In the House of Representatives, U. S., 

February 25, 2019. 

Resolved, That the bill from the Senate (S. 483) entitled 

‘‘An Act to enact into law a bill by reference.’’, do pass with 

the following 

AMENDMENT: 

Strike out all after the enacting clause and insert: 

1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the ‘‘Pes3 ticide Registration Improvement Extension Act of 2018’’. 

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

5 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Extension and modification of maintenance fee authority. 

Sec. 3. Reregistration and Expedited Processing Fund. 

Sec. 4. Experimental use permits for pesticides. 

Sec. 5. Pesticide registration service fees. 

Sec. 6. Revision of tables regarding covered pesticide registration applications 

and other covered actions and their corresponding registration 

service fees. 

Sec. 7. Agricultural worker protection standard; certification of pesticide applicators. 

6 SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE 

7 FEE AUTHORITY. 

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

10 136a–1(i)(1)) is amended— 
2 

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1 (1) in subparagraph (C), by striking ‘‘an aggre2 gate amount of $27,800,000 for each of fiscal years 

3 2013 through 2017’’ and inserting ‘‘an average 

4 amount of $31,000,000 for each of fiscal years 2019 

5 through 2023’’; 

6 (2) in subparagraph (D)— 

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

8 each of fiscal years 2013 through 2017’’ and in9 serting ‘‘$129,400 for each of fiscal years 2019 

10 through 2023’’; and 

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

12 each of fiscal years 2013 through 2017’’ and in13 serting ‘‘$207,000 for each of fiscal years 2019 

14 through 2023’’; 

15 (3) in subparagraph (E)(i)— 

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

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

18 inserting ‘‘$79,100 for each of fiscal years 2019 

19 through 2023’’; and 

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

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

22 inserting ‘‘$136,800 for each of fiscal years 2019 

23 through 2023’’; and 

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

25 and inserting ‘‘2023.’’. 
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1 (b) PROHIBITION ON OTHER FEES.—Section 4(i)(2) of 

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

3 U.S.C. 136a–1(i)(2)) is amended— 

4 (1) by striking ‘‘the date of enactment of this sec5 tion and ending on September 30, 2019’’ and insert6 ing ‘‘the effective date of the Pesticide Registration 

7 Improvement Extension Act of 2018 and ending on 

8 September 30, 2025’’; and 

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

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

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

12 (c) EXTENSION OF PROHIBITION ON TOLERANCE

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

14 Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by strik15 ing ‘‘2017’’ and inserting ‘‘2023’’. 

16 SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING 

17 FUND. 

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

19 of the Federal Insecticide, Fungicide, and Rodenticide Act 

20 (7 U.S.C. 136a–1(k)(2)(A)) is amended— 

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

22 and inserting ‘‘the Reregistration and Expedited 

23 Processing Fund’’; 

24 (2) by striking ‘‘paragraph (3),’’ in the first sen25 tence and all that follows through the period at the 
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1 end of the second sentence and inserting the following: 

2 ‘‘paragraph (3), to offset the costs of registration re3 view under section 3(g), including the costs associated 

4 with any review under the Endangered Species Act of 

5 1973 (16 U.S.C. 1531 et seq.) required as part of the 

6 registration review, to offset the costs associated with 

7 tracking and implementing registration review deci8 sions, including registration review decisions designed 

9 to reduce risk, for the purposes specified in para10 graphs (4) and (5), and to enhance the information 

11 systems capabilities to improve the tracking of pes12 ticide registration decisions.’’; 

13 (3) in clause (i), by striking ‘‘are allocated sole14 ly’’ and all that follows through ‘‘3(g);’’ and inserting 

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

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

17 and 

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

19 achieve’’ and all that follows through ‘‘3(g);’’ and in20 serting the following: ‘‘necessary to achieve the pur21 poses specified in the first sentence of this subpara22 graph;’’. 

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

24 AND EXPEDITED PROCESSING OF SIMILAR APPLICA25 TIONS.—Section 4(k)(3)(A) of the Federal Insecticide, Fun-
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1 gicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is 

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

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

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

5 ‘‘For each of fiscal years 2018 through 2023, the Administrator shall use between 1⁄9 and 1 6 ⁄8 of the maintenance fees 

7 collected in such fiscal year to obtain sufficient personnel 

8 and resources—’’. 

