II 
Calendar No. 163 
115TH CONGRESS 
1ST SESSION H. R. 1029 
IN THE SENATE OF THE UNITED STATES 
MARCH 21, 2017 
Received; read twice and referred to the Committee on Agriculture, Nutrition, 
and Forestry 
JUNE 29, 2017 
Reported by Mr. ROBERTS, with amendments 
[Omit the part struck through and insert the part printed in italic] 
AN ACT 
To 
amend 
the 
Federal 
Insecticide, 
Fungicide, 
and 
Rodenticide Act to improve pesticide registration and 
other activities under the Act, to extend and modify 
fee authorities, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pesticide Registration Enhancement Act of 2017’’. ‘‘Pes-
ticide Registration Improvement Extension Act of 2017’’. 
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(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. Effective date. 
SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE 
FEE AUTHORITY. 
(a) MAINTENANCE FEE.—Section 4(i)(1) of the Fed-
eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
136a–1(i)(1)) is amended— 
(1) in subparagraph (C), by striking ‘‘an aggre-
gate amount of $27,800,000 for each of fiscal years 
2013 through 2017’’ and inserting ‘‘an average 
amount of $31,000,000 for each of fiscal years 2017 
through 2023 2018 through 2020’’; 
(2) in subparagraph (D)— 
(A) in clause (i), by striking ‘‘$115,500 for 
each of fiscal years 2013 through 2017’’ and 
inserting ‘‘$129,400 for each of fiscal years 
2017 through 2023 2018 through 2020’’; and 
(B) in clause (ii), by striking ‘‘$184,800 
for each of fiscal years 2013 through 2017’’ 
and inserting ‘‘$207,000 for each of fiscal years 
2017 through 2023 2018 through 2020’’; 
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(3) in subparagraph (E)(i)— 
(A) in subclause (I), by striking ‘‘$70,600 
for each of fiscal years 2013 through 2017’’ 
and inserting ‘‘$79,100 for each of fiscal years 
2017 through 2023 2018 through 2020’’; and 
(B) 
in 
subclause 
(II), 
by 
striking 
‘‘$122,100 for each of fiscal years 2013 
through 2017’’ and inserting ‘‘$136,800 for 
each of fiscal years 2017 through 2023 2018 
through 2020’’; and 
(4) in subparagraph (I), by striking ‘‘2017’’ 
and inserting ‘‘2023 2020’’. 
(b) PROHIBITION ON OTHER FEES.—Section 4(i)(2) 
of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136a–1(i)(2)) is amended— 
(1) by striking ‘‘during the period beginning on 
the date of enactment of this section and ending on 
September 30, 2019’’ and inserting ‘‘until Sep-
tember 30, 2025’’; and 
(1) by striking ‘‘the date of enactment of this sec-
tion and ending on September 30, 2019’’ and insert-
ing ‘‘the effective date of the Pesticide Registration 
Improvement Extension Act of 2017 and ending on 
September 30, 2022’’; and 
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(2) by inserting after ‘‘registration of a pes-
ticide 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 2020’’. 
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 fol-
lowing: ‘‘paragraph (3), to offset the costs of reg-
istration review under section 3(g), including the 
costs associated with any review under the Endan-
gered 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 
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registration review decisions, including registration 
review decisions designed to reduce risk, for the pur-
poses specified in paragraphs (4) and (5), and to en-
hance the information systems capabilities to im-
prove the tracking of pesticide registration deci-
sions.’’; 
(3) in clause (i), by striking ‘‘are allocated sole-
ly’’ and all that follows through ‘‘3(g);’’ and insert-
ing the following: ‘‘are allocated solely for the pur-
poses specified in the first sentence of this subpara-
graph;’’; and 
(4) in clause (ii), by striking ‘‘necessary to 
achieve’’ and all that follows through ‘‘3(g);’’ and in-
serting the following: ‘‘necessary to achieve the pur-
poses specified in the first sentence of this subpara-
graph;’’. 
(b) SET-ASIDE FOR REVIEW OF INERT INGREDIENTS 
AND EXPEDITED PROCESSING
OF SIMILAR APPLICA-
TIONS.—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 fol-
lows through ‘‘personnel and resources—’’ and inserting 
the following: ‘‘For each of fiscal years 2017 through 2023 
2018 through 2020, the Administrator shall use between 
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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
PERFORM-
ANCE DATA REQUIREMENTS.— 
‘‘(A) SET-ASIDE.—For each of fiscal years 
2017 through 2021 2018 through 2020, the Ad-
ministrator shall use not more than $500,000 
of the amounts made available to the Adminis-
trator in the Reregistration and Expedited 
Processing Fund for the activities described in 
subparagraph (B). 
‘‘(B) 
PRODUCTS
CLAIMING
EFFICACY 
AGAINST
INVERTEBRATE
PESTS
OF
SIGNIFI-
CANT
PUBLIC
HEALTH
OR
ECONOMIC
IMPOR-
TANCE.—The Administrator shall use amounts 
made available under subparagraph (A) to de-
velop, receive comments with respect to, final-
ize, and implement the necessary rulemaking 
and guidance for product performance data re-
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quirements to evaluate products claiming effi-
cacy against the following invertebrate pests of 
significant public health or economic impor-
tance (in order of importance): 
‘‘(i) Bed bugs. 
‘‘(ii) Premise (including crawling in-
sects, flying insects, and baits). 
‘‘(iii) Pests of pets (including pet 
pests controlled by spot-ons, collars, sham-
poos, powders, or dips). 
‘‘(iv) Fire ants. 
‘‘(C) DEADLINES
FOR
GUIDANCE.—The 
Administrator shall develop, and publish guid-
ance required by subparagraph (B) with respect 
to claims of efficacy against pests described in 
such subparagraph as follows: 
‘‘(i) With respect to bed bugs, issue 
final guidance not later than June 30, 
2017. 30 days after the effective date of the 
Pesticide Registration Improvement Exten-
sion Act of 2017. 
‘‘(ii) With respect to pests specified in 
clause (ii) of such subparagraph— 
‘‘(I) submit draft guidance to the 
Scientific Advisory Panel and for pub-
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lic comment not later than June 30, 
2018; and 
‘‘(II) complete any response to 
comments received with respect to 
such draft guidance and finalize the 
guidance not later than September 30, 
2020 2019. 
‘‘(iii) With respect to pests specified 
in clauses (iii) and (iv) of such subpara-
graph— 
‘‘(I) submit to the Scientific Ad-
visory Panel and for public comment 
draft guidance not later than June 
30, 2019; and 
‘‘(II) complete any response to 
comments received with respect to 
such draft guidance and finalize the 
guidance not later than March 31, 
2021. 
‘‘(D) REVISION.—The Administrator shall 
revise the guidance required by subparagraph 
(B) from time-to-time time to time, but shall 
permit applicants and registrants sufficient 
time to obtain data that meet the requirements 
specified in such revised guidance. 
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‘‘(E) DEADLINE FOR PRODUCT PERFORM-
ANCE
DATA
REQUIREMENTS.—The Adminis-
trator shall, not later than September 30, 2021, 
issue regulations prescribing product perform-
ance data requirements for any pesticide in-
tended for preventing, destroying, repelling, or 
mitigating any invertebrate pest of significant 
public health or economic importance specified 
in clauses (i) through (iv) of subparagraph 
(B).’’. 
(d) SET-ASIDE FOR GOOD LABORATORY PRACTICES 
INSPECTIONS.—Section 4(k) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is 
amended— 
(1) by redesignating paragraphs (5) and (6) as 
paragraphs (6) and (7), respectively; 
(2) by inserting after paragraph (4) the fol-
lowing new paragraph: 
‘‘(5) GOOD
LABORATORY
PRACTICES
INSPEC-
TIONS.— 
‘‘(A) SET-ASIDE.—For each of fiscal years 
2017 through 2023 2018 through 2020, the Ad-
ministrator shall use not more than $500,000 
of the amounts made available to the Adminis-
trator in the Reregistration and Expedited 
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Processing Fund for the activities described in 
subparagraph (B). 
‘‘(B) 
ACTIVITIES.—The 
Administrator 
shall use amounts made available under sub-
paragraph (A) for enhancements to the good 
laboratory practices standards compliance moni-
toring program established under part 160 of 
title 40 of the Code of Federal Regulations (or 
successor regulations), with respect to labora-
tory 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 insert-
ing ‘‘ 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— 
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(1) by striking ‘‘permit for a pesticide.’’ and in-
serting ‘‘permit for a pesticide. An application for an 
experimental use permit for a covered application 
under section 33(b) shall conform with the require-
ments of that section.’’; and 
(2) by inserting ‘‘(or in the case of an applica-
tion 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 appli-
cation specified in such section)’’ after ‘‘all required 
supporting data’’. 
SEC. 5. PESTICIDE REGISTRATION SERVICE FEES. 
(a) EXTENSION AND MODIFICATION OF FEE AU-
THORITY.—Section 33(b) of the Federal Insecticide, Fun-
gicide, 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 Reg-
istration Improvement Act of 2003’’; 
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(2) in paragraph (5)— 
(A) in the heading, by striking ‘‘PESTICIDE 
REGISTRATION
APPLICATIONS’’ and inserting 
‘‘COVERED APPLICATION’’; and ‘‘COVERED AP-
PLICATIONS’’; and 
(B) by striking ‘‘pesticide registration ap-
plication’’ both places it appears and inserting 
‘‘covered application’’; 
(3) in paragraph (6)— 
(A) in subparagraph (A)— 
(i)
by
striking
‘‘pesticide
registra-
tion’’; and 
(ii) by striking ‘‘October 1, 2013, and 
ending on September 30, 2015’’ and in-
serting ‘‘October 1, 2019, and ending on 
September 30, 2021’’; 
(B) in subparagraph (B)— 
(i)
by
striking
‘‘pesticide
registra-
tion’’; and 
(ii) by striking ‘‘2015’’ both places in 
appears, and inserting ‘‘2021’’; and 
(C) in 
(A) in subparagraph (A), by striking ‘‘pes-
ticide registration’’; and 
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(B) in subparagraph (C), by striking ‘‘re-
vised registration service fee schedules’’ and in-
serting ‘‘service fee schedules revised pursuant 
to this paragraph’’; 
(4) in paragraph (7)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘covered pesticide reg-
istration’’ and inserting ‘‘covered applica-
tion’’; 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 ‘‘pes-
ticide 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 
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(ii) in clause (ii)(I), by striking ‘‘pes-
ticide registration’’ and inserting ‘‘cov-
ered’’. 
