[Congressional Record Volume 165, Number 34 (Monday, February 25, 2019)]
[House]
[Pages H2068-H2087]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 ENACTING INTO LAW A BILL BY REFERENCE

  Mr. PETERSON. Mr. Speaker, I ask unanimous consent to take from the 
Speaker's table the bill (S. 483) to enact into law a bill by 
reference, and ask for its immediate consideration in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Minnesota?
  There was no objection.
  The text of the bill is as follows:

                                 S. 483

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,
       Section 1. (a) H.R. 1029 of the 115th Congress, as passed 
     by the Senate on June 28, 2018, is enacted into law.
       (b) In publishing this Act in slip form and in the United 
     States Statutes at Large pursuant to section 112 of title 1, 
     United States Code, the Archivist of the United States shall 
     include after the date of approval at the end an appendix 
     setting forth the text of the bill referred to in subsection 
     (a).


                   Amendment Offered by Mr. Peterson

  Mr. PETERSON. Mr. Speaker, I have an amendment at the desk.
  The Clerk read as follows:
  Amendment offered by Mr. Peterson:
       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Pesticide 
     Registration Improvement Extension Act of 2018''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

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

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

       (a) Maintenance Fee.--Section 4(i)(1) of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-
     1(i)(1)) is amended--
       (1) in subparagraph (C), by striking ``an aggregate amount 
     of $27,800,000 for each of fiscal years 2013 through 2017'' 
     and inserting ``an average amount of $31,000,000 for each of 
     fiscal years 2019 through 2023'';
       (2) in subparagraph (D)--
       (A) in clause (i), by striking ``$115,500 for each of 
     fiscal years 2013 through 2017'' and inserting ``$129,400 for 
     each of fiscal years 2019 through 2023''; and
       (B) in clause (ii), by striking ``$184,800 for each of 
     fiscal years 2013 through 2017'' and inserting ``$207,000 for 
     each of fiscal years 2019 through 2023'';
       (3) in subparagraph (E)(i)--
       (A) in subclause (I), by striking ``$70,600 for each of 
     fiscal years 2013 through 2017'' and inserting ``$79,100 for 
     each of fiscal years 2019 through 2023''; and
       (B) in subclause (II), by striking ``$122,100 for each of 
     fiscal years 2013 through 2017'' and inserting ``$136,800 for 
     each of fiscal years 2019 through 2023''; and
       (4) in subparagraph (I), by striking ``2017..'' and 
     inserting ``2023.''.
       (b) Prohibition on Other Fees.--Section 4(i)(2) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136a-1(i)(2)) is amended--
       (1) by striking ``the date of enactment of this section and 
     ending on September 30, 2019'' and inserting ``the effective 
     date of the Pesticide Registration Improvement Extension Act 
     of 2018 and ending on September 30, 2025''; and
       (2) by inserting after ``registration of a pesticide under 
     this Act'' the following: ``or any other action covered under 
     a table specified in section 33(b)(3),''.
       (c) Extension of Prohibition on Tolerance Fees.--Section 
     408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 346a(m)(3)) is amended by striking ``2017'' and 
     inserting ``2023''.

     SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.

       (a) Authorized Use of Fund.--Section 4(k)(2)(A) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136a-1(k)(2)(A)) is amended--
       (1) in the first sentence, by striking ``the fund'' and 
     inserting ``the Reregistration and Expedited Processing 
     Fund'';
       (2) by striking ``paragraph (3),'' in the first sentence 
     and all that follows through the period at the end of the 
     second sentence and inserting the following: ``paragraph (3), 
     to offset the costs of registration review under section 
     3(g), including the costs associated with any review under 
     the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) 
     required as part of the registration review, to offset the 
     costs associated with tracking and implementing registration 
     review decisions, including registration review decisions 
     designed to reduce risk, for the purposes specified in 
     paragraphs (4) and (5), and to enhance the information 
     systems capabilities to improve the tracking of pesticide 
     registration decisions.'';
       (3) in clause (i), by striking ``are allocated solely'' and 
     all that follows through ``3(g);'' and inserting the 
     following: ``are allocated solely for the purposes specified 
     in the first sentence of this subparagraph;''; and
       (4) in clause (ii), by striking ``necessary to achieve'' 
     and all that follows through ``3(g);'' and inserting the 
     following: ``necessary to achieve the purposes specified in 
     the first sentence of this subparagraph;''.
       (b) Set-Aside for Review of Inert Ingredients and Expedited 
     Processing of Similar Applications.--Section 4(k)(3)(A) of 
     the Federal Insecticide, Fungicide, and Rodenticide Act (7 
     U.S.C. 136a-1(k)(3)(A)) is amended, in the matter preceding 
     clause (i), by striking ``The Administrator shall use'' and 
     all that follows through ``personnel and resources--'' and 
     inserting the following: ``For each of fiscal years 2018 
     through 2023, the Administrator shall use between \1/9\ and 
     \1/8\ of the maintenance fees collected in such fiscal year 
     to obtain sufficient personnel and resources--''.
       (c) Set-Aside for Expedited Rulemaking and Guidance 
     Development for Certain Purposes.--Paragraph (4) of section 
     4(k) of the Federal Insecticide, Fungicide, and Rodenticide 
     Act (7 U.S.C. 136a-1(k)) is amended to read as follows:
       ``(4) Expedited rulemaking and guidance development for 
     certain product performance data requirements.--
       ``(A) Set-aside.--For each of fiscal years 2018 through 
     2023, the Administrator shall use not more than $500,000 of 
     the amounts made available to the Administrator in the 
     Reregistration and Expedited Processing Fund for the 
     activities described in subparagraph (B).
       ``(B) Products claiming efficacy against invertebrate pests 
     of significant public health or economic importance.--The 
     Administrator shall use amounts made available under 
     subparagraph (A) to develop, receive comments with respect 
     to, finalize, and implement the necessary rulemaking and 
     guidance for product performance data requirements to 
     evaluate products claiming efficacy against the following 
     invertebrate pests of significant public health or economic 
     importance (in order of importance):
       ``(i) Bed bugs.
       ``(ii) Premise (including crawling insects, flying insects, 
     and baits).
       ``(iii) Pests of pets (including pet pests controlled by 
     spot-ons, collars, shampoos, powders, or dips).
       ``(iv) Fire ants.
       ``(C) Deadlines for guidance.--The Administrator shall 
     develop, and publish guidance required by subparagraph (B), 
     with respect to claims of efficacy against pests described in 
     such subparagraph as follows:
       ``(i) With respect to bed bugs, issue final guidance not 
     later than 30 days after the effective date of the Pesticide 
     Registration Improvement Extension Act of 2018.
       ``(ii) With respect to pests specified in clause (ii) of 
     such subparagraph--