9 (c) SET-ASIDE FOR EXPEDITED RULEMAKING AND

10 GUIDANCE DEVELOPMENT FOR CERTAIN PURPOSES.— 

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

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

13 amended to read as follows: 

14 ‘‘(4) EXPEDITED RULEMAKING AND GUIDANCE

15 DEVELOPMENT FOR CERTAIN PRODUCT PERFORMANCE

16 DATA REQUIREMENTS.— 

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

18 2018 through 2023, the Administrator shall use 

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

20 available to the Administrator in the Reregistra21 tion and Expedited Processing Fund for the ac22 tivities described in subparagraph (B). 

23 ‘‘(B) PRODUCTS CLAIMING EFFICACY

24 AGAINST INVERTEBRATE PESTS OF SIGNIFICANT

25 PUBLIC HEALTH OR ECONOMIC IMPORTANCE.— 
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1 The Administrator shall use amounts made 

2 available under subparagraph (A) to develop, re3 ceive comments with respect to, finalize, and im4 plement the necessary rulemaking and guidance 

5 for product performance data requirements to 

6 evaluate products claiming efficacy against the 

7 following invertebrate pests of significant public 

8 health or economic importance (in order of im9 portance): 

10 ‘‘(i) Bed bugs. 

11 ‘‘(ii) Premise (including crawling in12 sects, flying insects, and baits). 

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

14 controlled by spot-ons, collars, shampoos, 

15 powders, or dips). 

16 ‘‘(iv) Fire ants. 

17 ‘‘(C) DEADLINES FOR GUIDANCE.—The Ad18 ministrator shall develop, and publish guidance 

19 required by subparagraph (B), with respect to 

20 claims of efficacy against pests described in such 

21 subparagraph as follows: 

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

23 final guidance not later than 30 days after 

24 the effective date of the Pesticide Registra25 tion Improvement Extension Act of 2018. 
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1 ‘‘(ii) With respect to pests specified in 

2 clause (ii) of such subparagraph— 

3 ‘‘(I) submit draft guidance to the 

4 Scientific Advisory Panel and for pub5 lic comment not later than June 30, 

6 2018; and 

7 ‘‘(II) complete any response to 

8 comments received with respect to such 

9 draft guidance and finalize the guid10 ance not later than September 30, 

11 2019. 

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

13 clauses (iii) and (iv) of such subpara14 graph— 

15 ‘‘(I) submit draft guidance to the 

16 Scientific Advisory Panel and for pub17 lic comment not later than June 30, 

18 2019; and 

19 ‘‘(II) complete any response to 

20 comments received with respect to such 

21 draft guidance and finalize the guid22 ance not later than March 31, 2021. 

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

24 revise the guidance required by subparagraph 

25 (B) from time to time, but shall permit appli-
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1 cants and registrants sufficient time to obtain 

2 data that meet the requirements specified in such 

3 revised guidance. 

4 ‘‘(E) DEADLINE FOR PRODUCT PERFORM5 ANCE DATA REQUIREMENTS.—The Administrator 

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

7 regulations prescribing product performance 

8 data requirements for any pesticide intended for 

9 preventing, destroying, repelling, or mitigating 

10 any invertebrate pest of significant public health 

11 or economic importance specified in clauses (i) 

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

13 (d) SET-ASIDE FOR GOOD LABORATORY PRACTICES

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

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

16 amended— 

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

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

19 (2) by inserting after paragraph (4) the fol20 lowing new paragraph: 

21 ‘‘(5) GOOD LABORATORY PRACTICES INSPEC22 TIONS.— 

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

24 2018 through 2023, the Administrator shall use 

25 not more than $500,000 of the amounts made 
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1 available to the Administrator in the Reregistra2 tion and Expedited Processing Fund for the ac3 tivities described in subparagraph (B). 

