I 
115TH CONGRESS 
1ST SESSION H. R. 1029 
To amend the Federal Insecticide, Fungicide, and Rodenticide Act to improve 
pesticide registration and other activities under the Act, to extend and 
modify fee authorities, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 14, 2017 
Mr. RODNEY DAVIS of Illinois introduced the following bill; which was referred 
to the Committee on Agriculture, and in addition to the Committee on 
Energy and Commerce, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To 
amend 
the 
Federal 
Insecticide, 
Fungicide, 
and 
Rodenticide Act to improve pesticide registration and 
other activities under the Act, to extend and modify 
fee authorities, and for other purposes. 
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’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
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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. 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’’; 
(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’’; 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’’; 
(3) in subparagraph (E)(i)— 
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(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’’; 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’’; and 
(4) in subparagraph (I), by striking ‘‘2017’’ 
and inserting ‘‘2023’’. 
(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 
(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’’. 
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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 second sen-
tence and inserting the following: ‘‘paragraph (3), to 
offset the costs of registration review under section 
3(g), including the costs associated with any review 
under the Endangered Species Act of 1973 (16 
U.S.C. 1531 et seq.) required as part of the reg-
istration review, to offset the costs associated with 
tracking and implementing registration review deci-
sions, including registration review decisions de-
signed to reduce risk, for the purposes specified in 
paragraphs (4) and (5), and to enhance the informa-
tion systems capabilities to improve the tracking of 
pesticide registration decisions.’’; 
(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-
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‘‘(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, but shall permit appli-
cants and registrants sufficient time to obtain 
data that meet the requirements specified in 
such revised guidance. 
‘‘(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 
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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, the Administrator shall use 
not more than $500,000 of the amounts made 
available to the Administrator in the Rereg-
istration and Expedited 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 
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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. 
Subsection (a) of section 5 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136c) is amend-
ed to read as follows: 
‘‘(a) APPLICATION AND ISSUANCE.— 
‘‘(1) APPLICATION.—Any person may apply to 
the Administrator for an experimental use permit 
for a pesticide. An application for an experimental 
use permit may be filed at any time. 
‘‘(2) REQUIREMENTS.—An application for an 
experimental use permit shall conform with the re-
quirements of section 33(b). 
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‘‘(3) ISSUANCE.—The decision whether to grant 
an experimental use permit shall be made within the 
time-frame specified in the applicable covered appli-
cation category specified in section 33(b)(3).’’. 
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’’; 
(2) in paragraph (5)— 
(A) in the heading, by striking ‘‘PESTICIDE 
REGISTRATION
APPLICATIONS’’ and inserting 
‘‘COVERED APPLICATION’’; and 
(B) by striking ‘‘pesticide registration ap-
plication’’ both places it appears and inserting 
‘‘covered application’’; 
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(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 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 
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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 
(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)— 
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(A) by striking ‘‘2017’’ and inserting 
‘‘2023’’; and 
(B) by inserting before the period at the 
end the following: ‘‘, with an emphasis on field- 
worker populations in the United States’’; 
(3) in clause (ii), by striking ‘‘2017’’ and in-
serting ‘‘2023’’; and 
(4) in clause (iii), by striking ‘‘2017’’ and in-
serting ‘‘2023’’. 
(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— 
(1) by striking ‘‘Pesticide Registration Improve-
ment Extension Act of 2012’’ and inserting ‘‘Pes-
ticide Registration Enhancement 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)) is amended— 
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(1) in paragraph (1) by striking ‘‘2017’’ and in-
serting ‘‘2023’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (D), by striking 
clause (i) and inserting the following new 
clause: 
‘‘(i) the number of pesticides or pes-
ticide cases reviewed and the number of 
registration review decisions completed, in-
cluding— 
‘‘(I) the number of cases can-
celled; 
‘‘(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)— 
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(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; 
‘‘(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); 
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(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-
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 for 
use in the United States, including each terri-
tory 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 
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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— 
‘‘(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, 
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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.’’. 