(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 ‘‘, PARTNER-
SHIP GRANTS, AND PESTICIDE SAFETY EDUCATION’’ 
after ‘‘WORKER PROTECTION’’; 
(2) in clause (i)— 
(A) by striking ‘‘2017’’ and inserting 
‘‘2023 2020’’; 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 in-
serting ‘‘2023 2020’’; and 
(4) in clause (iii), by striking ‘‘2017’’ and in-
serting ‘‘2023 2020’’. 
(c) REFORMS TO REDUCE DECISION TIME REVIEW 
PERIODS.—Section 33(e) of the Federal Insecticide, Fun-
gicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is 
amended— 
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(1) by striking ‘‘Pesticide Registration Improve-
ment Extension Act of 2012’’ and inserting ‘‘Pes-
ticide Registration Enhancement Improvement Ex-
tension Act of 2017’’; and 
(2) by inserting at the end the following new 
sentence: ‘‘Such reforms shall include identifying op-
portunities for streamlining review processes for ap-
plications for a new active ingredient or a new use 
and providing prompt feedback to applicants during 
such review process.’’. 
(d) DECISION
TIME
REVIEW
PERIODS.—Section 
33(f) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136w–8(f)(1)) (7 U.S.C. 136w– 
8(f)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘Pesticide Registration Im-
provement Extension Act of 2012’’ and insert-
ing ‘‘Pesticide Registration Enhancement Im-
provement Extension Act of 2017’’; and 
(B) by inserting after ‘‘covered pesticide 
registration actions’’ the following: ‘‘or for any 
other action covered by a table specified in sub-
section (b)(3)’’; 
(2) in paragraph (3), by striking subparagraph 
(C) and inserting the following new subparagraph: 
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‘‘(C) applications for any other action cov-
ered 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 applica-
tion’’; and 
(B) by striking ‘‘covered pesticide registra-
tion application’’ and inserting ‘‘covered appli-
cation’’. 
(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 in-
serting ‘‘2023 2020’’; 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 pes-
ticide cases reviewed and the number of 
registration review decisions completed, in-
cluding— 
‘‘(I) the number of cases can-
celled; 
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‘‘(II) the number of cases requir-
ing risk mitigation measures; 
‘‘(III) the number of cases re-
moving risk mitigation measures; 
‘‘(IV) the number of cases with 
no risk mitigation needed; and 
‘‘(V) the number of cases in 
which risk mitigation has been fully 
implemented;’’; 
(B) in subparagraph (G)— 
(i) in clause (i)— 
(I) by striking ‘‘section 4(k)(4)’’ 
and inserting ‘‘paragraphs (4) and (5) 
of section 4(k)’’; and 
(II) by striking ‘‘that section’’ 
and inserting ‘‘such paragraphs’’; 
(ii) by striking clauses (ii), (iii), (iv), 
(v), and (vi); 
(iii) by inserting after clause (i) the 
following new clause: 
‘‘(ii) implementing enhancements to— 
‘‘(I) the electronic tracking of 
covered applications; 
‘‘(II) the electronic tracking of 
conditional registrations; 
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‘‘(III) the endangered species 
database; 
‘‘(IV) the electronic review of la-
bels submitted with covered applica-
tions; and 
‘‘(V) the electronic review and as-
sessment of confidential statements of 
formula submitted with covered appli-
cations; 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 de-
veloping, updating, and implementing product 
performance test guidelines for pesticide prod-
ucts that are intended to control invertebrate 
pests of significant public health importance 
and, by regulation, prescribing product per-
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formance data requirements for such pesticide 
products registered under section 3; 
‘‘(L) a review of the progress made in the 
priority review and approval of new pesticides 
to control vector-born public health pests inver-
tebrate 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 im-
plementing enhancements to the good labora-
tory practices standards compliance monitoring 
program established under part 160 of title 40 
of the Code of Federal Regulations (or suc-
cessor 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— 
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‘‘(i) a description of the amount and 
use of such funds— 
‘‘(I) to carry out activities relat-
ing 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 appropriate-
ness and effectiveness of the activities, 
grants, and program described in clause 
(i); 
‘‘(iii) a description of how stake-
holders are engaged in the decision to fund 
such activities, grants, and program; and 
‘‘(iv) with respect to activities relating 
to worker protection carried out under sub-
paragraph (B)(i) of such subsection, a 
summary of the analyses from stake-
holders, including from worker community- 
based organizations, on the appropriate-
ness and effectiveness of such activities.’’. 
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(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 2020’’; 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 ‘‘FISCAL YEAR 2021.—During 
fiscal year 2021’’; and 
(ii) by striking ‘‘2017’’ and inserting 
‘‘2023 2020’’; 
(B) in subparagraph (B)— 
(i) by striking ‘‘FISCAL YEAR 2019.— 
During fiscal year 2019’’ and inserting 
‘‘FISCAL
YEAR
2025.—During fiscal year 
2025’’; and ‘‘FISCAL YEAR 2022.—During 
fiscal year 2022’’; and 
(ii) by striking ‘‘2017’’ and inserting 
‘‘2023 2020’’; 
(C) in subparagraph (C), by striking ‘‘SEP-
TEMBER
30, 2019.—Effective September 30, 
2019’’ and inserting ‘‘SEPTEMBER 30, 2025.— 
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Effective September 30, 2025’’; and 2019’’ and 
inserting ‘‘SEPTEMBER 30, 2022.—Effective Sep-
tember 30, 2022’’; and 
(D) in subparagraph (D), by striking 
‘‘2017’’ both places it appears and inserting 
‘‘2023 2020’’. 
SEC. 6. REVISION OF TABLES REGARDING COVERED PES-
TICIDE REGISTRATION APPLICATIONS AND 
OTHER COVERED ACTIONS AND THEIR COR-
RESPONDING REGISTRATION SERVICE FEES. 
Paragraph (3) of section 33(b) of the Federal Insecti-
cide, 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 cov-
ered 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) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R010 
New Active In-
gredient, Food 
use. (2)(3) 
753,082 
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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R020 
New Active In-
gredient, Food 
use; reduced 
risk. (2)(3) 
627,568 
R040 
New Active In-
gredient, Food 
use; Experi-
mental Use 
Permit appli-
cation; estab-
lish temporary 
tolerance; sub-
mitted before 
application for 
registration; 
credit 45% of 
fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
462,502 
R060 
New Active In-
gredient, Non- 
food use; out-
door. (2)(3) 
523,205 
R070 
New Active In-
gredient, Non- 
food use; out-
door; reduced 
risk. (2)(3) 
436,004 
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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R090 
New Active In-
gredient, Non- 
food use; out-
door; Experi-
mental Use 
Permit appli-
cation; sub-
mitted before 
application for 
registration; 
credit 45% of 
fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
323,690 
R110 
New Active In-
gredient, Non- 
food use; in-
door. (2)(3) 
290,994 
R120 
New Active In-
gredient, Non- 
food use; in-
door; reduced 
risk. (2)(3) 
242,495 
R121 
New Active In-
gredient, Non- 
food use; in-
door; Experi-
mental Use 
Permit appli-
cation; sub-
mitted before 
application for 
registration; 
credit 45% of 
fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
182,327 
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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R122 
Enriched iso-
mer(s) of reg-
istered mixed- 
isomer active 
ingredient. 
(2)(3) 
317,128 
R123 
New Active In-
gredient, Seed 
treatment 
only; includes 
agricultural 
and non-agri-
cultural seeds; 
residues not 
expected in 
raw agricul-
tural commod-
ities. (2)(3) 
471,861 
R125 
New Active In-
gredient, Seed 
treatment; Ex-
perimental 
Use Permit 
application; 
submitted be-
fore applica-
tion for reg-
istration; cred-
it 45% of fee 
toward new 
active ingre-
dient applica-
tion that fol-
lows. (3) 
323,690 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R130 
First food use; 
indoor; food/ 
food handling. 
(2) (3) 
191,444 
R140 
Additional food 
use; Indoor; 
food/food han-
dling. (3) (4) 
44,672 
R150 
First food use. 
(2)(3) 
317,104 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R155 
16 (new) 
First food use, 
Experimental 
Use Permit ap-
plication; a.i. 
registered for 
non-food out-
door use. 
(3)(4) 
264,253 
R160 
First food use; 
reduced risk. 
(2)(3) 
264,253 
R170 
Additional food 
use. (3) (4) 
79,349 
R175 
Additional food 
uses covered 
within a crop 
group resulting 
from the con-
version of ex-
isting approved 
crop group(s) 
to one or more 
revised crop 
groups. (3)(4) 
66,124 
R180 
Additional food 
use; reduced 
risk. (3)(4) 
66,124 
R190 
Additional food 
uses; 6 or 
more sub-
mitted in one 
application. 
(3)(4) 
476,090 
R200 
Additional Food 
Use; 6 or more 
submitted in 
one applica-
tion; Reduced 
Risk. (3)(4) 
396,742 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R210 
Additional food 
use; Experi-
mental Use 
Permit applica-
tion; establish 
temporary tol-
erance; no 
credit toward 
new use reg-
istration. 
