IIB 

115TH CONGRESS 

1ST SESSION H. R. 1029 

IN THE SENATE OF THE UNITED STATES 

MARCH 21, 2017 

Received; read twice and referred to the Committee on Agriculture, Nutrition, 

and Forestry 

AN ACT 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Pesticide Registration Enhancement Act of 2017’’. 

4 (b) TABLE OF CONTENTS.—The table of contents for 

5 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. 

6 SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE 

7 FEE AUTHORITY. 

8 (a) MAINTENANCE FEE.—Section 4(i)(1) of the Fed9 eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

10 136a–1(i)(1)) is amended— 

11 (1) in subparagraph (C), by striking ‘‘an aggre12 gate amount of $27,800,000 for each of fiscal years 

13 2013 through 2017’’ and inserting ‘‘an average 

14 amount of $31,000,000 for each of fiscal years 2017 

15 through 2023’’; 

16 (2) in subparagraph (D)— 

17 (A) in clause (i), by striking ‘‘$115,500 for 

18 each of fiscal years 2013 through 2017’’ and 

19 inserting ‘‘$129,400 for each of fiscal years 

20 2017 through 2023’’; and 

21 (B) in clause (ii), by striking ‘‘$184,800 

22 for each of fiscal years 2013 through 2017’’ 


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1 and inserting ‘‘$207,000 for each of fiscal years 

2 2017 through 2023’’; 

3 (3) in subparagraph (E)(i)— 

4 (A) in subclause (I), by striking ‘‘$70,600 

5 for each of fiscal years 2013 through 2017’’ 

6 and inserting ‘‘$79,100 for each of fiscal years 

7 2017 through 2023’’; and 

8 (B) in subclause (II), by striking 

9 ‘‘$122,100 for each of fiscal years 2013 

10 through 2017’’ and inserting ‘‘$136,800 for 

11 each of fiscal years 2017 through 2023’’; and 

12 (4) in subparagraph (I), by striking ‘‘2017’’ 

13 and inserting ‘‘2023’’. 

14 (b) PROHIBITION ON OTHER FEES.—Section 4(i)(2) 

15 of the Federal Insecticide, Fungicide, and Rodenticide Act 

16 (7 U.S.C. 136a–1(i)(2)) is amended— 

17 (1) by striking ‘‘during the period beginning on 

18 the date of enactment of this section and ending on 

19 September 30, 2019’’ and inserting ‘‘until Sep20 tember 30, 2025’’; and 

21 (2) by inserting after ‘‘registration of a pes22 ticide under this Act’’ the following: ‘‘or any other 

23 action covered under a table specified in section 

24 33(b)(3),’’. 


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1 (c) EXTENSION OF PROHIBITION ON TOLERANCE

2 FEES.—Section 408(m)(3) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by 

4 striking ‘‘2017’’ and inserting ‘‘2023’’. 

5 SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING 

6 FUND. 

7 (a) AUTHORIZED USE OF FUND.—Section 4(k)(2)(A) 

8 of the Federal Insecticide, Fungicide, and Rodenticide Act 

9 (7 U.S.C. 136a–1(k)(2)(A)) is amended— 

10 (1) in the first sentence, by striking ‘‘the fund’’ 

11 and inserting ‘‘the Reregistration and Expedited 

12 Processing Fund’’; 

13 (2) by striking ‘‘paragraph (3),’’ in the first 

14 sentence and all that follows through the second sen15 tence and inserting the following: ‘‘paragraph (3), to 

16 offset the costs of registration review under section 

17 3(g), including the costs associated with any review 

18 under the Endangered Species Act of 1973 (16 

19 U.S.C. 1531 et. seq.) required as part of the reg20 istration review, to offset the costs associated with 

21 tracking and implementing registration review deci22 sions, including registration review decisions de23 signed to reduce risk, for the purposes specified in 

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1 tion systems capabilities to improve the tracking of 

2 pesticide registration decisions.’’; 

3 (3) in clause (i), by striking ‘‘are allocated sole4 ly’’ and all that follows through ‘‘3(g);’’ and insert5 ing the following: ‘‘are allocated solely for the pur6 poses specified in the first sentence of this subpara7 graph;’’; and 

8 (4) in clause (ii), by striking ‘‘necessary to 

9 achieve’’ and all that follows through ‘‘3(g);’’ and in10 serting the following: ‘‘necessary to achieve the pur11 poses specified in the first sentence of this subpara12 graph;’’. 

13 (b) SET-ASIDE FOR REVIEW OF INERT INGREDIENTS

14 AND EXPEDITED PROCESSING OF SIMILAR APPLICA15 TIONS.—Section 4(k)(3)(A) of the Federal Insecticide, 

16 Fungicide, and Rodenticide Act (7 U.S.C. 136a– 

17 1(k)(3)(A)) is amended, in the matter preceding clause (i), 

18 by striking ‘‘The Administrator shall use’’ and all that fol19 lows through ‘‘personnel and resources—’’ and inserting 

20 the following: ‘‘For each of fiscal years 2017 through 

2023, the Administrator shall use between 1⁄9 and 1 21 ⁄8 of 

22 the maintenance fees collected in such fiscal year to obtain 

23 sufficient personnel and resources—’’. 

24 (c) SET-ASIDE FOR EXPEDITED RULEMAKING AND

25 GUIDANCE DEVELOPMENT FOR CERTAIN PURPOSES.— 


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1 Paragraph (4) of section 4(k) of the Federal Insecticide, 

2 Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is 

3 amended to read as follows: 

4 ‘‘(4) EXPEDITED RULEMAKING AND GUIDANCE

5 DEVELOPMENT FOR CERTAIN PRODUCT PERFORM6 ANCE DATA REQUIREMENTS.— 

7 ‘‘(A) SET-ASIDE.—For each of fiscal years 

8 2017 through 2021, the Administrator shall use 

9 not more than $500,000 of the amounts made 

10 available to the Administrator in the Rereg11 istration and Expedited Processing Fund for 

12 the activities described in subparagraph (B). 

13 ‘‘(B) PRODUCTS CLAIMING EFFICACY

14 AGAINST INVERTEBRATE PESTS OF SIGNIFI15 CANT PUBLIC HEALTH OR ECONOMIC IMPOR16 TANCE.—The Administrator shall use amounts 

17 made available under subparagraph (A) to de18 velop, receive comments with respect to, final19 ize, and implement the necessary rulemaking 

20 and guidance for product performance data re21 quirements to evaluate products claiming effi22 cacy against the following invertebrate pests of 

23 significant public health or economic impor24 tance (in order of importance): 

25 ‘‘(i) Bed bugs. 


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1 ‘‘(ii) Premise (including crawling in2 sects, flying insects, and baits). 

3 ‘‘(iii) Pests of pets (including pet 

4 pests controlled by spot-ons, collars, sham5 poos, powders, dips). 

6 ‘‘(iv) Fire ants. 

7 ‘‘(C) DEADLINES FOR GUIDANCE.—The 

8 Administrator shall develop, and publish guid9 ance required by subparagraph (B) with respect 

10 to claims of efficacy against pests described in 

11 such subparagraph as follows: 

12 ‘‘(i) With respect to bed bugs, issue 

13 final guidance not later than June 30, 

14 2017. 