(f) TERMINATION
OF
EFFECTIVENESS.—Section 
33(m) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136w–8(m)) is amended— 
(1) in paragraph (1), by striking ‘‘2017’’ and 
inserting ‘‘2023’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘FISCAL YEAR 2018.— 
During fiscal year 2018’’ and inserting 
‘‘FISCAL
YEAR
2024.—During fiscal year 
2024’’; and 
(ii) by striking ‘‘2017’’ and inserting 
‘‘2023’’; 
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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 
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 
($) 
R090 
New Active In-
gredient, Non- 
food use; out-
door; Experi-
mental Use 
Permit appli-
cation; sub-
mitted before 
application for 
registration; 
credit 45% of 
fee toward 
new active in-
gredient appli-
cation that fol-
lows (3) 
323,690 
R110 
New Active In-
gredient, Non- 
food use; in-
door (2) (3) 
242,495 
R120 
New Active In-
gredient, Non- 
food use; in-
door; reduced 
risk (2) (3) 
242,495 
R121 
New Active In-
gredient, Non- 
food use; in-
door; Experi-
mental Use 
Permit appli-
cation; sub-
mitted before 
application for 
registration; 
credit 45% of 
fee toward 
new active in-
gredient appli-
cation that fol-
lows (3) 
182,327 
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‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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 registered) 
to an identical or 
substantially simi-
lar in composition 
and use to a reg-
istered product; 
registered source 
of active ingre-
dient; no data re-
view on acute tox-
icity, efficacy or 
CRP – only prod-
uct chemistry data; 
cite-all data cita-
tion, or selective 
data citation where 
applicant owns all 
required data, or 
applicant submits 
specific authoriza-
tion letter from 
data owner. Cat-
egory also includes 
100% re-package 
of registered end- 
use or manufac-
turing-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) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R301 
New product; or 
similar combina-
tion product (al-
ready registered) 
to an identical or 
substantially simi-
lar in composition 
and use to a reg-
istered product; 
registered source 
of active ingre-
dient; selective 
data citation only 
for data on prod-
uct chemistry and/ 
or acute toxicity 
and/or public 
health pest efficacy 
(identical data ci-
tation and claims 
to cited prod-
uct(s)), where ap-
plicant does not 
own all required 
data and does not 
have a specific au-
thorization letter 
from data owner 
(2) (3) 
1,897 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R310 
New end-use or man-
ufacturing-use 
product with reg-
istered source(s) of 
active ingre-
dient(s); includes 
products con-
taining two or 
more registered ac-
tive ingredients 
previously com-
bined in other reg-
istered products; 
excludes products 
requiring or citing 
an animal safety 
study; requires re-
view of data pack-
age within RD 
only; includes data 
and/or waivers of 
data for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests (2) (3) 
7,301 
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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 
($) 
R314 
New end use product 
containing up to 
three registered ac-
tive ingredients 
never before reg-
istered as this 
combination in a 
formulated prod-
uct; new product 
label is identical or 
substantially simi-
lar to the labels of 
currently reg-
istered products 
which separately 
contain the respec-
tive component ac-
tive ingredients; 
excludes products 
requiring or citing 
an animal safety 
study; requires re-
view of data pack-
age within RD 
only; includes data 
and/or waivers of 
data for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests (2) (3) 
8,626 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R319 
New end use product 
containing up to 
three registered ac-
tive ingredients 
never before reg-
istered as this 
combination in a 
formulated prod-
uct; new product 
label is identical or 
substantially simi-
lar to the labels of 
currently reg-
istered products 
which separately 
contain the respec-
tive component ac-
tive ingredients; 
excludes products 
requiring or citing 
an animal safety 
study; requires re-
view of data pack-
age within RD 
only; includes data 
and/or waivers of 
data for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 4 
to 7 target pests 
(2) (3) 
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 
($) 
R318 
50 (new) New end use product 
containing four or 
more registered ac-
tive ingredients 
never before reg-
istered as this 
combination in a 
formulated prod-
uct; new product 
label is identical or 
substantially simi-
lar to the labels of 
currently reg-
istered products 
which separately 
contain the respec-
tive component ac-
tive ingredients; 
excludes products 
requiring or citing 
an animal safety 
study; requires re-
view of data pack-
age within RD 
only; includes data 
and/or waivers of 
data for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests (2) (3) 
13,252 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R321 
51 (new) New end use product 
containing four or 
more registered ac-
tive ingredients 
never before reg-
istered as this 
combination in a 
formulated prod-
uct; new product 
label is identical or 
substantially simi-
lar to the labels of 
currently reg-
istered products 
which separately 
contain the respec-
tive component ac-
tive ingredients; 
excludes products 
requiring or citing 
an animal safety 
study; requires re-
view of data pack-
age within RD 
only; includes data 
and/or waivers of 
data for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 4 
to 7 target pests 
(2) (3) 
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 
($) 
R315 
New end-use, on-ani-
mal product, reg-
istered source of 
active ingre-
dient(s), with the 
submission of data 
and/or waivers for 
only: 
∑ animal safety and 
∑ pest(s) requiring 
efficacy (4) and/or 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging (2) (3) 
9,820 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R316 
53 (new) New end-use or man-
ufacturing product 
with registered 
source(s) of active 
ingredient(s) in-
cluding products 
containing two or 
more registered ac-
tive ingredients 
previously com-
bined in other reg-
istered products; 
excludes products 
requiring or citing 
an animal safety 
study; and requires 
review of data and/ 
or waivers for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 3 and 
up to 7 target 
pests (2) (3) 
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 
($) 
R317 
54 (new) New end-use or man-
ufacturing product 
with registered 
source(s) of active 
ingredient(s) in-
cluding products 
containing 2 or 
more registered ac-
tive ingredients 
previously com-
bined in other reg-
istered products; 
excludes products 
requiring or citing 
an animal safety 
study; and requires 
review of data and/ 
or waivers for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging and/or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 7 tar-
get pests (2) (3) 
15,301 
R320 
New product; new 
physical form; re-
quires data review 
in science divisions 
(2) (3) 
13,226 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R331 
New product; repack 
of identical reg-
istered end-use 
product as a man-
ufacturing-use 
product, or iden-
tical registered 
manufacturing-use 
product as an end 
use product; same 
registered uses 
only (2) (3) 
2,530 
R332 
New manufacturing- 
use product; reg-
istered active in-
gredient; unregis-
tered source of ac-
tive ingredient; 
submission of com-
pletely new generic 
data package; reg-
istered uses only; 
requires review in 
RD and science di-
visions (2) (3) 
283,215 
R333 
New product; MUP 
or End use prod-
uct with unregis-
tered source of ac-
tive ingredient; re-
quires science data 
review; new phys-
ical form; etc. Cite- 
all or selective data 
citation where ap-
plicant owns all re-
quired data (2) (3) 
19,838 
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‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R334 
New product; MUP 
or End use prod-
uct with unregis-
tered source of the 
active ingredient; 
requires science 
data review; new 
physical form; etc. 