[[Page H2069]]

       ``(I) submit draft guidance to the Scientific Advisory 
     Panel and for public comment not later than June 30, 2018; 
     and
       ``(II) complete any response to comments received with 
     respect to such draft guidance and finalize the guidance not 
     later than September 30, 2019.

       ``(iii) With respect to pests specified in clauses (iii) 
     and (iv) of such subparagraph--

       ``(I) submit draft guidance to the Scientific Advisory 
     Panel and for public comment not later than June 30, 2019; 
     and
       ``(II) complete any response to comments received with 
     respect to such draft guidance and finalize the guidance not 
     later than March 31, 2021.

       ``(D) Revision.--The Administrator shall revise the 
     guidance required by subparagraph (B) from time to time, but 
     shall permit applicants and registrants sufficient time to 
     obtain data that meet the requirements specified in such 
     revised guidance.
       ``(E) Deadline for product performance data requirements.--
     The Administrator shall, not later than September 30, 2021, 
     issue regulations prescribing product performance data 
     requirements for any pesticide intended for preventing, 
     destroying, repelling, or mitigating any invertebrate pest of 
     significant public health or economic importance specified in 
     clauses (i) through (iv) of subparagraph (B).''.
       (d) Set-Aside for Good Laboratory Practices Inspections.--
     Section 4(k) of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
       (1) by redesignating paragraphs (5) and (6) as paragraphs 
     (6) and (7), respectively;
       (2) by inserting after paragraph (4) the following new 
     paragraph:
       ``(5) Good laboratory practices inspections.--
       ``(A) Set-aside.--For each of fiscal years 2018 through 
     2023, the Administrator shall use not more than $500,000 of 
     the amounts made available to the Administrator in the 
     Reregistration and Expedited Processing Fund for the 
     activities described in subparagraph (B).
       ``(B) Activities.--The Administrator shall use amounts made 
     available under subparagraph (A) for enhancements to the good 
     laboratory practices standards compliance monitoring program 
     established under part 160 of title 40 of the Code of Federal 
     Regulations (or successor regulations), with respect to 
     laboratory inspections and data audits conducted in support 
     of pesticide product registrations under this Act. As part of 
     such monitoring program, the Administrator shall make 
     available to each laboratory inspected under such program in 
     support of such registrations a preliminary summary of 
     inspection observations not later than 60 days after the date 
     on which such an inspection is completed.''; and
       (3) in paragraph (7), as so redesignated, by striking 
     ``paragraphs (2), (3), and (4)'' and inserting ``paragraphs 
     (2), (3), (4), and (5)''.

     SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.

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

     SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.