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

5 use amounts made available under subparagraph 

6 (A) for enhancements to the good laboratory 

7 practices standards compliance monitoring pro8 gram established under part 160 of title 40 of the 

9 Code of Federal Regulations (or successor regula10 tions), with respect to laboratory inspections and 

11 data audits conducted in support of pesticide 

12 product registrations under this Act. As part of 

13 such monitoring program, the Administrator 

14 shall make available to each laboratory inspected 

15 under such program in support of such registra16 tions a preliminary summary of inspection ob17 servations not later than 60 days after the date 

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

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

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

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

22 SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES. 

23 Section 5(a) of the Federal Insecticide, Fungicide, and 

24 Rodenticide Act (7 U.S.C. 136c(a)) is amended— 
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1 (1) by striking ‘‘permit for a pesticide.’’ and in2 serting ‘‘permit for a pesticide. An application for an 

3 experimental use permit for a covered application 

4 under section 33(b) shall conform with the require5 ments of that section.’’; and 

6 (2) by inserting ‘‘(or in the case of an applica7 tion for an experimental use permit for a covered ap8 plication under section 33(b), not later than the last 

9 day of the applicable timeframe for such application 

10 specified in such section)’’ after ‘‘all required sup11 porting data’’. 

12 SEC. 5. PESTICIDE REGISTRATION SERVICE FEES. 

13 (a) EXTENSION AND MODIFICATION OF FEE AUTHOR14 ITY.—Section 33(b) of the Federal Insecticide, Fungicide, 

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

16 (1) in paragraph (2)— 

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

18 REGISTRATION’’; and 

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

20 for any other action covered by a table specified 

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

22 is received by the Administrator on or after the 

23 effective date of the Pesticide Registration Im24 provement Act of 2003’’; 

25 (2) in paragraph (5)— 
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1 (A) in the heading, by striking ‘‘PESTICIDE

2 REGISTRATION APPLICATIONS’’ and inserting 

3 ‘‘COVERED APPLICATIONS’’; and 

4 (B) by striking ‘‘pesticide registration ap5 plication’’ both places it appears and inserting 

6 ‘‘covered application’’; 

7 (3) in paragraph (6)— 

8 (A) in subparagraph (A)— 

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

10 and 

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

12 ending on September 30, 2015’’ and insert13 ing ‘‘October 1, 2019, and ending on Sep14 tember 30, 2021’’; 

15 (B) in subparagraph (B)— 

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

17 and 

18 (ii) by striking ‘‘2015’’ each place it 

19 appears and inserting ‘‘2021’’; and 

20 (C) in subparagraph (C), by striking ‘‘re21 vised registration service fee schedules’’ and in22 serting ‘‘service fee schedules revised pursuant to 

23 this paragraph’’; 

24 (4) in paragraph (7)— 

25 (A) in subparagraph (A)— 
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1 (i) by striking ‘‘covered pesticide reg2 istration’’ and inserting ‘‘covered applica3 tion’’; and 

4 (ii) by inserting before the period at 

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

6 waiver or fee reduction shall be provided in 

7 connection with a request for a letter of cer8 tification (commonly referred to as a Gold 

9 Seal letter)’’; and 

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

11 ‘‘pesticide registration’’; and 

12 (5) in paragraph (8)— 

13 (A) in subparagraph (A), by striking ‘‘pes14 ticide registration’’; 

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

16 ‘‘pesticide registration’’; and 

17 (C) in subparagraph (C)— 

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

19 registration’’ and inserting ‘‘covered’’; and 

20 (ii) in clause (ii)(I), by striking ‘‘pes21 ticide registration’’ and inserting ‘‘covered’’. 

22 (b) PESTICIDE REGISTRATION FUND SET-ASIDES FOR

23 WORKER PROTECTION, PARTNERSHIP GRANTS, AND PES24 TICIDE SAFETY EDUCATION.—Section 33(c)(3)(B) of the 
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1 Federal Insecticide, Fungicide, and Rodenticide Act (7 

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

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

4 GRANTS, AND PESTICIDE SAFETY EDUCATION’’ after 

5 ‘‘WORKER PROTECTION’’; 

6 (2) in clause (i)— 

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

8 ‘‘2023’’; and 

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

10 the following:‘‘, with an emphasis on field-worker 

11 populations in the United States’’; 

12 (3) in clause (ii), by striking ‘‘2017’’ and insert13 ing ‘‘2023’’; and 

14 (4) in clause (iii), by striking ‘‘2017’’ and in15 serting ‘‘2023’’. 

