IB 

Union Calendar No. 29 

115TH CONGRESS 

1ST SESSION H. R. 1029 

[Report No. 115–49, Part I] 

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. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 14, 2017 

Mr. RODNEY DAVIS of Illinois introduced the following bill; which was referred 

to the Committee on Agriculture, and in addition to the Committee on 

Energy and Commerce, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

MARCH 20, 2017 

Reported from the Committee on Agriculture with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

MARCH 20, 2017 

The Committee on Energy and Commerce discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be 

printed 

[For text of introduced bill, see copy of bill as introduced on February 14, 2017] 


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A BILL 

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. 


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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the ‘‘Pes5 ticide Registration Enhancement Act of 2017’’. 

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

7 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. 

8 SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE 

9 FEE AUTHORITY. 

10 (a) MAINTENANCE FEE.—Section 4(i)(1) of the Fed11 eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

12 136a–1(i)(1)) is amended— 

13 (1) in subparagraph (C), by striking ‘‘an aggre14 gate amount of $27,800,000 for each of fiscal years 

15 2013 through 2017’’ and inserting ‘‘an average 

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

17 through 2023’’; 

18 (2) in subparagraph (D)— 

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

20 each of fiscal years 2013 through 2017’’ and inVerDate Sep 11 2014 23:09 Mar 20, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H1029.RH H1029

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1 serting ‘‘$129,400 for each of fiscal years 2017 

2 through 2023’’; and 

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

4 each of fiscal years 2013 through 2017’’ and in5 serting ‘‘$207,000 for each of fiscal years 2017 

6 through 2023’’; 

7 (3) in subparagraph (E)(i)— 

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

9 for each of fiscal years 2013 through 2017’’ and 

10 inserting ‘‘$79,100 for each of fiscal years 2017 

11 through 2023’’; and 

12 (B) in subclause (II), by striking ‘‘$122,100 

13 for each of fiscal years 2013 through 2017’’ and 

14 inserting ‘‘$136,800 for each of fiscal years 2017 

15 through 2023’’; and 

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

17 inserting ‘‘2023’’. 

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

19 the Federal Insecticide, Fungicide, and Rodenticide Act (7 

20 U.S.C. 136a–1(i)(2)) is amended— 

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

22 the date of enactment of this section and ending on 

23 September 30, 2019’’ and inserting ‘‘until September 

24 30, 2025’’; and 


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1 (2) by inserting after ‘‘registration of a pesticide 

2 under this Act’’ the following: ‘‘or any other action 

3 covered under a table specified in section 33(b)(3),’’. 

4 (c) EXTENSION OF PROHIBITION ON TOLERANCE

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

6 Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by strik7 ing ‘‘2017’’ and inserting ‘‘2023’’. 

8 SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING 

9 FUND. 

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

11 of the Federal Insecticide, Fungicide, and Rodenticide Act 

12 (7 U.S.C. 136a–1(k)(2)(A)) is amended— 

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

14 and inserting ‘‘the Reregistration and Expedited 

15 Processing Fund’’; 

16 (2) by striking ‘‘paragraph (3),’’ in the first sen17 tence and all that follows through the second sentence 

18 and inserting the following: ‘‘paragraph (3), to offset 

19 the costs of registration review under section 3(g), in20 cluding the costs associated with any review under the 

21 Endangered Species Act of 1973 (16 U.S.C. 1531 et. 

22 seq.) required as part of the registration review, to 

23 offset the costs associated with tracking and imple24 menting registration review decisions, including reg25 istration review decisions designed to reduce risk, for 


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1 the purposes specified in paragraphs (4) and (5), and 

2 to enhance the information systems capabilities to im3 prove the tracking of pesticide registration deci4 sions.’’; 

5 (3) in clause (i), by striking ‘‘are allocated sole6 ly’’ and all that follows through ‘‘3(g);’’ and inserting 

7 the following: ‘‘are allocated solely for the purposes 

8 specified in the first sentence of this subparagraph;’’; 

9 and 

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

11 achieve’’ and all that follows through ‘‘3(g);’’ and in12 serting the following: ‘‘necessary to achieve the pur13 poses specified in the first sentence of this subpara14 graph;’’. 