       (a) Extension and Modification of Fee Authority.--Section 
     33(b) of the Federal Insecticide, Fungicide, and Rodenticide 
     Act (7 U.S.C. 136w-8(b)) is amended--
       (1) in paragraph (2)--
       (A) in the heading, by striking ``pesticide registration''; 
     and
       (B) in subparagraph (A), by inserting ``or for any other 
     action covered by a table specified in paragraph (3)'' after 
     ``covered by this Act that is received by the Administrator 
     on or after the effective date of the Pesticide Registration 
     Improvement Act of 2003'';
       (2) in paragraph (5)--
       (A) in the heading, by striking ``pesticide registration 
     applications'' and inserting ``covered applications''; and
       (B) by striking ``pesticide registration application'' both 
     places it appears and inserting ``covered application'';
       (3) in paragraph (6)--
       (A) in subparagraph (A)--
       (i) by striking ``pesticide registration''; and
       (ii) by striking ``October 1, 2013, and ending on September 
     30, 2015'' and inserting ``October 1, 2019, and ending on 
     September 30, 2021'';
       (B) in subparagraph (B)--
       (i) by striking ``pesticide registration''; and
       (ii) by striking ``2015'' each place it appears and 
     inserting ``2021''; and
       (C) in subparagraph (C), by striking ``revised registration 
     service fee schedules'' and inserting ``service fee schedules 
     revised pursuant to this paragraph'';
       (4) in paragraph (7)--
       (A) in subparagraph (A)--
       (i) by striking ``covered pesticide registration'' and 
     inserting ``covered application''; and
       (ii) by inserting before the period at the end the 
     following: ``, except that no waiver or fee reduction shall 
     be provided in connection with a request for a letter of 
     certification (commonly referred to as a Gold Seal letter)''; 
     and
       (B) in subparagraph (F)(i), by striking ``pesticide 
     registration''; and
       (5) in paragraph (8)--
       (A) in subparagraph (A), by striking ``pesticide 
     registration'';
       (B) in subparagraph (B)(i), by striking ``pesticide 
     registration''; and
       (C) in subparagraph (C)--
       (i) in clause (i), by striking ``pesticide registration'' 
     and inserting ``covered''; and
       (ii) in clause (ii)(I), by striking ``pesticide 
     registration'' and inserting ``covered''.
       (b) Pesticide Registration Fund Set-Asides for Worker 
     Protection, Partnership Grants, and Pesticide Safety 
     Education.--Section 33(c)(3)(B) of the Federal Insecticide, 
     Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is 
     amended--
       (1) in the heading, by inserting ``, partnership grants, 
     and pesticide safety education'' after ``Worker protection'';
       (2) in clause (i)--
       (A) by striking ``2017'' and inserting ``2023''; and
       (B) by inserting before the period at the end the 
     following:``, with an emphasis on field-worker populations in 
     the United States'';
       (3) in clause (ii), by striking ``2017'' and inserting 
     ``2023''; and
       (4) in clause (iii), by striking ``2017'' and inserting 
     ``2023''.
       (c) Reforms To Reduce Decision Time Review Periods.--
     Section 33(e) of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136w-8(e)) is amended--
       (1) by striking ``Pesticide Registration Improvement 
     Extension Act of 2012'' and inserting ``Pesticide 
     Registration Improvement Extension Act of 2018''; and
       (2) by inserting at the end the following new sentence: 
     ``Such reforms shall include identifying opportunities for 
     streamlining review processes for applications for a new 
     active ingredient or a new use and providing prompt feedback 
     to applicants during such review process.''.
       (d) Decision Time Review Periods.--Section 33(f) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136w-8(f)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``Pesticide Registration Improvement 
     Extension Act of 2012'' and inserting ``Pesticide 
     Registration Improvement Extension Act of 2018''; and
       (B) by inserting after ``covered pesticide registration 
     actions'' the following: ``or for any other action covered by 
     a table specified in subsection (b)(3)'';
       (2) in paragraph (3), by striking subparagraph (C) and 
     inserting the following new subparagraph:
       ``(C) applications for any other action covered by a table 
     specified in subsection (b)(3).''; and
       (3) in paragraph (4)(A)--
       (A) by striking ``a pesticide registration application'' 
     and inserting ``a covered application''; and
       (B) by striking ``covered pesticide registration 
     application'' and inserting ``covered application''.
       (e) Reporting Requirements.--Section 33(k) of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
     8(k)) is amended--
       (1) in paragraph (1) by striking ``2017'' and inserting 
     ``2023''; and
       (2) in paragraph (2)--
       (A) in subparagraph (D), by striking clause (i) and 
     inserting the following new clause:
       ``(i) the number of pesticides or pesticide cases reviewed 
     and the number of registration review decisions completed, 
     including--

       ``(I) the number of cases cancelled;
       ``(II) the number of cases requiring risk mitigation 
     measures;
       ``(III) the number of cases removing risk mitigation 
     measures;
       ``(IV) the number of cases with no risk mitigation needed; 
     and
       ``(V) the number of cases in which risk mitigation has been 
     fully implemented;'';

       (B) in subparagraph (G)--
       (i) in clause (i)--

       (I) by striking ``section 4(k)(4)'' and inserting 
     ``paragraphs (4) and (5) of section 4(k)''; and
       (II) by striking ``that section'' and inserting ``such 
     paragraphs'';

       (ii) by striking clauses (ii), (iii), (iv), (v), and (vi);
       (iii) by inserting after clause (i) the following new 
     clause:
       ``(ii) implementing enhancements to--

       ``(I) the electronic tracking of covered applications;
       ``(II) the electronic tracking of conditional 
     registrations;
       ``(III) the endangered species database;
       ``(IV) the electronic review of labels submitted with 
     covered applications; and
       ``(V) the electronic review and assessment of confidential 
     statements of formula submitted with covered applications; 
     and''; and

       (iv) by redesignating clause (vii) as clause (iii);
       (C) in subparagraph (I), by striking ``and'' at the end;
       (D) in subparagraph (J), by striking the period at the end 
     and inserting a semicolon; and
       (E) by adding at the end the following new subparagraphs:

[[Page H2070]]

       ``(K) a review of the progress made in developing, 
     updating, and implementing product performance test 
     guidelines for pesticide products that are intended to 
     control invertebrate pests of significant public health 
     importance and, by regulation, prescribing product 
     performance data requirements for such pesticide products 
     registered under section 3;
       ``(L) a review of the progress made in the priority review 
     and approval of new pesticides to control invertebrate public 
     health pests that may transmit vector-borne disease for use 
     in the United States, including each territory or possession 
     of the United States, and United States military 
     installations globally;
       ``(M) a review of the progress made in implementing 
     enhancements to the good laboratory practices standards 
     compliance monitoring program established under part 160 of 
     title 40 of the Code of Federal Regulations (or successor 
     regulations);
       ``(N) the number of approvals for active ingredients, new 
     uses, and pesticide end use products granted in connection 
     with the Design for the Environment program (or any successor 
     program) of the Environmental Protection Agency; and
       ``(O) with respect to funds in the Pesticide Registration 
     Fund reserved under subsection (c)(3), a review that 
     includes--
       ``(i) a description of the amount and use of such funds--

       ``(I) to carry out activities relating to worker protection 
     under clause (i) of subsection (c)(3)(B);
       ``(II) to award partnership grants under clause (ii) of 
     such subsection; and
       ``(III) to carry out the pesticide safety education program 
     under clause (iii) of such subsection;

       ``(ii) an evaluation of the appropriateness and 
     effectiveness of the activities, grants, and program 
     described in clause (i);
       ``(iii) a description of how stakeholders are engaged in 
     the decision to fund such activities, grants, and program; 
     and
       ``(iv) with respect to activities relating to worker 
     protection carried out under subparagraph (B)(i) of such 
     subsection, a summary of the analyses from stakeholders, 
     including from worker community-based organizations, on the 
     appropriateness and effectiveness of such activities.''.
       (f) Termination of Effectiveness.--Section 33(m) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136w-8(m)) is amended--
       (1) in paragraph (1), by striking ``2017'' and inserting 
     ``2023''; and
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) by striking ``Fiscal year 2018.--During fiscal year 
     2018'' and inserting ``Fiscal year 2024.--During fiscal year 
     2024''; and
       (ii) by striking ``2017'' and inserting ``2023'';
       (B) in subparagraph (B)--
       (i) by striking ``Fiscal year 2019.--During fiscal year 
     2019'' and inserting ``Fiscal year 2025.--During fiscal year 
     2025''; and
       (ii) by striking ``2017'' and inserting ``2023'';
       (C) in subparagraph (C), by striking ``September 30, 
     2019.--Effective September 30, 2019'' and inserting 
     ``September 30, 2025.--Effective September 30, 2025''; and
       (D) in subparagraph (D), by striking ``2017'' both places 
     it appears and inserting ``2023''.

