[Congressional Record Volume 163, Number 48 (Monday, March 20, 2017)]
[House]
[Pages H2190-H2208]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             PESTICIDE REGISTRATION ENHANCEMENT ACT OF 2017

  Mr. RODNEY DAVIS of Illinois. Madam Speaker, I move to suspend the 
rules and pass the bill (H.R. 1029) to amend the Federal Insecticide, 
Fungicide, and Rodenticide Act to improve pesticide registration and 
other activities under the Act, to extend and modify fee authorities, 
and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1029

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

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

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

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

     SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.

       (a) Authorized Use of Fund.--Section 4(k)(2)(A) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136a-1(k)(2)(A)) is amended--
       (1) in the first sentence, by striking ``the fund'' and 
     inserting ``the Reregistration and Expedited Processing 
     Fund'';
       (2) by striking ``paragraph (3),'' in the first sentence 
     and all that follows through the second sentence and 
     inserting the following: ``paragraph (3), to offset the costs 
     of registration review under section 3(g), including the 
     costs associated with any review under the Endangered Species 
     Act of 1973 (16 U.S.C. 1531 et. seq.) required as part of the 
     registration review, to offset the costs associated with 
     tracking and implementing registration review decisions, 
     including registration review decisions designed to reduce 
     risk, for the purposes specified in paragraphs (4) and (5), 
     and to enhance the information systems capabilities to 
     improve the tracking of pesticide registration decisions.'';
       (3) in clause (i), by striking ``are allocated solely'' and 
     all that follows through ``3(g);'' and inserting the 
     following: ``are allocated solely for the purposes specified 
     in the first sentence of this subparagraph;''; and
       (4) in clause (ii), by striking ``necessary to achieve'' 
     and all that follows through ``3(g);'' and inserting the 
     following: ``necessary to achieve the purposes specified in 
     the first sentence of this subparagraph;''.
       (b) Set-aside for Review of Inert Ingredients and Expedited 
     Processing of Similar Applications.--Section 4(k)(3)(A) of 
     the Federal Insecticide, Fungicide, and Rodenticide Act (7 
     U.S.C. 136a-1(k)(3)(A)) is amended, in the matter preceding 
     clause (i), by striking ``The Administrator shall use'' and 
     all that follows through ``personnel and resources--'' and 
     inserting the following: ``For each of fiscal years 2017 
     through 2023, the Administrator shall use between \1/9\ and 
     \1/8\ of the maintenance fees collected in such fiscal year 
     to obtain sufficient personnel and resources--''.
       (c) Set-aside for Expedited Rulemaking and Guidance 
     Development for Certain Purposes.--Paragraph (4) of section 
     4(k) of the Federal Insecticide, Fungicide, and Rodenticide 
     Act (7 U.S.C. 136a-1(k)) is amended to read as follows:
       ``(4) Expedited rulemaking and guidance development for 
     certain product performance data requirements.--
       ``(A) Set-aside.--For each of fiscal years 2017 through 
     2021, the Administrator shall use not more than $500,000 of 
     the amounts made available to the Administrator in the 
     Reregistration and Expedited Processing Fund for the 
     activities described in subparagraph (B).
       ``(B) Products claiming efficacy against invertebrate pests 
     of significant public health or economic importance.--The 
     Administrator shall use amounts made available under 
     subparagraph (A) to develop, receive comments with respect 
     to, finalize, and implement the necessary rulemaking and 
     guidance for product performance data requirements to 
     evaluate products claiming efficacy against the following 
     invertebrate pests of significant public health or economic 
     importance (in order of importance):
       ``(i) Bed bugs.
       ``(ii) Premise (including crawling insects, flying insects, 
     and baits).
       ``(iii) Pests of pets (including pet pests controlled by 
     spot-ons, collars, shampoos, powders, dips).
       ``(iv) Fire ants.
       ``(C) Deadlines for guidance.--The Administrator shall 
     develop, and publish guidance required by subparagraph (B) 
     with respect to claims of efficacy against pests described in 
     such subparagraph as follows:
       ``(i) With respect to bed bugs, issue final guidance not 
     later than June 30, 2017.
       ``(ii) With respect to pests specified in clause (ii) of 
     such subparagraph--

       ``(I) submit draft guidance to the Scientific Advisory 
     Panel and for public comment not later than June 30, 2018; 
     and
       ``(II) complete any response to comments received with 
     respect to such draft guidance and finalize the guidance not 
     later than September 30, 2020.