16 (c) REFORMS TO REDUCE DECISION TIME REVIEW

17 PERIODS.—Section 33(e) of the Federal Insecticide, Fun18 gicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amend19 ed— 

20 (1) by striking ‘‘Pesticide Registration Improve21 ment Extension Act of 2012’’ and inserting ‘‘Pesticide 

22 Registration Improvement Extension Act of 2018’’; 

23 and 

24 (2) by inserting at the end the following new sen25 tence: ‘‘Such reforms shall include identifying oppor-
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1 tunities for streamlining review processes for applica2 tions for a new active ingredient or a new use and 

3 providing prompt feedback to applicants during such 

4 review process.’’. 

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

6 of the Federal Insecticide, Fungicide, and Rodenticide Act 

7 (7 U.S.C. 136w–8(f)) is amended— 

8 (1) in paragraph (1)— 

9 (A) by striking ‘‘Pesticide Registration Im10 provement Extension Act of 2012’’ and inserting 

11 ‘‘Pesticide Registration Improvement Extension 

12 Act of 2018’’; and 

13 (B) by inserting after ‘‘covered pesticide 

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

15 other action covered by a table specified in sub16 section (b)(3)’’; 

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

18 (C) and inserting the following new subparagraph: 

19 ‘‘(C) applications for any other action cov20 ered by a table specified in subsection (b)(3).’’; 

21 and 

22 (3) in paragraph (4)(A)— 

23 (A) by striking ‘‘a pesticide registration ap24 plication’’ and inserting ‘‘a covered applica25 tion’’; and 
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1 (B) by striking ‘‘covered pesticide registra2 tion application’’ and inserting ‘‘covered appli3 cation’’. 

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

5 Federal Insecticide, Fungicide, and Rodenticide Act (7 

6 U.S.C. 136w–8(k)) is amended— 

7 (1) in paragraph (1) by striking ‘‘2017’’ and in8 serting ‘‘2023’’; and 

9 (2) in paragraph (2)— 

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

11 (i) and inserting the following new clause: 

12 ‘‘(i) the number of pesticides or pes13 ticide cases reviewed and the number of reg14 istration review decisions completed, includ15 ing— 

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

17 ‘‘(II) the number of cases requir18 ing risk mitigation measures; 

19 ‘‘(III) the number of cases remov20 ing risk mitigation measures; 

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

22 risk mitigation needed; and 

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

24 risk mitigation has been fully imple25 mented;’’; 
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1 (B) in subparagraph (G)— 

2 (i) in clause (i)— 

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

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

5 of section 4(k)’’; and 

6 (II) by striking ‘‘that section’’ 

7 and inserting ‘‘such paragraphs’’; 

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

9 (v), and (vi); 

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

11 following new clause: 

12 ‘‘(ii) implementing enhancements to— 

13 ‘‘(I) the electronic tracking of cov14 ered applications; 

15 ‘‘(II) the electronic tracking of 

16 conditional registrations; 

17 ‘‘(III) the endangered species 

18 database; 

19 ‘‘(IV) the electronic review of la20 bels submitted with covered applica21 tions; and 

22 ‘‘(V) the electronic review and as23 sessment of confidential statements of 

24 formula submitted with covered appli25 cations; and’’; and 
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1 (iv) by redesignating clause (vii) as 

2 clause (iii); 

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

4 at the end; 

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

6 period at the end and inserting a semicolon; and 

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

8 subparagraphs: 

9 ‘‘(K) a review of the progress made in devel10 oping, updating, and implementing product per11 formance test guidelines for pesticide products 

12 that are intended to control invertebrate pests of 

13 significant public health importance and, by reg14 ulation, prescribing product performance data 

15 requirements for such pesticide products reg16 istered under section 3; 

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

18 priority review and approval of new pesticides 

19 to control invertebrate public health pests that 

20 may transmit vector-borne disease for use in the 

21 United States, including each territory or posses22 sion of the United States, and United States 

23 military installations globally; 

24 ‘‘(M) a review of the progress made in im25 plementing enhancements to the good laboratory 
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1 practices standards compliance monitoring pro2 gram established under part 160 of title 40 of the 