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

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

                          ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                  Decision
  EPA  No.     New  CR                          Action                          Review Time       Registration
                 No.                                                            (Months)(1)     Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      R010           1   New Active Ingredient, Food use. (2)(3)                          24            753,082
----------------------------------------------------------------------------------------------------------------
      R020           2   New Active Ingredient, Food use; reduced risk.                   18            627,568
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R040           3   New Active Ingredient, Food use; Experimental Use                18            462,502
                          Permit application; establish temporary tolerance;
                          submitted before application for registration;
                          credit 45% of fee toward new active ingredient
                          application that follows. (3)
----------------------------------------------------------------------------------------------------------------
      R060           4   New Active Ingredient, Non-food use; outdoor.                    21            523,205
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R070           5   New Active Ingredient, Non-food use; outdoor;                    16            436,004
                          reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R090           6   New Active Ingredient, Non-food use; outdoor;                    16            323,690
                          Experimental Use Permit application; submitted
                          before application for registration; credit 45% of
                          fee toward new active ingredient application that
                          follows. (3)
----------------------------------------------------------------------------------------------------------------
      R110           7   New Active Ingredient, Non-food use; indoor. (2)(3)              20            290,994
----------------------------------------------------------------------------------------------------------------
      R120           8   New Active Ingredient, Non-food use; indoor;                     14            242,495
                          reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R121           9   New Active Ingredient, Non-food use; indoor;                     18            182,327
                          Experimental Use Permit application; submitted
                          before application for registration; credit 45% of
                          fee toward new active ingredient application that
                          follows. (3)
----------------------------------------------------------------------------------------------------------------
      R122          10   Enriched isomer(s) of registered mixed-isomer                    18            317,128
                          active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R123          11   New Active Ingredient, Seed treatment only;                      18            471,861
                          includes agricultural and non-agricultural seeds;
                          residues not expected in raw agricultural
                          commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R125          12   New Active Ingredient, Seed treatment; Experimental              16            323,690
                          Use Permit application; submitted before
                          application for registration; credit 45% of fee
                          toward new active ingredient application that
                          follows. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page H2071]]

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


                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      R130          13   First food use; indoor; food/food        21                                    191,444
                          handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R140          14   Additional food use; Indoor; food/food   15                                     44,672
                          handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R150          15   First food use. (2)(3)                   21                                    317,104
----------------------------------------------------------------------------------------------------------------
      R155    16 (new)   First food use, Experimental Use Permit  21                                    264,253
                          application; a.i. registered for non-
                          food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R160          17   First food use; reduced risk. (2)(3)     16                                    264,253
----------------------------------------------------------------------------------------------------------------
      R170          18   Additional food use. (3) (4)             15                                     79,349
----------------------------------------------------------------------------------------------------------------
      R175          19   Additional food uses covered within a    10                                     66,124
                          crop group resulting from the
                          conversion of existing approved crop
                          group(s) to one or more revised crop
                          groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R180          20   Additional food use; reduced risk.       10                                     66,124
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      R190          21   Additional food uses; 6 or more          15                                    476,090
                          submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R200          22   Additional Food Use; 6 or more           10                                    396,742
                          submitted in one application; Reduced
                          Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R210          23   Additional food use; Experimental Use    12                                     48,986
                          Permit application; establish
                          temporary tolerance; no credit toward
                          new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R220          24   Additional food use; Experimental Use    6                                      19,838
                          Permit application; crop destruct
                          basis; no credit toward new use
                          registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R230          25   Additional use; non-food; outdoor. (3)   15                                     31,713
                          (4)
----------------------------------------------------------------------------------------------------------------
      R240          26   Additional use; non-food; outdoor;       10                                     26,427
                          reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R250          27   Additional use; non-food; outdoor;       6                                      19,838
                          Experimental Use Permit application;
                          no credit toward new use registration.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      R251          28   Experimental Use Permit application      8                                      19,838
                          which requires no changes to the
                          tolerance(s); non-crop destruct basis.
                          (3)
----------------------------------------------------------------------------------------------------------------
      R260          29   New use; non-food; indoor. (3) (4)       12                                     15,317
----------------------------------------------------------------------------------------------------------------
      R270          30   New use; non-food; indoor; reduced       9                                      12,764
                          risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R271          31   New use; non-food; indoor; Experimental  6                                       9,725
                          Use Permit application; no credit
                          toward new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R273          32   Additional use; seed treatment; limited  12                                     50,445
                          uptake into Raw Agricultural
                          Commodities; includes crops with
                          established tolerances (e.g., for soil
                          or foliar application); includes food
                          and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
      R274          33   Additional uses; seed treatment only; 6  12                                    302,663
                          or more submitted in one application;
                          limited uptake into raw agricultural
                          commodities; includes crops with
                          established tolerances (e.g., for soil
                          or foliar application); includes food
                          and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page H2072]]

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


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

[[Page H2073]]

 
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
  base fee for the category. All items in the covered application must be submitted together in one package.
  Each application for an additional new product registration and new inert approval(s) that is submitted in the
  amendment application package is subject to the registration service fee for a new product or a new inert
  approval. However, if an amendment application only proposes to register the amendment for a new product and
  there are no amendments in the application, then review of one new product application is covered by the base
  fee. All such associated applications that are submitted together will be subject to the category decision
  review time.