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

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

       ``(D) Revision.--The Administrator shall revise the 
     guidance required by subparagraph (B) from time-to-time, but 
     shall permit applicants and registrants sufficient time to 
     obtain data that meet the requirements specified in such 
     revised guidance.
       ``(E) Deadline for product performance data requirements.--
     The Administrator shall, not later than September 30, 2021, 
     issue regulations prescribing product performance data 
     requirements for any pesticide intended for preventing, 
     destroying, repelling, or mitigating any invertebrate pest of 
     significant public health or economic importance specified in 
     clauses (i) through (iv) of subparagraph (B).''.
       (d) Set-aside for Good Laboratory Practices Inspections.--
     Section 4(k) of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
       (1) by redesignating paragraphs (5) and (6) as paragraphs 
     (6) and (7), respectively;
       (2) by inserting after paragraph (4) the following new 
     paragraph:
       ``(5) Good laboratory practices inspections.--

[[Page H2191]]

       ``(A) Set-aside.--For each of fiscal years 2017 through 
     2023, the Administrator shall use not more than $500,000 of 
     the amounts made available to the Administrator in the 
     Reregistration and Expedited Processing Fund for the 
     activities described in subparagraph (B).
       ``(B) Activities.--The Administrator shall use amounts made 
     available under subparagraph (A) for enhancements to the good 
     laboratory practices standards compliance monitoring program 
     established under part 160 of title 40 of the Code of Federal 
     Regulations (or successor regulations), with respect to 
     laboratory inspections and data audits conducted in support 
     of pesticide product registrations under this Act. As part of 
     such monitoring program, the Administrator shall make 
     available to each laboratory inspected under such program in 
     support of such registrations a preliminary summary of 
     inspection observations not later than 60 days after the date 
     on which such an inspection is completed.''; and
       (3) in paragraph (7), as so redesignated, by striking `` 
     paragraphs (2), (3), and (4)'' and inserting `` paragraphs 
     (2), (3), (4), and (5)''.

     SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.

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

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

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

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

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

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

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

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

       ``(ii) an evaluation of the appropriateness and 
     effectiveness of the activities, grants, and program 
     described in clause (i);

[[Page H2192]]

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

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

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

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


                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      R130          13   First food use; indoor; food/food       21                                     191,444
                          handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
      R140          14   Additional food use; Indoor; food/food  15                                      44,672
                          handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
      R150          15   First food use. (2)(3)                  21                                     317,104
----------------------------------------------------------------------------------------------------------------

[[Page H2193]]

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


                       ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      R280          34   Establish import tolerance; new active  21                                     319,072
                          ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
      R290          35   Establish Import tolerance; Additional  15                                      63,816
                          new food use.
----------------------------------------------------------------------------------------------------------------

[[Page H2194]]

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


                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
            New  CR                                        Decision  Review Time     FY'17 & FY'18 Registration
 EPA  No.     No.                   Action                      (Months)(1)               Service Fee  ($)
----------------------------------------------------------------------------------------------------------------
    R300         45   New product; or similar            4                         1,582
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient; no
                       data review on acute toxicity,
                       efficacy or CRP - only product
                       chemistry data; cite-all data
                       citation, or selective data
                       citation where applicant owns
                       all required data, or applicant
                       submits specific authorization
                       letter from data owner. Category
                       also includes 100% re-package of
                       registered end-use or
                       manufacturing-use product that
                       requires no data submission nor
                       data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R301         46   New product; or similar            4                         1,897
                       combination product (already
                       registered) to an identical or
                       substantially similar in
                       composition and use to a
                       registered product; registered
                       source of active ingredient;
                       selective data citation only for
                       data on product chemistry and/or
                       acute toxicity and/or public
                       health pest efficacy (identical
                       data citation and claims to
                       cited product(s)), where
                       applicant does not own all
                       required data and does not have
                       a specific authorization letter
                       from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page H2195]]

 
    R310         47   New end-use or manufacturing-use   7                         7,301
                       product with registered
                       source(s) of active
                       ingredient(s); includes products
                       containing two or more
                       registered active ingredients
                       previously combined in other
                       registered products; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R314         48   New end use product containing up  8                         8,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R319         49   New end use product containing up  10                        12,626
                       to three registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R318   50 (new)   New end use product containing     9                         13,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for up to 3
                       target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R321   51 (new)   New end use product containing     11                        17,252
                       four or more registered active
                       ingredients never before
                       registered as this combination
                       in a formulated product; new
                       product label is identical or
                       substantially similar to the
                       labels of currently registered
                       products which separately
                       contain the respective component
                       active ingredients; excludes
                       products requiring or citing an
                       animal safety study; requires
                       review of data package within RD
                       only; includes data and/or
                       waivers of data for only:
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging and/or
                       pest(s) requiring
                       efficacy (4) - for 4 to 7 target
                       pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
    R315         52   New end-use, on-animal product,    9                         9,820
                       registered source of active
                       ingredient(s), with the
                       submission of data and/or
                       waivers for only:
                       animal safety and
                       pest(s) requiring
                       efficacy (4) and/or
                       product chemistry and/or
                       acute toxicity and/or
                       child resistant
                       packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------

[[Page H2196]]