15 ‘‘(ii) With respect to pests specified in 

16 clause (ii) of such subparagraph— 

17 ‘‘(I) submit draft guidance to the 

18 Scientific Advisory Panel and for pub19 lic comment not later than June 30, 

20 2018; and 

21 ‘‘(II) complete any response to 

22 comments received with respect to 

23 such draft guidance and finalize the 

24 guidance not later than September 30, 

25 2020. 


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1 ‘‘(iii) With respect to pests specified 

2 in clauses (iii) and (iv) of such subpara3 graph— 

4 ‘‘(I) submit to the Scientific Ad5 visory Panel and for public comment 

6 draft guidance not later than June 

7 30, 2019; and 

8 ‘‘(II) complete any response to 

9 comments received with respect to 

10 such draft guidance and finalize the 

11 guidance not later than March 31, 

12 2021. 

13 ‘‘(D) REVISION.—The Administrator shall 

14 revise the guidance required by subparagraph 

15 (B) from time-to-time, but shall permit appli16 cants and registrants sufficient time to obtain 

17 data that meet the requirements specified in 

18 such revised guidance. 

19 ‘‘(E) DEADLINE FOR PRODUCT PERFORM20 ANCE DATA REQUIREMENTS.—The Adminis21 trator shall, not later than September 30, 2021, 

22 issue regulations prescribing product perform23 ance data requirements for any pesticide in24 tended for preventing, destroying, repelling, or 

25 mitigating any invertebrate pest of significant 


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1 public health or economic importance specified 

2 in clauses (i) through (iv) of subparagraph 

3 (B).’’. 

4 (d) SET-ASIDE FOR GOOD LABORATORY PRACTICES

5 INSPECTIONS.—Section 4(k) of the Federal Insecticide, 

6 Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is 

7 amended— 

8 (1) by redesignating paragraphs (5) and (6) as 

9 paragraphs (6) and (7), respectively; 

10 (2) by inserting after paragraph (4) the fol11 lowing new paragraph: 

12 ‘‘(5) GOOD LABORATORY PRACTICES INSPEC13 TIONS.— 

14 ‘‘(A) SET-ASIDE.—For each of fiscal years 

15 2017 through 2023, the Administrator shall use 

16 not more than $500,000 of the amounts made 

17 available to the Administrator in the Rereg18 istration and Expedited Processing Fund for 

19 the activities described in subparagraph (B). 

20 ‘‘(B) ACTIVITIES.—The Administrator 

21 shall use amounts made available under sub22 paragraph (A) for enhancements to the good 

23 laboratory practices standards compliance moni24 toring program established under part 160 of 

25 title 40 of the Code of Federal Regulations (or 


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1 successor regulations), with respect to labora2 tory inspections and data audits conducted in 

3 support of pesticide product registrations under 

4 this Act. As part of such monitoring program, 

5 the Administrator shall make available to each 

6 laboratory inspected under such program in 

7 support of such registrations a preliminary 

8 summary of inspection observations not later 

9 than 60 days after the date on which such an 

10 inspection is completed.’’; and 

11 (3) in paragraph (7), as so redesignated, by 

12 striking ‘‘ paragraphs (2), (3), and (4)’’ and insert13 ing ‘‘ paragraphs (2), (3), (4), and (5)’’. 

14 SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES. 

15 Section 5(a) of the Federal Insecticide, Fungicide, 

16 and Rodenticide Act (7 U.S.C. 136c(a)) is amended— 

17 (1) by striking ‘‘permit for a pesticide.’’ and in18 serting ‘‘permit for a pesticide. An application for an 

19 experimental use permit for a covered application 

20 under section 33(b) shall conform with the require21 ments of that section.’’; and 

22 (2) by inserting ‘‘(or in the case of an applica23 tion for an experimental use permit for a covered 

24 application under section 33(b), not later than the 

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1 cation specified in such section)’’ after ‘‘all required 

2 supporting data’’. 

3 SEC. 5. PESTICIDE REGISTRATION SERVICE FEES. 

4 (a) EXTENSION AND MODIFICATION OF FEE AU5 THORITY.—Section 33(b) of the Federal Insecticide, Fun6 gicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is 

7 amended— 

8 (1) in paragraph (2)— 

9 (A) in the heading, by striking ‘‘PESTICIDE

10 REGISTRATION’’; and 

11 (B) in subparagraph (A), by inserting ‘‘or 

12 for any other action covered by a table specified 

13 in paragraph (3)’’ after ‘‘covered by this Act 

14 that is received by the Administrator on or 

15 after the effective date of the Pesticide Reg16 istration Improvement Act of 2003’’; 

17 (2) in paragraph (5)— 

18 (A) in the heading, by striking ‘‘PESTICIDE

19 REGISTRATION APPLICATIONS’’ and inserting 

20 ‘‘COVERED APPLICATION’’; and 

21 (B) by striking ‘‘pesticide registration ap22 plication’’ both places it appears and inserting 

23 ‘‘covered application’’; 

24 (3) in paragraph (6)— 

25 (A) in subparagraph (A)— 


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1 (i) by striking ‘‘pesticide registra2 tion’’; and 

3 (ii) by striking ‘‘October 1, 2013, and 

4 ending on September 30, 2015’’ and in5 serting ‘‘October 1, 2019, and ending on 

6 September 30, 2021’’; 

7 (B) in subparagraph (B)— 

8 (i) by striking ‘‘pesticide registra9 tion’’; and 

10 (ii) by striking ‘‘2015’’ both places in 

11 appears, and inserting ‘‘2021’’; and 

12 (C) in subparagraph (C), by striking ‘‘re13 vised registration service fee schedules’’ and in14 serting ‘‘service fee schedules revised pursuant 

15 to this paragraph’’; 

16 (4) in paragraph (7)— 

17 (A) in subparagraph (A)— 

18 (i) by striking ‘‘covered pesticide reg19 istration’’ and inserting ‘‘covered applica20 tion’’; and 

21 (ii) by inserting before the period at 

22 the end the following: ‘‘, except that no 

23 waiver or fee reduction shall be provided in 

24 connection with a request for a letter of 


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1 certification (commonly referred to as a 

2 Gold Seal letter)’’; and 

3 (B) in subparagraph (F)(i), by striking 

4 ‘‘pesticide registration’’; and 

5 (5) in paragraph (8)— 

6 (A) in subparagraph (A), by striking ‘‘pes7 ticide registration’’; 

8 (B) in subparagraph (B)(i), by striking 

9 ‘‘pesticide registration’’; and 

10 (C) in subparagraph (C)— 

11 (i) in clause (i), by striking ‘‘pesticide 

12 registration’’ and inserting ‘‘covered’’; and 

13 (ii) in clause (ii)(I), by striking ‘‘pes14 ticide registration’’ and inserting ‘‘cov15 ered’’. 

16 (b) PESTICIDE REGISTRATION FUND SET-ASIDES

17 FOR WORKER PROTECTION, PARTNERSHIP GRANTS, AND

18 PESTICIDE SAFETY EDUCATION.—Section 33(c)(3)(B) of 

19 the Federal Insecticide, Fungicide, and Rodenticide Act 

20 (7 U.S.C. 136w–8(c)(3)(B)) is amended— 

21 (1) in the heading, by inserting ‘‘, PARTNER22 SHIP GRANTS, AND PESTICIDE SAFETY EDUCATION’’ 

23 after ‘‘WORKER PROTECTION’’; 

24 (2) in clause (i)— 


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1 (A) by striking ‘‘2017’’ and inserting 

2 ‘‘2023’’; and 

3 (B) by inserting before the period at the 

4 end the following:‘‘, with an emphasis on field5 worker populations in the United States’’; 

6 (3) in clause (ii), by striking ‘‘2017’’ and in7 serting ‘‘2023’’; and 

8 (4) in clause (iii), by striking ‘‘2017’’ and in9 serting ‘‘2023’’. 