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

16 AND EXPEDITED PROCESSING OF SIMILAR APPLICA17 TIONS.—Section 4(k)(3)(A) of the Federal Insecticide, Fun18 gicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is 

19 amended, in the matter preceding clause (i), by striking 

20 ‘‘The Administrator shall use’’ and all that follows through 

21 ‘‘personnel and resources—’’ and inserting the following: 

22 ‘‘For each of fiscal years 2017 through 2023, the Administrator shall use between 1⁄9 and 1 23 ⁄8 of the maintenance fees 

24 collected in such fiscal year to obtain sufficient personnel 

25 and resources—’’. 


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1 (c) SET-ASIDE FOR EXPEDITED RULEMAKING AND

2 GUIDANCE DEVELOPMENT FOR CERTAIN PURPOSES.— 

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

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

5 amended to read as follows: 

6 ‘‘(4) EXPEDITED RULEMAKING AND GUIDANCE

7 DEVELOPMENT FOR CERTAIN PRODUCT PERFORMANCE

8 DATA REQUIREMENTS.— 

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

10 2017 through 2021, the Administrator shall use 

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

12 available to the Administrator in the Reregistra13 tion and Expedited Processing Fund for the ac14 tivities described in subparagraph (B). 

15 ‘‘(B) PRODUCTS CLAIMING EFFICACY

16 AGAINST INVERTEBRATE PESTS OF SIGNIFICANT

17 PUBLIC HEALTH OR ECONOMIC IMPORTANCE.— 

18 The Administrator shall use amounts made 

19 available under subparagraph (A) to develop, re20 ceive comments with respect to, finalize, and im21 plement the necessary rulemaking and guidance 

22 for product performance data requirements to 

23 evaluate products claiming efficacy against the 

24 following invertebrate pests of significant public 


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1 health or economic importance (in order of im2 portance): 

3 ‘‘(i) Bed bugs. 

4 ‘‘(ii) Premise (including crawling in5 sects, flying insects, and baits). 

6 ‘‘(iii) Pests of pets (including pet pests 

7 controlled by spot-ons, collars, shampoos, 

8 powders, dips). 

9 ‘‘(iv) Fire ants. 

10 ‘‘(C) DEADLINES FOR GUIDANCE.—The Ad11 ministrator shall develop, and publish guidance 

12 required by subparagraph (B) with respect to 

13 claims of efficacy against pests described in such 

14 subparagraph as follows: 

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

16 final guidance not later than June 30, 

17 2017. 

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

19 clause (ii) of such subparagraph— 

20 ‘‘(I) submit draft guidance to the 

21 Scientific Advisory Panel and for pub22 lic comment not later than June 30, 

23 2018; and 

24 ‘‘(II) complete any response to 

25 comments received with respect to such 


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1 draft guidance and finalize the guid2 ance not later than September 30, 

3 2020. 

4 ‘‘(iii) With respect to pests specified in 

5 clauses (iii) and (iv) of such subpara6 graph— 

7 ‘‘(I) submit to the Scientific Advi8 sory Panel and for public comment 

9 draft guidance not later than June 30, 

10 2019; and 

11 ‘‘(II) complete any response to 

12 comments received with respect to such 

13 draft guidance and finalize the guid14 ance not later than March 31, 2021. 

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

16 revise the guidance required by subparagraph 

17 (B) from time-to-time, but shall permit appli18 cants and registrants sufficient time to obtain 

19 data that meet the requirements specified in such 

20 revised guidance. 

21 ‘‘(E) DEADLINE FOR PRODUCT PERFORM22 ANCE DATA REQUIREMENTS.—The Administrator 

23 shall, not later than September 30, 2021, issue 

24 regulations prescribing product performance 

25 data requirements for any pesticide intended for 


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1 preventing, destroying, repelling, or mitigating 

2 any invertebrate pest of significant public health 

3 or economic importance specified in clauses (i) 

4 through (iv) of subparagraph (B).’’. 