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


                                ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
            New  CR                                                   Decision Review  Time        Registration
 EPA  No.     No.                       Action                             (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
    R340        60   Amendment requiring data review within RD    4                                       4,988
                      (e.g., changes to precautionary label
                      statements); includes adding/modifying
                      pest(s) claims for up to 2 target pests,
                      excludes products requiring or citing an
                      animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
    R341   61 (New)  Amendment requiring data review within RD    6                                       5,988
                      (e.g., changes to precautionary label
                      statements), includes adding/modifying
                      pest(s) claims for greater than 2 target
                      pests, excludes products requiring or
                      citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------

[[Page H2197]]

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


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


                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
  EPA  No.      No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A380         71   New Active Ingredient; Indirect Food use;  24                                   137,841
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A390         72   New Active Ingredient; Direct Food use;    24                                   229,733
                         establish tolerance or tolerance
                         exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A410         73   New Active Ingredient Non-food use.(2)(3)  21                                   229,733
----------------------------------------------------------------------------------------------------------------
      A431         74   New Active Ingredient, Non-food use; low-  12                                    80,225
                         risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page H2198]]

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


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


                      ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A530          81    New product, identical or              4                                        1,278
                          substantially similar in composition
                          and use to a registered product; no
                          data review or only product chemistry
                          data; cite all data citation or
                          selective data citation where
                          applicant owns all required data; or
                          applicant submits specific
                          authorization letter from data owner.
                          Category also includes 100% re-
                          package of registered end-use or
                          manufacturing use product that
                          requires no data submission nor data
                          matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A531          82    New product; identical or              4                                        1,824
                          substantially similar in composition
                          and use to a registered product;
                          registered source of active
                          ingredient: selective data citation
                          only for data on product chemistry
                          and/or acute toxicity and/or public
                          health pest efficacy, where applicant
                          does not own all required data and
                          does not have a specific
                          authorization letter from data owner.
                          (2)(3)
----------------------------------------------------------------------------------------------------------------
      A532          83   New product; identical or               5                                        5,107
                          substantially similar in composition
                          and use to a registered product;
                          registered active ingredient;
                          unregistered source of active
                          ingredient; cite-all data citation
                          except for product chemistry; product
                          chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A540          84    New end use product; FIFRA Sec. 2(mm)  5                                        5,107
                          uses only; up to 25 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------

[[Page H2199]]

 
      A541    85 (new)    New end use product; FIFRA Sec. 2(mm)  7                                        8,500
                          uses only; 26-50 public health
                          organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A542    86 (new)    New end use product; FIFRA Sec. 2(mm)  10                                      15,000
                          uses only; $ 51 public health
                          organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A550          87    New end-use product; uses other than   9                                       13,226
                          FIFRA Sec. 2(mm); non-FQPA product.
                          (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
      A560          88    New manufacturing use product;         6                                       12,596
                          registered active ingredient;
                          selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A565    89 (new)    New manufacturing-use product;         12                                      18,234
                          registered active ingredient;
                          unregistered source of active
                          ingredient; submission of new generic
                          data package; registered uses only;
                          requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
      A570          90    Label amendment requiring data         4                                        3,831
                          review; up to 25 public health
                          organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
      A573    91 (new)    Label amendment requiring data         6                                        6,350
                          review; 26-50 public health
                          organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A574    92 (new)    Label amendment requiring data         9                                       11,000
                          review; $ 51 public health organisms.
                          (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
      A572          93   New Product or amendment requiring      9                                       13,226
                          data review for risk assessment by
                          Science Branch (e.g., changes to REI,
                          or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
  method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number or organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number or organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.


              ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      A520          94    Experimental Use Permit application,   9                                        6,383
                          non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      A521          95   Review of public health efficacy study  4                                        4,726
                          protocol within AD, per AD Internal
                          Guidance for the Efficacy Protocol
                          Review Process; Code will also
                          include review of public health
                          efficacy study protocol and data
                          review for devices making pesticidal
                          claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
      A522          96    Review of public health efficacy       12                                      12,156
                          study protocol outside AD by members
                          of AD Efficacy Protocol Review Expert
                          Panel; Code will also include review
                          of public health efficacy study
                          protocol and data review for devices
                          making pesticidal claims; applicant-
                          initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
      A537    97 (new)    New Active Ingredient/New Use,         18                                     153,156
                          Experimental Use Permit application;
                          Direct food use; Establish tolerance
                          or tolerance exemption if required.
                          Credit 45% of fee toward new active
                          ingredient/new use application that
                          follows.
----------------------------------------------------------------------------------------------------------------
      A538    98 (new)    New Active Ingredient/New Use,         18                                      95,724
                          Experimental Use Permit application;
                          Indirect food use; Establish
                          tolerance or tolerance exemption if
                          required Credit 45% of fee toward new
                          active ingredient/new use application
                          that follows.
----------------------------------------------------------------------------------------------------------------
      A539    99 (new)    New Active Ingredient/New Use,         15                                      92,163
                          Experimental Use Permit application;
                          Nonfood use. Credit 45% of fee toward
                          new active ingredient/new use
                          application that follows.
----------------------------------------------------------------------------------------------------------------
      A529         100    Amendment to Experimental Use Permit;  9                                       11,429
                          requires data review or risk
                          assessment. (2)
----------------------------------------------------------------------------------------------------------------
      A523         101    Review of protocol other than a        9                                       12,156
                          public health efficacy study (i.e.,
                          Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
      A571         102    Science reassessment: Cancer risk,     18                                      95,724
                          refined ecological risk, and/or
                          endangered species; applicant-
                          initiated.
----------------------------------------------------------------------------------------------------------------
      A533   103 (new)   Exemption from the requirement of an    4                                        2,482
                          Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------