10 (c) REFORMS TO REDUCE DECISION TIME REVIEW

11 PERIODS.—Section 33(e) of the Federal Insecticide, Fun12 gicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is 

13 amended— 

14 (1) by striking ‘‘Pesticide Registration Improve15 ment Extension Act of 2012’’ and inserting ‘‘Pes16 ticide Registration Enhancement Act of 2017’’; and 

17 (2) by inserting at the end the following new 

18 sentence: ‘‘Such reforms shall include identifying op19 portunities for streamlining review processes for ap20 plications for a new active ingredient or a new use 

21 and providing prompt feedback to applicants during 

22 such review process.’’. 

23 (d) DECISION TIME REVIEW PERIODS.—Section 

24 33(f) of the Federal Insecticide, Fungicide, and 

25 Rodenticide Act (7 U.S.C. 136w–8(f)(1)) is amended— 


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1 (1) in paragraph (1)— 

2 (A) by striking ‘‘Pesticide Registration Im3 provement Extension Act of 2012’’ and insert4 ing ‘‘Pesticide Registration Enhancement Act of 

5 2017’’; and 

6 (B) by inserting after ‘‘covered pesticide 

7 registration actions’’ the following: ‘‘or for any 

8 other action covered by a table specified in sub9 section (b)(3)’’; 

10 (2) in paragraph (3), by striking subparagraph 

11 (C) and inserting the following new subparagraph: 

12 ‘‘(C) applications for any other action cov13 ered by a table specified in subsection (b)(3).’’; 

14 and 

15 (3) in paragraph (4)(A)— 

16 (A) by striking ‘‘a pesticide registration 

17 application’’ and inserting ‘‘a covered applica18 tion’’; and 

19 (B) by striking ‘‘covered pesticide registra20 tion application’’ and inserting ‘‘covered appli21 cation’’. 

22 (e) REPORTING REQUIREMENTS.—Section 33(k) of 

23 the Federal Insecticide, Fungicide, and Rodenticide Act 

24 (7 U.S.C. 136w–8(k)) is amended— 


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1 (1) in paragraph (1) by striking ‘‘2017’’ and in2 serting ‘‘2023’’; and 

3 (2) in paragraph (2)— 

4 (A) in subparagraph (D), by striking 

5 clause (i) and inserting the following new 

6 clause: 

7 ‘‘(i) the number of pesticides or pes8 ticide cases reviewed and the number of 

9 registration review decisions completed, in10 cluding— 

11 ‘‘(I) the number of cases can12 celled; 

13 ‘‘(II) the number of cases requir14 ing risk mitigation measures; 

15 ‘‘(III) the number of cases re16 moving risk mitigation measures; 

17 ‘‘(IV) the number of cases with 

18 no risk mitigation needed; and 

19 ‘‘(V) the number of cases in 

20 which risk mitigation has been fully 

21 implemented;’’; 

22 (B) in subparagraph (G)— 

23 (i) in clause (i)— 


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1 (I) by striking ‘‘section 4(k)(4)’’ 

2 and inserting ‘‘paragraphs (4) and (5) 

3 of section 4(k)’’; and 

4 (II) by striking ‘‘that section’’ 

5 and inserting ‘‘such paragraphs’’; 

6 (ii) by striking clauses (ii), (iii), (iv), 

7 (v), and (vi); 

8 (iii) by inserting after clause (i) the 

9 following new clause: 

10 ‘‘(ii) implementing enhancements to— 

11 ‘‘(I) the electronic tracking of 

12 covered applications; 

13 ‘‘(II) the electronic tracking of 

14 conditional registrations; 

15 ‘‘(III) the endangered species 

16 database; 

17 ‘‘(IV) the electronic review of la18 bels submitted with covered applica19 tions; and 

20 ‘‘(V) the electronic review and as21 sessment of confidential statements of 

22 formula submitted with covered appli23 cations; and’’; and 

24 (iv) by redesignating clause (vii) as 

25 clause (iii); 


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1 (C) in subparagraph (I), by striking ‘‘and’’ 

2 at the end; 

3 (D) in subparagraph (J), by striking the 

4 period at the end and inserting a semicolon; 

5 and 

6 (E) by adding at the end the following new 

7 subparagraphs: 

8 ‘‘(K) a review of the progress made in de9 veloping, updating, and implementing product 

10 performance test guidelines for pesticide prod11 ucts that are intended to control invertebrate 

12 pests of significant public health importance 

13 and, by regulation, prescribing product per14 formance data requirements for such pesticide 

15 products registered under section 3; 

16 ‘‘(L) a review of the progress made in the 

17 priority review and approval of new pesticides 

18 to control vector-born public health pests for 

19 use in the United States, including each terri20 tory or possession of the United States, and 

21 United States military installations globally; 

22 ‘‘(M) a review of the progress made in im23 plementing enhancements to the good labora24 tory practices standards compliance monitoring 

25 program established under part 160 of title 40 


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1 of the Code of Federal Regulations (or suc2 cessor regulations); 

3 ‘‘(N) the number of approvals for active 

4 ingredients, new uses, and pesticide end use 

5 products granted in connection with the Design 

6 for the Environment program (or any successor 

7 program) of the Environmental Protection 

8 Agency; and 

9 ‘‘(O) with respect to funds in the Pesticide 

10 Registration Fund reserved under subsection 

11 (c)(3), a review that includes— 

12 ‘‘(i) a description of the amount and 

13 use of such funds— 

14 ‘‘(I) to carry out activities relat15 ing to worker protection under clause 

16 (i) of subsection (c)(3)(B); 

17 ‘‘(II) to award partnership grants 

18 under clause (ii) of such subsection; 

19 and 

20 ‘‘(III) to carry out the pesticide 

21 safety education program under 

22 clause (iii) of such subsection; 

23 ‘‘(ii) an evaluation of the appropriate24 ness and effectiveness of the activities, 


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1 grants, and program described in clause 

2 (i); 

3 ‘‘(iii) a description of how stake4 holders are engaged in the decision to fund 

5 such activities, grants, and program; and 

6 ‘‘(iv) with respect to activities relating 

7 to worker protection carried out under sub8 paragraph (B)(i) of such subsection, a 

9 summary of the analyses from stake10 holders, including from worker community11 based organizations, on the appropriate12 ness and effectiveness of such activities.’’. 

