indoor; food/food       12                                      31,910
                          handling. (2)(4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 539]]

 
      B644         120   New use, no change to an established    8                                       12,764
                          tolerance or tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B650         121   New use; non-food. (3)(4)               7                                        6,383
----------------------------------------------------------------------------------------------------------------
      B645   122 (new)    New food use; Experimental Use Permit  12                                      12,764
                          application; petition to amend or add
                          a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
      B646   123 (new)   New use; non-food use including crop    7                                        6,383
                          destruct; Experimental Use Permit
                          application. (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.

[[Page 133 STAT. 540]]

 
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.

[[Page 133 STAT. 541]]

 
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




[[Page 133 STAT. 542]]


                              ``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
 EPA  No.     New  CR                     Action                       Decision  Review Time       Service Fee
                No.                                                         (Months)(1)                ($)
----------------------------------------------------------------------------------------------------------------
     B652         124   New product; registered source of active   13                                    12,764
                         ingredient; requires petition to amend
                         established tolerance or tolerance
                         exemption; requires 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of scientifically-
                         sound rationale based on publicly
                         available literature or other relevant
                         information that addresses the data
                         requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 543]]

 
     B660         125    New product; registered source of active  4                                      1,278
                         ingredient(s); identical or
                         substantially similar in composition and
                         use to a registered product. No data
                         review, or only product chemistry data;
                         cite-all data citation, or selective
                         data citation where applicant owns all
                         required data or authorization from data
                         owner is demonstrated. Category includes
                         100% re-package of registered end-use or
                         manufacturing-use product that requires
                         no data submission or data matrix. For
                         microbial pesticides, the active
                         ingredient(s) must not be re-isolated.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 544]]

 
     B670         126    New product; registered source of active  7                                      5,107
                         ingredient(s); requires: 1) submission
                         of product specific data; or 2) citation
                         of previously reviewed and accepted
                         data; or 3) submission or citation of
                         data generated at government expense; or
                         4) submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 545]]

 
     B671         127    New product; unregistered source of       17                                    12,764
                         active ingredient(s); requires a
                         petition to amend an established
                         tolerance or tolerance exemption;
                         requires: 1) submission of product
                         specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 546]]

 
     B672         128    New product; unregistered source of       13                                     9,118
                         active ingredient(s); non-food use or
                         food use requires: 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 547]]

 
     B673         129    New product MUP/EP; unregistered source   10                                     5,107
                         of active ingredient(s); citation of
                         Technical Grade Active Ingredient (TGAI)
                         data previously reviewed and accepted by
                         the Agency. Requires an Agency
                         determination that the cited data
                         supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B674         130    New product MUP; Repack of identical      4                                      1,278
                         registered end-use product as a
                         manufacturing-use product; same
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B675         131    New Product MUP; registered source of     10                                     9,118
                         active ingredient; submission of
                         completely new generic data package;
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 548]]

 
     B676         132    New product; more than one active         13                                     9,118
                         ingredient where one active ingredient
                         is an unregistered source; product
                         chemistry data must be submitted;
                         requires: 1) submission of product
                         specific data, and 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 549]]

 
     B677         133   New end-use non-food animal product with   10                                     8,820
                         submission of two or more target animal
                         safety studies; includes data and/or
                         waivers of data for only:
                        <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)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




[[Page 133 STAT. 550]]


                               ``TABLE 14. -- BIOPESTICIDES DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                     Action                       Decision  Review Time      Service Fee
                 No.                                                         (Months)(1)               ($)
----------------------------------------------------------------------------------------------------------------
      B621         134   Amendment; Experimental Use Permit; no      7                                    5,107
                          change to an established temporary
                          tolerance or tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B622         135   Amendment; Experimental Use Permit;         11                                  12,764
                          petition to amend an established or
                          temporary tolerance or tolerance
                          exemption. (3)
----------------------------------------------------------------------------------------------------------------
      B641         136   Amendment of an established tolerance or    13                                  12,764
                          tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B680         137    Amendment; registered sources of active    5                                    5,107
                          ingredient(s); no new use(s); no changes
                          to an established tolerance or tolerance
                          exemption. Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B681         138    Amendment; unregistered source of active   7                                    6,079
                          ingredient(s). Requires data submission.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B683         139    Label amendment; requires review/update    6                                    5,107
                          of previous risk assessment(s) without
                          data submission (e.g., labeling changes
                          to REI, PPE, PHI). (2)(3)
----------------------------------------------------------------------------------------------------------------
      B684         140    Amending non-food animal product that      8                                    8,820
                          includes submission of target animal
                          safety data; previously registered.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 551]]