(3)(4) 
48,986 
R220 
Additional food 
use; Experi-
mental Use 
Permit applica-
tion; crop de-
struct basis; no 
credit toward 
new use reg-
istration. 
(3)(4) 
19,838 
R230 
Additional use; 
non-food; out-
door. (3) (4) 
31,713 
R240 
Additional use; 
non-food; out-
door; reduced 
risk. (3)(4) 
26,427 
R250 
Additional use; 
non-food; out-
door; Experi-
mental Use 
Permit applica-
tion; no credit 
toward new 
use registra-
tion. (3)(4) 
19,838 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R251 
Experimental 
Use Permit ap-
plication which 
requires no 
changes to the 
tolerance(s); 
non-crop de-
struct basis. 
(3) 
19,838 
R260 
New use; non- 
food; indoor. 
(3) (4) 
15,317 
R270 
New use; non- 
food; indoor; 
reduced risk. 
(3)(4) 
12,764 
R271 
New use; non- 
food; indoor; 
Experimental 
Use Permit ap-
plication; no 
credit toward 
new use reg-
istration. 
(3)(4) 
9,725 
R273 
Additional use; 
seed treatment; 
limited uptake 
into Raw Agri-
cultural Com-
modities; in-
cludes crops 
with estab-
lished toler-
ances (e.g., for 
soil or foliar 
application); 
includes food 
and/or non- 
food uses. 
(3)(4) 
50,445 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R274 
Additional uses; 
seed treatment 
only; 6 or more 
submitted in 
one applica-
tion; limited 
uptake into 
raw agricul-
tural commod-
ities; includes 
crops with es-
tablished toler-
ances (e.g., for 
soil or foliar 
application); 
includes food 
and/or non- 
food uses. 
(3)(4) 
302,663 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, must be assessed 25% of the full registration service fee for the new active 
ingredient or first food use application. 
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(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
(4) Amendment applications to add the new use(s) to registered product labels 
are covered by the base fee for the new use(s). All items in the covered applica-
tion must be submitted together in one package. Each application for an addi-
tional 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 amend-
ments 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 deci-
sion review time for a new use. If the new-use application includes non-food (in-
door 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 appli-
cant at the applicant’s initiative to support the application after completion of 
the technical deficiency screen, and (c) is not itself a covered registration appli-
cation, must be assessed 25% of the full registration service fee for the new use 
application. 
‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R280 
Establish import 
tolerance; new 
active ingre-
dient or first 
food use. (2) 
319,072 
R290 
Establish Import 
tolerance; Ad-
ditional new 
food use. 
63,816 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R291 
Establish import 
tolerances; ad-
ditional food 
uses; 6 or 
more crops 
submitted in 
one petition. 
382,886 
R292 
Amend an estab-
lished tolerance 
(e.g., decrease 
or increase) 
and/or har-
monize estab-
lished toler-
ances with 
Codex MRLs; 
domestic or 
import; appli-
cant-initiated. 
45,341 
R293 
Establish toler-
ance(s) for in-
advertent resi-
dues in one 
crop; appli-
cant-initiated. 
53,483 
R294 
Establish toler-
ances for inad-
vertent resi-
dues; 6 or 
more crops 
submitted in 
one applica-
tion; applicant- 
initiated. 
320,894 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R295 
Establish toler-
ance(s) for res-
idues in one 
rotational crop 
in response to 
a specific rota-
tional crop ap-
plication; sub-
mission of cor-
responding 
label amend-
ments which 
specify the nec-
essary plant- 
back restric-
tions; appli-
cant-initiated. 
(3) (4) 
66,124 
R296 
Establish toler-
ances for resi-
dues in rota-
tional crops in 
response to a 
specific rota-
tional crop pe-
tition; 6 or 
more crops 
submitted in 
one applica-
tion; submis-
sion of cor-
responding 
label amend-
ments which 
specify the nec-
essary plant- 
back restric-
tions; appli-
cant-initiated. 
(3) (4) 
396,742 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R297 
Amend 6 or more 
established tol-
erances (e.g., 
decrease or in-
crease) in one 
petition; do-
mestic or im-
port; applicant- 
initiated. 
272,037 
R298 
Amend an estab-
lished tolerance 
(e.g., decrease 
or increase); 
domestic or 
import; sub-
mission of cor-
responding 
amended labels 
(requiring 
science review). 
(3) (4) 
58,565 
R299 
Amend 6 or more 
established tol-
erances (e.g., 
decrease or in-
crease); domes-
tic or import; 
submission of 
corresponding 
amended labels 
(requiring 
science review). 
(3) (4) 
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. 
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(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’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 cov-
ered application must be submitted together in one package. Each application 
for an additional new product registration and new inert approval(s) that is sub-
mitted in the amendment application package is subject to the registration serv-
ice 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 ap-
plication is covered by the base fee. All such associated applications that are 
submitted together will be subject to the category decision review time. 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R300 
New product; or 
similar combina-
tion product (al-
ready reg-
istered) to an 
identical or sub-
stantially simi-
lar in composi-
tion and use to 
a registered 
product; reg-
istered source of 
active ingre-
dient; no data 
review on acute 
toxicity, efficacy 
or CRP – only 
product chem-
istry data; cite- 
all data citation, 
or selective data 
citation where 
applicant owns 
all required 
data, or appli-
cant submits 
specific author-
ization letter 
from data 
owner. Category 
also includes 
100% re-pack-
age of reg-
istered end-use 
or manufac-
turing-use prod-
uct that re-
quires no data 
submission nor 
data matrix. 
(2)(3) 
1,582 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R301 
New product; or 
similar combina-
tion product (al-
ready reg-
istered) to an 
identical or sub-
stantially simi-
lar in composi-
tion and use to 
a registered 
product; reg-
istered source of 
active ingre-
dient; selective 
data citation 
only for data on 
product chem-
istry and/or 
acute toxicity 
and/or public 
health pest effi-
cacy (identical 
data citation 
and claims to 
cited prod-
uct(s)), where 
applicant does 
not own all re-
quired data and 
does not have a 
specific author-
ization letter 
from data 
owner. (2)(3) 
1,897 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R310 
New end-use or 
manufacturing- 
use product 
with registered 
source(s) of ac-
tive ingre-
dient(s); in-
cludes products 
containing two 
or more reg-
istered active 
ingredients pre-
viously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; requires 
review of data 
package within 
RD only; in-
cludes data and/ 
or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
7,301 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R314 
New end use prod-
uct containing 
up to three reg-
istered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
8,626 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R319 
New end use prod-
uct containing 
up to three reg-
istered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
12,626 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R318 
50 (new) New end use prod-
uct containing 
four or more 
registered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
13,252 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R321 
51 (new) New end use prod-
uct containing 
four or more 
registered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
17,252 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R315 
New end-use, on- 
animal product, 
registered 
source of active 
ingredient(s), 
with the sub-
mission of data 
and/or waivers 
for only: 
∑ animal safety 
and 
∑ pest(s) requiring 
efficacy (4) and/ 
or 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging. (2) 
(3) 
9,820 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R316 
53 (new) New end-use or 
manufacturing 
product with 
registered 
source(s) of ac-
tive ingre-
dient(s) includ-
ing products 
containing two 
or more reg-
istered active 
ingredients pre-
viously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; and re-
quires review of 
data and/or 
waivers for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 3 
and up to 7 tar-
get pests. (2)(3) 
11,301 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R317 
54 (new) New end-use or 
manufacturing 
product with 
registered 
source(s) of ac-
tive ingre-
dient(s) includ-
ing products 
containing 2 or 
more registered 
active ingredi-
ents previously 
combined in 
other registered 
products; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; 
and requires re-
view of data 
and/or waivers 
for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 7 
target pests. 
(2)(3) 
15,301 
R320 
New product; new 
physical form; 
requires data 
review in 
science divi-
sions. (2)(3) 
13,226 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R331 
New product; re-
pack of identical 
registered end- 
use product as a 
manufacturing- 
use product, or 
identical reg-
istered manu-
facturing-use 
product as an 
end use prod-
uct; same reg-
istered uses 
only. (2)(3) 
2,530 
R332 
New manufac-
turing-use prod-
uct; registered 
active ingre-
dient; unregis-
tered source of 
active ingre-
dient; submis-
sion of com-
pletely new ge-
neric data pack-
age; registered 
uses only; re-
quires review in 
RD and science 
divisions. (2)(3) 
283,215 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R333 
New product; 
MUP or End 
use product 
with unregis-
tered source of 
active ingre-
dient; requires 
science data re-
view; new phys-
ical form; etc. 
Cite-all or selec-
tive data cita-
tion where ap-
plicant owns all 
required data. 
(2)(3) 
19,838 
R334 
New product; 
MUP or End 
use product 
with unregis-
tered source of 
the active ingre-
dient; requires 
science data re-
view; new phys-
ical form; etc. 
Selective data 
citation. (2)(3) 
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 ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient. 
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(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’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 No-
tice 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/re-
fined 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 (ex-
cluding carpenter ants), fire and harvester ants, wood destroying beetles, car-
penter ants, termites, subterranean termites, dry wood termites, arboreal ter-
mites, damp wood termites and invasive species. If seeking a claim against a 
specific pest without a general claim then each specific pest will count as 1. 
‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R340 
Amendment requiring 
data review within 
RD (e.g., changes 
to precautionary 
label statements); 
includes adding/ 
modifying pest(s) 
claims for up to 2 
target pests, ex-
cludes products re-
quiring or citing an 
animal safety 
study. (2)(3)(4) 
4,988 
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‘‘TABLE 5. — REGISTRATION DIVISION — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R341 
(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) 
5,988 
R345 
Amending on-animal 
products previously 
registered, with the 
submission of data 
and/or waivers for 
only: 
∑ animal safety and 
∑ pest(s) requiring ef-
ficacy (4) and/or 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging. (2)(3) 
8,820 
R350 
Amendment requiring 
data review in 
science divisions 
(e.g., changes to 
REI, or PPE, or 
PHI, or use rate, 
or number of appli-
cations; or add aer-
ial application; or 
modify GW/SW ad-
visory statement). 