13 (f) TERMINATION OF EFFECTIVENESS.—Section 

14 33(m) of the Federal Insecticide, Fungicide, and 

15 Rodenticide Act (7 U.S.C. 136w–8(m)) is amended— 

16 (1) in paragraph (1), by striking ‘‘2017’’ and 

17 inserting ‘‘2023’’; and 

18 (2) in paragraph (2)— 

19 (A) in subparagraph (A)— 

20 (i) by striking ‘‘FISCAL YEAR 2018.— 

21 During fiscal year 2018’’ and inserting 

22 ‘‘FISCAL YEAR 2024.—During fiscal year 

23 2024’’; and 

24 (ii) by striking ‘‘2017’’ and inserting 

25 ‘‘2023’’; 


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1 (B) in subparagraph (B)— 

2 (i) by striking ‘‘FISCAL YEAR 2019.— 

3 During fiscal year 2019’’ and inserting 

4 ‘‘FISCAL YEAR 2025.—During fiscal year 

5 2025’’; and 

6 (ii) by striking ‘‘2017’’ and inserting 

7 ‘‘2023’’; 

8 (C) in subparagraph (C), by striking ‘‘SEP9 TEMBER 30, 2019.—Effective September 30, 

10 2019’’ and inserting ‘‘SEPTEMBER 30, 2025.— 

11 Effective September 30, 2025’’; and 

12 (D) in subparagraph (D), by striking 

13 ‘‘2017’’ both places it appears and inserting 

14 ‘‘2023’’. 

15 SEC. 6. REVISION OF TABLES REGARDING COVERED PES16 TICIDE REGISTRATION APPLICATIONS AND 

17 OTHER COVERED ACTIONS AND THEIR COR18 RESPONDING REGISTRATION SERVICE FEES. 

19 Paragraph (3) of section 33(b) of the Federal Insecti20 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136w– 

21 8(b)) is amended to read as follows: 

22 ‘‘(3) SCHEDULE OF COVERED APPLICATIONS

23 AND OTHER ACTIONS AND THEIR REGISTRATION

24 SERVICE FEES.—Subject to paragraph (6), the 

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1 ered actions and their corresponding registration 

2 service fees shall be as follows: 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R010 1 New Active Ingredient, Food 

use. (2)(3) 

24 753,082 

R020 2 New Active Ingredient, Food 

use; reduced 

risk. (2)(3) 

18 627,568 

R040 3 New Active Ingredient, Food 

use; Experimental Use 

Permit application; establish temporary 

tolerance; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

18 462,502 

R060 4 New Active Ingredient, Nonfood use; outdoor. (2)(3) 21 523,205 

R070 5 New Active Ingredient, Nonfood use; outdoor; reduced 

risk. (2)(3) 

16 436,004 


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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R090 6 New Active Ingredient, Nonfood use; outdoor; Experimental Use 

Permit application; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

16 323,690 

R110 7 New Active Ingredient, Nonfood use; indoor. (2)(3) 20 290,994 

R120 8 New Active Ingredient, Nonfood use; indoor; reduced 

risk. (2)(3) 

14 242,495 

R121 9 New Active Ingredient, Nonfood use; indoor; Experimental Use 

Permit application; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

18 182,327 


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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R122 10 Enriched isomer(s) of registered mixedisomer active 

ingredient. 

(2)(3) 

18 317,128 

R123 11 New Active Ingredient, Seed 

treatment 

only; includes 

agricultural 

and non-agricultural seeds; 

residues not 

expected in 

raw agricultural commodities. (2)(3) 

18 471,861 

R125 12 New Active Ingredient, Seed 

treatment; Experimental 

Use Permit 

application; 

submitted before application for registration; credit 45% of fee 

toward new 

active ingredient application that follows. (3) 

16 323,690 

(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. 


sradovich on DSK3GMQ082PROD with BILLS
25 

HR 1029 RFS 

(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R130 13 First food use; 

indoor; food/ 

food handling. 

(2) (3) 

21 191,444 

R140 14 Additional food 

use; Indoor; 

food/food handling. (3) (4) 

15 44,672 

R150 15 First food use. 

(2)(3) 

21 317,104 


sradovich on DSK3GMQ082PROD with BILLS
26 

HR 1029 RFS 

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R155 16 (new) First food use, 

Experimental 

Use Permit application; a.i. 

registered for 

non-food outdoor use. 

(3)(4) 

21 264,253 

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 crop 

group resulting 

from the conversion of existing approved 

crop group(s) 

to one or more 

revised crop 

groups. (3)(4) 

10 66,124 

R180 20 Additional food 

use; reduced 

risk. (3)(4) 

10 66,124 

R190 21 Additional food 

uses; 6 or 

more submitted in one 

application. 

(3)(4) 

15 476,090 

R200 22 Additional Food 

Use; 6 or more 

submitted in 

one application; Reduced 

Risk. (3)(4) 

10 396,742 


sradovich on DSK3GMQ082PROD with BILLS
27 

HR 1029 RFS 

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R210 23 Additional food 

use; Experimental Use 

Permit application; establish 

temporary tolerance; no 

credit toward 

new use registration. 

(3)(4) 

12 48,986 

R220 24 Additional food 

use; Experimental Use 

Permit application; crop destruct basis; no 

credit toward 

new use registration. 

(3)(4) 

6 19,838 

R230 25 Additional use; 

non-food; outdoor. (3) (4) 

15 31,713 

R240 26 Additional use; 

non-food; outdoor; reduced 

risk. (3)(4) 

10 26,427 

R250 27 Additional use; 

non-food; outdoor; Experimental Use 

Permit application; no credit 

toward new 

use registration. (3)(4) 

6 19,838 


sradovich on DSK3GMQ082PROD with BILLS
28 

HR 1029 RFS 

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R251 28 Experimental 

Use Permit application which 

requires no 

changes to the 

tolerance(s); 

non-crop destruct basis. 

(3) 

8 19,838 

R260 29 New use; nonfood; indoor. 

(3) (4) 

12 15,317 

R270 30 New use; nonfood; indoor; 

reduced risk. 

(3)(4) 

9 12,764 

R271 31 New use; nonfood; indoor; 

Experimental 

Use Permit application; no 

credit toward 

new use registration. 

(3)(4) 

6 9,725 

R273 32 Additional use; 

seed treatment; 

limited uptake 

into Raw Agricultural Commodities; includes crops 

with established tolerances (e.g., for 

soil or foliar 

application); 

includes food 

and/or nonfood uses. 

(3)(4) 

12 50,445 


sradovich on DSK3GMQ082PROD with BILLS
29 

HR 1029 RFS 

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R274 33 Additional uses; 

seed treatment 

only; 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 nonfood uses. 

(3)(4) 

12 302,663 

(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. 


sradovich on DSK3GMQ082PROD with BILLS
30 

HR 1029 RFS 

(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R280 34 Establish import 

tolerance; new 

active ingredient or first 

food use. (2) 

21 319,072 

R290 35 Establish Import 

tolerance; Additional new 

food use. 

15 63,816 


sradovich on DSK3GMQ082PROD with BILLS
31 

HR 1029 RFS 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R291 36 Establish import 

tolerances; additional food 

uses; 6 or 

more crops 

submitted in 

one petition. 

15 382,886 

R292 37 Amend an established tolerance 

(e.g., decrease 

or increase) 

and/or harmonize established tolerances with 

Codex MRLs; 

domestic or 

import; applicant-initiated. 

11 45,341 

R293 38 Establish tolerance(s) for inadvertent residues in one 

crop; applicant-initiated. 

12 53,483 

R294 39 Establish tolerances for inadvertent residues; 6 or 

more crops 

submitted in 

one application; applicantinitiated. 

12 320,894 


sradovich on DSK3GMQ082PROD with BILLS
32 

HR 1029 RFS 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R295 40 Establish tolerance(s) for residues in one 

rotational crop 

in response to 

a specific rotational crop application; submission of corresponding 

label amendments which 

specify the necessary plantback restrictions; applicant-initiated. 