                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
               New  CR                                          Decision  Review Time     Registration  Service
  EPA  No.       No.                    Action                       (Months)(1)                Fee  ($)
----------------------------------------------------------------------------------------------------------------
      R300          45   New product; or similar combination   4                        1,582
                          product (already registered) to an
                          identical or substantially similar
                          in composition and use to a
                          registered product; registered
                          source of active ingredient; no
                          data review on acute toxicity,
                          efficacy or CRP - only product
                          chemistry data; cite-all data
                          citation, or selective data
                          citation where applicant owns all
                          required data, or applicant submits
                          specific authorization letter from
                          data owner. Category also includes
                          100% re-package of registered end-
                          use or manufacturing-use product
                          that requires no data submission
                          nor data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R301          46   New product; or similar combination   4                        1,897
                          product (already registered) to an
                          identical or substantially similar
                          in composition and use to a
                          registered product; registered
                          source of active ingredient;
                          selective data citation only for
                          data on product chemistry and/or
                          acute toxicity and/or public health
                          pest efficacy (identical data
                          citation and claims to cited
                          product(s)), where applicant does
                          not own all required data and does
                          not have a specific authorization
                          letter from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R310          47   New end-use or manufacturing-use      7                        7,301
                          product with registered source(s)
                          of active ingredient(s); includes
                          products containing two or more
                          registered active ingredients
                          previously combined in other
                          registered products; excludes
                          products requiring or citing an
                          animal safety study; requires
                          review of data package within RD
                          only; includes data and/or waivers
                          of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for up to 3 target pests.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R314          48   New end use product containing up to  8                        8,626
                          three registered active ingredients
                          never before registered as this
                          combination in a formulated
                          product; new product label is
                          identical or substantially similar
                          to the labels of currently
                          registered products which
                          separately contain the respective
                          component active ingredients;
                          excludes products requiring or
                          citing an animal safety study;
                          requires review of data package
                          within RD only; includes data and/
                          or waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for up to 3 target pests.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R319          49   New end use product containing up to  10                       12,626
                          three registered active ingredients
                          never before registered as this
                          combination in a formulated
                          product; new product label is
                          identical or substantially similar
                          to the labels of currently
                          registered products which
                          separately contain the respective
                          component active ingredients;
                          excludes products requiring or
                          citing an animal safety study;
                          requires review of data package
                          within RD only; includes data and/
                          or waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for 4 to 7 target pests.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R318    50 (new)   New end use product containing four   9                        13,252
                          or more registered active
                          ingredients never before registered
                          as this combination in a formulated
                          product; new product label is
                          identical or substantially similar
                          to the labels of currently
                          registered products which
                          separately contain the respective
                          component active ingredients;
                          excludes products requiring or
                          citing an animal safety study;
                          requires review of data package
                          within RD only; includes data and/
                          or waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for up to 3 target pests.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R321    51 (new)   New end use product containing four   11                       17,252
                          or more registered active
                          ingredients never before registered
                          as this combination in a formulated
                          product; new product label is
                          identical or substantially similar
                          to the labels of currently
                          registered products which
                          separately contain the respective
                          component active ingredients;
                          excludes products requiring or
                          citing an animal safety study;
                          requires review of data package
                          within RD only; includes data and/
                          or waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for 4 to 7 target pests.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page H2074]]

 
      R315          52   New end-use, on-animal product,       9                        9,820
                          registered source of active
                          ingredient(s), with the submission
                          of data and/or waivers for only:
                          animal safety and
                          pest(s) requiring efficacy
                          (4) and/or
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging.
                          (2) (3)
----------------------------------------------------------------------------------------------------------------
      R316    53 (new)   New end-use or manufacturing product  9                        11,301
                          with registered source(s) of active
                          ingredient(s) including products
                          containing two or more registered
                          active ingredients previously
                          combined in other registered
                          products; excludes products
                          requiring or citing an animal
                          safety study; and requires review
                          of data and/or waivers for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for greater than 3 and up to
                          7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R317    54 (new)   New end-use or manufacturing product  10                       15,301
                          with registered source(s) of active
                          ingredient(s) including products
                          containing 2 or more registered
                          active ingredients previously
                          combined in other registered
                          products; excludes products
                          requiring or citing an animal
                          safety study; and requires review
                          of data and/or waivers for only:
                          product chemistry and/or
                          acute toxicity and/or
                          child resistant packaging
                          and/or
                          pest(s) requiring efficacy
                          (4) - for greater than 7 target
                          pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R320          55   New product; new physical form;       12                       13,226
                          requires data review in science
                          divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R331          56   New product; repack of identical      3                        2,530
                          registered end-use product as a
                          manufacturing-use product, or
                          identical registered manufacturing-
                          use product as an end use product;
                          same registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R332          57   New manufacturing-use product;        24                       283,215
                          registered active ingredient;
                          unregistered source of active
                          ingredient; submission of
                          completely new generic data
                          package; registered uses only;
                          requires review in RD and science
                          divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R333          58   New product; MUP or End use product   10                       19,838
                          with unregistered source of active
                          ingredient; requires science data
                          review; new physical form; etc.
                          Cite-all or selective data citation
                          where applicant owns all required
                          data. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R334          59   New product; MUP or End use product   11                       23,100
                          with unregistered source of the
                          active ingredient; requires science
                          data review; new physical form;
                          etc. Selective data citation.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