5 (d) SET-ASIDE FOR GOOD LABORATORY PRACTICES

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

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

8 amended— 

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

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

11 (2) by inserting after paragraph (4) the fol12 lowing new paragraph: 

13 ‘‘(5) GOOD LABORATORY PRACTICES INSPEC14 TIONS.— 

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

16 2017 through 2023, the Administrator shall use 

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

18 available to the Administrator in the Reregistra19 tion and Expedited Processing Fund for the ac20 tivities described in subparagraph (B). 

21 ‘‘(B) ACTIVITIES.—The Administrator shall 

22 use amounts made available under subparagraph 

23 (A) for enhancements to the good laboratory 

24 practices standards compliance monitoring pro25 gram established under part 160 of title 40 of the 


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1 Code of Federal Regulations (or successor regula2 tions), with respect to laboratory inspections and 

3 data audits conducted in support of pesticide 

4 product registrations under this Act. As part of 

5 such monitoring program, the Administrator 

6 shall make available to each laboratory inspected 

7 under such program in support of such registra8 tions a preliminary summary of inspection ob9 servations not later than 60 days after the date 

10 on which such an inspection is completed.’’; and 

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

12 striking ‘‘paragraphs (2), (3), and (4)’’ and inserting 

13 ‘‘paragraphs (2), (3), (4), and (5)’’. 

14 SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES. 

15 Subsection (a) of section 5 of the Federal Insecticide, 

16 Fungicide, and Rodenticide Act (7 U.S.C. 136c) is amended 

17 to read as follows: 

18 ‘‘(a) APPLICATION AND ISSUANCE.— 

19 ‘‘(1) APPLICATION.—Any person may apply to 

20 the Administrator for an experimental use permit for 

21 a pesticide. An application for an experimental use 

22 permit may be filed at any time. 

23 ‘‘(2) REQUIREMENTS.—An application for an 

24 experimental use permit shall conform with the re25 quirements of section 33(b). 


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1 ‘‘(3) ISSUANCE.—The decision whether to grant 

2 an experimental use permit shall be made within the 

3 time-frame specified in the applicable covered appli4 cation category specified in section 33(b)(3).’’. 

5 SEC. 5. PESTICIDE REGISTRATION SERVICE FEES. 

6 (a) EXTENSION AND MODIFICATION OF FEE AUTHOR7 ITY.—Section 33(b) of the Federal Insecticide, Fungicide, 

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

9 (1) in paragraph (2)— 

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

11 REGISTRATION’’; and 

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

13 for any other action covered by a table specified 

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

15 is received by the Administrator on or after the 

16 effective date of the Pesticide Registration Im17 provement Act of 2003’’; 

18 (2) in paragraph (5)— 

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

20 REGISTRATION APPLICATIONS’’ and inserting 

21 ‘‘COVERED APPLICATION’’; and 

22 (B) by striking ‘‘pesticide registration ap23 plication’’ both places it appears and inserting 

24 ‘‘covered application’’; 

25 (3) in paragraph (6)— 


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1 (A) in subparagraph (A)— 

2 (i) by striking ‘‘pesticide registration’’; 

3 and 

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

5 ending on September 30, 2015’’ and insert6 ing ‘‘October 1, 2019, and ending on Sep7 tember 30, 2021’’; 

8 (B) in subparagraph (B)— 

9 (i) by striking ‘‘pesticide registration’’; 

10 and 

11 (ii) by striking ‘‘2015’’ both places it 

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

13 (C) in subparagraph (C), by striking ‘‘re14 vised registration service fee schedules’’ and in15 serting ‘‘service fee schedules revised pursuant to 

16 this paragraph’’; 

17 (4) in paragraph (7)— 

18 (A) in subparagraph (A)— 

19 (i) by striking ‘‘covered pesticide reg20 istration’’ and inserting ‘‘covered applica21 tion’’; and 

22 (ii) by inserting before the period at 

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

24 waiver or fee reduction shall be provided in 

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1 tification (commonly referred to as a Gold 

2 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 ‘‘covered’’. 