 
      B685   141 (new)    Amendment; add a new biochemical           5                                    5,107
                          unregistered source of active ingredient
                          or a new microbial production site.
                          Requires submission of analysis of
                          samples data and source/production site-
                          specific manufacturing process
                          description. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




[[Page 133 STAT. 552]]


                                  ``TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      B690         142   New active ingredient; food or non-     7                                        2,554
                          food use. (2)(6)
----------------------------------------------------------------------------------------------------------------
      B700         143    Experimental Use Permit application;   7                                        1,278
                          new active ingredient or new use. (6)
----------------------------------------------------------------------------------------------------------------
      B701         144    Extend or amend Experimental Use       4                                        1,278
                          Permit. (6)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 553]]

 
      B710         145    New product; registered source of      4                                        1,278
                          active ingredient(s); identical or
                          substantially similar in composition
                          and use to a registered product; no
                          change in an established tolerance or
                          tolerance exemption. No data review,
                          or only product chemistry data; cite-
                          all data citation, or selective data
                          citation where applicant owns all
                          required data or authorization from
                          data owner is demonstrated. Category
                          includes 100% re-package of
                          registered end-use or manufacturing-
                          use product that requires no data
                          submission or data matrix. (3)(6)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 554]]

 
      B720         146    New product; registered source of      5                                        1,278
                          active ingredient(s); requires: 1)
                          submission of product specific data;
                          or 2) citation of previously reviewed
                          and accepted data; or 3) submission
                          or citation of data generated at
                          government expense; or 4) submission
                          or citation of a scientifically-sound
                          rationale based on publicly available
                          literature or other relevant
                          information that addresses the data
                          requirement; or 5) submission of a
                          request for a data requirement to be
                          waived supported by a scientifically-
                          sound rationale explaining why the
                          data requirement does not apply.
                          (3)(6)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 555]]

 
      B721         147    New product; unregistered source of    7                                        2,676
                          active ingredient. (3)(6)
----------------------------------------------------------------------------------------------------------------
      B722         148   New use and/or amendment; petition to   7                                        2,477
                          establish a tolerance or tolerance
                          exemption. (4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      B730         149   Label amendment requiring data          5                                        1,278
                          submission. (4)(6)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.

[[Page 133 STAT. 556]]

 
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




[[Page 133 STAT. 557]]


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




[[Page 133 STAT. 558]]


                                  ``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.   New  CR                     Action                        Decision  Review Time       Service Fee
                No.                                                         (Months)(1)                ($)
----------------------------------------------------------------------------------------------------------------
      B740      153   Experimental Use Permit application; no      6                                     95,724
                       petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP (12);
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct (12);
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 559]]

 
      B741      154   Experimental Use Permit application; no      12                                   159,538
              (new)    petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP;
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct;
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s);
                      SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
      B750      155   Experimental Use Permit application; with a  9                                    127,630
                       petition to establish a temporary or
                       permanent tolerance/tolerance exemption
                       for the active ingredient. Includes new
                       food/feed use for a registered (3) PIP.
                       (4)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 560]]

 
      B770      156   Experimental Use Permit application; new     15                                   191,444
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows;
                       SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B771      157   Experimental Use Permit application; new     10                                   127,630
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows.
                       (12)
----------------------------------------------------------------------------------------------------------------
      B772      158   Application to amend or extend an            3                                     12,764
                       Experimental Use Permit; no petition since
                       the established tolerance/tolerance
                       exemption for the active ingredient is
                       unaffected. (12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 561]]

 
      B773      159   Application to amend or extend an            5                                     31,910
                       Experimental Use Permit; with petition to
                       extend a temporary tolerance/tolerance
                       exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B780      160   Registration application; new (2) PIP; non-  12                                   159,537
                       food/feed. (12)
----------------------------------------------------------------------------------------------------------------
      B790      161   Registration application; new (2) PIP; non-  18                                   223,351
                       food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B800      162   Registration application; new (2) PIP; with  13                                   172,300
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 562]]

 
      B810      163   Registration application; new (2) PIP; with  19                                   236,114
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. SAP review.
                       (5)(12)
----------------------------------------------------------------------------------------------------------------
      B820      164   Registration application; new (2) PIP; with  15                                   204,208
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B840      165   Registration application; new (2) PIP; with  21                                   268,022
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 563]]

 
      B851      166   Registration application; new event of a     9                                    127,630
                       previously registered PIP active
                       ingredient(s); no petition since permanent
                       tolerance/tolerance exemption is already
                       established for the active ingredient(s).
                       (12)
----------------------------------------------------------------------------------------------------------------
      B870      167   Registration application; registered (3)     9                                     38,290
                       PIP; new product; new use; no petition
                       since a permanent tolerance/tolerance
                       exemption is already established for the
                       active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
      B880      168   Registration application; registered (3)     9                                     31,910
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 564]]

