S. 483 

One Hundred Sixteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and nineteen 

An Act 

To enact into law a bill by reference. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

Registration Improvement Extension Act of 2018’’. 

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

is as follows: 

Sec. 1. Short title; table of contents. 

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

Sec. 3. Reregistration and Expedited Processing Fund. 

Sec. 4. Experimental use permits for pesticides. 

Sec. 5. Pesticide registration service fees. 

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

other covered actions and their corresponding registration service fees. 

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

SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE FEE 

AUTHORITY. 

(a) MAINTENANCE FEE.—Section 4(i)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(1)) is 

amended— 

(1) in subparagraph (C), by striking ‘‘an aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017’’ 

and inserting ‘‘an average amount of $31,000,000 for each of 

fiscal years 2019 through 2023’’; 

(2) in subparagraph (D)— (A) in clause (i), by striking ‘‘$115,500 for each of fiscal years 2013 through 2017’’ and inserting ‘‘$129,400 

for each of fiscal years 2019 through 2023’’; and (B) in clause (ii), by striking ‘‘$184,800 for each of fiscal years 2013 through 2017’’ and inserting ‘‘$207,000 

for each of fiscal years 2019 through 2023’’; 

(3) in subparagraph (E)(i)— 

(A) in subclause (I), by striking ‘‘$70,600 for each of 

fiscal years 2013 through 2017’’ and inserting ‘‘$79,100 

for each of fiscal years 2019 through 2023’’; and 

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

of fiscal years 2013 through 2017’’ and inserting ‘‘$136,800 

for each of fiscal years 2019 through 2023’’; and 

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

‘‘2023.’’. 
S. 483—2 

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

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

is amended— 

(1) by striking ‘‘the date of enactment of this section and 

ending on September 30, 2019’’ and inserting ‘‘the effective 

date of the Pesticide Registration Improvement Extension Act 

of 2018 and ending on September 30, 2025’’; and 

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

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

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

(c) EXTENSION OF PROHIBITION ON TOLERANCE FEES.—Section 

408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

346a(m)(3)) is amended by striking ‘‘2017’’ and inserting ‘‘2023’’. 

SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND. 

(a) AUTHORIZED USE OF FUND.—Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a– 

1(k)(2)(A)) is amended— 

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

‘‘the Reregistration and Expedited Processing Fund’’; 

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

all that follows through the period at the end of the second 

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

the costs of registration review under section 3(g), including 

the costs associated with any review under the Endangered 

Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part 

of the registration review, to offset the costs associated with 

tracking and implementing registration review decisions, 

including registration review decisions designed to reduce risk, 

for the purposes specified in paragraphs (4) and (5), and to 

enhance the information systems capabilities to improve the 

tracking of pesticide registration decisions.’’; 

(3) in clause (i), by striking ‘‘are allocated solely’’ and 

all that follows through ‘‘3(g);’’ and inserting the following: 

‘‘are allocated solely for the purposes specified in the first 

sentence of this subparagraph;’’; and 

(4) in clause (ii), by striking ‘‘necessary to achieve’’ and 

all that follows through ‘‘3(g);’’ and inserting the following: 

‘‘necessary to achieve the purposes specified in the first sentence 

of this subparagraph;’’. 

(b) SET-ASIDE FOR REVIEW OF INERT INGREDIENTS AND EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—Section 4(k)(3)(A) 

of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

136a–1(k)(3)(A)) is amended, in the matter preceding clause (i), 

by striking ‘‘The Administrator shall use’’ and all that follows 

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

‘‘For each of fiscal years 2018 through 2023, the Administrator 

shall use between 1⁄9 and 1⁄8 of the maintenance fees collected 

in such fiscal year to obtain sufficient personnel and resources— 

’’. 

(c) SET-ASIDE FOR EXPEDITED RULEMAKING AND GUIDANCE

DEVELOPMENT FOR CERTAIN PURPOSES.—Paragraph (4) of section 

4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act 

(7 U.S.C. 136a–1(k)) is amended to read as follows: 

‘‘(4) EXPEDITED RULEMAKING AND GUIDANCE DEVELOPMENT

FOR CERTAIN PRODUCT PERFORMANCE DATA REQUIREMENTS.— 
S. 483—3 

‘‘(A) SET-ASIDE.—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 

of the amounts made available to the Administrator in 

the Reregistration and Expedited Processing Fund for the 

activities described in subparagraph (B). 

‘‘(B) PRODUCTS CLAIMING EFFICACY AGAINST INVERTEBRATE PESTS OF SIGNIFICANT PUBLIC HEALTH OR ECONOMIC

IMPORTANCE.—The Administrator shall use amounts made 

available under subparagraph (A) to develop, receive comments with respect to, finalize, and implement the necessary rulemaking and guidance for product performance 

data requirements to evaluate products claiming efficacy 

against the following invertebrate pests of significant public 

health or economic importance (in order of importance): 

‘‘(i) Bed bugs. 

‘‘(ii) Premise (including crawling insects, flying 

insects, and baits). 

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

by spot-ons, collars, shampoos, powders, or dips). 

‘‘(iv) Fire ants. 

‘‘(C) DEADLINES FOR GUIDANCE.—The Administrator 

shall develop, and publish guidance required by subparagraph (B), with respect to claims of efficacy against pests 

described in such subparagraph as follows: 

‘‘(i) With respect to bed bugs, issue final guidance 

not later than 30 days after the effective date of the 

Pesticide Registration Improvement Extension Act of 

2018. 