(2)(3) 
13,226 
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‘‘TABLE 5. — REGISTRATION DIVISION — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R351 
Amendment adding a 
new unregistered 
source of active in-
gredient. (2)(3) 
13,226 
R352 
Amendment adding 
already approved 
uses; selective 
method of support; 
does not apply if 
the applicant owns 
all cited data. (2) 
(3) 
13,226 
R371 
Amendment to Ex-
perimental Use 
Permit; (does not 
include extending a 
permit’s time pe-
riod). (3) 
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 reg-
istration 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) Reg-
istrant 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
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(4) For the purposes of classifying proposed registration actions into PRIA 
categories, ‘‘pest(s) requiring efficacy’’ are: public health pests listed in PR No-
tice 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/re-
fined 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 (ex-
cluding carpenter ants), fire and harvester ants, wood destroying beetles, car-
penter ants, termites, subterranean termites, dry wood termites, arboreal ter-
mites, damp wood termites and invasive species. If seeking a claim against a 
specific pest without a general claim then each specific pest will count as 1. 
‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R124 
Conditional Rul-
ing on Pre-ap-
plication Study 
Waivers; appli-
cant-initiated. 
2,530 
R272 
Review of Study 
Protocol appli-
cant-initiated; 
excludes 
DART, pre-reg-
istration con-
ference, Rapid 
Response re-
view, DNT pro-
tocol review, 
protocol need-
ing HSRB re-
view. 
2,530 
R275 
Rebuttal of agen-
cy reviewed 
protocol, appli-
cant initiated. 
2,530 
R370 
Cancer reassess-
ment; appli-
cant-initiated. 
198,250 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW 
ACTIVE INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A380 
New Active Ingre-
dient; Indirect 
Food use; es-
tablish tolerance 
or tolerance ex-
emption if re-
quired. (2)(3) 
137,841 
A390 
New Active Ingre-
dient; Direct 
Food use; es-
tablish tolerance 
or tolerance ex-
emption if re-
quired. (2)(3) 
229,733 
A410 
New Active Ingre-
dient Non-food 
use.(2)(3) 
229,733 
A431 
New Active Ingre-
dient, Non-food 
use; low-risk. 
(2)(3) 
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 applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, must be assessed 25% of the full registration service fee for the new active 
ingredient or first food use application. 
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(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A440 
New Use, Indi-
rect Food 
Use, estab-
lish tolerance 
or tolerance 
exemption. 
(2)(3)(4) 
31,910 
A441 
Additional In-
direct food 
uses; estab-
lish toler-
ances or tol-
erance ex-
emptions if 
required; 6 
or more sub-
mitted in one 
application. 
(3)(4)(5) 
114,870 
A450 
New use, Di-
rect food 
use, establish 
tolerance or 
tolerance ex-
emption. 
(2)(3)(4) 
95,724 
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‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW 
USES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A451 
Additional Di-
rect food 
uses; estab-
lish toler-
ances or tol-
erance ex-
emptions if 
required; 6 
or more sub-
mitted in one 
application. 
(3)(4)(5) 
182,335 
A500 
New use, non- 
food. (4)(5) 
31,910 
A501 
New use, non- 
food; 6 or 
more sub-
mitted in one 
application. 
(4)(5) 
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 applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, must be assessed 25% of the full registration service fee for the new active 
ingredient or first food use application. 
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(3) If EPA data rules are amended to newly require clearance under section 
408 of the FFDCA for an ingredient of an antimicrobial product where such in-
gredient 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’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 applica-
tion must be submitted together in one package. Each application for an addi-
tional 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 amend-
ments 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 deci-
sion review time for a new use. If the new-use application includes non-food (in-
door 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 appli-
cant at the applicant’s initiative to support the application after completion of 
the technical deficiency screen, and (c) is not itself a covered registration appli-
cation, must be assessed 25% of the full registration service fee for the new use 
application. 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A530 
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 appli-
cant owns all 
required data; 
or applicant 
submits spe-
cific authoriza-
tion letter 
from data 
owner. Cat-
egory also in-
cludes 100% 
re-package of 
registered end- 
use or manu-
facturing use 
product that 
requires no 
data submis-
sion nor data 
matrix. (2)(3) 
1,278 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A531 
New product; 
identical or 
substantially 
similar in 
composition 
and use to a 
registered 
product; reg-
istered source 
of active in-
gredient: selec-
tive data cita-
tion only for 
data on prod-
uct chemistry 
and/or acute 
toxicity and/or 
public health 
pest efficacy, 
where appli-
cant does not 
own all re-
quired data 
and does not 
have a specific 
authorization 
letter from 
data owner. 
(2)(3) 
1,824 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A532 
New product; 
identical or 
substantially 
similar in 
composition 
and use to a 
registered 
product; reg-
istered active 
ingredient; un-
registered 
source of ac-
tive ingre-
dient; cite-all 
data citation 
except for 
product chem-
istry; product 
chemistry data 
submitted. 
(2)(3) 
5,107 
A540 
New end use 
product; 
FIFRA 
§2(mm) uses 
only; up to 25 
public health 
organisms. 
(2)(3)(5)(6) 
5,107 
A541 
85 (new) 
New end use 
product; 
FIFRA 
§2(mm) uses 
only; 26-50 
public health 
organisms. 
(2)(3)(5)(6) 
8,500 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A542 
86 (new) 
New end use 
product; 
FIFRA 
§2(mm) uses 
only; ≥ 51 
public health 
organisms. 
(2)(3)(5) 
15,000 
A550 
New end-use 
product; uses 
other than 
FIFRA 
§2(mm); non- 
FQPA prod-
uct. (2)(3)(5) 
13,226 
A560 
New manufac-
turing use 
product; reg-
istered active 
ingredient; se-
lective data ci-
tation. (2)(3) 
12,596 
A565 
89 (new) 
New manufac-
turing-use 
product; reg-
istered active 
ingredient; un-
registered 
source of ac-
tive ingre-
dient; submis-
sion of new 
generic data 
package; reg-
istered uses 
only; requires 
science review. 
(2)(3) 
18,234 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A570 
Label amend-
ment requiring 
data review; 
up to 25 pub-
lic health or-
ganisms. 
(3)(4)(5)(6) 
3,831 
A573 
91 (new) 
Label amend-
ment requiring 
data review; 
26-50 public 
health orga-
nisms. 
(2)(3)(5)(7) 
6,350 
A574 
92 (new) 
Label amend-
ment requiring 
data review; ≥ 
51 public 
health orga-
nisms. 
(2)(3)(5)(7) 
11,000 
A572 
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) 
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 ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient. 
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(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
(4)(a) EPA-initiated amendments shall not be charged registration service 
fees. (b) Registrant-initiated fast-track amendments are to be completed within 
the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to reg-
istration 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) Reg-
istrant 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 sub-
mitted for the same product before expiration of the first submission’s original 
decision review time period will result in reclassification of both the original and 
subsequent submission into the appropriate new category based on the sum of 
the number or organisms in both submissions. A reclassification would result in 
a new PRIA start date and require additional fees to meet the fee of the new 
category. 
(7) Once a submission for a label amendment with public health organisms 
has been submitted and classified in either A570 or A573, additional organisms 
submitted for the same product before expiration of the first submission’s origi-
nal decision review time period will result in reclassification of both the original 
and subsequent submission into the appropriate new category based on the sum 
of the number or organisms in both submissions. A reclassification would result 
in a new PRIA start date and require additional fees to meet the fee of the new 
category. 
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — 
EXPERIMENTAL USE PERMITS AND OTHER ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A520 
Experimental 
Use Permit 
application, 
non-food use. 
(2) 
6,383 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A521 
Review of public 
health efficacy 
study protocol 
within AD, 
per AD Inter-
nal Guidance 
for the Effi-
cacy Protocol 
Review Proc-
ess; Code will 
also include 
review of pub-
lic health effi-
cacy study 
protocol and 
data review 
for devices 
making pes-
ticidal claims; 
applicant-initi-
ated; Tier 1. 
4,726 
A522 
Review of public 
health efficacy 
study protocol 
outside AD by 
members of 
AD Efficacy 
Protocol Re-
view Expert 
Panel; Code 
will also in-
clude review of 
public health 
efficacy study 
protocol and 
data review 
for devices 
making pes-
ticidal claims; 
applicant-initi-
ated; Tier 2. 
12,156 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A537 
97 (new) 
New Active In-
gredient/New 
Use, Experi-
mental Use 
Permit appli-
cation; Direct 
food use; Es-
tablish toler-
ance or toler-
ance exemp-
tion if re-
quired. Credit 
45% of fee to-
ward new ac-
tive ingre-
dient/new use 
application 
that follows. 
153,156 
A538 
98 (new) 
New Active In-
gredient/New 
Use, Experi-
mental Use 
Permit appli-
cation; Indi-
rect food use; 
Establish tol-
erance or tol-
erance exemp-
tion if re-
quired Credit 
45% of fee to-
ward new ac-
tive ingre-
dient/new use 
application 
that follows. 
95,724 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A539 
99 (new) 
New Active In-
gredient/New 
Use, Experi-
mental Use 
Permit appli-
cation; 
Nonfood use. 
Credit 45% of 
fee toward 
new active in-
gredient/new 
use application 
that follows. 
92,163 
A529 
100 
Amendment to 
Experimental 
Use Permit; 
requires data 
review or risk 
assessment. 