 
      B881      169   Registration application; registered (3)     15                                    95,724
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). SAP review.
                       (5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
      B882      170   Registration application; new (2) PIP, seed  15                                   191,444
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption; SAP Review.
                       (8)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 565]]

 
      B883      171   Registration application; new (2) PIP, seed  9                                    127,630
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B884      172   Registration application; new (2) PIP, seed  12                                   159,537
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B885      173   Registration application; registered (3)     6                                     31,910
                       PIP, seed increase; breeding stack of
                       previously approved PIPs, same crop; no
                       petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 566]]

 
      B886      174   Registration application; new (2) PIP, seed  18                                   223,351
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B890      175   Application to amend a seed increase         9                                     63,816
                       registration; converts registration to
                       commercial registration; no petition since
                       permanent tolerance/tolerance exemption is
                       already established for the active
                       ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B891      176   Application to amend a seed increase         15                                   127,630
                       registration; converts registration to a
                       commercial registration; no petition since
                       a permanent tolerance/tolerance exemption
                       already established for the active
                       ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 567]]

 
      B900      177   Application to amend a registration,         6                                     12,764
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled.
                       (10)(11)(12)
----------------------------------------------------------------------------------------------------------------
      B901      178   Application to amend a registration,         12                                    76,578
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled. SAP
                       review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
      B902      179   PIP Protocol review.                         3                                      6,383
----------------------------------------------------------------------------------------------------------------
      B903      180   Inert ingredient tolerance exemption; e.g.,  6                                     63,816
                       a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
      B904      181   Import tolerance or tolerance exemption;     9                                    127,630
                       processed commodities/food only (inert or
                       active ingredient).
----------------------------------------------------------------------------------------------------------------
      B905      182   SAP Review.                                  6                                     63,816
              (new)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 568]]

 
      B906      183   Petition to establish a temporary tolerance/ 3                                     31,907
              (new)    tolerance exemption for one or more active
                       ingredients.
----------------------------------------------------------------------------------------------------------------
      B907      184   Petition to establish a temporary tolerance/ 3                                     12,764
              (new)    tolerance exemption for one or more active
                       ingredients based on an existing temporary
                       tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B908      185   Petition to establish a temporary tolerance/ 3                                     44,671
              (new)    tolerance exemption for one or more active
                       ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).

[[Page 133 STAT. 569]]

 
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.




                                        ``TABLE 18. -- INERT INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.    New  CR                    Action                       Decision  Review Time        Service Fee
                No.                                                        (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      I001        186   Approval of new food use inert            13                                     27,000
                         ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      I002        187   Amend currently approved inert            11                                      7,500
                         ingredient tolerance or exemption from
                         tolerance; new data. (2)
----------------------------------------------------------------------------------------------------------------
      I003        188   Amend currently approved inert            9                                       3,308
                         ingredient tolerance or exemption from
                         tolerance; no new data. (2)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 570]]

 
      I004        189   Approval of new non-food use inert        6                                      11,025
                         ingredient. (2)
----------------------------------------------------------------------------------------------------------------
      I005        190   Amend currently approved non-food use     6                                       5,513
                         inert ingredient with new use pattern;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I006        191   Amend currently approved non-food use     3                                       3,308
                         inert ingredient with new use pattern;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I007        192   Approval of substantially similar non-    4                                       1,654
                         food use inert ingredients when
                         original inert is compositionally
                         similar with similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
      I008        193   Approval of new or amended polymer inert  5                                       3,749
                         ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
      I009        194   Approval of new or amended polymer inert  4                                       3,087
                         ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 571]]

 
      I010        195   Petition to amend a single tolerance      6                                       1,654
                         exemption descriptor, or single non-
                         food use descriptor, to add  10 CASRNs;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I011   196 (new)  Approval of new food use safener with     24                                    597,683
                         tolerance or exemption from tolerance.
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I012   197 (new)  Approval of new non-food use safener.     21                                    415,241
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I013   198 (new)  Approval of additional food use for       15                                     62,975
                         previously approved safener with
                         tolerance or exemption from tolerance.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I014   199 (new)  Approval of additional non-food use for   15                                     25,168
                         previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
      I015   200 (new)  Approval of new generic data for          24                                    269,728
                         previously approved food use safener.
                         (2)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 572]]

 
      I016   201 (new)  Approval of amendment(s) to tolerance     13                                     55,776
                         and label for previously approved
                         safener. (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

[[Page 133 STAT. 573]]

 
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.