3 Code of Federal Regulations (or successor regula4 tions); 

5 ‘‘(N) the number of approvals for active in6 gredients, new uses, and pesticide end use prod7 ucts granted in connection with the Design for 

8 the Environment program (or any successor pro9 gram) of the Environmental Protection Agency; 

10 and 

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

12 Registration Fund reserved under subsection 

13 (c)(3), a review that includes— 

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

15 use of such funds— 

16 ‘‘(I) to carry out activities relat17 ing to worker protection under clause 

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

19 ‘‘(II) to award partnership grants 

20 under clause (ii) of such subsection; 

21 and 

22 ‘‘(III) to carry out the pesticide 

23 safety education program under clause 

24 (iii) of such subsection; 
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1 ‘‘(ii) an evaluation of the appropriate2 ness and effectiveness of the activities, 

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

4 ‘‘(iii) a description of how stakeholders 

5 are engaged in the decision to fund such ac6 tivities, grants, and program; and 

7 ‘‘(iv) with respect to activities relating 

8 to worker protection carried out under sub9 paragraph (B)(i) of such subsection, a sum10 mary of the analyses from stakeholders, in11 cluding from worker community-based orga12 nizations, on the appropriateness and effec13 tiveness of such activities.’’. 

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

15 of the Federal Insecticide, Fungicide, and Rodenticide Act 

16 (7 U.S.C. 136w–8(m)) is amended— 

17 (1) in paragraph (1), by striking ‘‘2017’’ and in18 serting ‘‘2023’’; and 

19 (2) in paragraph (2)— 

20 (A) in subparagraph (A)— 

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

22 During fiscal year 2018’’ and inserting 

23 ‘‘FISCAL YEAR 2024.—During fiscal year 

24 2024’’; and 
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1 (ii) by striking ‘‘2017’’ and inserting 

2 ‘‘2023’’; 

3 (B) in subparagraph (B)— 

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

5 During fiscal year 2019’’ and inserting 

6 ‘‘FISCAL YEAR 2025.—During fiscal year 

7 2025’’; and 

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

9 ‘‘2023’’; 

10 (C) in subparagraph (C), by striking ‘‘SEP11 TEMBER 30, 2019.—Effective September 30, 2019’’ 

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

13 September 30, 2025’’; and 

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

15 ‘‘2017’’ both places it appears and inserting 

16 ‘‘2023’’. 

17 SEC. 6. REVISION OF TABLES REGARDING COVERED PES18 TICIDE REGISTRATION APPLICATIONS AND 

19 OTHER COVERED ACTIONS AND THEIR COR20 RESPONDING REGISTRATION SERVICE FEES. 

21 Paragraph (3) of section 33(b) of the Federal Insecti22 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) 

23 is amended to read as follows: 

24 ‘‘(3) SCHEDULE OF COVERED APPLICATIONS AND

25 OTHER ACTIONS AND THEIR REGISTRATION SERVICE
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1 FEES.—Subject to paragraph (6), the schedule of reg2 istration applications and other covered actions and 

3 their corresponding registration service fees shall be 

4 as follows: 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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)

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)

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. 
24 

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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)

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 
25 

•S 483 EAH 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
26 

•S 483 EAH 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
27 

•S 483 EAH 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
28 

•S 483 EAH 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
29 

•S 483 EAH 

(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)

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 
30 

•S 483 EAH 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
31 

•S 483 EAH 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
32 

•S 483 EAH 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
33 

•S 483 EAH 

(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. 
34 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
35 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
36 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
37 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
38 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
39 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
40 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
41 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
42 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
43 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
44 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
45 

•S 483 EAH 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
46 

•S 483 EAH 

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
47 

•S 483 EAH 

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
48 

•S 483 EAH 

(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)

Registration 

Service Fee 

($) 

R124 67 Conditional Ruling 

on Pre-application Study Waivers; applicant-initiated. 

