134 
(3) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
(4) For the purposes of classifying proposed registration actions into PRIA cat-
egories, ‘‘pest(s) requiring efficacy’’ are: public health pests listed in PR Notice 
2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests (e.g. ter-
mites, carpenter ants, wood-boring beetles) and certain invasive species (e.g. Asian 
Longhorned beetle, Emerald Ashborer). This list may be updated/refined as 
invasive pest needs arise. To determine the number of pests for the PRIA cat-
egories, pests have been placed into groups (general; e.g., cockroaches) and pest 
specific (specifically a test species). If seeking a label claim against a pest group 
(general), use the group listing below and each group will count as 1. The general 
pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle 
ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, bot flies, 
screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, biting flies, 
horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true bugs, 
bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter 
ants), fire and harvester ants, wood destroying beetles, carpenter ants, termites, 
subterranean termites, dry wood termites, arboreal termites, damp wood termites 
and invasive species. If seeking a claim against a specific pest without a general 
claim then each specific pest will count as 1. 
‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R124 
Conditional Ruling 
on Pre-applica-
tion Study Waiv-
ers; applicant-ini-
tiated. 
2,530 
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‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
R272 
Review of Study 
Protocol appli-
cant-initiated; ex-
cludes DART, 
pre-registration 
conference, Rapid 
Response review, 
DNT protocol re-
view, protocol 
needing HSRB 
review. 
2,530 
R275 
Rebuttal of agency 
reviewed protocol, 
applicant initi-
ated. 
2,530 
R370 
Cancer reassess-
ment; applicant- 
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) 
Registra-
tion 
Service Fee 
($) 
A380 
New Active Ingre-
dient; Indirect 
Food use; establish 
tolerance or toler-
ance exemption if 
required. (2)(3) 
137,841 
A390 
New Active Ingre-
dient; Direct Food 
use; establish tol-
erance or toler-
ance exemption if 
required. (2)(3) 
229,733 
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‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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 deci-
sion time review period as the new active ingredient or first food use application. 
The application must be received by the agency in one package. The base fee for 
the category covers a maximum of five new products. Each application for an ad-
ditional new product registration and new inert approval that is submitted in the 
new active ingredient application package or first food use application package is 
subject to the registration service fee for a new product or a new inert approval. 
All such associated applications that are submitted together will be subject to the 
new active ingredient or first food use decision review time. In the case of a new 
active ingredient application, until that new active ingredient is approved, any 
subsequent application for another new product containing the same active ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient application, subject to the registration service fee and decision review 
time for a new active ingredient. In the case of a first food use application, until 
that first food use is approved, any subsequent application for an additional new 
food use or uses will be subject to the registration service fee and decision review 
time for a first food use. Any information that (a) was neither requested nor re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
(3) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
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‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A440 
New Use, Indi-
rect Food Use, 
establish tol-
erance or tol-
erance exemp-
tion. (2)(3)(4) 
31,910 
A441 
Additional Indi-
rect food uses; 
establish tol-
erances or tol-
erance exemp-
tions if re-
quired; 6 or 
more sub-
mitted in one 
application. 
(3)(4)(5) 
114,870 
A450 
New use, Direct 
food use, es-
tablish toler-
ance or toler-
ance exemp-
tion. (2)(3)(4) 
95,724 
A451 
Additional Di-
rect food uses; 
establish tol-
erances or tol-
erance exemp-
tions if re-
quired; 6 or 
more sub-
mitted in one 
application. 
(3)(4)(5) 
182,335 
A500 
New use, non- 
food. (4)(5) 
31,910 
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‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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 deci-
sion time review period as the new active ingredient or first food use application. 
The application must be received by the agency in one package. The base fee for 
the category covers a maximum of five new products. Each application for an ad-
ditional new product registration and new inert approval that is submitted in the 
new active ingredient application package or first food use application package is 
subject to the registration service fee for a new product or a new inert approval. 