Selective data cita-
tion (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 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. 
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‘‘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) 
4,988 
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 
products requiring 
or citing an animal 
safety study (2) (3) 
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 
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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 
($) 
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 
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. 
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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 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 
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‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R272 
Review of Study 
Protocol appli-
cant-initiated; 
excludes 
DART, pre-reg-
istration con-
ference, Rapid 
Response re-
view, DNT pro-
tocol review, 
protocol need-
ing HSRB re-
view 
2,530 
R275 
Rebuttal of agen-
cy reviewed 
protocol, appli-
cant initiated 
2,530 
R370 
Cancer reassess-
ment; appli-
cant-initiated 
198,250 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW 
ACTIVE INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A380 
New Active Ingre-
dient; Indirect 
Food use; es-
tablish tolerance 
or tolerance ex-
emption if re-
quired (2) (3) 
137,841 
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‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW 
ACTIVE INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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 
($) 
A542 
86 (new) 
New end use 
product; 
FIFRA 
§2(mm) uses 
only; ≥ 51 
public health 
organisms 
(2(3)(5) 
15,000 
A550 
New end-use 
product; uses 
other than 
FIFRA 
§2(mm); non- 
FQPA product 
(2)(3)(5) 
13,226 
A560 
New manufac-
turing use 
product; reg-
istered active 
ingredient; se-
lective data ci-
tation (2)(3) 
12,596 
A565 
89 (new) 
New manufac-
turing-use 
product; reg-
istered active 
ingredient; un-
registered 
source of ac-
tive ingre-
dient; submis-
sion of new 
generic data 
package; reg-
istered uses 
only; requires 
science review 
(2)(3) 
18,234 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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 
A533 
103 (new) Exemption from 
the require-
ment of an 
Experimental 
Use Permit 
(2) 
2,482 
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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 
($) 
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. 
(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. 
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‘‘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 
B611 
111 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
petition to es-
tablish perma-
nent tolerance 
exemption (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 
($) 
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 
($) 
B673 
129 
New product 
MUP/EP; un-
registered 
source of active 
ingredient(s); ci-
tation of Tech-
nical Grade Ac-
tive Ingredient 
(TGAI) data 
previously re-
viewed and ac-
cepted by the 
Agency. Re-
quires an Agen-
cy determina-
tion that the 
cited data sup-
ports the new 
product. (2)(3) 
5,107 
B674 
130 
New product 
MUP; Repack 
of identical reg-
istered end-use 
product as a 
manufacturing- 
use product; 
same registered 
uses only (2)(3) 
1,278 
B675 
131 
New Active Ingre-
dient, Non-food 
use; indoor; re-
duced risk 
(2)(3) 
9,118 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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 
($) 
B883 
171 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient based 
on an existing 
temporary toler-
ance/tolerance ex-
emption. (8) (12) 
127,630 
B884 
172 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient. 
(8)(12) 
159,537 
B885 
173 
Registration applica-
tion; registered 
(3) PIP, seed in-
crease; breeding 
stack of pre-
viously approved 
PIPs, same crop; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). (9)(12) 
31,910 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B886 
174 
(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. SAP 
Review (8) (12) 
223,351 
B890 
175 
Application to 
amend a seed in-
crease registra-
tion; converts reg-
istration to com-
mercial registra-
tion; no petition 
since permanent 
tolerance/toler-
ance exemption is 
already estab-
lished for the ac-
tive ingredient(s). 
(12) 
63,816 
B891 
176 
Application to 
amend a seed in-
crease registra-
tion; converts reg-
istration to a 
commercial reg-
istration; no peti-
tion since a per-
manent tolerance/ 
tolerance exemp-
tion already es-
tablished for the 
active ingre-
dient(s); SAP re-
view. (5)(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 
($) 
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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