(3) (4) 

15 66,124 

R296 41 Establish tolerances for residues in 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 plantback restrictions; applicant-initiated. 

(3) (4) 

15 396,742 


sradovich on DSK3GMQ082PROD with BILLS
33 

HR 1029 RFS 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R297 42 Amend 6 or more 

established tolerances (e.g., 

decrease or increase) in one 

petition; domestic or import; applicantinitiated. 

11 272,037 

R298 43 Amend an established tolerance 

(e.g., decrease 

or increase); 

domestic or 

import; submission of corresponding 

amended labels 

(requiring 

science review). 

(3) (4) 

13 58,565 

R299 44 Amend 6 or more 

established tolerances (e.g., 

decrease or increase); domestic or import; 

submission of 

corresponding 

amended labels 

(requiring 

science review). 

(3) (4) 

13 285,261 

(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. 


sradovich on DSK3GMQ082PROD with BILLS
34 

HR 1029 RFS 

(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. 


sradovich on DSK3GMQ082PROD with BILLS
35 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R300 45 New product; or 

similar 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; citeall 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) 

4 1,582 


sradovich on DSK3GMQ082PROD with BILLS
36 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R301 46 New product; or 

similar 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) 

4 1,897 


sradovich on DSK3GMQ082PROD with BILLS
37 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R310 47 New end-use or 

manufacturinguse 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) 

7 7,301 


sradovich on DSK3GMQ082PROD with BILLS
38 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R314 48 New end use product containing 

up 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) 

8 8,626 


sradovich on DSK3GMQ082PROD with BILLS
39 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R319 49 New end use product containing 

up 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) 

10 12,626 


sradovich on DSK3GMQ082PROD with BILLS
40 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R318 50 (new) New end use product containing 

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) 

9 13,252 


sradovich on DSK3GMQ082PROD with BILLS
41 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R321 51 (new) New end use product containing 

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) 

11 17,252 


sradovich on DSK3GMQ082PROD with BILLS
42 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R315 52 New end-use, onanimal product, 

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) 

9 9,820 


sradovich on DSK3GMQ082PROD with BILLS
43 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R316 53 (new) New end-use or 

manufacturing 

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) 

9 11,301 


sradovich on DSK3GMQ082PROD with BILLS
44 

HR 1029 RFS 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R317 54 (new) New end-use or 

manufacturing 

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) 

10 15,301 

R320 55 New product; new 

physical form; 

requires data 

review in 

science divisions. (2)(3) 

12 13,226 


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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R331 56 New product; repack of identical 

registered enduse product as a 

manufacturinguse product, or 

identical registered manufacturing-use 

product as an 

end use product; same registered uses 

only. (2)(3) 

3 2,530 

R332 57 New manufacturing-use product; 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) 

24 283,215 


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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R333 58 New product; 

MUP or End 

use 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) 

10 19,838 

R334 59 New product; 

MUP or End 

use product 

with unregistered source of 

the active ingredient; requires 

science data review; new physical form; etc. 

Selective data 

citation. (2)(3) 

11 23,100 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R340 60 Amendment requiring 

data review within 

RD (e.g., changes 

to precautionary 

label statements); 

includes adding/ 

modifying pest(s) 

claims for up to 2 

target pests, excludes products requiring or citing an 

animal safety 

study. (2)(3)(4) 

4 4,988 


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‘‘TABLE 5. — REGISTRATION DIVISION — 

AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R341 61 

(New) 

Amendment requiring 

data review within 

RD (e.g., changes 

to precautionary 

label statements), 

includes adding/ 

modifying pest(s) 

claims for greater 

than 2 target 

pests, excludes 

products requiring 

or citing an animal 

safety study. 

(2)(3)(4) 

6 5,988 

R345 62 Amending on-animal 

products previously 

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) 

7 8,820 

R350 63 Amendment requiring 

data review in 

science divisions 

(e.g., changes to 

REI, or PPE, or 

PHI, or use rate, 

or number of applications; or add aerial application; or 

modify GW/SW advisory statement). 

(2)(3) 

9 13,226 


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‘‘TABLE 5. — REGISTRATION DIVISION — 

AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R351 64 Amendment adding a 

new unregistered 

source of active ingredient. (2)(3) 

8 13,226 

R352 65 Amendment adding 

already approved 

uses; selective 

method of support; 

does not apply if 

the applicant owns 

all cited data. (2) 

(3) 

8 13,226 

R371 66 Amendment to Experimental Use 

Permit; (does not 

include extending a 

permit’s time period). (3) 

6 10,090 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

R124 67 Conditional Ruling on Pre-application Study 

Waivers; applicant-initiated. 

6 2,530 

R272 68 Review of Study 

Protocol applicant-initiated; 

excludes 

DART, pre-registration conference, Rapid 

Response review, DNT protocol review, 

protocol needing HSRB review. 

3 2,530 

R275 69 Rebuttal of agency reviewed 

protocol, applicant initiated. 

3 2,530 

R370 70 Cancer reassessment; applicant-initiated. 18 198,250 

(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. 


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‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW 

ACTIVE INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A380 71 New Active Ingredient; Indirect 

Food use; establish tolerance 

or tolerance exemption if required. (2)(3) 

24 137,841 

A390 72 New Active Ingredient; Direct 

Food use; establish tolerance 

or tolerance exemption if required. (2)(3) 

24 229,733 

A410 73 New Active Ingredient Non-food 

use.(2)(3) 

21 229,733 

A431 74 New Active Ingredient, Non-food 

use; low-risk. 

(2)(3) 

12 80,225 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A440 75 New Use, Indirect Food 

Use, establish tolerance 

or tolerance 

exemption. 

(2)(3)(4) 

21 31,910 

A441 76 Additional Indirect food 

uses; establish tolerances or tolerance exemptions if 

required; 6 

or more submitted in one 

application. 

(3)(4)(5) 

21 114,870 

A450 77 New use, Direct food 

use, establish 

tolerance or 

tolerance exemption. 

(2)(3)(4) 

21 95,724 


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‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW 

USES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A451 78 Additional Direct food 

uses; establish tolerances or tolerance exemptions if 

required; 6 

or more submitted in one 

application. 

(3)(4)(5) 

21 182,335 

A500 79 New use, nonfood. (4)(5) 12 31,910 

A501 80 New use, nonfood; 6 or 

more submitted in one 

application. 

(4)(5) 

15 76,583 

(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. 


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(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. 


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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A530 81 New product, 

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 applicant 

submits specific authorization letter 

from data 

owner. Category also includes 100% 

re-package of 

registered enduse or manufacturing use 

product that 

requires no 

data submission nor data 

matrix. (2)(3) 

4 1,278 


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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A531 82 New product; 

identical or 

substantially 

similar in 

composition 

and use to a 

registered 

product; registered source 

of active ingredient: selective data citation only for 

data on product chemistry 

and/or acute 

toxicity and/or 

public health 

pest efficacy, 

where applicant does not 

own all required data 

and does not 

have a specific 

authorization 

letter from 

data owner. 

(2)(3) 

4 1,824 


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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A532 83 New product; 

identical or 

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) 

5 5,107 

A540 84 New end use 

product; 

FIFRA 

§2(mm) uses 

only; up to 25 

public health 

organisms. 