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

of such subparagraph— 

‘‘(I) submit draft guidance to the Scientific 

Advisory Panel and for public comment not later 

than June 30, 2018; and 

‘‘(II) complete any response to comments 

received with respect to such draft guidance and 

finalize the guidance not later than September 

30, 2019. 

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

(iii) and (iv) of such subparagraph— 

‘‘(I) submit draft guidance to the Scientific 

Advisory Panel and for public comment not later 

than June 30, 2019; and 

‘‘(II) complete any response to comments 

received with respect to such draft guidance and 

finalize the guidance not later than March 31, 

2021. 

‘‘(D) REVISION.—The Administrator shall revise the 

guidance required by subparagraph (B) from time to time, 

but shall permit applicants and registrants sufficient time 

to obtain data that meet the requirements specified in 

such revised guidance. 

‘‘(E) DEADLINE FOR PRODUCT PERFORMANCE DATA

REQUIREMENTS.—The Administrator shall, not later than 

September 30, 2021, issue regulations prescribing product 

performance data requirements for any pesticide intended 

for preventing, destroying, repelling, or mitigating any 

invertebrate pest of significant public health or economic 
S. 483—4 

importance specified in clauses (i) through (iv) of subparagraph (B).’’. 

(d) SET-ASIDE FOR GOOD LABORATORY PRACTICES INSPEC- TIONS.—Section 4(k) of the Federal Insecticide, Fungicide, and 

Rodenticide Act (7 U.S.C. 136a–1(k)) is amended— 

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

(6) and (7), respectively; 

(2) by inserting after paragraph (4) the following new paragraph: 

‘‘(5) GOOD LABORATORY PRACTICES INSPECTIONS.— ‘‘(A) SET-ASIDE.—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 

of the amounts made available to the Administrator in 

the Reregistration and Expedited Processing Fund for the 

activities described in subparagraph (B). 

‘‘(B) ACTIVITIES.—The Administrator shall use amounts 

made available under subparagraph (A) for enhancements 

to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of 

the Code of Federal Regulations (or successor regulations), 

with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under 

this Act. As part of such monitoring program, the Administrator shall make available to each laboratory inspected 

under such program in support of such registrations a 

preliminary summary of inspection observations not later 

than 60 days after the date on which such an inspection 

is completed.’’; and 

(3) in paragraph (7), as so redesignated, by striking ‘‘paragraphs (2), (3), and (4)’’ and inserting ‘‘paragraphs (2), (3), 

(4), and (5)’’. 

SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES. 

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

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

(1) by striking ‘‘permit for a pesticide.’’ and inserting 

‘‘permit for a pesticide. An application for an experimental 

use permit for a covered application under section 33(b) shall 

conform with the requirements of that section.’’; and 

(2) by inserting ‘‘(or in the case of an application for an 

experimental use permit for a covered application under section 

33(b), not later than the last day of the applicable timeframe 

for such application specified in such section)’’ after ‘‘all 

required supporting data’’. 

SEC. 5. PESTICIDE REGISTRATION SERVICE FEES. 

(a) EXTENSION AND MODIFICATION OF FEE AUTHORITY.—Section 

33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act 

(7 U.S.C. 136w–8(b)) is amended— 

(1) in paragraph (2)— 

(A) in the heading, by striking ‘‘PESTICIDE REGISTRATION’’; and 

(B) in subparagraph (A), by inserting ‘‘or for any other 

action covered by a table specified in paragraph (3)’’ after 

‘‘covered by this Act that is received by the Administrator 

on or after the effective date of the Pesticide Registration 

Improvement Act of 2003’’; 

(2) in paragraph (5)— 
S. 483—5 

(A) in the heading, by striking ‘‘PESTICIDE REGISTRATION APPLICATIONS’’ and inserting ‘‘COVERED APPLICATIONS’’; 

and 

(B) by striking ‘‘pesticide registration application’’ both 

places it appears and inserting ‘‘covered application’’; 

(3) in paragraph (6)— 

(A) in subparagraph (A)— 

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

(ii) by striking ‘‘October 1, 2013, and ending on 

September 30, 2015’’ and inserting ‘‘October 1, 2019, 

and ending on September 30, 2021’’; 

(B) in subparagraph (B)— 

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

(ii) by striking ‘‘2015’’ each place it appears and 

inserting ‘‘2021’’; and 

(C) in subparagraph (C), by striking ‘‘revised registration service fee schedules’’ and inserting ‘‘service fee schedules revised pursuant to this paragraph’’; 

(4) in paragraph (7)— 

(A) in subparagraph (A)— 

(i) by striking ‘‘covered pesticide registration’’ and 

inserting ‘‘covered application’’; and 

(ii) by inserting before the period at the end the 

following: ‘‘, except that no waiver or fee reduction 

shall be provided in connection with a request for 

a letter of certification (commonly referred to as a 

Gold Seal letter)’’; and 

(B) in subparagraph (F)(i), by striking ‘‘pesticide registration’’; and 

(5) in paragraph (8)— 

(A) in subparagraph (A), by striking ‘‘pesticide registration’’; 

(B) in subparagraph (B)(i), by striking ‘‘pesticide registration’’; and 

(C) in subparagraph (C)— 

(i) in clause (i), by striking ‘‘pesticide registration’’ 

and inserting ‘‘covered’’; and 

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

(b) PESTICIDE REGISTRATION FUND SET-ASIDES FOR WORKER

PROTECTION, PARTNERSHIP GRANTS, AND PESTICIDE SAFETY EDUCATION.—Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, 

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

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

AND PESTICIDE SAFETY EDUCATION’’ after ‘‘WORKER PROTECTION’’; 

(2) in clause (i)— 

(A) by striking ‘‘2017’’ and inserting ‘‘2023’’; and 

(B) by inserting before the period at the end the following:‘‘, with an emphasis on field-worker populations in 

the United States’’; 

(3) in clause (ii), by striking ‘‘2017’’ and inserting ‘‘2023’’; 

and 

(4) in clause (iii), by striking ‘‘2017’’ and inserting ‘‘2023’’. 