[[Page H2200]]

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


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


                                ``TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B630         115    First food use; petition to establish  13                                      12,764
                          a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B631         116    New food use; petition to amend an     12                                      12,764
                          established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
      B640         117   First food use; petition to establish   19                                      19,146
                          a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B643         118   New Food use; petition to amend an      10                                      12,764
                          established tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B642         119   First food use; indoor; food/food       12                                      31,910
                          handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
      B644         120   New use, no change to an established    8                                       12,764
                          tolerance or tolerance exemption.
                          (3)(4)
----------------------------------------------------------------------------------------------------------------
      B650         121   New use; non-food. (3)(4)               7                                        6,383
----------------------------------------------------------------------------------------------------------------

[[Page H2201]]

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


                              ``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
 EPA  No.       No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
     B652         124   New product; registered source of active   13                                    12,764
                         ingredient; requires petition to amend
                         established tolerance or tolerance
                         exemption; requires 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of scientifically-
                         sound rationale based on publicly
                         available literature or other relevant
                         information that addresses the data
                         requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B660         125    New product; registered source of active  4                                      1,278
                         ingredient(s); identical or
                         substantially similar in composition and
                         use to a registered product. No data
                         review, or only product chemistry data;
                         cite-all data citation, or selective
                         data citation where applicant owns all
                         required data or authorization from data
                         owner is demonstrated. Category includes
                         100% re-package of registered end-use or
                         manufacturing-use product that requires
                         no data submission or data matrix. For
                         microbial pesticides, the active
                         ingredient(s) must not be re-isolated.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------
     B670         126    New product; registered source of active  7                                      5,107
                         ingredient(s); requires: 1) submission
                         of product specific data; or 2) citation
                         of previously reviewed and accepted
                         data; or 3) submission or citation of
                         data generated at government expense; or
                         4) submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B671         127    New product; unregistered source of       17                                    12,764
                         active ingredient(s); requires a
                         petition to amend an established
                         tolerance or tolerance exemption;
                         requires: 1) submission of product
                         specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B672         128    New product; unregistered source of       13                                     9,118
                         active ingredient(s); non-food use or
                         food use requires: 1) submission of
                         product specific data; or 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B673         129    New product MUP/EP; unregistered source   10                                     5,107
                         of active ingredient(s); citation of
                         Technical Grade Active Ingredient (TGAI)
                         data previously reviewed and accepted by
                         the Agency. Requires an Agency
                         determination that the cited data
                         supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B674         130    New product MUP; Repack of identical      4                                      1,278
                         registered end-use product as a
                         manufacturing-use product; same
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------

[[Page H2202]]

 
     B675         131    New Product MUP; registered source of     10                                     9,118
                         active ingredient; submission of
                         completely new generic data package;
                         registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B676         132    New product; more than one active         13                                     9,118
                         ingredient where one active ingredient
                         is an unregistered source; product
                         chemistry data must be submitted;
                         requires: 1) submission of product
                         specific data, and 2) citation of
                         previously reviewed and accepted data;
                         or 3) submission or citation of data
                         generated at government expense; or 4)
                         submission or citation of a
                         scientifically-sound rationale based on
                         publicly available literature or other
                         relevant information that addresses the
                         data requirement; or 5) submission of a
                         request for a data requirement to be
                         waived supported by a scientifically-
                         sound rationale explaining why the data
                         requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
     B677         133   New end-use non-food animal product with   10                                     8,820
                         submission of two or more target animal
                         safety studies; includes data and/or
                         waivers of data for only:
                         product chemistry and/or
                         acute toxicity and/or
                         public health pest efficacy and/
                         or
                         animal safety studies and/or
                         child resistant packaging.
                         (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


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


[[Page H2203]]


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


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


[[Page H2204]]