(2)(3)(5)(6) 

5 5,107 

A541 85 (new) New end use 

product; 

FIFRA 

§2(mm) uses 

only; 26-50 

public health 

organisms. 

(2)(3)(5)(6) 

7 8,500 


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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A542 86 (new) New end use 

product; 

FIFRA 

§2(mm) uses 

only; ≥ 51 

public health 

organisms. 

(2)(3)(5) 

10 15,000 

A550 87 New end-use 

product; uses 

other than 

FIFRA 

§2(mm); nonFQPA product. (2)(3)(5) 

9 13,226 

A560 88 New manufacturing use 

product; registered active 

ingredient; selective data citation. (2)(3) 

6 12,596 

A565 89 (new) New manufacturing-use 

product; registered active 

ingredient; unregistered 

source of active ingredient; submission of new 

generic data 

package; registered uses 

only; requires 

science review. 

(2)(3) 

12 18,234 


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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A570 90 Label amendment requiring 

data review; 

up to 25 public health organisms. 

(3)(4)(5)(6) 

4 3,831 

A573 91 (new) Label amendment requiring 

data review; 

26-50 public 

health organisms. 

(2)(3)(5)(7) 

6 6,350 

A574 92 (new) Label amendment requiring 

data review; ≥ 

51 public 

health organisms. 

(2)(3)(5)(7) 

9 11,000 

A572 93 New Product or 

amendment 

requiring data 

review for risk 

assessment by 

Science 

Branch (e.g., 

changes to 

REI, or PPE, 

or use rate). 

(2)(3)(4) 

9 13,226 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A520 94 Experimental 

Use Permit 

application, 

non-food use. 

(2) 

9 6,383 


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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A521 95 Review of public 

health efficacy 

study 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. 

4 4,726 

A522 96 Review of public 

health efficacy 

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. 

12 12,156 


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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A537 97 (new) New Active Ingredient/New 

Use, 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. 

18 153,156 

A538 98 (new) New Active Ingredient/New 

Use, 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. 

18 95,724 


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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A539 99 (new) New Active Ingredient/New 

Use, Experimental Use 

Permit application; 

Nonfood use. 

Credit 45% of 

fee toward 

new active ingredient/new 

use application 

that follows. 

15 92,163 

A529 100 Amendment to 

Experimental 

Use Permit; 

requires data 

review or risk 

assessment. 

(2) 

9 11,429 

A523 101 Review of protocol other 

than a public 

health efficacy 

study (i.e., 

Toxicology or 

Exposure Protocols). 

9 12,156 

A571 102 Science reassessment: Cancer 

risk, refined 

ecological risk, 

and/or endangered species; 

applicant-initiated. 

18 95,724 


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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

A533 103 (new) Exemption from 

the requirement of an 

Experimental 

Use Permit. 

(2) 

4 2,482 

A534 104 (new) Rebuttal of 

agency reviewed protocol, applicant initiated. 

4 4,726 

A535 105 (new) Conditional Ruling on Pre-application 

Study Waiver 

or Data 

Bridging Argument; applicant-initiated. 

6 2,409 

A536 106 (new) Conditional Ruling on Pre-application Direct Food, Indirect Food, 

Nonfood use 

determination; 

applicant-initiated. 

4 2,482 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B580 107 New active ingredient; food 

use; petition to 

establish a tolerance. (2)(3) 

20 51,053 

B590 108 New active ingredient; food 

use; petition to 

establish a tolerance exemption. (2)(3) 

18 31,910 

B600 109 New active ingredient; nonfood use. 

(2)(3) 

13 19,146 

B610 110 New active ingredient; Experimental 

Use Permit 

application; 

petition to establish a temporary tolerance or temporary tolerance exemption. (3) 

10 12,764 


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‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B611 111 New active ingredient; Experimental 

Use Permit 

application; 

petition to establish permanent tolerance 

exemption. (3) 

12 12,764 

B612 112 New active ingredient; no 

change to a 

permanent tolerance exemption. (2)(3) 

10 17,550 

B613 113 New active ingredient; petition to convert 

a temporary 

tolerance or a 

temporary tolerance exemption to a permanent tolerance or tolerance exemption. (2)(3) 

11 17,550 

B620 114 New active ingredient; Experimental 

Use Permit 

application; 

non-food use 

including crop 

destruct. (3) 

7 6,383 

(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. 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B630 115 First food use; 

petition to establish a tolerance exemption. (2)(4) 

13 12,764 

B631 116 New food use; 

petition to 

amend an established tolerance. (3)(4) 

12 12,764 


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‘‘TABLE 12. — BIOPESTICIDES DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B640 117 First food use; 

petition to establish a tolerance. (2)(4) 

19 19,146 

B643 118 New Food use; 

petition to 

amend an established tolerance exemption. (3)(4) 

10 12,764 

B642 119 First food use; 

indoor; food/ 

food handling. 

(2)(4) 

12 31,910 

B644 120 New use, no 

change to an 

established tolerance or tolerance exemption. (3)(4) 

8 12,764 

B650 121 New use; nonfood. (3)(4) 7 6,383 

B645 122 (new) New food use; 

Experimental 

Use Permit 

application; 

petition to 

amend or add 

a tolerance exemption. (4) 

12 12,764 

B646 123 (new) New use; nonfood use including crop 

destruct; Experimental 

Use Permit 

application. 

(4) 

7 6,383 

(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. 


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(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. 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B652 124 New product; registered source of 

active ingredient; requires 

petition to 

amend established tolerance 

or tolerance exemption; requires 1) submission of product specific 

data; or 2) citation of previously reviewed 

and accepted 

data; or 3) submission or citation of data 

generated at 

government expense; or 4) 

submission or 

citation of scientifically-sound 

rationale based 

on publicly 

available literature or other 

relevant information that addresses the data 

requirement; or 

5) submission of 

a request for a 

data requirement to be 

waived supported by a scientifically-sound 

rationale explaining why the 

data requirement does not 

apply. (2)(3) 

13 12,764 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B660 125 New product; registered source of 

active ingredient(s); identical or substantially similar in 

composition and 

use to a registered product. 

No data review, 

or only product 

chemistry data; 

cite-all data citation, or selective data citation where applicant owns all 

required data or 

authorization 

from data owner 

is demonstrated. 

Category includes 100% repackage 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) 

4 1,278 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B670 126 New product; registered source of 

active ingredient(s); requires: 1) submission of product specific 

data; or 2) citation of previously reviewed 

and accepted 

data; or 3) submission or citation of data 

generated at 

government expense; or 4) 

submission or 

citation of a scientifically-sound 

rationale based 

on publicly 

available literature or other 

relevant information that addresses the data 

requirement; or 

5) submission of 

a request for a 

data requirement to be 

waived supported by a scientifically-sound 

rationale explaining why the 

data requirement does not 

apply. (2)(3) 

7 5,107 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B671 127 New product; unregistered 

source of 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) 

17 12,764 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B672 128 New product; unregistered 

source of 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) 

13 9,118 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B673 129 New product 

MUP/EP; unregistered 

source of active 

ingredient(s); citation of Technical Grade Active Ingredient 

(TGAI) data 

previously reviewed and accepted by the 

Agency. Requires an Agency determination that the 

cited data supports the new 

product. (2)(3) 

10 5,107 

B674 130 New product 

MUP; Repack 

of identical registered end-use 

product as a 

manufacturinguse product; 

same registered 

uses only. (2)(3) 

4 1,278 

B675 131 New Product 

MUP; registered 

source of active 

ingredient; submission of completely new generic data package; registered 

uses only. (2)(3) 

10 9,118 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B676 132 New product; 

more than one 

active 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) 

13 9,118 


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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B677 133 New end-use nonfood animal 

product with 

submission of 

two or more target animal safety studies; includes data and/ 

or waivers of 

data for only: 

∑ product chemistry and/or 

∑ acute toxicity 

and/or 

∑ public health 

pest efficacy 

and/or 

∑ animal safety 

studies and/or 

∑ child resistant 

packaging. 