(c) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS.— 

Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide 

Act (7 U.S.C. 136w–8(e)) is amended— 
S. 483—6 

(1) by striking ‘‘Pesticide Registration Improvement Extension Act of 2012’’ and inserting ‘‘Pesticide Registration Improvement Extension Act of 2018’’; and 

(2) by inserting at the end the following new sentence: 

‘‘Such reforms shall include identifying opportunities for 

streamlining review processes for applications for a new active 

ingredient or a new use and providing prompt feedback to 

applicants during such review process.’’. 

(d) DECISION TIME REVIEW PERIODS.—Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w– 

8(f)) is amended— 

(1) in paragraph (1)— 

(A) by striking ‘‘Pesticide Registration Improvement 

Extension Act of 2012’’ and inserting ‘‘Pesticide Registration Improvement Extension Act of 2018’’; and 

(B) by inserting after ‘‘covered pesticide registration 

actions’’ the following: ‘‘or for any other action covered 

by a table specified in subsection (b)(3)’’; 

(2) in paragraph (3), by striking subparagraph (C) and 

inserting the following new subparagraph: 

‘‘(C) applications for any other action covered by a 

table specified in subsection (b)(3).’’; and 

(3) in paragraph (4)(A)— 

(A) by striking ‘‘a pesticide registration application’’ 

and inserting ‘‘a covered application’’; and 

(B) by striking ‘‘covered pesticide registration application’’ and inserting ‘‘covered application’’. 

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

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) 

is amended— 

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

and 

(2) in paragraph (2)— 

(A) in subparagraph (D), by striking clause (i) and 

inserting the following new clause: 

‘‘(i) the number of pesticides or pesticide cases 

reviewed and the number of registration review 

decisions completed, including— 

‘‘(I) the number of cases cancelled; 

‘‘(II) the number of cases requiring risk mitigation measures; 

‘‘(III) the number of cases removing risk mitigation measures; 

‘‘(IV) the number of cases with no risk mitigation needed; and 

‘‘(V) the number of cases in which risk mitigation has been fully implemented;’’; 

(B) in subparagraph (G)— 

(i) in clause (i)— 

(I) by striking ‘‘section 4(k)(4)’’ and inserting 

‘‘paragraphs (4) and (5) of section 4(k)’’; and 

(II) by striking ‘‘that section’’ and inserting 

‘‘such paragraphs’’; 

(ii) by striking clauses (ii), (iii), (iv), (v), and (vi); 

(iii) by inserting after clause (i) the following new 

clause: 

‘‘(ii) implementing enhancements to— 
S. 483—7 

‘‘(I) the electronic tracking of covered applications; 

‘‘(II) the electronic tracking of conditional registrations; 

‘‘(III) the endangered species database; 

‘‘(IV) the electronic review of labels submitted 

with covered applications; and 

‘‘(V) the electronic review and assessment of 

confidential statements of formula submitted with 

covered applications; and’’; and 

(iv) by redesignating clause (vii) as clause (iii); 

(C) in subparagraph (I), by striking ‘‘and’’ at the end; 

(D) in subparagraph (J), by striking the period at the 

end and inserting a semicolon; and 

(E) by adding at the end the following new subparagraphs: 

‘‘(K) a review of the progress made in developing, 

updating, and implementing product performance test 

guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and, by regulation, prescribing product performance 

data requirements for such pesticide products registered 

under section 3; 

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

review and approval of new pesticides to control invertebrate public health pests that may transmit vector-borne 

disease for use in the United States, including each territory or possession of the United States, and United States 

military installations globally; 

‘‘(M) a review of the progress made in implementing 

enhancements to the good laboratory practices standards 

compliance monitoring program established under part 160 

of title 40 of the Code of Federal Regulations (or successor 

regulations); 

‘‘(N) the number of approvals for active ingredients, 

new uses, and pesticide end use products granted in connection with the Design for the Environment program (or 

any successor program) of the Environmental Protection 

Agency; and 

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

Fund reserved under subsection (c)(3), a review that 

includes— 

‘‘(i) a description of the amount and use of such 

funds— 

‘‘(I) to carry out activities relating to worker 

protection under clause (i) of subsection (c)(3)(B); 

‘‘(II) to award partnership grants under clause 

(ii) of such subsection; and 

‘‘(III) to carry out the pesticide safety education program under clause (iii) of such subsection; 

‘‘(ii) an evaluation of the appropriateness and 

effectiveness of the activities, grants, and program 

described in clause (i); 

‘‘(iii) a description of how stakeholders are engaged 

in the decision to fund such activities, grants, and 

program; and 
S. 483—8 

‘‘(iv) with respect to activities relating to worker 

protection carried out under subparagraph (B)(i) of 

such subsection, a summary of the analyses from stakeholders, including from worker community-based 

organizations, on the appropriateness and effectiveness 

of such activities.’’. 