                                ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision Review  Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      R340          60   Amendment requiring data review within   4                                       4,988
                          RD (e.g., changes to precautionary
                          label statements); includes adding/
                          modifying pest(s) claims for up to 2
                          target pests, excludes products
                          requiring or citing an animal safety
                          study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------

[[Page H2075]]

 
      R341    61 (New)   Amendment requiring data review within   6                                       5,988
                          RD (e.g., changes to precautionary
                          label statements), includes adding/
                          modifying pest(s) claims for greater
                          than 2 target pests, excludes products
                          requiring or citing an animal safety
                          study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
      R345          62   Amending on-animal products previously   7                                       8,820
                          registered, with the submission of
                          data and/or waivers for only:
                          animal safety and
                          pest(s) requiring efficacy (4)
                          and/or
                          product chemistry and/or
                          acute toxicity and/or
                           child resistant packaging.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      R350          63   Amendment requiring data review in       9                                      13,226
                          science divisions (e.g., changes to
                          REI, or PPE, or PHI, or use rate, or
                          number of applications; or add aerial
                          application; or modify GW/SW advisory
                          statement). (2)(3)
----------------------------------------------------------------------------------------------------------------
      R351          64   Amendment adding a new unregistered      8                                      13,226
                          source of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      R352          65   Amendment adding already approved uses;  8                                      13,226
                          selective method of support; does not
                          apply if the applicant owns all cited
                          data. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R371          66   Amendment to Experimental Use Permit;    6                                      10,090
                          (does not include extending a permit's
                          time period). (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


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


                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      A380          71   New Active Ingredient; Indirect Food     24                                    137,841
                          use; establish tolerance or tolerance
                          exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A390          72   New Active Ingredient; Direct Food use;  24                                    229,733
                          establish tolerance or tolerance
                          exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page H2076]]

 
      A410          73   New Active Ingredient Non-food           21                                    229,733
                          use.(2)(3)
----------------------------------------------------------------------------------------------------------------
      A431          74   New Active Ingredient, Non-food use;     12                                     80,225
                          low-risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


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

[[Page H2077]]

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


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

[[Page H2078]]

 
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number of organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number of organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.


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


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

[[Page H2079]]

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


                                ``TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      B630         115    First food use; petition to establish   13                                     12,764
                          a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B631         116    New food use; petition to amend an      12                                     12,764
                          established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
      B640         117   First food use; petition to establish a  19                                     19,146
                          tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B643         118   New Food use; petition to amend an       10                                     12,764
                          established tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B642         119   First food use; indoor; food/food        12                                     31,910
                          handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B644         120   New use, no change to an established     8                                      12,764
                          tolerance or tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B650         121   New use; non-food. (3)(4)                7                                       6,383
----------------------------------------------------------------------------------------------------------------
      B645   122 (new)    New food use; Experimental Use Permit   12                                     12,764
                          application; petition to amend or add
                          a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
      B646   123 (new)   New use; non-food use including crop     7                                       6,383
                          destruct; Experimental Use Permit
                          application. (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page H2080]]

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


                              ``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      B652         124   New product; registered source of        13                                     12,764
                          active ingredient; requires petition
                          to amend established tolerance or
                          tolerance exemption; requires 1)
                          submission of product specific data;
                          or 2) citation of previously reviewed
                          and accepted data; or 3) submission or
                          citation of data generated at
                          government expense; or 4) submission
                          or citation of scientifically-sound
                          rationale based on publicly available
                          literature or other relevant
                          information that addresses the data
                          requirement; or 5) submission of a
                          request for a data requirement to be
                          waived supported by a scientifically-
                          sound rationale explaining why the
                          data requirement does not apply.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B660         125    New product; registered source of       4                                       1,278
                          active ingredient(s); identical or
                          substantially similar in composition
                          and use to a registered product. No
                          data review, or only product chemistry
                          data; cite-all data citation, or
                          selective data citation where
                          applicant owns all required data or
                          authorization from data owner is
                          demonstrated. Category includes 100%
                          re-package of registered end-use or
                          manufacturing-use product that
                          requires no data submission or data
                          matrix. For microbial pesticides, the
                          active ingredient(s) must not be re-
                          isolated. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B670         126    New product; registered source of       7                                       5,107
                          active ingredient(s); requires: 1)
                          submission of product specific data;
                          or 2) citation of previously reviewed
                          and accepted data; or 3) submission or
                          citation of data generated at
                          government expense; or 4) submission
                          or citation of a scientifically-sound
                          rationale based on publicly available
                          literature or other relevant
                          information that addresses the data
                          requirement; or 5) submission of a
                          request for a data requirement to be
                          waived supported by a scientifically-
                          sound rationale explaining why the
                          data requirement does not apply.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      B671         127    New product; unregistered source of     17                                     12,764
                          active ingredient(s); requires a
                          petition to amend an established
                          tolerance or tolerance exemption;
                          requires: 1) submission of product
                          specific data; or 2) citation of
                          previously reviewed and accepted data;
                          or 3) submission or citation of data
                          generated at government expense; or 4)
                          submission or citation of a
                          scientifically-sound rationale based
                          on publicly available literature or
                          other relevant information that
                          addresses the data requirement; or 5)
                          submission of a request for a data
                          requirement to be waived supported by
                          a scientifically-sound rationale
                          explaining why the data requirement
                          does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B672         128    New product; unregistered source of     13                                      9,118
                          active ingredient(s); non-food use or
                          food use requires: 1) submission of
                          product specific data; or 2) citation
                          of previously reviewed and accepted
                          data; or 3) submission or citation of
                          data generated at government expense;
                          or 4) submission or citation of a
                          scientifically-sound rationale based
                          on publicly available literature or
                          other relevant information that
                          addresses the data requirement; or 5)
                          submission of a request for a data
                          requirement to be waived supported by
                          a scientifically-sound rationale
                          explaining why the data requirement
                          does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B673         129    New product MUP/EP; unregistered        10                                      5,107
                          source of active ingredient(s);
                          citation of Technical Grade Active
                          Ingredient (TGAI) data previously
                          reviewed and accepted by the Agency.
                          Requires an Agency determination that
                          the cited data supports the new
                          product. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B674         130    New product MUP; Repack of identical    4                                       1,278
                          registered end-use product as a
                          manufacturing-use product; same
                          registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B675         131    New Product MUP; registered source of   10                                      9,118
                          active ingredient; submission of
                          completely new generic data package;
                          registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page H2081]]