(2)(3) 

10 8,820 

(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. 


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‘‘TABLE 14. — BIOPESTICIDES DIVISION — 

AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 

Registration 

Service 

Fee 

($) 

B621 134 Amendment; Experimental 

Use Permit; no change to 

an established temporary 

tolerance or tolerance exemption. (3) 

7 5,107 

B622 135 Amendment; Experimental 

Use Permit; petition to 

amend an established or 

temporary tolerance or tolerance exemption. (3) 

11 12,764 

B641 136 Amendment of an established 

tolerance or tolerance exemption. 

13 12,764 

B680 137 Amendment; registered 

sources of active ingredient(s); no new use(s); no 

changes to an established 

tolerance or tolerance exemption. Requires data submission. (2)(3) 

5 5,107 

B681 138 Amendment; unregistered 

source of active ingredient(s). Requires data submission. (2)(3) 

7 6,079 

B683 139 Label amendment; requires review/update of previous risk 

assessment(s) without data 

submission (e.g., labeling 

changes to REI, PPE, 

PHI). (2)(3) 

6 5,107 

B684 140 Amending non-food animal 

product that includes submission of target animal 

safety data; previously registered. (2)(3) 

8 8,820 

B685 141 (new) Amendment; add a new biochemical 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) 

5 5,107 

(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. 


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(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrantinitiated 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 Agencystamped label to the registrant within 2 business days following the registrant’s written or electronic 

confirmation of agreement to the Agency. 

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B690 142 New active ingredient; food 

or non-food 

use. (2)(6) 

7 2,554 

B700 143 Experimental 

Use Permit 

application; 

new active ingredient or 

new use. (6) 

7 1,278 

B701 144 Extend or amend 

Experimental 

Use Permit. 

(6) 

4 1,278 


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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B710 145 New product; 

registered 

source of 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 enduse or manufacturing-use 

product that 

requires no 

data submission or data 

matrix. (3)(6) 

4 1,278 


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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B720 146 New product; 

registered 

source of 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 

scientificallysound 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 

scientificallysound rationale explaining 

why the data 

requirement 

does not 

apply. (3)(6) 

5 1,278 


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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B721 147 New product; 

unregistered 

source of active ingredient. (3)(6) 

7 2,676 

B722 148 New use and/or 

amendment; 

petition to establish a tolerance or tolerance exemption. (4)(5)(6) 

7 2,477 

B730 149 Label amendment requiring 

data submission. (4)(6) 

5 1,278 

(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. 


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(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. 


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‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 

ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B614 150 Pre-application; 

Conditional 

Ruling on rationales for 

addressing a 

data requirement in lieu of 

data; applicant-initiated; 

applies to one 

rationale at a 

time. 

3 2,530 

B615 151 Rebuttal of 

agency reviewed protocol, applicant initiated. 

3 2,530 

B682 152 Protocol review; 

applicant initiated; excludes 

time for 

HSRB review. 

3 2,432 

(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. 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B740 153 Experimental Use 

Permit application; no 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) 

6 95,724 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B741 154 

(new) 

Experimental Use 

Permit application; no 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) 

12 159,538 

B750 155 Experimental Use 

Permit application; with a petition to establish a 

temporary or permanent tolerance/ 

tolerance exemption for the active 

ingredient. Includes new food/ 

feed use for a 

registered (3) 

PIP. (4)(12) 

9 127,630 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B770 156 Experimental Use 

Permit application; new (2) PIP; 

with petition to 

establish a temporary tolerance/ 

tolerance exemption for the active 

ingredient; credit 

75% of B771 fee 

toward registration application 

for a new active 

ingredient that 

follows; SAP review. (5)(12) 

15 191,444 

B771 157 Experimental Use 

Permit application; new (2) PIP; 

with petition to 

establish a temporary tolerance/ 

tolerance exemption for the active 

ingredient; credit 

75% of B771 fee 

toward registration application 

for a new active 

ingredient that 

follows. (12) 

10 127,630 

B772 158 Application to 

amend or extend 

an Experimental 

Use Permit; no 

petition since the 

established tolerance/tolerance exemption for the 

active ingredient 

is unaffected. 

(12) 

3 12,764 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B773 159 Application to 

amend or extend 

an Experimental 

Use Permit; with 

petition to extend 

a temporary tolerance/tolerance exemption for the 

active ingredient. 

(12) 

5 31,910 

B780 160 Registration application; new (2) PIP; 

non-food/feed. 

(12) 

12 159,537 

B790 161 Registration application; new (2) PIP; 

non-food/feed; 

SAP review. 

(5)(12) 

18 223,351 

B800 162 Registration application; new (2) PIP; 

with petition to 

establish permanent tolerance/tolerance exemption 

for the active ingredient based on 

an existing temporary tolerance/ 

tolerance exemption. (12) 

13 172,300 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B810 163 Registration application; new (2) PIP; 

with petition to 

establish permanent tolerance/tolerance exemption 

for the active ingredient based on 

an existing temporary tolerance/ 

tolerance exemption. SAP review. 

(5)(12) 

19 236,114 

B820 164 Registration application; new (2) PIP; 

with petition to 

establish or 

amend a permanent tolerance/tolerance exemption 

of an active ingredient. (12) 

15 204,208 

B840 165 Registration application; new (2) PIP; 

with petition to 

establish or 

amend a permanent tolerance/tolerance exemption 

of an active ingredient. SAP review. (5)(12) 

21 268,022 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B851 166 Registration application; new event of 

a previously registered PIP active 

ingredient(s); no 

petition since permanent tolerance/ 

tolerance exemption is already established for the 

active ingredient(s). (12) 

9 127,630 

B870 167 Registration application; registered 

(3) PIP; new 

product; new use; 

no petition since a 

permanent tolerance/tolerance exemption is already 

established for 

the active ingredient(s). (4) (12) 

9 38,290 

B880 168 Registration application; registered 

(3) PIP; new 

product or new 

terms of registration; additional 

data submitted; 

no petition since a 

permanent tolerance/tolerance exemption is already 

established for 

the active ingredient(s). (6) (7) 

(12) 

9 31,910 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B881 169 Registration application; registered 

(3) PIP; new 

product or new 

terms of registration; additional 

data submitted; 

no petition since a 

permanent tolerance/tolerance exemption is already 

established for 

the active ingredient(s). SAP review. 