(f) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w– 

8(m)) is amended— 

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

‘‘2023’’; and 

(2) in paragraph (2)— 

(A) in subparagraph (A)— 

(i) by striking ‘‘FISCAL YEAR 2018.—During fiscal 

year 2018’’ and inserting ‘‘FISCAL YEAR 2024.—During 

fiscal year 2024’’; and 

(ii) by striking ‘‘2017’’ and inserting ‘‘2023’’; 

(B) in subparagraph (B)— 

(i) by striking ‘‘FISCAL YEAR 2019.—During fiscal 

year 2019’’ and inserting ‘‘FISCAL YEAR 2025.—During 

fiscal year 2025’’; and 

(ii) by striking ‘‘2017’’ and inserting ‘‘2023’’; 

(C) in subparagraph (C), by striking ‘‘SEPTEMBER 30, 

2019.—Effective September 30, 2019’’ and inserting ‘‘SEP- TEMBER 30, 2025.—Effective September 30, 2025’’; and 

(D) in subparagraph (D), by striking ‘‘2017’’ both places 

it appears and inserting ‘‘2023’’. 

SEC. 6. REVISION OF TABLES REGARDING COVERED PESTICIDE REGISTRATION APPLICATIONS AND OTHER COVERED ACTIONS 

AND THEIR CORRESPONDING REGISTRATION SERVICE FEES. 

Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended to 

read as follows: 

‘‘(3) SCHEDULE OF COVERED APPLICATIONS AND OTHER

ACTIONS AND THEIR REGISTRATION SERVICE FEES.—Subject to 

paragraph (6), the schedule of registration applications and 

other covered actions and their corresponding registration 

service fees shall be as follows: 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS 

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 
S. 483—9 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

R040 3 New Active Ingredient, Food 

use; Experimental Use 

Permit application; establish temporary 

tolerance; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

18 462,502 

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

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

risk. (2)(3) 

16 436,004 

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

Permit application; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

16 323,690 
S. 483—10 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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

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

risk. (2)(3) 

14 242,495 

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

Permit application; submitted before 

application for 

registration; 

credit 45% of 

fee toward 

new active ingredient application that follows. (3) 

18 182,327 

R122 10 Enriched isomer(s) of registered mixedisomer active 

ingredient. 

(2)(3) 

18 317,128 

R123 11 New Active Ingredient, Seed 

treatment 

only; includes 

agricultural 

and non-agricultural seeds; 

residues not 

expected in 

raw agricultural commodities. (2)(3) 

18 471,861 
S. 483—11 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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. 

(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. 
S. 483—12 

(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 

R155 16 (new) First food use, 

Experimental 

Use Permit 

application; 

a.i. registered 

for non-food 

outdoor use. 

(3)(4) 

21 264,253 

R160 17 First food use; 

reduced risk. 

(2)(3) 

16 264,253 

R170 18 Additional food 

use. (3) (4) 

15 79,349 
S. 483—13 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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 

R210 23 Additional food 

use; Experimental Use 

Permit application; establish temporary 

tolerance; no 

credit toward 

new use registration. (3)(4) 

12 48,986 
S. 483—14 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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); noncrop destruct 

basis. (3) 

8 19,838 

R260 29 New use; nonfood; indoor. 

(3) (4) 

12 15,317 

R270 30 New use; nonfood; indoor; 

reduced risk. 

(3)(4) 

9 12,764 
S. 483—15 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

R271 31 New use; nonfood; indoor; 

Experimental 

Use Permit 

application; no 

credit toward 

new use registration. (3)(4) 

6 9,725 

R273 32 Additional use; 

seed treatment; limited 

uptake into 

Raw Agricultural Commodities; includes 

crops with established tolerances (e.g., 

for soil or 

foliar application); includes 

food and/or 

non-food uses. 

(3)(4) 

12 50,445 

R274 33 Additional uses; 

seed treatment 

only; 6 or 

more submitted in one 

application; 

limited uptake 

into raw agricultural commodities; includes crops 

with established tolerances (e.g., for 

soil or foliar 

application); 

includes food 

and/or nonfood uses. 

(3)(4) 

12 302,663 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 
S. 483—16 

(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. 
S. 483—17 

(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 

R291 36 Establish import 

tolerances; additional food 

uses; 6 or 

more crops 

submitted in 

one petition. 

15 382,886 
S. 483—18 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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 

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 

plant-back restrictions; applicant-initiated. (3) (4) 

15 66,124 
S. 483—19 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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 

plant-back 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 

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 
S. 483—20 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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. 
S. 483—21 

(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. 
S. 483—22 

‘‘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 manufacturing-use 

product that requires no data 

submission nor 

data matrix. 

(2)(3) 

4 1,582 
S. 483—23 

‘‘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 
S. 483—24 

‘‘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 
S. 483—25 

‘‘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 
S. 483—26 

‘‘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 
S. 483—27 

‘‘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 
S. 483—28 

‘‘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 
S. 483—29 

‘‘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 
S. 483—30 

‘‘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 
S. 483—31 

‘‘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 
S. 483—32 

‘‘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 manufacturing-use 

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 
S. 483—33 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

R333 58 New product; 

MUP or End 

use product 

with unregistered source of 

active ingredient; requires 

science data review; new physical form; etc. 

Cite-all or selective data citation where 

applicant owns 

all required 

data. (2)(3) 

10 19,838 

R334 59 New product; 

MUP or End 

use product 

with unregistered source of 

the active ingredient; requires science 

data review; 

new physical 

form; etc. Selective data citation. (2)(3) 

11 23,100 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending 

with the Agency for review, will be considered an application for a new 

product with an unregistered source of active ingredient. 
S. 483—34 

(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. 
S. 483—35 

‘‘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 
S. 483—36 

‘‘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. 
S. 483—37 

(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 
S. 483—38 

‘‘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; applicant-initiated. 18 198,250 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

‘‘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 
S. 483—39 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

A390 72 New Active Ingredient; Direct 

Food use; establish tolerance or tolerance exemption 

if required. 