                                  ``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
             New  CR                                                   Decision  Review Time       Registration
  EPA  No.      No.                      Action                             (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      B740      153   Experimental Use Permit application; no      6                                     95,724
                       petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP (12);
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct (12);
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
      B741      154   Experimental Use Permit application; no      12                                   159,538
              (new)    petition for tolerance/tolerance
                       exemption. Includes:
                      ...........................................
                      1. non-food/feed use(s) for a new (2) or
                       registered (3) PIP;
                      2. food/feed use(s) for a new or registered
                       PIP with crop destruct;
                      3. food/feed use(s) for a new or registered
                       PIP in which an established tolerance/
                       tolerance exemption exists for the
                       intended use(s);
                      SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
      B750      155   Experimental Use Permit application; with a  9                                    127,630
                       petition to establish a temporary or
                       permanent tolerance/tolerance exemption
                       for the active ingredient. Includes new
                       food/feed use for a registered (3) PIP.
                       (4)(12)
----------------------------------------------------------------------------------------------------------------
      B770      156   Experimental Use Permit application; new     15                                   191,444
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows;
                       SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B771      157   Experimental Use Permit application; new     10                                   127,630
                       (2) PIP; with petition to establish a
                       temporary tolerance/tolerance exemption
                       for the active ingredient; credit 75% of
                       B771 fee toward registration application
                       for a new active ingredient that follows.
                       (12)
----------------------------------------------------------------------------------------------------------------
      B772      158   Application to amend or extend an            3                                     12,764
                       Experimental Use Permit; no petition since
                       the established tolerance/tolerance
                       exemption for the active ingredient is
                       unaffected. (12)
----------------------------------------------------------------------------------------------------------------
      B773      159   Application to amend or extend an            5                                     31,910
                       Experimental Use Permit; with petition to
                       extend a temporary tolerance/tolerance
                       exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B780      160   Registration application; new (2) PIP; non-  12                                   159,537
                       food/feed. (12)
----------------------------------------------------------------------------------------------------------------
      B790      161   Registration application; new (2) PIP; non-  18                                   223,351
                       food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B800      162   Registration application; new (2) PIP; with  13                                   172,300
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------
      B810      163   Registration application; new (2) PIP; with  19                                   236,114
                       petition to establish permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. SAP review.
                       (5)(12)
----------------------------------------------------------------------------------------------------------------
      B820      164   Registration application; new (2) PIP; with  15                                   204,208
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. (12)
----------------------------------------------------------------------------------------------------------------
      B840      165   Registration application; new (2) PIP; with  21                                   268,022
                       petition to establish or amend a permanent
                       tolerance/tolerance exemption of an active
                       ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B851      166   Registration application; new event of a     9                                    127,630
                       previously registered PIP active
                       ingredient(s); no petition since permanent
                       tolerance/tolerance exemption is already
                       established for the active ingredient(s).
                       (12)
----------------------------------------------------------------------------------------------------------------
      B870      167   Registration application; registered (3)     9                                     38,290
                       PIP; new product; new use; no petition
                       since a permanent tolerance/tolerance
                       exemption is already established for the
                       active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
      B880      168   Registration application; registered (3)     9                                     31,910
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
      B881      169   Registration application; registered (3)     15                                    95,724
                       PIP; new product or new terms of
                       registration; additional data submitted;
                       no petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). SAP review.
                       (5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
      B882      170   Registration application; new (2) PIP, seed  15                                   191,444
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption; SAP Review.
                       (8)(12)
----------------------------------------------------------------------------------------------------------------
      B883      171   Registration application; new (2) PIP, seed  9                                    127,630
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient based on an existing temporary
                       tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
      B884      172   Registration application; new (2) PIP, seed  12                                   159,537
                       increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
      B885      173   Registration application; registered (3)     6                                     31,910
                       PIP, seed increase; breeding stack of
                       previously approved PIPs, same crop; no
                       petition since a permanent tolerance/
                       tolerance exemption is already established
                       for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
      B886      174   Registration application; new (2) PIP, seed  18                                   223,351
              (new)    increase with negotiated acreage cap and
                       time-limited registration; with petition
                       to establish a permanent tolerance/
                       tolerance exemption for the active
                       ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------

[[Page H2205]]