 
      B676         132    New product; more than one active       13                                      9,118
                          ingredient where one active ingredient
                          is an unregistered source; product
                          chemistry data must be submitted;
                          requires: 1) submission of product
                          specific data, and 2) citation of
                          previously reviewed and accepted data;
                          or 3) submission or citation of data
                          generated at government expense; or 4)
                          submission or citation of a
                          scientifically-sound rationale based
                          on publicly available literature or
                          other relevant information that
                          addresses the data requirement; or 5)
                          submission of a request for a data
                          requirement to be waived supported by
                          a scientifically-sound rationale
                          explaining why the data requirement
                          does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
      B677         133   New end-use non-food animal product      10                                      8,820
                          with submission of two or more target
                          animal safety studies; includes data
                          and/or waivers of data for only:
                          product chemistry and/or
                          acute toxicity and/or
                          public health pest efficacy
                          and/or
                          animal safety studies and/or
                          child resistant packaging.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


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


[[Page H2082]]


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


                             ``TABLE 16. -- BIOPESTICIDES DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      B614         150   Pre-application; Conditional Ruling on   3                                       2,530
                          rationales for addressing a data
                          requirement in lieu of data; applicant-
                          initiated; applies to one rationale at
                          a time.
----------------------------------------------------------------------------------------------------------------

[[Page H2083]]

 
      B615         151   Rebuttal of agency reviewed protocol,    3                                       2,530
                          applicant initiated.
----------------------------------------------------------------------------------------------------------------
      B682         152   Protocol review; applicant initiated;    3                                       2,432
                          excludes time for HSRB review.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


                                  ``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
               New  CR                                               Decision  Review Time        Registration
  EPA  No.       No.                      Action                          (Months)(1)           Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
      B740         153   Experimental Use Permit application; no  6                                      95,724
                          petition for tolerance/tolerance
                          exemption. Includes:
                         .......................................
                         1. non-food/feed use(s) for a new (2)
                          or registered (3) PIP (12);
                         2. food/feed use(s) for a new or
                          registered PIP with crop destruct
                          (12);
                         3. food/feed use(s) for a new or
                          registered PIP in which an established
                          tolerance/tolerance exemption exists
                          for the intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
      B741   154 (new)   Experimental Use Permit application; no  12                                    159,538
                          petition for tolerance/tolerance
                          exemption. Includes:
                         .......................................
                         1. non-food/feed use(s) for a new (2)
                          or registered (3) PIP;
                         2. food/feed use(s) for a new or
                          registered PIP with crop destruct;
                         3. food/feed use(s) for a new or
                          registered PIP in which an established
                          tolerance/tolerance exemption exists
                          for the intended use(s);
                         SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
      B750         155   Experimental Use Permit application;     9                                     127,630
                          with a petition to establish a
                          temporary or permanent tolerance/
                          tolerance exemption for the active
                          ingredient. Includes new food/feed use
                          for a registered (3) PIP. (4)(12)
----------------------------------------------------------------------------------------------------------------
      B770         156   Experimental Use Permit application;     15                                    191,444
                          new (2) PIP; with petition to
                          establish a temporary tolerance/
                          tolerance exemption for the active
                          ingredient; credit 75% of B771 fee
                          toward registration application for a
                          new active ingredient that follows;
                          SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B771         157   Experimental Use Permit application;     10                                    127,630
                          new (2) PIP; with petition to
                          establish a temporary tolerance/
                          tolerance exemption for the active
                          ingredient; credit 75% of B771 fee
                          toward registration application for a
                          new active ingredient that follows.
                          (12)
----------------------------------------------------------------------------------------------------------------
      B772         158   Application to amend or extend an        3                                      12,764
                          Experimental Use Permit; no petition
                          since the established tolerance/
                          tolerance exemption for the active
                          ingredient is unaffected. (12)
----------------------------------------------------------------------------------------------------------------
      B773         159   Application to amend or extend an        5                                      31,910
                          Experimental Use Permit; with petition
                          to extend a temporary tolerance/
                          tolerance exemption for the active
                          ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B780         160   Registration application; new (2) PIP;   12                                    159,537
                          non-food/feed. (12)
----------------------------------------------------------------------------------------------------------------
      B790         161   Registration application; new (2) PIP;   18                                    223,351
                          non-food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B800         162   Registration application; new (2) PIP;   13                                    172,300
                          with petition to establish permanent
                          tolerance/tolerance exemption for the
                          active ingredient based on an existing
                          temporary tolerance/tolerance
                          exemption. (12)
----------------------------------------------------------------------------------------------------------------
      B810         163   Registration application; new (2) PIP;   19                                    236,114
                          with petition to establish permanent
                          tolerance/tolerance exemption for the
                          active ingredient based on an existing
                          temporary tolerance/tolerance
                          exemption. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B820         164   Registration application; new (2) PIP;   15                                    204,208
                          with petition to establish or amend a
                          permanent tolerance/tolerance
                          exemption of an active ingredient.
                          (12)
----------------------------------------------------------------------------------------------------------------
      B840         165   Registration application; new (2) PIP;   21                                    268,022
                          with petition to establish or amend a
                          permanent tolerance/tolerance
                          exemption of an active ingredient. SAP
                          review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B851         166   Registration application; new event of   9                                     127,630
                          a previously registered PIP active
                          ingredient(s); no petition since
                          permanent tolerance/tolerance
                          exemption is already established for
                          the active ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B870         167   Registration application; registered     9                                      38,290
                          (3) PIP; new product; new use; no
                          petition since a permanent tolerance/
                          tolerance exemption is already
                          established for the active
                          ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------