(2)(3) 

24 229,733 

A410 73 New Active Ingredient Non-food 

use.(2)(3) 

21 229,733 

A431 74 New Active Ingredient, Non-food 

use; low-risk. 

(2)(3) 

12 80,225 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the 

base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or 

first food use application. The application must be received by the agency 

in one package. The base fee for the category covers a maximum of five 

new products. Each application for an additional new product registration 

and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new 

active ingredient or first food use decision review time. In the case of a 

new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be 

deemed a new active ingredient application, subject to the registration 

service fee and decision review time for a new active ingredient. In the 

case of a first food use application, until that first food use is approved, 

any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first 

food use. Any information that (a) was neither requested nor required by 

the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency 

screening, and (c) is not itself a covered registration application, must be 

assessed 25% of the full registration service fee for the new active ingredient or first food use application. 
S. 483—40 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
S. 483—41 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

A451 78 Additional Direct 

food uses; establish tolerances 

or tolerance exemptions if required; 6 or 

more submitted 

in one application. (3)(4)(5) 

21 182,335 

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

A501 80 New use, nonfood; 6 or more 

submitted in 

one application. 

(4)(5) 

15 76,583 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the 

base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or 

first food use application. The application must be received by the agency 

in one package. The base fee for the category covers a maximum of five 

new products. Each application for an additional new product registration 

and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new 

active ingredient or first food use decision review time. In the case of a 

new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be 

deemed a new active ingredient application, subject to the registration 

service fee and decision review time for a new active ingredient. In the 

case of a first food use application, until that first food use is approved, 

any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first 

food use. Any information that (a) was neither requested nor required by 

the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency 

screening, and (c) is not itself a covered registration application, must be 

assessed 25% of the full registration service fee for the new active ingredient or first food use application. 
S. 483—42 

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where 

such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective 

date of the rule. 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 

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

labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) 

that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if 

a new use application only proposes to register the new use for a new 

product and there are no amendments in the application, then review of 

one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new 

use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of 

the new use application and (b) prior to conclusion of its decision review 

time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new 

decision review time for a new use. If the new-use application includes 

non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the 

appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any 

information that (a) was neither requested nor required by the Agency, 

and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and 

(c) is not itself a covered registration application, must be assessed 25% of 

the full registration service fee for the new use application. 
S. 483—43 

‘‘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 
S. 483—44 

‘‘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 
S. 483—45 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS 

AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

A532 83 New product; 

identical or 

substantially 

similar in 

composition 

and use to a 

registered 

product; registered active 

ingredient; unregistered 

source of active ingredient; cite-all 

data citation 

except for 

product chemistry; product 

chemistry 

data submitted. (2)(3) 

5 5,107 

A540 84 New end use 

product; 

FIFRA 

§2(mm) uses 

only; up to 25 

public health 

organisms. 

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

5 5,107 

A541 85 (new) New end use 

product; 

FIFRA 

§2(mm) uses 

only; 26–50 

public health 

organisms. 

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

7 8,500 

A542 86 (new) New end use 

product; 

FIFRA 

§2(mm) uses 

only; ≥ 51 public health organisms. 

(2)(3)(5) 

10 15,000 
S. 483—46 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS 

AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

A550 87 New end-use 

product; uses 

other than 

FIFRA 

§2(mm); nonFQPA product. 

(2)(3)(5) 

9 13,226 

A560 88 New manufacturing use 

product; registered active 

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

6 12,596 

A565 89 (new) New manufacturing-use 

product; registered active 

ingredient; unregistered 

source of active ingredient; submission of new generic data 

package; registered uses 

only; requires 

science review. 

(2)(3) 

12 18,234 

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 
S. 483—47 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS 

AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

A574 92 (new) Label amendment requiring data review; ≥ 51 

public health 

organisms. 

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

9 11,000 

A572 93 New Product or 

amendment 

requiring data 

review for risk 

assessment by 

Science 

Branch (e.g., 

changes to 

REI, or PPE, 

or use rate). 

(2)(3)(4) 

9 13,226 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending 

with the Agency for review, will be considered an application for a new 

product with an unregistered source of active ingredient. 

(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. 
S. 483—48 

(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. 

(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 
S. 483—49 

‘‘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 

($) 

A521 95 Review of public 

health efficacy 

study protocol 

within AD, per 

AD Internal 

Guidance for 

the Efficacy 

Protocol Review Process; 

Code will also 

include review 

of public 

health efficacy 

study protocol 

and data review for devices making 

pesticidal 

claims; applicant-initiated; 

Tier 1. 

4 4,726 

A522 96 Review of public 

health efficacy 

study protocol 

outside AD by 

members of 

AD Efficacy 

Protocol Review Expert 

Panel; Code 

will also include review 

of public 

health efficacy 

study protocol 

and data review for devices making 

pesticidal 

claims; applicant-initiated; 

Tier 2. 

12 12,156 
S. 483—50 

‘‘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 

($) 

A537 97 (new) New Active Ingredient/New 

Use, Experimental Use 

Permit application; Direct 

food use; Establish tolerance or tolerance exemption if required. Credit 

45% of fee toward new active ingredient/new use 

application 

that follows. 

18 153,156 

A538 98 (new) New Active Ingredient/New 

Use, Experimental Use 

Permit application; Indirect food use; 

Establish tolerance or tolerance exemption if required Credit 

45% of fee toward new active ingredient/new use 

application 

that follows. 