15 (b) PESTICIDE REGISTRATION FUND SET-ASIDES FOR

16 WORKER PROTECTION, PARTNERSHIP GRANTS, AND PES17 TICIDE SAFETY EDUCATION.—Section 33(c)(3)(B) of the 

18 Federal Insecticide, Fungicide, and Rodenticide Act (7 

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

20 (1) in the heading, by inserting ‘‘, PARTNERSHIP

21 GRANTS, AND PESTICIDE SAFETY EDUCATION’’ after 

22 ‘‘WORKER PROTECTION’’; 

23 (2) in clause (i)— 

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

25 ‘‘2023’’; and 


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1 (B) by inserting before the period at the end 

2 the following: ‘‘, with an emphasis on field-work3 er populations in the United States’’; 

4 (3) in clause (ii), by striking ‘‘2017’’ and insert5 ing ‘‘2023’’; and 

6 (4) in clause (iii), by striking ‘‘2017’’ and in7 serting ‘‘2023’’. 

8 (c) REFORMS TO REDUCE DECISION TIME REVIEW

9 PERIODS.—Section 33(e) of the Federal Insecticide, Fun10 gicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amend11 ed— 

12 (1) by striking ‘‘Pesticide Registration Improve13 ment Extension Act of 2012’’ and inserting ‘‘Pesticide 

14 Registration Enhancement Act of 2017’’; and 

15 (2) by inserting at the end the following new sen16 tence: ‘‘Such reforms shall include identifying oppor17 tunities for streamlining review processes for applica18 tions for a new active ingredient or a new use and 

19 providing prompt feedback to applicants during such 

20 review process.’’. 

21 (d) DECISION TIME REVIEW PERIODS.—Section 33(f) 

22 of the Federal Insecticide, Fungicide, and Rodenticide Act 

23 (7 U.S.C. 136w–8(f)(1)) is amended— 

24 (1) in paragraph (1)— 


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1 (A) by striking ‘‘Pesticide Registration Im2 provement Extension Act of 2012’’ and inserting 

3 ‘‘Pesticide Registration Enhancement Act of 

4 2017’’; and 

5 (B) by inserting after ‘‘covered pesticide 

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

7 other action covered by a table specified in sub8 section (b)(3)’’; 

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

10 (C) and inserting the following new subparagraph: 

11 ‘‘(C) applications for any other action cov12 ered by a table specified in subsection (b)(3).’’; 

13 and 

14 (3) in paragraph (4)(A)— 

15 (A) by striking ‘‘a pesticide registration ap16 plication’’ and inserting ‘‘a covered applica17 tion’’; and 

18 (B) by striking ‘‘covered pesticide registra19 tion application’’ and inserting ‘‘covered appli20 cation’’. 

21 (e) REPORTING REQUIREMENTS.—Section 33(k) of the 

22 Federal Insecticide, Fungicide, and Rodenticide Act (7 

23 U.S.C. 136w–8(k)) is amended— 

24 (1) in paragraph (1) by striking ‘‘2017’’ and in25 serting ‘‘2023’’; and 


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1 (2) in paragraph (2)— 

2 (A) in subparagraph (D), by striking clause 

3 (i) and inserting the following new clause: 

4 ‘‘(i) the number of pesticides or pes5 ticide cases reviewed and the number of reg6 istration review decisions completed, includ7 ing— 

8 ‘‘(I) the number of cases cancelled; 

9 ‘‘(II) the number of cases requir10 ing risk mitigation measures; 

11 ‘‘(III) the number of cases remov12 ing risk mitigation measures; 

13 ‘‘(IV) the number of cases with no 

14 risk mitigation needed; and 

15 ‘‘(V) the number of cases in which 

16 risk mitigation has been fully imple17 mented;’’; 

18 (B) in subparagraph (G)— 

19 (i) in clause (i)— 

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

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

22 of section 4(k)’’; and 

23 (II) by striking ‘‘that section’’ 

24 and inserting ‘‘such paragraphs’’; 


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

2 (v), and (vi); 

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

4 following new clause: 