All such associated applications that are submitted together will be subject to the 
new active ingredient or first food use decision review time. In the case of a new 
active ingredient application, until that new active ingredient is approved, any 
subsequent application for another new product containing the same active ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient application, subject to the registration service fee and decision review 
time for a new active ingredient. In the case of a first food use application, until 
that first food use is approved, any subsequent application for an additional new 
food use or uses will be subject to the registration service fee and decision review 
time for a first food use. Any information that (a) was neither requested nor re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
(3) 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 before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
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139 
(5) Amendment applications to add the new use(s) to registered product labels 
are covered by the base fee for the new use(s). All items in the covered application 
must be submitted together in one package. Each application for an additional 
new product registration and new inert approval(s) that is submitted in the new 
use application package is subject to the registration service fee for a new product 
or a new inert approval. However, if a new use application only proposes to reg-
ister the new use for a new product and there are no amendments in the applica-
tion, then review of one new product application is covered by the new use fee. All 
such associated applications that are submitted together will be subject to the new 
use decision review time. Any application for a new product or an amendment to 
the proposed labeling (a) submitted subsequent to submission of the new use appli-
cation and (b) prior to conclusion of its decision review time and (c) containing 
the same new uses, will be deemed a separate new-use application, subject to a 
separate registration service fee and new decision review time for a new use. If the 
new-use application includes non-food (indoor and/or outdoor), and food (outdoor 
and/or indoor) uses, the appropriate fee is due for each type of new use and the 
longest decision review time applies to all of the new uses requested in the applica-
tion. Any information that (a) was neither requested nor required by the Agency, 
and (b) is submitted by the applicant at the applicant’s initiative to support the 
application after completion of the technical deficiency screen, and (c) is not itself 
a covered registration application, must be assessed 25% of the full registration 
service fee for the new use application. 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A530 
New product, iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product; 
no data review 
or only product 
chemistry data; 
cite all data ci-
tation or selec-
tive data cita-
tion where ap-
plicant owns all 
required data; or 
applicant sub-
mits specific au-
thorization letter 
from data 
owner. Category 
also includes 
100% re-package 
of registered 
end-use or man-
ufacturing use 
product that re-
quires no data 
submission nor 
data matrix. 
(2)(3) 
1,278 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A531 
New product; iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product; 
registered source 
of active ingre-
dient: selective 
data citation 
only for data on 
product chem-
istry and/or 
acute toxicity 
and/or public 
health pest effi-
cacy, where ap-
plicant does not 
own all required 
data and does 
not have a spe-
cific authoriza-
tion letter from 
data owner. 
(2)(3) 
1,824 
A532 
New product; iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product; 
registered active 
ingredient; un-
registered source 
of active ingre-
dient; cite-all 
data citation ex-
cept for product 
chemistry; prod-
uct chemistry 
data submitted. 
(2)(3) 
5,107 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A540 
New end use prod-
uct; FIFRA 
§2(mm) uses 
only; up to 25 
public health or-
ganisms. 
(2)(3)(5)(6) 
5,107 
A541 
85 (new) 
New end use prod-
uct; FIFRA 
§2(mm) uses 
only; 26-50 pub-
lic health orga-
nisms. 
(2)(3)(5)(6) 
8,500 
A542 
86 (new) 
New end use prod-
uct; FIFRA 
§2(mm) uses 
only; ≥ 51 pub-
lic health orga-
nisms. (2)(3)(5) 
15,000 
A550 
New end-use prod-
uct; uses other 
than FIFRA 
§2(mm); non- 
FQPA product. 
(2)(3)(5) 
13,226 
A560 
New manufac-
turing use prod-
uct; registered 
active ingre-
dient; selective 
data citation. 
(2)(3) 
12,596 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A565 
89 (new) 
New manufac-
turing-use prod-
uct; registered 
active ingre-
dient; unregis-
tered source of 
active ingre-
dient; submis-
sion of new ge-
neric data pack-
age; registered 
uses only; re-
quires science re-
view. (2)(3) 
18,234 
A570 
Label amendment 
requiring data 
review; up to 25 
public health or-
ganisms. 
(3)(4)(5)(6) 
3,831 
A573 
91 (new) 
Label amendment 
requiring data 
review; 26-50 
public health or-
ganisms. 
(2)(3)(5)(7) 
6,350 
A574 
92 (new) 
Label amendment 
requiring data 
review; ≥ 51 
public health or-
ganisms. 