18 95,724 
S. 483—51 

‘‘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 

($) 

A539 99 (new) New Active Ingredient/New 

Use, Experimental Use 

Permit application; 

Nonfood use. 

Credit 45% of 

fee toward 

new active ingredient/new 

use application that follows. 

15 92,163 

A529 100 Amendment to 

Experimental 

Use Permit; 

requires data 

review or risk 

assessment. 

(2) 

9 11,429 

A523 101 Review of protocol other 

than a public 

health efficacy 

study (i.e., 

Toxicology or 

Exposure Protocols). 

9 12,156 

A571 102 Science reassessment: Cancer 

risk, refined 

ecological risk, 

and/or endangered species; 

applicant-initiated. 

18 95,724 

A533 103 

(new) 

Exemption from 

the requirement of an Experimental 

Use Permit. 

(2) 

4 2,482 
S. 483—52 

‘‘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 

($) 

A534 104 

(new) 

Rebuttal of 

agency reviewed protocol, applicant initiated. 

4 4,726 

A535 105 

(new) 

Conditional Ruling on Pre-application 

Study Waiver 

or Data Bridging Argument; 

applicant-initiated. 

6 2,409 

A536 106 

(new) 

Conditional Ruling on Pre-application Direct Food, Indirect Food, 

Nonfood use 

determination; 

applicant-initiated. 

4 2,482 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(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. 
S. 483—53 

‘‘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; nonfood use. (2)(3) 13 19,146 

B610 110 New active ingredient; Experimental 

Use Permit 

application; 

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

10 12,764 

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 
S. 483—54 

‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

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. 

(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. 
S. 483—55 

(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 

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 
S. 483—56 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B644 120 New use, no 

change to an 

established 

tolerance or 

tolerance exemption. (3)(4) 

8 12,764 

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

B645 122 

(new) 

New food use; 

Experimental 

Use Permit 

application; 

petition to 

amend or add 

a tolerance exemption. (4) 

12 12,764 

B646 123 

(new) 

New use; nonfood use including crop 

destruct; Experimental 

Use Permit 

application. (4) 

7 6,383 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 
S. 483—57 

(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. 
S. 483—58 

(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. 
S. 483—59 

‘‘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 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 12,764 
S. 483—60 

‘‘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 end-use 

or manufacturing-use product that requires no data 

submission or 

data matrix. 

For microbial 

pesticides, the 

active ingredient(s) must 

not be re-isolated. (2)(3) 

4 1,278 
S. 483—61 

‘‘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 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) 

7 5,107 
S. 483—62 

‘‘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 
S. 483—63 

‘‘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 
S. 483—64 

‘‘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 
S. 483—65 

‘‘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 
S. 483—66 

‘‘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. 
S. 483—67 

‘‘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 
S. 483—68 

‘‘TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service 

Fee 

($) 

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 sitespecific 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. 

(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. 
S. 483—69 

‘‘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 
S. 483—70 

‘‘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% 

re-package of 

registered 

end-use or 

manufacturing-use 

product that 

requires no 

data submission or data 

matrix. (3)(6) 

4 1,278 
S. 483—71 

‘‘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 

scientificallysound rationale explaining 

why the data 

requirement 

does not 

apply. (3)(6) 

5 1,278 
S. 483—72 

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B721 147 New product; 

unregistered 

source of active ingredient. (3)(6) 

7 2,676 

B722 148 New use and/or 

amendment; 

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

7 2,477 

B730 149 Label amendment requiring data submission. (4)(6) 5 1,278 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the 

base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or 

first food use application. The application must be received by the agency 

in one package. The base fee for the category covers a maximum of five 

new products. Each application for an additional new product registration 

and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new 

active ingredient or first food use decision review time. In the case of a 

new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be 

deemed a new active ingredient application, subject to the registration 

service fee and decision review time for a new active ingredient. In the 

case of a first food use application, until that first food use is approved, 

any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first 

food use. Any information that (a) was neither requested nor required by 

the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency 

screening, and (c) is not itself a covered registration application, must be 

assessed 25% of the full registration service fee for the new active ingredient or first food use application. 

(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending 

with the Agency for review, will be considered an application for a new 

product with an unregistered source of active ingredient. 
S. 483—73 

(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are 

not subject to registration service fees. (c) Registrant-initiated fast-track 

amendments handled by the Antimicrobials Division are to be completed 

within the timelines specified in FIFRA Section 3(h) and are not subject to 

registration service fees. (d) Registrant initiated amendments submitted by 

notification under PR Notices, such as PR Notice 98–10, continue under 

PR Notice timelines and are not subject to registration service fees. (e) 

Submissions with data and requiring data review are subject to registration service fees. 

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

labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) 

that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if 

a new use application only proposes to register the new use for a new 

product and there are no amendments in the application, then review of 

one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new 

use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of 

the new use application and (b) prior to conclusion of its decision review 

time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new 

decision review time for a new use. If the new-use application includes 

non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the 

appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any 

information that (a) was neither requested nor required by the Agency, 

and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and 

(c) is not itself a covered registration application, must be assessed 25% of 

the full registration service fee for the new use application. 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 
S. 483—74 

‘‘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 

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. 
S. 483—75 

‘‘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 
S. 483—76 

‘‘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 
S. 483—77 

‘‘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 
S. 483—78 

‘‘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 
S. 483—79 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B810 163 Registration application; new (2) 

PIP; with petition to establish 

permanent tolerance/tolerance 

exemption for 

the active ingredient based on 

an existing temporary tolerance/ 

tolerance exemption. SAP review. 