5 ‘‘(ii) implementing enhancements to— 

6 ‘‘(I) the electronic tracking of cov7 ered applications; 

8 ‘‘(II) the electronic tracking of 

9 conditional registrations; 

10 ‘‘(III) the endangered species 

11 database; 

12 ‘‘(IV) the electronic review of la13 bels submitted with covered applica14 tions; and 

15 ‘‘(V) the electronic review and as16 sessment of confidential statements of 

17 formula submitted with covered appli18 cations; and’’; and 

19 (iv) by redesignating clause (vii) as 

20 clause (iii); 

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

22 at the end; 

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

24 period at the end and inserting a semicolon; and 


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

2 subparagraphs: 

3 ‘‘(K) a review of the progress made in devel4 oping, updating, and implementing product per5 formance test guidelines for pesticide products 

6 that are intended to control invertebrate pests of 

7 significant public health importance and, by reg8 ulation, prescribing product performance data 

9 requirements for such pesticide products reg10 istered under section 3; 

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

12 priority review and approval of new pesticides 

13 to control vector-born public health pests for use 

14 in the United States, including each territory or 

15 possession of the United States, and United 

16 States military installations globally; 

17 ‘‘(M) a review of the progress made in im18 plementing enhancements to the good laboratory 

19 practices standards compliance monitoring pro20 gram established under part 160 of title 40 of the 

21 Code of Federal Regulations (or successor regula22 tions); 

23 ‘‘(N) the number of approvals for active in24 gredients, new uses, and pesticide end use prod25 ucts granted in connection with the Design for 


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1 the Environment program (or any successor pro2 gram) of the Environmental Protection Agency; 

3 and 

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

5 Registration Fund reserved under subsection 

6 (c)(3), a review that includes— 

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

8 use of such funds— 

9 ‘‘(I) to carry out activities relat10 ing to worker protection under clause 

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

12 ‘‘(II) to award partnership grants 

13 under clause (ii) of such subsection; 

14 and 

15 ‘‘(III) to carry out the pesticide 

16 safety education program under clause 

17 (iii) of such subsection; 

18 ‘‘(ii) an evaluation of the appropriate19 ness and effectiveness of the activities, 

20 grants, and program described in clause (i); 

21 ‘‘(iii) a description of how stakeholders 

22 are engaged in the decision to fund such ac23 tivities, grants, and program; and 

24 ‘‘(iv) with respect to activities relating 

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1 paragraph (B)(i) of such subsection, a sum2 mary of the analyses from stakeholders, in3 cluding from worker community-based orga4 nizations, on the appropriateness and effec5 tiveness of such activities.’’. 

6 (f) TERMINATION OF EFFECTIVENESS.—Section 33(m) 

7 of the Federal Insecticide, Fungicide, and Rodenticide Act 

8 (7 U.S.C. 136w–8(m)) is amended— 

9 (1) in paragraph (1), by striking ‘‘2017’’ and in10 serting ‘‘2023’’; and 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

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

14 During fiscal year 2018’’ and inserting 

15 ‘‘FISCAL YEAR 2024.—During fiscal year 

16 2024’’; and 

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

18 ‘‘2023’’; 

19 (B) in subparagraph (B)— 

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

21 During fiscal year 2019’’ and inserting 

22 ‘‘FISCAL YEAR 2025.—During fiscal year 

23 2025’’; and 

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

25 ‘‘2023’’; 


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1 (C) in subparagraph (C), by striking ‘‘SEP2 TEMBER 30, 2019.—Effective September 30, 2019’’ 

3 and inserting ‘‘SEPTEMBER 30, 2025.—Effective 

4 September 30, 2025’’; and 

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

6 ‘‘2017’’ both places it appears and inserting 

7 ‘‘2023’’. 