6 2,530 
49 

•S 483 EAH 

‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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)

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 
50 

•S 483 EAH 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
51 

•S 483 EAH 

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
52 

•S 483 EAH 

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
53 

•S 483 EAH 

(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. 
54 

•S 483 EAH 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
55 

•S 483 EAH 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
56 

•S 483 EAH 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
57 

•S 483 EAH 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
58 

•S 483 EAH 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 

PRODUCTS AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 of organisms in both submissions. A reclassification would result in a new 

PRIA start date and require additional fees to meet the fee of the new category. 
59 

•S 483 EAH 

(7) Once a submission for a label amendment with public health organisms has 

been submitted and classified in either A570 or A573, additional organisms submitted for the same product before expiration of the first submission’s original decision review time period will result in reclassification of both the original and 

subsequent submission into the appropriate new category based on the sum of the 

number of organisms in both submissions. A reclassification would result in a new 

PRIA start date and require additional fees to meet the fee of the new category. 

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — 

EXPERIMENTAL USE PERMITS AND OTHER ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
60 

•S 483 EAH 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
61 

•S 483 EAH 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
62 

•S 483 EAH 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
63 

•S 483 EAH 

(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)

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 
64 

•S 483 EAH 

‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
65 

•S 483 EAH 

(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)

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 
66 

•S 483 EAH 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
67 

•S 483 EAH 

(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. 
68 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
69 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
70 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
71 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
72 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
73 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
74 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
75 

•S 483 EAH 

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 

PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
76 

•S 483 EAH 

‘‘TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months)(1)

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. 
77 

•S 483 EAH 

(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)

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 
78 

•S 483 EAH 

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
79 

•S 483 EAH 

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
80 

•S 483 EAH 

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
81 

•S 483 EAH 

(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)

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 
82 

•S 483 EAH 

‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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)

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 
83 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
84 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
85 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
86 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
87 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
88 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
89 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
90 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
91 

•S 483 EAH 

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
92 

•S 483 EAH 

(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)

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 
93 

•S 483 EAH 

‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
94 

•S 483 EAH 

‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
95 

•S 483 EAH 

(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)

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 
96 

•S 483 EAH 

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
97 

•S 483 EAH 

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
98 

•S 483 EAH 

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
99 

•S 483 EAH 

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 

ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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. 
100 

•S 483 EAH 

(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.’’. 

1 SEC. 7. AGRICULTURAL WORKER PROTECTION STANDARD; 

2 CERTIFICATION OF PESTICIDE APPLICATORS. 

3 (a) IN GENERAL.—Except as provided in subsection 

4 (b), during the period beginning on the date of enactment 

5 of this Act and ending not earlier than October 1, 2021, 

6 the Administrator of the Environmental Protection Agency 

7 (referred to in this section as the ‘‘Administrator’’)— 

8 (1) shall carry out— 

9 (A) the final rule of the Administrator enti10 tled ‘‘Pesticides; Agricultural Worker Protection 

11 Standard Revisions’’ (80 Fed. Reg. 67496 (No12 vember 2, 2015)); and 
101 

•S 483 EAH 

1 (B) the final rule of the Administrator enti2 tled ‘‘Pesticides; Certification of Pesticide Appli3 cators’’ (82 Fed. Reg. 952 (January 4, 2017)); 

4 and 

5 (2) shall not revise or develop revisions to the 

6 rules described in subparagraphs (A) and (B) of 

7 paragraph (1). 

8 (b) EXCEPTIONS.—Prior to October 1, 2021, the Ad9 ministrator may propose, and after a notice and public 

10 comment period of not less than 90 days, promulgate revi11 sions to the final rule described in subsection (a)(1)(A) ad12 dressing application exclusion zones under part 170 of title 

13 40, Code of Federal Regulations, consistent with the Federal 

14 Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 

15 et seq.). 

16 (c) GAO REPORT.—The Comptroller General of the 

17 United States shall— 

18 (1) conduct a study on the use of the designated 

19 representative, including the effect of that use on the 

20 availability of pesticide application and hazard infor21 mation and worker health and safety; and 

22 (2) not later than October 1, 2021, make pub23 lically available a report describing the study under 

24 paragraph (1), including any recommendations to 
102 

•S 483 EAH 

1 prevent the misuse of pesticide application and haz2 ard information, if that misuse is identified. 

Attest: 

Clerk. 

116TH CONGRESS 

1ST SESSION S. 483 

AMENDMENT