                            ``TABLE 19. -- EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Registration
  EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                 No.                                                       (Months)(1)                 ($)
----------------------------------------------------------------------------------------------------------------
      M001         202   Study protocol requiring Human Studies  9                                        7,938
                          Review Board review as defined in 40
                          CFR Part 26 in support of an active
                          ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M002         203   Completed study requiring Human         9                                        7,938
                          Studies Review Board review as
                          defined in 40 CFR Part 26 in support
                          of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 574]]

 
      M003         204   External technical peer review of new   12                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of less than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 575]]

 
      M004         205   External technical peer review of new   18                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of greater than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 576]]

 
      M005         206   New Product: Combination, Contains a    9                                       22,050
                          combination of active ingredients
                          from a registered and/or unregistered
                          source; conventional, antimicrobial
                          and/or biopesticide. Requires
                          coordination with other regulatory
                          divisions to conduct review of data,
                          label and/or verify the validity of
                          existing data as cited. Only existing
                          uses for each active ingredient in
                          the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
      M006         207   Request for up to 5 letters of          1                                          277
                          certification (Gold Seal) for one
                          actively registered product (excludes
                          distributor products). (8)
----------------------------------------------------------------------------------------------------------------
      M007         208   Request to extend Exclusive Use of      12                                       5,513
                          data as provided by FIFRA Section
                          3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------

[[Page 133 STAT. 577]]

 
      M008         209   Request to grant Exclusive Use of data  15                                       1,654
                          as provided by FIFRA Section
                          3(c)(1)(F)(vi) for a minor use, when
                          a FIFRA Section 2(ll)(2)
                          determination is required.
----------------------------------------------------------------------------------------------------------------
      M009   210 (new)   Non-FIFRA Regulated Determination:      4                                        2,363
                          Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
      M010   211 (new)   Conditional ruling on pre-application,  4                                        2,363
                          product substantial similarity.
----------------------------------------------------------------------------------------------------------------
      M011   212 (new)   Label amendment to add the DfE logo;    4                                        3,648
                          requires data review; no other label
                          changes. (9)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.

[[Page 133 STAT. 578]]

 
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
  applies to one registered product.
(9) This category includes amendments the sole purpose of which is to add DfE (or equivalent terms that do not
  use ``safe'' or derivatives of ``safe'') logos to a label. DfE is a voluntary program. A label bearing a DfE
  logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet
  objective, scientific criteria established and widely publicized by EPA.''.


''.SEC. 7. <<NOTE: Time periods. Regulations.>>  AGRICULTURAL 
                    WORKER PROTECTION STANDARD; CERTIFICATION OF 
                    PESTICIDE APPLICATORS.

    (a) In General <<NOTE: 7 USC 136w note.>> .--Except as provided in 
subsection (b), during the period beginning on the date of enactment of 
this Act and ending not earlier than October 1, 2021, the Administrator 
of the Environmental Protection Agency (referred to in this section as 
the ``Administrator'')--
            (1) shall carry out--
                    (A) the final rule of the Administrator entitled 
                ``Pesticides; Agricultural Worker Protection Standard 
                Revisions'' (80 Fed. Reg. 67496 (November 2, 2015)); and
                    (B) the final rule of the Administrator entitled 
                ``Pesticides; Certification of Pesticide Applicators'' 
                (82 Fed. Reg. 952 (January 4, 2017)); and
            (2) shall not revise or develop revisions to the rules 
        described in subparagraphs (A) and (B) of paragraph (1).

    (b) Exceptions <<NOTE: Deadline. Notice. Public comments. 7 USC 136w 
note.>> .--Prior to October 1, 2021, the Administrator may propose, and 
after a notice and public comment period of not less than 90 days, 
promulgate revisions to the final rule described in subsection (a)(1)(A) 
addressing application exclusion zones under part 170 of title 40, Code 
of Federal Regulations,

[[Page 133 STAT. 579]]

consistent with the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136 et seq.).

    (c) GAO Report.--The Comptroller General of the United States 
shall--
            (1) <<NOTE: Study.>>  conduct a study on the use of the 
        designated representative, including the effect of that use on 
        the availability of pesticide application and hazard information 
        and worker health and safety; and
            (2) <<NOTE: Public information. Recommenda- tions.>>  not 
        later than October 1, 2021, make publically available a report 
        describing the study under paragraph (1), including any 
        recommendations to prevent the misuse of pesticide application 
        and hazard information, if that misuse is identified.

    Approved March 8, 2019.

LEGISLATIVE HISTORY--S. 483:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 165 (2019):
            Feb. 14, considered and passed Senate.
            Feb. 25, considered and passed House, amended.
            Feb. 28, Senate concurred in House amendment.

                                  <all>