8 SEC. 6. REVISION OF TABLES REGARDING COVERED PES9 TICIDE REGISTRATION APPLICATIONS AND 

10 OTHER COVERED ACTIONS AND THEIR COR11 RESPONDING REGISTRATION SERVICE FEES. 

12 Paragraph (3) of section 33(b) of the Federal Insecti13 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) 

14 is amended to read as follows: 

15 ‘‘(3) SCHEDULE OF COVERED APPLICATIONS AND

16 OTHER ACTIONS AND THEIR REGISTRATION SERVICE

17 FEES.—Subject to paragraph (6), the schedule of reg18 istration applications and other covered actions and 

19 their corresponding registration service fees shall be 

20 as follows: 


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‘‘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, Non-food 

use; outdoor. 

(2)(3) 

21 523,205 

R070 5 New Active Ingredient, Non-food 

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, Non-food 

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, Non-food 

use; indoor. 

(2)(3) 

20 290,994 

R120 8 New Active Ingredient, Non-food 

use; indoor; reduced risk. 

(2)(3) 

14 242,495 

R121 9 New Active Ingredient, Non-food 

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 

R122 10 Enriched isomer(s) 

of registered 

mixed-isomer active ingredient. 

(2)(3) 

18 317,128 


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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 

($) 

R123 11 New Active Ingredient, Seed 

treatment only; 

includes agricultural and nonagricultural 

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. 


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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 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 


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‘‘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 nonfood 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 


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‘‘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 

R251 28 Experimental Use 

Permit application which requires no 

changes to the 

tolerance(s); 

non-crop destruct basis. (3) 

8 19,838 


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‘‘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 

($) 

R260 29 New use; non-food; 

indoor. (3) (4) 

12 15,317 

R270 30 New use; non-food; 

indoor; reduced 

risk. (3)(4) 

9 12,764 

R271 31 New use; non-food; 

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 non-food uses. 

(3)(4) 

12 50,445 


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‘‘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 non-food 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. 


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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) 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 


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‘‘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; applicant-initiated. 

12 320,894 


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‘‘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 

R297 42 Amend 6 or more 

established tolerances (e.g., decrease or increase) in one 

petition; domestic or import; 

applicant-initiated. 

11 272,037 


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‘‘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 

($) 

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. 

(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. 

(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. 


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‘‘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; 

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% repackage of registered end-use or 

manufacturinguse product that 

requires no data 

submission nor 

data matrix. 

(2)(3) 

4 1,582 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 


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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 

($) 

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 end-use 

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 

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 


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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 

($) 

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. 

(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. 


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‘‘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 

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 


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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 

($) 

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 

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. 


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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 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 


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‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

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; applicantinitiated. 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. 

‘‘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 


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‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

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. 

(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 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 

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 


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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 

($) 

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. 

(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. 


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(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 

end-use 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 

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 


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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 

($) 

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 

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 


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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 

($) 

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 

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 


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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 

($) 

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. 

(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. 


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(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 

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 


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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 

($) 

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 

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 


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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 

($) 

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 

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 


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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 

($) 

A571 102 Science reassessment: Cancer 

risk, refined ecological risk, and/ 

or endangered 

species; applicant-initiated. 

18 95,724 

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; applicantinitiated. 

6 2,409 

A536 106 

(new) 

Conditional Ruling 

on Pre-application Direct 

Food, Indirect 

Food, Nonfood 

use determination; applicantinitiated. 

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; non-food 

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; non-food. 

(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; non-food 

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 scientificallysound 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% re-package 

of registered enduse 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 scientificallysound 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 

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. (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 

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. (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 

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. (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. 

(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. 


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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 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% repackage of registered end-use 

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 scientifically-sound 

rationale explaining why 

the data requirement does not 

apply. (3)(6) 

5 1,278 

B721 147 New product; unregistered source 

of active ingredient. (3)(6) 

7 2,676 


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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 

($) 

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. 

(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. 


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(5) Amendment applications to add the new use(s) to registered product labels 

are covered by the base fee for the new use(s). All items in the covered application 

must be submitted together in one package. Each application for an additional 

new product registration and new inert approval(s) that is submitted in the new 

use application package is subject to the registration service fee for a new product 

or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All 

such associated applications that are submitted together will be subject to the new 

use decision review time. Any application for a new product or an amendment to 

the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing 

the same new uses, will be deemed a separate new-use application, subject to a 

separate registration service fee and new decision review time for a new use. If the 

new-use application includes non-food (indoor and/or outdoor), and food (outdoor 

and/or indoor) uses, the appropriate fee is due for each type of new use and the 

longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, 

and (b) is submitted by the applicant at the applicant’s initiative to support the 

application after completion of the technical deficiency screen, and (c) is not itself 

a covered registration application, must be assessed 25% of the full registration 

service fee for the new use application. 