[[Page H2084]]

 
      B880         168   Registration application; registered     9                                      31,910
                          (3) PIP; new product or new terms of
                          registration; additional data
                          submitted; no petition since a
                          permanent tolerance/tolerance
                          exemption is already established for
                          the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
      B881         169   Registration application; registered     15                                     95,724
                          (3) PIP; new product or new terms of
                          registration; additional data
                          submitted; no petition since a
                          permanent tolerance/tolerance
                          exemption is already established for
                          the active ingredient(s). SAP review.
                          (5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
      B882   170 (new)   Registration application; new (2) PIP,   15                                    191,444
                          seed increase with negotiated acreage
                          cap and time-limited registration;
                          with petition to establish a permanent
                          tolerance/tolerance exemption for the
                          active ingredient based on an existing
                          temporary tolerance/tolerance
                          exemption; SAP Review. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B883         171   Registration application; new (2) PIP,   9                                     127,630
                          seed increase with negotiated acreage
                          cap and time-limited registration;
                          with petition to establish a permanent
                          tolerance/tolerance exemption for the
                          active ingredient based on an existing
                          temporary tolerance/tolerance
                          exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B884         172   Registration application; new (2) PIP,   12                                    159,537
                          seed increase with negotiated acreage
                          cap and time-limited registration;
                          with petition to establish a permanent
                          tolerance/tolerance exemption for the
                          active ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B885         173   Registration application; registered     6                                      31,910
                          (3) PIP, seed increase; breeding stack
                          of previously approved PIPs, same
                          crop; no petition since a permanent
                          tolerance/tolerance exemption is
                          already established for the active
                          ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
      B886   174 (new)   Registration application; new (2) PIP,   18                                    223,351
                          seed increase with negotiated acreage
                          cap and time-limited registration;
                          with petition to establish a permanent
                          tolerance/tolerance exemption for the
                          active ingredient. SAP Review. (8)
                          (12)
----------------------------------------------------------------------------------------------------------------
      B890         175   Application to amend a seed increase     9                                      63,816
                          registration; converts registration to
                          commercial registration; no petition
                          since permanent tolerance/tolerance
                          exemption is already established for
                          the active ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B891         176   Application to amend a seed increase     15                                    127,630
                          registration; converts registration to
                          a commercial registration; no petition
                          since a permanent tolerance/tolerance
                          exemption already established for the
                          active ingredient(s); SAP review.
                          (5)(12)
----------------------------------------------------------------------------------------------------------------
      B900         177   Application to amend a registration,     6                                      12,764
                          including actions such as extending an
                          expiration date, modifying an IRM
                          plan, or adding an insect to be
                          controlled. (10)(11)(12)
----------------------------------------------------------------------------------------------------------------
      B901         178   Application to amend a registration,     12                                     76,578
                          including actions such as extending an
                          expiration date, modifying an IRM
                          plan, or adding an insect to be
                          controlled. SAP review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
      B902         179   PIP Protocol review.                     3                                       6,383
----------------------------------------------------------------------------------------------------------------
      B903         180   Inert ingredient tolerance exemption;    6                                      63,816
                          e.g., a marker such as NPT II;
                          reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
      B904         181   Import tolerance or tolerance            9                                     127,630
                          exemption; processed commodities/food
                          only (inert or active ingredient).
----------------------------------------------------------------------------------------------------------------
      B905   182 (new)   SAP Review.                              6                                      63,816
----------------------------------------------------------------------------------------------------------------
      B906   183 (new)   Petition to establish a temporary        3                                      31,907
                          tolerance/tolerance exemption for one
                          or more active ingredients.
----------------------------------------------------------------------------------------------------------------
      B907   184 (new)   Petition to establish a temporary        3                                      12,764
                          tolerance/tolerance exemption for one
                          or more active ingredients based on an
                          existing temporary tolerance/tolerance
                          exemption.
----------------------------------------------------------------------------------------------------------------
      B908   185 (new)   Petition to establish a temporary        3                                      44,671
                          tolerance/tolerance exemption for one
                          or more active ingredients or inert
                          ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).

[[Page H2085]]

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


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

[[Page H2086]]

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


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

     SEC. 7. AGRICULTURAL WORKER PROTECTION STANDARD; 
                   CERTIFICATION OF PESTICIDE APPLICATORS.

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

[[Page H2087]]

       (2) shall not revise or develop revisions to the rules 
     described in subparagraphs (A) and (B) of paragraph (1).
       (b) Exceptions.--Prior to October 1, 2021, the 
     Administrator may propose, and after a notice and public 
     comment period of not less than 90 days, promulgate revisions 
     to the final rule described in subsection (a)(1)(A) 
     addressing application exclusion zones under part 170 of 
     title 40, Code of Federal Regulations, consistent with the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136 et seq.).
       (c) GAO Report.--The Comptroller General of the United 
     States shall--
       (1) conduct a study on the use of the designated 
     representative, including the effect of that use on the 
     availability of pesticide application and hazard information 
     and worker health and safety; and
       (2) not later than October 1, 2021, make publically 
     available a report describing the study under paragraph (1), 
     including any recommendations to prevent the misuse of 
     pesticide application and hazard information, if that misuse 
     is identified.
  Mr. PETERSON (during the reading). Mr. Speaker, I ask unanimous 
consent to dispense with the reading of the amendment.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Minnesota?
  There was no objection.
  The amendment was agreed to.
  The bill was ordered to be read a third time, was read the third 
time, and passed, and a motion to reconsider was laid on the table.

                          ____________________