(2) 
11,429 
A523 
101 
Review of pro-
tocol other 
than a public 
health efficacy 
study (i.e., 
Toxicology or 
Exposure Pro-
tocols). 
12,156 
A571 
102 
Science reassess-
ment: Cancer 
risk, refined 
ecological risk, 
and/or endan-
gered species; 
applicant-initi-
ated. 
95,724 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A533 
103 (new) Exemption from 
the require-
ment of an 
Experimental 
Use Permit. 
(2) 
2,482 
A534 
104 (new) Rebuttal of 
agency re-
viewed pro-
tocol, appli-
cant initiated. 
4,726 
A535 
105 (new) Conditional Rul-
ing on Pre-ap-
plication 
Study Waiver 
or Data 
Bridging Ar-
gument; appli-
cant-initiated. 
2,409 
A536 
106 (new) Conditional Rul-
ing on Pre-ap-
plication Di-
rect Food, In-
direct Food, 
Nonfood use 
determination; 
applicant-initi-
ated. 
2,482 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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(2) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 
INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B580 
107 
New active in-
gredient; food 
use; petition to 
establish a tol-
erance. (2)(3) 
51,053 
B590 
108 
New active in-
gredient; food 
use; petition to 
establish a tol-
erance exemp-
tion. (2)(3) 
31,910 
B600 
109 
New active in-
gredient; non- 
food use. 
(2)(3) 
19,146 
B610 
110 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
petition to es-
tablish a tem-
porary toler-
ance or tem-
porary toler-
ance exemp-
tion. (3) 
12,764 
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‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B611 
111 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
petition to es-
tablish perma-
nent tolerance 
exemption. (3) 
12,764 
B612 
112 
New active in-
gredient; no 
change to a 
permanent tol-
erance exemp-
tion. (2)(3) 
17,550 
B613 
113 
New active in-
gredient; peti-
tion to convert 
a temporary 
tolerance or a 
temporary tol-
erance exemp-
tion to a per-
manent toler-
ance or toler-
ance exemp-
tion. (2)(3) 
17,550 
B620 
114 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
non-food use 
including crop 
destruct. (3) 
6,383 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 12. — BIOPESTICIDES DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B630 
115 
First food use; 
petition to es-
tablish a toler-
ance exemp-
tion. (2)(4) 
12,764 
B631 
116 
New food use; 
petition to 
amend an es-
tablished toler-
ance. (3)(4) 
12,764 
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‘‘TABLE 12. — BIOPESTICIDES DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B640 
117 
First food use; 
petition to es-
tablish a toler-
ance. (2)(4) 
19,146 
B643 
118 
New Food use; 
petition to 
amend an es-
tablished toler-
ance exemp-
tion. (3)(4) 
12,764 
B642 
119 
First food use; 
indoor; food/ 
food handling. 
(2)(4) 
31,910 
B644 
120 
New use, no 
change to an 
established tol-
erance or tol-
erance exemp-
tion. (3)(4) 
12,764 
B650 
121 
New use; non- 
food. (3)(4) 
6,383 
B645 
122 (new) New food use; 
Experimental 
Use Permit 
application; 
petition to 
amend or add 
a tolerance ex-
emption. (4) 
12,764 
B646 
123 (new) New use; non- 
food use in-
cluding crop 
destruct; Ex-
perimental 
Use Permit 
application. 
(4) 
6,383 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, 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 applica-
tion must be submitted together in one package. Each application for an addi-
tional 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 amend-
ments 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 deci-
sion review time for a new use. If the new-use application includes non-food (in-
door 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 appli-
cant at the applicant’s initiative to support the application after completion of 
the technical deficiency screen, and (c) is not itself a covered registration appli-
cation, must be assessed 25% of the full registration service fee for the new use 
application. 
(4) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B652 
124 
New product; reg-
istered source of 
active ingre-
dient; requires 
petition to 
amend estab-
lished tolerance 
or tolerance ex-
emption; re-
quires 1) sub-
mission of prod-
uct specific 
data; or 2) cita-
tion of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
12,764 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B660 
125 
New product; reg-
istered source of 
active ingre-
dient(s); iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product. 
No data review, 
or only product 
chemistry data; 
cite-all data ci-
tation, or selec-
tive data cita-
tion where ap-
plicant owns all 
required data or 
authorization 
from data owner 
is demonstrated. 
Category in-
cludes 100% re- 
package of reg-
istered end-use 
or manufac-
turing-use prod-
uct that re-
quires no data 
submission or 
data matrix. 
For microbial 
pesticides, the 
active ingre-
dient(s) must 
not be re-iso-
lated. (2)(3) 
1,278 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B670 
126 
New product; reg-
istered source of 
active ingre-
dient(s); re-
quires: 1) sub-
mission of prod-
uct specific 
data; or 2) cita-
tion of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
5,107 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B671 
127 
New product; un-
registered 
source of active 
ingredient(s); 
requires a peti-
tion to amend 
an established 
tolerance or tol-
erance exemp-
tion; requires: 
1) submission of 
product specific 
data; or 2) cita-
tion of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
12,764 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B672 
128 
New product; un-
registered 
source of active 
ingredient(s); 
non-food use or 
food use re-
quires: 1) sub-
mission of prod-
uct specific 
data; or 2) cita-
tion of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
9,118 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B673 
129 
New product 
MUP/EP; un-
registered 
source of active 
ingredient(s); ci-
tation of Tech-
nical Grade Ac-
tive Ingredient 
(TGAI) data 
previously re-
viewed and ac-
cepted by the 
Agency. Re-
quires an Agen-
cy determina-
tion that the 
cited data sup-
ports the new 
product. (2)(3) 
5,107 
B674 
130 
New product 
MUP; Repack 
of identical reg-
istered end-use 
product as a 
manufacturing- 
use product; 
same registered 
uses only. (2)(3) 
1,278 
B675 
131 
New Product 
MUP; registered 
source of active 
ingredient; sub-
mission of com-
pletely new ge-
neric data pack-
age; registered 
uses only. (2)(3) 
9,118 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B676 
132 
New product; 
more than one 
active ingredient 
where one active 
ingredient is an 
unregistered 
source; product 
chemistry data 
must be sub-
mitted; requires: 
1) submission of 
product specific 
data, and 2) ci-
tation of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
9,118 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B677 
133 
New end-use non- 
food animal 
product with 
submission of 
two or more tar-
get animal safe-
ty studies; in-
cludes data and/ 
or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ public health 
pest efficacy 
and/or 
∑ animal safety 
studies and/or 
∑ child resistant 
packaging. 
(2)(3) 
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 ingre-
dient 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
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‘‘TABLE 14. — BIOPESTICIDES DIVISION — 
AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 
Registra-
tion 
Service 
Fee 
($) 
B621 
134 
Amendment; Experimental 
Use Permit; no change to 
an established temporary 
tolerance or tolerance ex-
emption. (3) 
5,107 
B622 
135 
Amendment; Experimental 
Use Permit; petition to 
amend an established or 
temporary tolerance or tol-
erance exemption. (3) 
12,764 
B641 
136 
Amendment of an established 
tolerance or tolerance ex-
emption. 
12,764 
B680 
137 
Amendment; registered 
sources of active ingre-
dient(s); no new use(s); no 
changes to an established 
tolerance or tolerance ex-
emption. Requires data sub-
mission. (2)(3) 
5,107 
B681 
138 
Amendment; unregistered 
source of active ingre-
dient(s). Requires data sub-
mission. (2)(3) 
6,079 
B683 
139 
Label amendment; requires re-
view/update of previous risk 
assessment(s) without data 
submission (e.g., labeling 
changes to REI, PPE, 
PHI). (2)(3) 
5,107 
B684 
140 
Amending non-food animal 
product that includes sub-
mission of target animal 
safety data; previously reg-
istered. (2)(3) 
8,820 
B685 
141 (new) 
Amendment; add a new bio-
chemical unregistered 
source of active ingredient 
or a new microbial produc-
tion site. Requires submis-
sion of analysis of samples 
data and source/production 
site-specific manufacturing 
process description. (3) 
5,107 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, 
will be extended to end on the next business day. 
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(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) 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 amend-
ments 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 amend-
ments 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 re-
quiring 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 re-
quests 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 ap-
plicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of 
the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), 
including upon resolution of differences in (b), the Agency shall provide an accepted final Agency- 
stamped label to the registrant within 2 business days following the registrant’s written or electronic 
confirmation of agreement to the Agency. 
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B690 
142 
New active in-
gredient; food 
or non-food 
use. (2)(6) 
2,554 
B700 
143 
Experimental 
Use Permit 
application; 
new active in-
gredient or 
new use. (6) 
1,278 
B701 
144 
Extend or amend 
Experimental 
Use Permit. 
(6) 
1,278 
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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B710 
145 
New product; 
registered 
source of ac-
tive ingre-
dient(s); iden-
tical or sub-
stantially simi-
lar in composi-
tion and use 
to a registered 
product; no 
change in an 
established tol-
erance or tol-
erance exemp-
tion. No data 
review, or only 
product chem-
istry data; 
cite-all data ci-
tation, or se-
lective data ci-
tation where 
applicant owns 
all required 
data or au-
thorization 
from data 
owner is dem-
onstrated. 