(5)(12) 

19 236,114 

B820 164 Registration application; new (2) 

PIP; with petition to establish 

or amend a permanent tolerance/tolerance 

exemption of an 

active ingredient. 

(12) 

15 204,208 

B840 165 Registration application; new (2) 

PIP; with petition to establish 

or amend a permanent tolerance/tolerance 

exemption of an 

active ingredient. 

SAP review. 

(5)(12) 

21 268,022 
S. 483—80 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B851 166 Registration application; new event 

of a previously 

registered PIP 

active ingredient(s); no petition since permanent tolerance/ 

tolerance exemption is already 

established for 

the active ingredient(s). (12) 

9 127,630 

B870 167 Registration application; registered 

(3) PIP; new 

product; new use; 

no petition since 

a permanent tolerance/tolerance 

exemption is already established 

for the active ingredient(s). (4) 

(12) 

9 38,290 

B880 168 Registration application; registered 

(3) PIP; new 

product or new 

terms of registration; additional 

data submitted; 

no petition since 

a permanent tolerance/tolerance 

exemption is already established 

for the active ingredient(s). (6) 

(7) (12) 

9 31,910 
S. 483—81 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B881 169 Registration application; registered 

(3) PIP; new 

product or new 

terms of registration; additional 

data submitted; 

no petition since 

a permanent tolerance/tolerance 

exemption is already established 

for the active ingredient(s). SAP 

review. 

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

15 95,724 

B882 170 

(new) 

Registration application; new (2) 

PIP, seed increase with negotiated acreage 

cap and timelimited registration; with petition to establish 

a permanent tolerance/tolerance 

exemption for 

the active ingredient based on 

an existing temporary tolerance/ 

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

15 191,444 
S. 483—82 

‘‘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 timelimited registration; with petition to establish 

a permanent tolerance/tolerance 

exemption for 

the active ingredient based on 

an existing temporary tolerance/ 

tolerance exemption. (8) (12) 

9 127,630 

B884 172 Registration application; new (2) 

PIP, seed increase with negotiated acreage 

cap and timelimited registration; with petition to establish 

a permanent tolerance/tolerance 

exemption for 

the active ingredient. (8)(12) 

12 159,537 

B885 173 Registration application; registered 

(3) PIP, seed increase; breeding 

stack of previously approved 

PIPs, same crop; 

no petition since 

a permanent tolerance/tolerance 

exemption is already established 

for the active ingredient(s). 

(9)(12) 

6 31,910 
S. 483—83 

‘‘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 timelimited registration; with petition to establish 

a permanent tolerance/tolerance 

exemption for 

the active ingredient. SAP Review. (8) (12) 

18 223,351 

B890 175 Application to 

amend a seed increase registration; converts 

registration to 

commercial registration; no petition since permanent tolerance/ 

tolerance exemption is already 

established for 

the active ingredient(s). (12) 

9 63,816 

B891 176 Application to 

amend a seed increase registration; converts 

registration to a 

commercial registration; no petition since a permanent tolerance/tolerance 

exemption already established 

for the active ingredient(s); SAP 

review. (5)(12) 

15 127,630 
S. 483—84 

‘‘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 
S. 483—85 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

B906 183 

(new) 

Petition to establish a temporary 

tolerance/tolerance exemption 

for one or more 

active ingredients. 

3 31,907 

B907 184 

(new) 

Petition to establish a temporary 

tolerance/tolerance exemption 

for one or more 

active ingredients based on an 

existing temporary tolerance/ 

tolerance exemption. 

3 12,764 

B908 185 

(new) 

Petition to establish a temporary 

tolerance/tolerance exemption 

for one or more 

active ingredients or inert ingredients. 

3 44,671 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) New PIP = a PIP with an active ingredient that has not been registered. 

(3) Registered PIP = a PIP with an active ingredient that is currently 

registered. 

(4) Transfer registered PIP through conventional breeding for new food/ 

feed use, such as from field corn to sweet corn. 

(5) The scientific data involved in this category are complex. EPA often 

seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding 

new technologies. The scientists of the SAP neither make nor recommend 

policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time 

it takes to schedule and prepare for meetings with the SAP, additional 

time and costs are needed. 

(6) Registered PIPs stacked through conventional breeding. 

(7) Deployment of a registered PIP with a different IRM plan (e.g., seed 

blend). 
S. 483—86 

(8) The negotiated acreage cap will depend upon EPA’s determination of 

the potential environmental exposure, risk(s) to non-target organisms, and 

the risk of targeted pest developing resistance to the pesticidal substance. 

The uncertainty of these risks may reduce the allowable acreage, based 

upon the quantity and type of non-target organism data submitted and the 

lack of insect resistance management data, which is usually not required 

for seed-increase registrations. Registrants are encouraged to consult with 

EPA prior to submission of a registration application in this category. 

(9) Application can be submitted prior to or concurrently with an application for commercial registration. 

(10) For example, IRM plan modifications that are applicant-initiated. 

(11) EPA-initiated amendments shall not be charged fees. 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 

‘‘TABLE 18. — INERT INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

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 
S. 483—87 

‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

I004 189 Approval of new 

non-food use 

inert ingredient. (2) 

6 11,025 

I005 190 Amend currently 

approved nonfood use inert 

ingredient with 

new use pattern; new data. 