 
      B890      175   Application to amend a seed increase         9                                     63,816
                       registration; converts registration to
                       commercial registration; no petition since
                       permanent tolerance/tolerance exemption is
                       already established for the active
                       ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
      B891      176   Application to amend a seed increase         15                                   127,630
                       registration; converts registration to a
                       commercial registration; no petition since
                       a permanent tolerance/tolerance exemption
                       already established for the active
                       ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
      B900      177   Application to amend a registration,         6                                     12,764
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled.
                       (10)(11)(12)
----------------------------------------------------------------------------------------------------------------
      B901      178   Application to amend a registration,         12                                    76,578
                       including actions such as extending an
                       expiration date, modifying an IRM plan, or
                       adding an insect to be controlled. SAP
                       review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
      B902      179   PIP Protocol review.                         3                                      6,383
----------------------------------------------------------------------------------------------------------------
      B903      180   Inert ingredient tolerance exemption; e.g.,  6                                     63,816
                       a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
      B904      181   Import tolerance or tolerance exemption;     9                                    127,630
                       processed commodities/food only (inert or
                       active ingredient).
----------------------------------------------------------------------------------------------------------------
      B905      182   SAP Review.                                  6                                     63,816
              (new)
----------------------------------------------------------------------------------------------------------------
      B906      183   Petition to establish a temporary tolerance/ 3                                     31,907
              (new)    tolerance exemption for one or more active
                       ingredients.
----------------------------------------------------------------------------------------------------------------
      B907      184   Petition to establish a temporary tolerance/ 3                                     12,764
              (new)    tolerance exemption for one or more active
                       ingredients based on an existing temporary
                       tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
      B908      185   Petition to establish a temporary tolerance/ 3                                     44,671
              (new)    tolerance exemption for one or more active
                       ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                        ``TABLE 18. -- INERT INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
              New  CR                                                  Decision  Review Time       Registration
  EPA  No.      No.                       Action                            (Months)(1)            Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      I001        186   Approval of new food use inert             13                                    27,000
                         ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
      I002        187   Amend currently approved inert ingredient  11                                     7,500
                         tolerance or exemption from tolerance;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I003        188   Amend currently approved inert ingredient  9                                      3,308
                         tolerance or exemption from tolerance;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I004        189   Approval of new non-food use inert         6                                     11,025
                         ingredient. (2)
----------------------------------------------------------------------------------------------------------------
      I005        190   Amend currently approved non-food use      6                                      5,513
                         inert ingredient with new use pattern;
                         new data. (2)
----------------------------------------------------------------------------------------------------------------
      I006        191   Amend currently approved non-food use      3                                      3,308
                         inert ingredient with new use pattern;
                         no new data. (2)
----------------------------------------------------------------------------------------------------------------
      I007        192   Approval of substantially similar non-     4                                      1,654
                         food use inert ingredients when original
                         inert is compositionally similar with
                         similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
      I008        193   Approval of new or amended polymer inert   5                                      3,749
                         ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
      I009        194   Approval of new or amended polymer inert   4                                      3,087
                         ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------
      I010        195   Petition to amend a single tolerance       6                                      1,654
                         exemption descriptor, or single non-food
                         use descriptor, to add  10 CASRNs; no
                         new data. (2)
----------------------------------------------------------------------------------------------------------------

[[Page H2206]]

 
      I011   196 (new)  Approval of new food use safener with      24                                   597,683
                         tolerance or exemption from tolerance.
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I012   197 (new)  Approval of new non-food use safener.      21                                   415,241
                         (2)(8)
----------------------------------------------------------------------------------------------------------------
      I013   198 (new)  Approval of additional food use for        15                                    62,975
                         previously approved safener with
                         tolerance or exemption from tolerance.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I014   199 (new)  Approval of additional non-food use for    15                                    25,168
                         previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
      I015   200 (new)  Approval of new generic data for           24                                   269,728
                         previously approved food use safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
      I016   201 (new)  Approval of amendment(s) to tolerance and  13                                    55,776
                         label for previously approved safener.
                         (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.


                            ``TABLE 19. -- EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                  FY'17 & FY'18
               New  CR                                                Decision  Review Time        Registration
  EPA  No.       No.                     Action                            (Months)(1)             Service Fee
                                                                                                       ($)
----------------------------------------------------------------------------------------------------------------
      M001         202   Study protocol requiring Human Studies  9                                        7,938
                          Review Board review as defined in 40
                          CFR Part 26 in support of an active
                          ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M002         203   Completed study requiring Human         9                                        7,938
                          Studies Review Board review as
                          defined in 40 CFR Part 26 in support
                          of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------
      M003         204   External technical peer review of new   12                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of less than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M004         205   External technical peer review of new   18                                      63,945
                          active ingredient, product, or
                          amendment (e.g., consultation with
                          FIFRA Scientific Advisory Panel) for
                          an action with a decision timeframe
                          of greater than 12 months. Applicant
                          initiated request based on a
                          requirement of the Administrator, as
                          defined by FIFRA Sec.  25(d), in
                          support of a novel active ingredient,
                          or unique use pattern or application
                          technology. Excludes PIP active
                          ingredients. (5)
----------------------------------------------------------------------------------------------------------------
      M005         206   New Product: Combination, Contains a    9                                       22,050
                          combination of active ingredients
                          from a registered and/or unregistered
                          source; conventional, antimicrobial
                          and/or biopesticide. Requires
                          coordination with other regulatory
                          divisions to conduct review of data,
                          label and/or verify the validity of
                          existing data as cited. Only existing
                          uses for each active ingredient in
                          the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
      M006         207   Request for up to 5 letters of          1                                          277
                          certification (Gold Seal) for one
                          actively registered product (excludes
                          distributor products). (8)
----------------------------------------------------------------------------------------------------------------
      M007         208   Request to extend Exclusive Use of      12                                       5,513
                          data as provided by FIFRA Section
                          3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------
      M008         209   Request to grant Exclusive Use of data  15                                       1,654
                          as provided by FIFRA Section
                          3(c)(1)(F)(vi) for a minor use, when
                          a FIFRA Section 2(ll)(2)
                          determination is required.
----------------------------------------------------------------------------------------------------------------
      M009   210 (new)   Non-FIFRA Regulated Determination:      4                                        2,363
                          Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
      M010   211 (new)   Conditional ruling on pre-application,  4                                        2,363
                          product substantial similarity.
----------------------------------------------------------------------------------------------------------------

[[Page H2207]]

 
      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.''.