Category in-
cludes 100% 
re-package of 
registered end- 
use or manu-
facturing-use 
product that 
requires no 
data submis-
sion or data 
matrix. (3)(6) 
1,278 
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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B720 
146 
New product; 
registered 
source of ac-
tive ingre-
dient(s); re-
quires: 1) sub-
mission of 
product spe-
cific data; or 
2) citation of 
previously re-
viewed and ac-
cepted data; or 
3) submission 
or citation of 
data generated 
at government 
expense; or 4) 
submission or 
citation of a 
scientifically- 
sound ration-
ale based on 
publicly avail-
able literature 
or other rel-
evant informa-
tion that ad-
dresses the 
data require-
ment; or 5) 
submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a 
scientifically- 
sound ration-
ale explaining 
why the data 
requirement 
does not 
apply. (3)(6) 
1,278 
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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B721 
147 
New product; 
unregistered 
source of ac-
tive ingre-
dient. (3)(6) 
2,676 
B722 
148 
New use and/or 
amendment; 
petition to es-
tablish a toler-
ance or toler-
ance exemp-
tion. (4)(5)(6) 
2,477 
B730 
149 
Label amend-
ment requiring 
data submis-
sion. (4)(6) 
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 applica-
tion 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 applica-
tion. 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 sub-
mitted in the new active ingredient application package or first food use applica-
tion 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 nei-
ther 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 applica-
tion, 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 ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient. 
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(4) (a) EPA-initiated amendments shall not be charged registration service 
fees. (b) Registrant-initiated fast-track amendments are to be completed within 
the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to reg-
istration 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) Reg-
istrant 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 applica-
tion must be submitted together in one package. Each application for an addi-
tional 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 amend-
ments 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 deci-
sion review time for a new use. If the new-use application includes non-food (in-
door 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 appli-
cant at the applicant’s initiative to support the application after completion of 
the technical deficiency screen, and (c) is not itself a covered registration appli-
cation, 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
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‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B614 
150 
Pre-application; 
Conditional 
Ruling on ra-
tionales for 
addressing a 
data require-
ment in lieu of 
data; appli-
cant-initiated; 
applies to one 
rationale at a 
time. 
2,530 
B615 
151 
Rebuttal of 
agency re-
viewed pro-
tocol, appli-
cant initiated. 
2,530 
B682 
152 
Protocol review; 
applicant initi-
ated; excludes 
time for 
HSRB review. 
2,432 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B740 
153 
Experimental Use 
Permit applica-
tion; no petition 
for tolerance/tol-
erance 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 reg-
istered PIP with 
crop destruct 
(12); 
3. food/feed use(s) 
for a new or reg-
istered PIP in 
which an estab-
lished tolerance/ 
tolerance exemp-
tion exists for the 
intended use(s). 
(4)(12) 
95,724 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B741 
154 
(new) 
Experimental Use 
Permit applica-
tion; no petition 
for tolerance/tol-
erance exemption. 
Includes: 
1. non-food/feed 
use(s) for a new 
(2) or registered 
(3) PIP; 
2. food/feed use(s) 
for a new or reg-
istered PIP with 
crop destruct; 
3. food/feed use(s) 
for a new or reg-
istered PIP in 
which an estab-
lished tolerance/ 
tolerance exemp-
tion exists for the 
intended use(s); 
SAP Review. (12) 
159,538 
B750 
155 
Experimental Use 
Permit applica-
tion; with a peti-
tion to establish a 
temporary or per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient. In-
cludes new food/ 
feed use for a 
registered (3) 
PIP. (4)(12) 
127,630 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B770 
156 
Experimental Use 
Permit applica-
tion; new (2) PIP; 
with petition to 
establish a tem-
porary tolerance/ 
tolerance exemp-
tion for the active 
ingredient; credit 
75% of B771 fee 
toward registra-
tion application 
for a new active 
ingredient that 
follows; SAP re-
view. (5)(12) 
191,444 
B771 
157 
Experimental Use 
Permit applica-
tion; new (2) PIP; 
with petition to 
establish a tem-
porary tolerance/ 
tolerance exemp-
tion for the active 
ingredient; credit 
75% of B771 fee 
toward registra-
tion application 
for a new active 
ingredient that 
follows. (12) 
127,630 
B772 
158 
Application to 
amend or extend 
an Experimental 
Use Permit; no 
petition since the 
established toler-
ance/tolerance ex-
emption for the 
active ingredient 
is unaffected. 
(12) 
12,764 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B773 
159 
Application to 
amend or extend 
an Experimental 
Use Permit; with 
petition to extend 
a temporary toler-
ance/tolerance ex-
emption for the 
active ingredient. 
(12) 
31,910 
B780 
160 
Registration applica-
tion; new (2) PIP; 
non-food/feed. 
(12) 
159,537 
B790 
161 
Registration applica-
tion; new (2) PIP; 
non-food/feed; 
SAP review. 
(5)(12) 
223,351 
B800 
162 
Registration applica-
tion; new (2) PIP; 
with petition to 
establish perma-
nent tolerance/tol-
erance exemption 
for the active in-
gredient based on 
an existing tem-
porary tolerance/ 
tolerance exemp-
tion. (12) 
172,300 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B810 
163 
Registration applica-
tion; new (2) PIP; 
with petition to 
establish perma-
nent tolerance/tol-
erance exemption 
for the active in-
gredient based on 
an existing tem-
porary tolerance/ 
tolerance exemp-
tion. SAP review. 
(5)(12) 
236,114 
B820 
164 
Registration applica-
tion; new (2) PIP; 
with petition to 
establish or 
amend a perma-
nent tolerance/tol-
erance exemption 
of an active ingre-
dient. (12) 
204,208 
B840 
165 
Registration applica-
tion; new (2) PIP; 
with petition to 
establish or 
amend a perma-
nent tolerance/tol-
erance exemption 
of an active ingre-
dient. SAP re-
view. (5)(12) 
268,022 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B851 
166 
Registration applica-
tion; new event of 
a previously reg-
istered PIP active 
ingredient(s); no 
petition since per-
manent tolerance/ 
tolerance exemp-
tion is already es-
tablished for the 
active ingre-
dient(s). (12) 
127,630 
B870 
167 
Registration applica-
tion; registered 
(3) PIP; new 
product; new use; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). (4) (12) 
38,290 
B880 
168 
Registration applica-
tion; registered 
(3) PIP; new 
product or new 
terms of registra-
tion; additional 
data submitted; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). (6) (7) 
(12) 
31,910 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B881 
169 
Registration applica-
tion; registered 
(3) PIP; new 
product or new 
terms of registra-
tion; additional 
data submitted; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). SAP re-
view. 
(5)(6)(7)(12) 
95,724 
B882 
170 
(new) 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient based 
on an existing 
temporary toler-
ance/tolerance ex-
emption; SAP Re-
view. (8)(12) 
191,444 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B883 
171 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient based 
on an existing 
temporary toler-
ance/tolerance ex-
emption. (8) (12) 
127,630 
B884 
172 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient. 
(8)(12) 
159,537 
B885 
173 
Registration applica-
tion; registered 
(3) PIP, seed in-
crease; breeding 
stack of pre-
viously approved 
PIPs, same crop; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). (9)(12) 
31,910 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B900 
177 
Application to 
amend a registra-
tion, including ac-
tions such as ex-
tending an expira-
tion date, modi-
fying an IRM 
plan, or adding 
an insect to be 
controlled. 
(10)(11)(12) 
12,764 
B901 
178 
Application to 
amend a registra-
tion, including ac-
tions such as ex-
tending an expira-
tion date, modi-
fying an IRM 
plan, or adding 
an insect to be 
controlled. SAP 
review. (10) (11) 
(12) 
76,578 
B902 
179 
PIP Protocol review. 
6,383 
B903 
180 
Inert ingredient tol-
erance exemption; 
e.g., a marker 
such as NPT II; 
reviewed in 
BPPD. 
63,816 
B904 
181 
Import tolerance or 
tolerance exemp-
tion; processed 
commodities/food 
only (inert or ac-
tive ingredient). 
127,630 
B905 
182 
(new) 
SAP Review. 
63,816 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B906 
183 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients. 
31,907 
B907 
184 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients based 
on an existing 
temporary toler-
ance/tolerance ex-
emption. 
12,764 
B908 
185 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients or inert 
ingredients. 
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 reg-
istered. 
(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 in-
sect resistance, and novel scientific issues surrounding new technologies. The sci-
entists of the SAP neither make nor recommend policy decisions. They provide 
advice on the science used to make these decisions. Their advice is invaluable to 
the EPA as it strives to protect humans and the environment from risks posed 
by pesticides. Due to the time it takes to schedule and prepare for meetings with 
the SAP, additional time and costs are needed. 
(6) Registered PIPs stacked through conventional breeding. 
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed 
blend). 
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(8) The negotiated acreage cap will depend upon EPA’s determination of the 
potential environmental exposure, risk(s) to non-target organisms, and the risk 
of targeted pest developing resistance to the pesticidal substance. The uncer-
tainty 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 reg-
istration 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 18. — INERT INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I001 
186 
Approval of new 
food use inert 
ingredient. 
(2)(3) 
27,000 
I002 
187 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; new data. 
(2) 
7,500 
I003 
188 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; no new 
data. (2) 
3,308 
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‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I004 
189 
Approval of new 
non-food use 
inert ingredient. 
(2) 
11,025 
I005 
190 
Amend currently 
approved non- 
food use inert 
ingredient with 
new use pattern; 
new data. (2) 
5,513 
I006 
191 
Amend currently 
approved non- 
food use inert 
ingredient with 
new use pattern; 
no new data. (2) 
3,308 
I007 
192 
Approval of sub-
stantially similar 
non-food use 
inert ingredients 
when original 
inert is 
compositionally 
similar with 
similar use pat-
tern. (2) 
1,654 
I008 
193 
Approval of new or 
amended poly-
mer inert ingre-
dient, food use. 
(2) 
3,749 
I009 
194 
Approval of new or 
amended poly-
mer inert ingre-
dient, non-food 
use. (2) 
3,087 
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‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I010 
195 
Petition to amend 
a single toler-
ance exemption 
descriptor, or 
single non-food 
use descriptor, 
to add ≤ 10 
CASRNs; no 
new data. (2) 
1,654 
I011 
196 
(new) 
Approval of new 
food use safener 
with tolerance 
or exemption 
from tolerance. 