(5)(6)(7)(12) 

15 95,724 

B882 170 

(new) 

Registration application; new (2) PIP, 

seed increase with 

negotiated acreage cap and timelimited 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) 

15 191,444 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B883 171 Registration application; new (2) PIP, 

seed increase with 

negotiated acreage cap and timelimited registration; with petition 

to establish a permanent tolerance/ 

tolerance exemption for the active 

ingredient based 

on an existing 

temporary tolerance/tolerance exemption. (8) (12) 

9 127,630 

B884 172 Registration application; new (2) PIP, 

seed increase with 

negotiated acreage cap and timelimited registration; with petition 

to establish a permanent tolerance/ 

tolerance exemption for the active 

ingredient. 

(8)(12) 

12 159,537 

B885 173 Registration application; registered 

(3) PIP, seed increase; breeding 

stack of previously approved 

PIPs, same crop; 

no petition since a 

permanent tolerance/tolerance exemption is already 

established for 

the active ingredient(s). (9)(12) 

6 31,910 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B886 174 

(new) 

Registration application; new (2) PIP, 

seed increase with 

negotiated acreage cap and timelimited registration; with petition 

to establish a permanent tolerance/ 

tolerance exemption for the active 

ingredient. SAP 

Review. (8) (12) 

18 223,351 

B890 175 Application to 

amend a seed increase registration; converts registration to commercial registration; no petition 

since permanent 

tolerance/tolerance exemption is 

already established for the active ingredient(s). 

(12) 

9 63,816 

B891 176 Application to 

amend a seed increase 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) 

15 127,630 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B900 177 Application to 

amend a registration, including actions such as extending an expiration date, modifying an IRM 

plan, or adding 

an insect to be 

controlled. 

(10)(11)(12) 

6 12,764 

B901 178 Application to 

amend a registration, including actions such as extending an expiration date, modifying an IRM 

plan, or adding 

an insect to be 

controlled. SAP 

review. (10) (11) 

(12) 

12 76,578 

B902 179 PIP Protocol review. 3 6,383 

B903 180 Inert ingredient tolerance exemption; 

e.g., a marker 

such as NPT II; 

reviewed in 

BPPD. 

6 63,816 

B904 181 Import tolerance or 

tolerance exemption; processed 

commodities/food 

only (inert or active ingredient). 

9 127,630 

B905 182 

(new) 

SAP Review. 6 63,816 


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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

B906 183 

(new) 

Petition to establish 

a temporary tolerance/tolerance exemption for one 

or more active ingredients. 

3 31,907 

B907 184 

(new) 

Petition to establish 

a temporary tolerance/tolerance exemption for one 

or more active ingredients based 

on an existing 

temporary tolerance/tolerance exemption. 

3 12,764 

B908 185 

(new) 

Petition to establish 

a temporary tolerance/tolerance exemption for one 

or more active ingredients or inert 

ingredients. 

3 44,671 

(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). 


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(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 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

I001 186 Approval of new 

food use inert 

ingredient. 

(2)(3) 

13 27,000 

I002 187 Amend currently 

approved inert 

ingredient tolerance or exemption from tolerance; new data. 

(2) 

11 7,500 

I003 188 Amend currently 

approved inert 

ingredient tolerance or exemption from tolerance; no new 

data. (2) 

9 3,308 


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‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

I004 189 Approval of new 

non-food use 

inert ingredient. 

(2) 

6 11,025 

I005 190 Amend currently 

approved nonfood use inert 

ingredient with 

new use pattern; 

new data. (2) 

6 5,513 

I006 191 Amend currently 

approved nonfood use inert 

ingredient with 

new use pattern; 

no new data. (2) 

3 3,308 

I007 192 Approval of substantially similar 

non-food use 

inert ingredients 

when original 

inert is 

compositionally 

similar with 

similar use pattern. (2) 

4 1,654 

I008 193 Approval of new or 

amended polymer inert ingredient, food use. 

(2) 

5 3,749 

I009 194 Approval of new or 

amended polymer inert ingredient, non-food 

use. (2) 

4 3,087 


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‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

I010 195 Petition to amend 

a single tolerance exemption 

descriptor, or 

single non-food 

use descriptor, 

to add ≤ 10 

CASRNs; no 

new data. (2) 

6 1,654 

I011 196 

(new) 

Approval of new 

food use safener 

with tolerance 

or exemption 

from tolerance. 

(2)(8) 

24 597,683 

I012 197 

(new) 

Approval of new 

non-food use 

safener. (2)(8) 

21 415,241 

I013 198 

(new) 

Approval of additional food use 

for previously 

approved 

safener with tolerance or exemption from 

tolerance. (2) 

15 62,975 

I014 199 

(new) 

Approval of additional non-food 

use for previously approved 

safener. (2) 

15 25,168 

I015 200 

(new) 

Approval of new 

generic data for 

previously approved food use 

safener. (2) 

24 269,728 


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‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

I016 201 

(new) 

Approval of 

amendment(s) 

to tolerance and 

label for previously approved 

safener. (2) 

13 55,776 

(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. 


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‘‘TABLE 19. — EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

M001 202 Study protocol 

requiring 

Human Studies Review 

Board review 

as defined in 

40 CFR Part 

26 in support 

of an active 

ingredient. (4) 

9 7,938 

M002 203 Completed study 

requiring 

Human Studies Review 

Board review 

as defined in 

40 CFR Part 

26 in support 

of an active 

ingredient. (4) 

9 7,938 


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‘‘TABLE 19. — EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

M003 204 External technical peer review of new 

active ingredient, product, 

or amendment 

(e.g., consultation with 

FIFRA Scientific Advisory Panel) 

for an action 

with a decision 

timeframe of 

less than 12 

months. Applicant initiated 

request based 

on a requirement of the 

Administrator, 

as defined by 

FIFRA § 

25(d), in support of a novel 

active ingredient, or 

unique use 

pattern or application technology. Excludes PIP active ingredients. (5) 

12 63,945 


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‘‘TABLE 19. — EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

M004 205 External technical peer review of new 

active ingredient, product, 

or amendment 

(e.g., consultation with 

FIFRA Scientific Advisory Panel) 

for an action 

with a decision 

timeframe of 

greater than 

12 months. 

Applicant initiated request 

based on a requirement of 

the Administrator, as defined by 

FIFRA § 

25(d), in support of a novel 

active ingredient, or 

unique use 

pattern or application technology. Excludes PIP active ingredients. (5) 

18 63,945 


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‘‘TABLE 19. — EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

M005 206 New Product: 

Combination, 

Contains a 

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) 

9 22,050 

M006 207 Request for up 

to 5 letters of 

certification 

(Gold Seal) 

for one actively registered product (excludes 

distributor 

products). (8) 

1 277 


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‘‘TABLE 19. — EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

M007 208 Request to extend Exclusive 

Use of data as 

provided by 

FIFRA Section 

3(c)(1)(F)(ii). 

12 5,513 

M008 209 Request to grant 

Exclusive Use 

of data as provided by 

FIFRA Section 

3(c)(1)(F)(vi) 

for a minor 

use, when a 

FIFRA Section 2(ll)(2) 

determination 

is required. 

15 1,654 

M009 210 (new) Non-FIFRA 

Regulated Determination: 

Applicant initiated, per 

product. 

4 2,363 

M010 211 (new) Conditional ruling on pre-application, 

product substantial similarity. 

4 2,363 

M011 212 (new) Label amendment to add 

the DfE logo; 

requires data 

review; no 

other label 

changes. (9) 

4 3,648 

(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. 


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(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.’’. 

Passed the House of Representatives March 20, 

2017. 

Attest: KAREN L. HAAS, 

Clerk. 


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