(6) Where the action involves approval of a new or amended label, on or before 

the end date of the decision review time, the Agency shall provide to the applicant 

a draft accepted label, including any changes made by the Agency that differ from 

the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all 

of the terms associated with the draft accepted label as amended by the Agency 

and requests that it be issued as the accepted final Agency-stamped label; or (b) 

does not agree to one or more of the terms of the draft accepted label as amended 

by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits 

the associated registration service fee. For cases described in (b), the applicant 

shall have up to 30 calendar days to reach agreement with the Agency on the final 

terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 

accepted label as in (a), including upon resolution of differences in (b), the Agency 

shall provide an accepted final Agency-stamped label to the registrant within 2 

business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 

ACTIONS 

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 


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‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

FY’17 & 

FY’18 Registration 

Service Fee 

($) 

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. 

‘‘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 

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 


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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 

($) 

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 

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 


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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 

($) 

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 

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 time-limited registration; 

with petition to establish a permanent 

tolerance/tolerance 

exemption for the 

active ingredient 

based on an existing 

temporary tolerance/tolerance exemption; SAP Review. (8)(12) 

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 time-limited registration; 

with petition to establish a permanent 

tolerance/tolerance 

exemption for the 

active ingredient 

based on an existing 

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

9 127,630 

B884 172 Registration application; new (2) PIP, 

seed increase with 

negotiated acreage 

cap and time-limited registration; 

with petition to establish a permanent 

tolerance/tolerance 

exemption for the 

active ingredient. 

(8)(12) 

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 time-limited 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 

B906 183 

(new) 

Petition to establish a 

temporary tolerance/tolerance exemption for one or 

more active ingredients. 

3 31,907 


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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 

($) 

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). 

(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. 


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(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 

I004 189 Approval of new 

non-food use inert 

ingredient. (2) 

6 11,025 

I005 190 Amend currently approved non-food 

use inert ingredient with new 

use pattern; new 

data. (2) 

6 5,513 


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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 

($) 

I006 191 Amend currently approved non-food 

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 

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 


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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 

($) 

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 

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. 


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(7) Where the action involves approval of a new or amended label, on or before 

the end date of the decision review time, the Agency shall provide to the applicant 

a draft accepted label, including any changes made by the Agency that differ from 

the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all 

of the terms associated with the draft accepted label as amended by the Agency 

and requests that it be issued as the accepted final Agency-stamped label; or (b) 

does not agree to one or more of the terms of the draft accepted label as amended 

by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits 

the associated registration service fee. For cases described in (b), the applicant 

shall have up to 30 calendar days to reach agreement with the Agency on the final 

terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 

accepted label as in (a), including upon resolution of differences in (b), the Agency 

shall provide an accepted final Agency-stamped label to the registrant within 2 

business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

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

safener would get the same reduced timeframe as the new active ingredient. 

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 

ACTIONS 

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 

M007 208 Request to extend 

Exclusive Use of 

data as provided 

by FIFRA Section 

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

12 5,513 


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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 

($) 

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. 

(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. 


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(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.’’. 


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Union Calendar No. 29 

115TH CONGRESS 

1ST SESSION H. R. 1029 

[Report No. 115–49, Part I] 

A BILL 

To amend the Federal Insecticide, Fungicide, and 

modify fee authorities, and for other purposes. and other activities under the Act, to extend and Rodenticide Act to improve pesticide registration 

MARCH 20, 2017 

Reported from the Committee on Agriculture with an 

amendment 

MARCH 20, 2017 

The Committee on Energy and Commerce discharged; 

the State of the Union and ordered to be printed committed to the Committee of the Whole House on 


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