(2) 

6 5,513 

I006 191 Amend currently 

approved nonfood use inert 

ingredient with 

new use pattern; no new 

data. (2) 

3 3,308 

I007 192 Approval of substantially similar non-food 

use inert ingredients when 

original inert is 

compositionally 

similar with 

similar use 

pattern. (2) 

4 1,654 

I008 193 Approval of new 

or amended 

polymer inert 

ingredient, food 

use. (2) 

5 3,749 

I009 194 Approval of new 

or amended 

polymer inert 

ingredient, 

non-food use. 

(2) 

4 3,087 
S. 483—88 

‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

I010 195 Petition to amend 

a single tolerance exemption 

descriptor, or 

single non-food 

use descriptor, 

to add ≤ 10 

CASRNs; no 

new data. (2) 

6 1,654 

I011 196 

(new) 

Approval of new 

food use 

safener with 

tolerance or exemption from 

tolerance. (2)(8) 

24 597,683 

I012 197 

(new) 

Approval of new 

non-food use 

safener. (2)(8) 

21 415,241 

I013 198 

(new) 

Approval of additional food use 

for previously 

approved 

safener with 

tolerance or exemption from 

tolerance. (2) 

15 62,975 

I014 199 

(new) 

Approval of additional non-food 

use for previously approved safener. 

(2) 

15 25,168 

I015 200 

(new) 

Approval of new 

generic data for 

previously approved food use 

safener. (2) 

24 269,728 
S. 483—89 

‘‘TABLE 18. — INERT INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months)(1)

Registration 

Service Fee 

($) 

I016 201 

(new) 

Approval of 

amendment(s) 

to tolerance 

and label for 

previously approved safener. 

(2) 

13 55,776 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to 

its respective registration service fee. The decision review time line for 

both submissions will be the longest of the associated applications. If the 

application covers multiple ingredients grouped by EPA into one chemical 

class, a single registration service fee will be assessed for approval of those 

ingredients. 

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where 

such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective 

date of the rule. 

(4) Any other covered application that is associated with and dependent 

on the HSRB review will be subject to its separate registration service fee. 

The decision review times for the associated actions run concurrently, but 

will end at the date of the latest review time. 

(5) Any other covered application that is associated with and dependent 

on the SAP review will be subject to its separate registration service fee. 

The decision review time for the associated action will be extended by the 

decision review time for the SAP review. 

(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending 

with the Agency for review, will be considered an application for a new 

product with an unregistered source of active ingredient. 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 
S. 483—90 

(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 
S. 483—91 

‘‘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 
S. 483—92 

‘‘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 
S. 483—93 

‘‘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 
S. 483—94 

‘‘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. 
S. 483—95 

(4) Any other covered application that is associated with and dependent 

on the HSRB review will be subject to its separate registration service fee. 

The decision review times for the associated actions run concurrently, but 

will end at the date of the latest review time. 

(5) Any other covered application that is associated with and dependent 

on the SAP review will be subject to its separate registration service fee. 

The decision review time for the associated action will be extended by the 

decision review time for the SAP review. 

(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending 

with the Agency for review, will be considered an application for a new 

product with an unregistered source of active ingredient. 

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

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

the applicant a draft accepted label, including any changes made by the 

Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency 

that the applicant either (a) agrees to all of the terms associated with the 

draft accepted label as amended by the Agency and requests that it be 

issued as the accepted final Agency-stamped label; or (b) does not agree to 

one or more of the terms of the draft accepted label as amended by the 

Agency and requests additional time to resolve the difference(s); or (c) 

withdraws the application without prejudice for subsequent resubmission, 

but forfeits the associated registration service fee. For cases described in 

(b), the applicant shall have up to 30 calendar days to reach agreement 

with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted 

final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to 

the Agency. 

(8) Due to low fee and short time frame this category is not eligible for 

small business waivers. Gold seal applies to one registered product. 

(9) This category includes amendments the sole purpose of which is to 

add DfE (or equivalent terms that do not use ‘‘safe’’ or derivatives of 

‘‘safe’’) logos to a label. DfE is a voluntary program. A label bearing a DfE 

logo is not considered an Agency endorsement because the ingredients in 

the qualifying product must meet objective, scientific criteria established 

and widely publicized by EPA.’’. 

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

(a) IN GENERAL.—Except as provided in subsection (b), during 

the period beginning on the date of enactment of this Act and 

ending not earlier than October 1, 2021, the Administrator of the 

Environmental Protection Agency (referred to in this section as 

the ‘‘Administrator’’)— 

(1) shall carry out— 

(A) the final rule of the Administrator entitled ‘‘Pesticides; Agricultural Worker Protection Standard Revisions’’ 

(80 Fed. Reg. 67496 (November 2, 2015)); and 

(B) the final rule of the Administrator entitled ‘‘Pesticides; Certification of Pesticide Applicators’’ (82 Fed. Reg. 

952 (January 4, 2017)); and 

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

described in subparagraphs (A) and (B) of paragraph (1). 

(b) EXCEPTIONS.—Prior to October 1, 2021, the Administrator 

may propose, and after a notice and public comment period of 

not less than 90 days, promulgate revisions to the final rule 

described in subsection (a)(1)(A) addressing application exclusion 

zones under part 170 of title 40, Code of Federal Regulations, 
S. 483—96 

consistent with the Federal Insecticide, Fungicide, and Rodenticide 

Act (7 U.S.C. 136 et seq.). 

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

States shall— 

(1) conduct a study on the use of the designated representative, including the effect of that use on the availability of 

pesticide application and hazard information and worker health 

and safety; and 

(2) not later than October 1, 2021, make publically available 

a report describing the study under paragraph (1), including 

any recommendations to prevent the misuse of pesticide 

application and hazard information, if that misuse is identified. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.