  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Illinois (Mr. Rodney Davis) and the gentleman from California (Mr. 
Panetta) each will control 20 minutes.
  The Chair recognizes the gentleman from Illinois.


                             General Leave

  Mr. RODNEY DAVIS of Illinois. Madam Speaker, I ask unanimous consent 
that all Members may have 5 legislative days within which to revise and 
extend their remarks and include extraneous material on the bill under 
consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Illinois?
  There was no objection.
  Mr. RODNEY DAVIS of Illinois. Madam Speaker, I yield myself such time 
as I may consume.
  Madam Speaker, and the gentleman from California (Mr. Panetta), my 
good friend and colleague, I rise in strong support as the author of 
H.R. 1029, the Pesticide Registration Enhancement Act of 2017, also 
known as PRIA. It is not every day in Washington that we see a 
bipartisan bill come to the House floor that is supported by both 
industry and industry advocates, but PRIA is that bill, Madam Speaker.
  PRIA initially passed in 2003, establishing a new section of the 
Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, which 
put in place a fee schedule for registering pesticides with the EPA. 
More specifically, PRIA constructed time frames for when the EPA was 
required to make a determination on pesticide registrations. The goal 
of PRIA was to create a more predictable and effective evaluation 
process for pesticide decisionmaking by coupling the collection of fees 
with specific decision review periods. It also promoted shorter 
decision review periods for reduced-risk pesticides.
  The nature of PRIA is very technical, but the widespread benefits 
across industries has gained it consistent bipartisan support. PRIA is 
backed by a broad coalition comprised of the companies that rely on the 
registration process and also labor and environmental advocates. Each 
member of this broad coalition had a seat at the table when the 
Committee on Agriculture held a roundtable discussing the merits of the 
bill last month before it passed unanimously out of our House Committee 
on Agriculture.
  This reauthorization bill that we are considering also provides a few 
modifications, including reasonable increases in registration fees, 
funding for good laboratory practices, and added efforts to promote 
transparency. Although it has generally been a 5-year authorization, 
this bill would extend PRIA for 7 years. A lengthened reauthorization, 
we believe, is appropriate because PRIA has been proven effective, it 
has enjoyed widespread, bipartisan support, and to date each 
reauthorization has only involved minor adjustments.
  PRIA expires on September 30 of this year, and I am glad to be 
presenting this bill well in advance of that expiration date because we 
need to provide folks with the certainty they need to conduct their 
business, educate farmworkers, and keep the communication with EPA open 
and transparent. This is the fourth time PRIA has come before Congress 
for reauthorization, and that is because it is working for everyone. It 
has always been a bipartisan effort, and we hope to continue that 
tradition. I urge my colleagues to join me in supporting this 
commonsense reauthorization.
  Madam Speaker, I reserve the balance of my time.

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                   Washington, DC, March 16, 2017.
     Hon. K. Michael Conaway,
     Chairman, Committee on Agriculture,
     Washington, DC.
       Dear Chairman Conaway: I write in regard to H.R. 1029, 
     Pesticide Registration Enhancement Act of 2017, which was 
     referred in addition to the Committee on Energy and Commerce. 
     I wanted to notify you that the Committee will forgo action 
     on the bill so that it may proceed expeditiously to the House 
     floor for consideration.
       The Committee on Energy and Commerce takes this action with 
     our mutual understanding that by foregoing consideration of 
     H.R. 1029, the Committee does not waive any jurisdiction over 
     the subject matter contained in this or similar legislation 
     and will be appropriately consulted and involved as this or 
     similar legislation moves forward to address any remaining 
     issues within the Committee's jurisdiction. The Committee 
     also reserves the right to seek appointment of an appropriate 
     number of conferees to any House-Senate conference involving 
     this or similar legislation and asks that you support any 
     such request.
       I would appreciate your response confirming this 
     understanding with respect to H.R. 1029 and ask that a copy 
     of our exchange of letters on this matter be included in your 
     committee's report on the legislation or the Congressional 
     Record during its consideration on the House floor.
           Sincerely,
                                                      Greg Walden,
     Chairman.
                                  ____

                                         House of Representatives,


                                     Committee on Agriculture,

                                   Washington, DC, March 16, 2017.
     Greg Walden,
     Committee on Energy and Commerce,
     Washington, DC.
       Dear Chairman Walden: Thank you for your letter regarding 
     H.R. 1029, the ``Pesticide Registration Enhancement Act of 
     2017.'' I appreciate your support in bringing this 
     legislation before the House of Representatives, and 
     accordingly, understand that the Committee on Energy and 
     Commerce will forego action on the bill.
       The Committee on Agriculture concurs in the mutual 
     understanding that by foregoing consideration of the bill at 
     this time, the Committee on Energy and Commerce does not 
     waive any jurisdiction over the subject matter contained in 
     this bill or similar legislation in the future. In addition, 
     should a conference on this bill be necessary, I would 
     support your request to have the Committee on Energy and 
     Commerce represented on the conference committee.