(2)(3)(5)(7) 
11,000 
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‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A572 
New Product or 
amendment re-
quiring data re-
view for risk as-
sessment 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. 
(3) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
(4)(a) EPA-initiated amendments shall not be charged registration service fees. 
(b) Registrant-initiated fast-track amendments are to be completed within the 
timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registra-
tion service fees. (c) Registrant-initiated fast-track amendments handled by the 
Antimicrobials Division are to be completed within the timelines specified in 
FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant 
initiated amendments submitted by notification under PR Notices, such as PR 
Notice 98–10, continue under PR Notice timelines and are not subject to registra-
tion service fees. (e) Submissions with data and requiring data review are subject 
to registration service fees. 
(5) The applicant must identify the substantially similar product if opting to 
use cite-all or the selective method to support acute toxicity data requirements. 
(6) Once a submission for a new product with public health organisms has been 
submitted and classified in either A540 or A541, additional organisms submitted 
for the same product before expiration of the first submission’s original decision 
review time period will result in reclassification of both the original and subse-
quent submission into the appropriate new category based on the sum of the num-
ber of organisms in both submissions. A reclassification would result in a new 
PRIA start date and require additional fees to meet the fee of the new category. 
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145 
(7) Once a submission for a label amendment with public health organisms has 
been submitted and classified in either A570 or A573, additional organisms sub-
mitted for the same product before expiration of the first submission’s original de-
cision review time period will result in reclassification of both the original and 
subsequent submission into the appropriate new category based on the sum of the 
number of organisms in both submissions. A reclassification would result in a new 
PRIA start date and require additional fees to meet the fee of the new category. 
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — 
EXPERIMENTAL USE PERMITS AND OTHER ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A520 
Experimental Use 
Permit applica-
tion, non-food 
use. (2) 
6,383 
A521 
Review of public 
health efficacy 
study protocol 
within AD, per 
AD Internal 
Guidance for the 
Efficacy Pro-
tocol Review 
Process; Code 
will also include 
review of public 
health efficacy 
study protocol 
and data review 
for devices mak-
ing pesticidal 
claims; appli-
cant-initiated; 
Tier 1. 
4,726 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A522 
Review of public 
health efficacy 
study protocol 
outside AD by 
members of AD 
Efficacy Pro-
tocol Review Ex-
pert Panel; Code 
will also include 
review of public 
health efficacy 
study protocol 
and data review 
for devices mak-
ing pesticidal 
claims; appli-
cant-initiated; 
Tier 2. 
12,156 
A537 
97 (new) 
New Active Ingre-
dient/New Use, 
Experimental 
Use Permit ap-
plication; Direct 
food use; Estab-
lish tolerance or 
tolerance exemp-
tion if required. 
Credit 45% of 
fee toward new 
active ingre-
dient/new use 
application that 
follows. 
153,156 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A538 
98 (new) 
New Active Ingre-
dient/New Use, 
Experimental 
Use Permit ap-
plication; Indi-
rect food use; 
Establish toler-
ance or tolerance 
exemption if re-
quired Credit 
45% of fee to-
ward new active 
ingredient/new 
use application 
that follows. 
95,724 
A539 
99 (new) 
New Active Ingre-
dient/New Use, 
Experimental 
Use Permit ap-
plication; 
Nonfood use. 
Credit 45% of 
fee toward new 
active ingre-
dient/new use 
application that 
follows. 
92,163 
A529 
100 
Amendment to Ex-
perimental Use 
Permit; requires 
data review or 
risk assessment. 
(2) 
11,429 
A523 
101 
Review of protocol 
other than a 
public health ef-
ficacy study 
(i.e., Toxicology 
or Exposure 
Protocols). 
12,156 
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‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
A571 
102 
Science reassess-
ment: Cancer 
risk, refined eco-
logical risk, and/ 
or endangered 
species; appli-
cant-initiated. 
95,724 
A533 
103 
(new) 
Exemption from 
the requirement 
of an Experi-
mental Use Per-
mit. (2) 
2,482 
A534 
104 
(new) 
Rebuttal of agency 
reviewed pro-
tocol, applicant 
initiated. 