(2)(8) 
597,683 
I012 
197 
(new) 
Approval of new 
non-food use 
safener. (2)(8) 
415,241 
I013 
198 
(new) 
Approval of addi-
tional food use 
for previously 
approved 
safener with tol-
erance or ex-
emption from 
tolerance. (2) 
62,975 
I014 
199 
(new) 
Approval of addi-
tional non-food 
use for pre-
viously approved 
safener. (2) 
25,168 
I015 
200 
(new) 
Approval of new 
generic data for 
previously ap-
proved food use 
safener. (2) 
269,728 
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100 
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I016 
201 
(new) 
Approval of 
amendment(s) 
to tolerance and 
label for pre-
viously approved 
safener. (2) 
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 applica-
tion to approve an inert ingredient, each application will be subject to its respec-
tive registration service fee. The decision review time line for both submissions 
will be the longest of the associated applications. If the application covers mul-
tiple 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 in-
gredient 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 de-
cision 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 deci-
sion 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 ingre-
dient 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
(8) If a new safener is submitted in the same package as a new active ingre-
dient, and that new active ingredient is determined to be reduced risk, then the 
safener would get the same reduced timeframe as the new active ingredient. 
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101 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M001 
202 
Study protocol 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient. (4) 
7,938 
M002 
203 
Completed study 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient. (4) 
7,938 
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102 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M003 
204 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
less than 12 
months. Appli-
cant initiated 
request based 
on a require-
ment of the 
Administrator, 
as defined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945 
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103 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M004 
205 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
greater than 
12 months. 
Applicant ini-
tiated request 
based on a re-
quirement of 
the Adminis-
trator, as de-
fined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945 
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104 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M005 
206 
New Product: 
Combination, 
Contains a 
combination of 
active ingredi-
ents from a 
registered and/ 
or unregis-
tered source; 
conventional, 
antimicrobial 
and/or biopes-
ticide. Re-
quires coordi-
nation with 
other regu-
latory divi-
sions to con-
duct review of 
data, label 
and/or verify 
the validity of 
existing data 
as cited. Only 
existing uses 
for each active 
ingredient in 
the combina-
tion product. 
(6)(7) 
22,050 
M006 
207 
Request for up 
to 5 letters of 
certification 
(Gold Seal) 
for one ac-
tively reg-
istered prod-
uct (excludes 
distributor 
products). (8) 
277 
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105 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M007 
208 
Request to ex-
tend Exclusive 
Use of data as 
provided by 
FIFRA Sec-
tion 
3(c)(1)(F)(ii). 
5,513 
M008 
209 
Request to grant 
Exclusive Use 
of data as pro-
vided by 
FIFRA Sec-
tion 
3(c)(1)(F)(vi) 
for a minor 
use, when a 
FIFRA Sec-
tion 2(ll)(2) 
determination 
is required. 
1,654 
M009 
210 (new) Non-FIFRA 
Regulated De-
termination: 
Applicant ini-
tiated, per 
product. 
2,363 
M010 
211 (new) Conditional rul-
ing on pre-ap-
plication, 
product sub-
stantial simi-
larity. 
2,363 
M011 
212 (new) Label amend-
ment to add 
the DfE logo; 
requires data 
review; no 
other label 
changes. (9) 
3,648 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
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106 
(2) If another covered application is submitted that depends upon an applica-
tion to approve an inert ingredient, each application will be subject to its respec-
tive registration service fee. The decision review time line for both submissions 
will be the longest of the associated applications. If the application covers mul-
tiple 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 in-
gredient 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 de-
cision 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 deci-
sion 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 ingre-
dient 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 be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’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 con-
sidered an Agency endorsement because the ingredients in the qualifying prod-
uct must meet objective, scientific criteria established and widely publicized by 
EPA.’’. 
‘‘(3) SCHEDULE OF COVERED APPLICATIONS AND 
OTHER ACTIONS AND THEIR REGISTRATION SERVICE 
FEES.—Subject to paragraph (6), the schedule of reg-
istration applications and other covered actions and 
their corresponding registration service fees shall be 
as follows: 
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107 
‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R010 
New Active Ingre-
dient, Food use. 
(2)(3) 
753,082 
R020 
New Active Ingre-
dient, Food use; 
reduced risk. 
(2)(3) 
627,568 
R040 
New Active Ingre-
dient, Food use; 
Experimental 
Use Permit ap-
plication; estab-
lish temporary 
tolerance; sub-
mitted before ap-
plication for reg-
istration; credit 
45% of fee to-
ward new active 
ingredient ap-
plication that 
follows. (3) 
462,502 
R060 
New Active Ingre-
dient, Non-food 
use; outdoor. 
(2)(3) 
523,205 
R070 
New Active Ingre-
dient, Non-food 
use; outdoor; re-
duced risk. 
(2)(3) 
436,004 
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108 
‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R090 
New Active Ingre-
dient, Non-food 
use; outdoor; Ex-
perimental Use 
Permit applica-
tion; submitted 
before applica-
tion for registra-
tion; credit 45% 
of fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
323,690 
R110 
New Active Ingre-
dient, Non-food 
use; indoor. 
(2)(3) 
290,994 
R120 
New Active Ingre-
dient, Non-food 
use; indoor; re-
duced risk. 
(2)(3) 
242,495 
R121 
New Active Ingre-
dient, Non-food 
use; indoor; Ex-
perimental Use 
Permit applica-
tion; submitted 
before applica-
tion for registra-
tion; credit 45% 
of fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
182,327 
R122 
Enriched isomer(s) 
of registered 
mixed-isomer ac-
tive ingredient. 
(2)(3) 
317,128 
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109 
‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R123 
New Active Ingre-
dient, Seed 
treatment only; 
includes agricul-
tural and non- 
agricultural 
seeds; residues 
not expected in 
raw agricultural 
commodities. 
(2)(3) 
471,861 
R125 
New Active Ingre-
dient, Seed 
treatment; Ex-
perimental Use 
Permit applica-
tion; submitted 
before applica-
tion for registra-
tion; credit 45% 
of fee toward 
new active in-
gredient appli-
cation that fol-
lows. (3) 
323,690 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
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110 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 deci-
sion 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 ad-
ditional 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 ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient 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 re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative 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 Agen-
cy. 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) with-
draws 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 agree-
ment to the Agency. 
‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R130 
First food use; in-
door; food/food 
handling. (2) (3) 
191,444 
R140 
Additional food 
use; Indoor; food/ 
food handling. 
(3) (4) 
44,672 
R150 
First food use. 
(2)(3) 
317,104 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R155 
16 (new) 
First food use, Ex-
perimental Use 
Permit applica-
tion; a.i. reg-
istered for non- 
food outdoor use. 
(3)(4) 
264,253 
R160 
First food use; re-
duced risk. 
(2)(3) 
264,253 
R170 
Additional food 
use. (3) (4) 
79,349 
R175 
Additional food 
uses covered 
within a crop 
group resulting 
from the conver-
sion of existing 
approved crop 
group(s) to one 
or more revised 
crop groups. 
(3)(4) 
66,124 
R180 
Additional food 
use; reduced risk. 
(3)(4) 
66,124 
R190 
Additional food 
uses; 6 or more 
submitted in one 
application. 
(3)(4) 
476,090 
R200 
Additional Food 
Use; 6 or more 
submitted in one 
application; Re-
duced Risk. 
(3)(4) 
396,742 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R210 
Additional food 
use; Experi-
mental Use Per-
mit application; 
establish tem-
porary tolerance; 
no credit toward 
new use registra-
tion. (3)(4) 
48,986 
R220 
Additional food 
use; Experi-
mental Use Per-
mit application; 
crop destruct 
basis; no credit 
toward new use 
registration. 
(3)(4) 
19,838 
R230 
Additional use; 
non-food; out-
door. (3) (4) 
31,713 
R240 
Additional use; 
non-food; out-
door; reduced 
risk. (3)(4) 
26,427 
R250 
Additional use; 
non-food; out-
door; Experi-
mental Use Per-
mit application; 
no credit toward 
new use registra-
tion. (3)(4) 
19,838 
R251 
Experimental Use 
Permit applica-
tion which re-
quires no 
changes to the 
tolerance(s); 
non-crop de-
struct basis. (3) 
19,838 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R260 
New use; non-food; 
indoor. (3) (4) 
15,317 
R270 
New use; non-food; 
indoor; reduced 
risk. (3)(4) 
12,764 
R271 
New use; non-food; 
indoor; Experi-
mental Use Per-
mit application; 
no credit toward 
new use registra-
tion. (3)(4) 
9,725 
R273 
Additional use; 
seed treatment; 
limited uptake 
into Raw Agri-
cultural Com-
modities; in-
cludes crops with 
established toler-
ances (e.g., for 
soil or foliar ap-
plication); in-
cludes food and/ 
or non-food uses. 
(3)(4) 
50,445 
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‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R274 
Additional uses; 
seed treatment 
only; 6 or more 
submitted in one 
application; lim-
ited uptake into 
raw agricultural 
commodities; in-
cludes crops with 
established toler-
ances (e.g., for 
soil or foliar ap-
plication); in-
cludes food and/ 
or non-food uses. 
(3)(4) 
302,663 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion 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 deci-
sion 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 ad-
ditional 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 ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient 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 re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
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115 
(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 Agen-
cy. 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) with-
draws 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 agree-
ment to the Agency. 
(4) Amendment applications to add the new use(s) to registered product labels 
are covered by the base fee for the new use(s). All items in the covered application 
must be submitted together in one package. Each application for an additional 
new product registration and new inert approval(s) that is submitted in the new 
use application package is subject to the registration service fee for a new product 
or a new inert approval. However, if a new use application only proposes to reg-
ister the new use for a new product and there are no amendments in the applica-
tion, 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 appli-
cation 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 applica-
tion. 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) 
Registra-
tion 
Service Fee 
($) 
R280 
Establish import 
tolerance; new 
active ingredient 
or first food use. 