[[Page H2208]]

       I will insert copies of this exchange in the Congressional 
     Record during Floor consideration. I appreciate your 
     cooperation regarding this legislation and look forward to 
     continuing to work the Committee on Energy and Commerce as 
     this bill moves through the legislative process.
           Sincerely,
                                               K. Michael Conaway,
                                                         Chairman.

  Mr. PANETTA. Madam Speaker, I yield myself such time as I may 
consume. I rise in support of H.R. 1029, the Pesticide Registration 
Enhancement Act of 2017.
  Once again, Madam Speaker, I stand before you to urge the passage of 
H.R. 1029. As we know, the Environmental Protection Agency is 
responsible for regulating the sale, use, and distribution of 
pesticides. To facilitate and expedite that pesticide approval process, 
pesticide manufacturers have long supplemented the EPA's annual budget. 
This system allows the products to be reviewed in a timely manner, 
without sacrificing environmental and safety protections. It is truly a 
win-win for both manufacturers and consumers, and, as you heard Mr. 
Davis speak about, it is a clear example of government at its best. It 
is exactly why I enjoy working on the Committee on Agriculture. It is 
exactly why I enjoy working with people such as Rodney Davis. We have a 
bipartisan, effective, public-private legislative solution for a more 
predictable pesticide evaluation process that literally helps 
everybody.
  The Pesticide Registration Enhancement Act, H.R. 1029, is an 
exceptional piece of legislation not only because it is supported by a 
unique coalition of pesticide registrants, environmental groups, and 
agricultural labor representatives, but H.R. 1029 provides a more 
effective, predictable, and transparent pesticide evaluation process. 
It promotes shorter review periods for reduced-risk pesticides and 
enhances scientific and regulatory activities related to farmworker 
protection.
  My district on the central coast of California is not only bountiful 
in its agriculture, it is absolutely beautiful with its environment. 
Therefore, we on the central coast work hard to find that balance of 
being known as the salad bowl of the world and one of the most scenic 
places in the world. That is why our agriculture producers are the most 
thoughtful stewards of the land and recognize the need to protect the 
environment and the natural resources.
  This legislation facilitates that balance. This legislation provides 
a unique coalition building and encourages the agriculture industry to 
work with environmentalists. Thus, H.R. 1029 helps all of us who live 
and work in our community and, ultimately, our country. That is why I 
am absolutely honored to speak in this debate, humbled to share the 
floor with Representative Davis, and why I urge all my colleagues to 
support this bill.
  Madam Speaker, I yield back the balance of my time.
  Mr. RODNEY DAVIS of Illinois. Madam Speaker, I yield myself the 
balance of my time.
  Madam Speaker, this is exactly why we are here today in a bipartisan 
way. The gentleman from California (Mr. Panetta) said it right: this 
affects his industry, and it affects his home area. As he likes to say, 
it is the salad bowl of America. I have been there, and I have seen the 
crops they grow. The crops I grow are much different in central 
Illinois, the crops that are grown by the farmers that I am proud to 
represent, but they all have to have a successful PRIA reauthorization 
to be able to grow those foods that we here in America continue to feed 
the world with and that we see in our grocery stores and on our 
supermarket shelves.
  Madam Speaker, I want to say thank you because this bill is 
essential, as we in central Illinois go out and take care of things 
such as making sure the weeds don't pop up in our yards. Every single 
small business that decides to put down product and pesticides to 
ensure that lawns in central Illinois continue to prosper as the spring 
and summer unfold, this is essential to their success.
  This is essential to our farmers, who are looking to get their fields 
ready to go plant, the stewards of the land, the best stewards of the 
land, as Congressman Panetta said. It assures them that they are going 
to be able to get that seed into the ground and, with the hope and 
prayers of rain and moisture, that it is going to grow and that we are 
still going to have a marketplace for those products.
  The risk that our farmers take every single year, when they risk and 
leverage their family incomes in many cases, in hopes that a seed is 
going to grow and a plant is going to grow, and they are going to be 
able to sell that, they need the certainty that this bill will actually 
give them. That is why I am proud to be here as the author, proud to 
stand with my colleagues.
  Madam Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Illinois (Mr. Rodney Davis) that the House suspend the 
rules and pass the bill, H.R. 1029, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________