(2) 
319,072 
R290 
Establish Import 
tolerance; Addi-
tional new food 
use. 
63,816 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R291 
Establish import 
tolerances; addi-
tional food uses; 
6 or more crops 
submitted in one 
petition. 
382,886 
R292 
Amend an estab-
lished tolerance 
(e.g., decrease or 
increase) and/or 
harmonize estab-
lished tolerances 
with Codex 
MRLs; domestic 
or import; appli-
cant-initiated. 
45,341 
R293 
Establish toler-
ance(s) for inad-
vertent residues 
in one crop; ap-
plicant-initiated. 
53,483 
R294 
Establish tolerances 
for inadvertent 
residues; 6 or 
more crops sub-
mitted in one 
application; ap-
plicant-initiated. 
320,894 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R295 
Establish toler-
ance(s) for resi-
dues in one rota-
tional crop in 
response to a 
specific rota-
tional crop ap-
plication; sub-
mission of cor-
responding label 
amendments 
which specify the 
necessary plant- 
back restrictions; 
applicant-initi-
ated. (3) (4) 
66,124 
R296 
Establish tolerances 
for residues in 
rotational crops 
in response to a 
specific rota-
tional crop peti-
tion; 6 or more 
crops submitted 
in one applica-
tion; submission 
of corresponding 
label amend-
ments which 
specify the nec-
essary plant- 
back restrictions; 
applicant-initi-
ated. (3) (4) 
396,742 
R297 
Amend 6 or more 
established toler-
ances (e.g., de-
crease or in-
crease) in one 
petition; domes-
tic or import; 
applicant-initi-
ated. 
272,037 
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‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 
OTHER TOLERANCES—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R298 
Amend an estab-
lished tolerance 
(e.g., decrease or 
increase); domes-
tic or import; 
submission of 
corresponding 
amended labels 
(requiring 
science review). 
(3) (4) 
58,565 
R299 
Amend 6 or more 
established toler-
ances (e.g., de-
crease or in-
crease); domestic 
or import; sub-
mission of cor-
responding 
amended labels 
(requiring 
science review). 
(3) (4) 
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 applica-
tion 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 deci-
sion 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 ad-
ditional 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 ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient 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 re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
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119 
(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 Agen-
cy. 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) with-
draws 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 agree-
ment 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 to-
gether will be subject to the category decision review time. 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R300 
New product; or 
similar combina-
tion product (al-
ready registered) 
to an identical or 
substantially 
similar in com-
position and use 
to a registered 
product; reg-
istered source of 
active ingredient; 
no data review 
on acute toxicity, 
efficacy or CRP 
– only product 
chemistry data; 
cite-all data cita-
tion, or selective 
data citation 
where applicant 
owns all required 
data, or appli-
cant submits spe-
cific authoriza-
tion letter from 
data owner. Cat-
egory also in-
cludes 100% re- 
package of reg-
istered end-use or 
manufacturing- 
use product that 
requires no data 
submission nor 
data matrix. 
(2)(3) 
1,582 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R301 
New product; or 
similar combina-
tion product (al-
ready registered) 
to an identical or 
substantially 
similar in com-
position and use 
to a registered 
product; reg-
istered source of 
active ingredient; 
selective data ci-
tation only for 
data on product 
chemistry and/or 
acute toxicity 
and/or public 
health pest effi-
cacy (identical 
data citation and 
claims to cited 
product(s)), 
where applicant 
does not own all 
required data 
and does not 
have a specific 
authorization let-
ter from data 
owner. (2)(3) 
1,897 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R310 
New end-use or 
manufacturing- 
use product with 
registered 
source(s) of ac-
tive ingre-
dient(s); includes 
products con-
taining two or 
more registered 
active ingredients 
previously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; requires 
review of data 
package within 
RD only; in-
cludes data and/ 
or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
7,301 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R314 
New end use prod-
uct containing 
up to three reg-
istered active in-
gredients never 
before registered 
as this combina-
tion in a formu-
lated product; 
new product label 
is identical or 
substantially 
similar to the la-
bels of currently 
registered prod-
ucts which sepa-
rately contain 
the respective 
component active 
ingredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
8,626 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R319 
New end use prod-
uct containing 
up to three reg-
istered active in-
gredients never 
before registered 
as this combina-
tion in a formu-
lated product; 
new product label 
is identical or 
substantially 
similar to the la-
bels of currently 
registered prod-
ucts which sepa-
rately contain 
the respective 
component active 
ingredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
12,626 
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125 
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R318 
(new) 
New end use prod-
uct containing 
four or more reg-
istered active in-
gredients never 
before registered 
as this combina-
tion in a formu-
lated product; 
new product label 
is identical or 
substantially 
similar to the la-
bels of currently 
registered prod-
ucts which sepa-
rately contain 
the respective 
component active 
ingredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
13,252 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R321 
(new) 
New end use prod-
uct containing 
four or more reg-
istered active in-
gredients never 
before registered 
as this combina-
tion in a formu-
lated product; 
new product label 
is identical or 
substantially 
similar to the la-
bels of currently 
registered prod-
ucts which sepa-
rately contain 
the respective 
component active 
ingredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers of 
data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
17,252 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R315 
New end-use, on- 
animal product, 
registered source 
of active ingre-
dient(s), with the 
submission of 
data and/or 
waivers for only: 
∑ animal safety 
and 
∑ pest(s) requiring 
efficacy (4) and/ 
or 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging. (2) 
(3) 
9,820 
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128 
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R316 
(new) 
New end-use or 
manufacturing 
product with reg-
istered source(s) 
of active ingre-
dient(s) includ-
ing products con-
taining two or 
more registered 
active ingredients 
previously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; and re-
quires review of 
data and/or 
waivers for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 3 
and up to 7 tar-
get pests. (2)(3) 
11,301 
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129 
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R317 
(new) 
New end-use or 
manufacturing 
product with reg-
istered source(s) 
of active ingre-
dient(s) includ-
ing products con-
taining 2 or 
more registered 
active ingredients 
previously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; and re-
quires review of 
data and/or 
waivers for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 7 
target pests. 
(2)(3) 
15,301 
R320 
New product; new 
physical form; 
requires data re-
view in science 
divisions. (2)(3) 
13,226 
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130 
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R331 
New product; re-
pack of identical 
registered end-use 
product as a 
manufacturing- 
use product, or 
identical reg-
istered manufac-
turing-use prod-
uct as an end use 
product; same 
registered uses 
only. (2)(3) 
2,530 
R332 
New manufac-
turing-use prod-
uct; registered ac-
tive ingredient; 
unregistered 
source of active 
ingredient; sub-
mission of com-
pletely new ge-
neric data pack-
age; registered 
uses only; re-
quires review in 
RD and science 
divisions. (2)(3) 
283,215 
R333 
New product; MUP 
or End use prod-
uct with unregis-
tered source of 
active ingredient; 
requires science 
data review; new 
physical form; 
etc. Cite-all or se-
lective data cita-
tion where appli-
cant owns all re-
quired data. 
(2)(3) 
19,838 
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131 
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R334 
New product; MUP 
or End use prod-
uct with unregis-
tered source of 
the active ingre-
dient; requires 
science data re-
view; new phys-
ical form; etc. 
Selective data ci-
tation. (2)(3) 
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 ingre-
dient 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 Agen-
cy. 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) with-
draws 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 agree-
ment to the Agency. 
(4) For the purposes of classifying proposed registration actions into PRIA cat-
egories, ‘‘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. ter-
mites, 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 cat-
egories, pests have been placed into groups (general; e.g., cockroaches) and pest 
specific (specifically a test species). If seeking a label claim against a pest group 
(general), use the group listing below and each group will count as 1. The general 
pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle 
ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, bot flies, 
screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, biting flies, 
horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true bugs, 
bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter 
ants), fire and harvester ants, wood destroying beetles, carpenter ants, termites, 
subterranean termites, dry wood termites, arboreal termites, damp wood termites 
and invasive species. If seeking a claim against a specific pest without a general 
claim then each specific pest will count as 1. 
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132 
‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R340 
Amendment requiring 
data review within 
RD (e.g., changes to 
precautionary label 
statements); includes 
adding/modifying 
pest(s) claims for up 
to 2 target pests, ex-
cludes products re-
quiring or citing an 
animal safety study. 
(2)(3)(4) 
4,988 
R341 
(New) 
Amendment requiring 
data review within 
RD (e.g., changes to 
precautionary label 
statements), includes 
adding/modifying 
pest(s) claims for 
greater than 2 target 
pests, excludes prod-
ucts requiring or cit-
ing an animal safety 
study. (2)(3)(4) 
5,988 
R345 
Amending on-animal 
products previously 
registered, with the 
submission of data 
and/or waivers for 
only: 
∑ animal safety and 
∑ pest(s) requiring effi-
cacy (4) and/or 
∑ product chemistry 
and/or 
∑ acute toxicity and/or 
∑ child resistant pack-
aging. (2)(3) 
8,820 
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‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R350 
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 advi-
sory statement). 
(2)(3) 
13,226 
R351 
Amendment adding a 
new unregistered 
source of active ingre-
dient. (2)(3) 
13,226 
R352 
Amendment adding al-
ready approved uses; 
selective method of 
support; does not 
apply if the appli-
cant owns all cited 
data. (2) (3) 
13,226 
R371 
Amendment to Experi-
mental Use Permit; 
(does not include ex-
tending a permit’s 
time period). (3) 
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 registra-
tion 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 registra-
tion service fees. (e) Submissions with data and requiring data review are subject 
to registration service fees. 
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