4,726 
A535 
105 
(new) 
Conditional Ruling 
on Pre-applica-
tion Study 
Waiver or Data 
Bridging Argu-
ment; applicant- 
initiated. 
2,409 
A536 
106 
(new) 
Conditional Ruling 
on Pre-applica-
tion Direct 
Food, Indirect 
Food, Nonfood 
use determina-
tion; applicant- 
initiated. 
2,482 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
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149 
(2) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 
INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B580 
107 
New active ingre-
dient; food use; 
petition to estab-
lish a tolerance. 
(2)(3) 
51,053 
B590 
108 
New active ingre-
dient; food use; 
petition to estab-
lish a tolerance 
exemption. 
(2)(3) 
31,910 
B600 
109 
New active ingre-
dient; non-food 
use. (2)(3) 
19,146 
B610 
110 
New active ingre-
dient; Experi-
mental Use Per-
mit application; 
petition to estab-
lish a temporary 
tolerance or tem-
porary 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) 
Registra-
tion 
Service Fee 
($) 
B611 
111 
New active ingre-
dient; Experi-
mental Use Per-
mit application; 
petition to estab-
lish permanent 
tolerance exemp-
tion. (3) 
12,764 
B612 
112 
New active ingre-
dient; no change 
to a permanent 
tolerance exemp-
tion. (2)(3) 
17,550 
B613 
113 
New active ingre-
dient; petition to 
convert a tem-
porary tolerance 
or a temporary 
tolerance exemp-
tion to a perma-
nent tolerance or 
tolerance exemp-
tion. (2)(3) 
17,550 
B620 
114 
New active ingre-
dient; Experi-
mental Use Per-
mit application; 
non-food use in-
cluding crop de-
struct. (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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151 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion for a new active ingredient or a first food use are covered by the base fee for 
that new active ingredient or first food use application and retain the same deci-
sion time review period as the new active ingredient or first food use application. 
The application must be received by the agency in one package. The base fee for 
the category covers a maximum of five new products. Each application for an ad-
ditional new product registration and new inert approval that is submitted in the 
new active ingredient application package or first food use application package is 
subject to the registration service fee for a new product or a new inert approval. 
All such associated applications that are submitted together will be subject to the 
new active ingredient or first food use decision review time. In the case of a new 
active ingredient application, until that new active ingredient is approved, any 
subsequent application for another new product containing the same active ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient application, subject to the registration service fee and decision review 
time for a new active ingredient. In the case of a first food use application, until 
that first food use is approved, any subsequent application for an additional new 
food use or uses will be subject to the registration service fee and decision review 
time for a first food use. Any information that (a) was neither requested nor re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
(3) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
‘‘TABLE 12. — BIOPESTICIDES DIVISION — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B630 
115 
First food use; pe-
tition to estab-
lish a tolerance 
exemption. 
(2)(4) 
12,764 
B631 
116 
New food use; peti-
tion to amend 
an established 
tolerance. (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) 
Registra-
tion 
Service Fee 
($) 
B640 
117 
First food use; pe-
tition to estab-
lish a tolerance. 
(2)(4) 
19,146 
B643 
118 
New Food use; pe-
tition to amend 
an established 
tolerance exemp-
tion. (3)(4) 
12,764 
B642 
119 
First food use; in-
door; food/food 
handling. (2)(4) 
31,910 
B644 
120 
New use, no change 
to an established 
tolerance 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; Ex-
perimental Use 
Permit applica-
tion; petition to 
amend or add a 
tolerance exemp-
tion. (4) 
12,764 
B646 
123 
(new) 
New use; non-food 
use including 
crop destruct; 
Experimental 
Use Permit ap-
plication. (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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153 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion for a new active ingredient or a first food use are covered by the base fee for 
that new active ingredient or first food use application and retain the same deci-
sion time review period as the new active ingredient or first food use application. 
The application must be received by the agency in one package. The base fee for 
the category covers a maximum of five new products. Each application for an ad-
ditional new product registration and new inert approval that is submitted in the 
new active ingredient application package or first food use application package is 
subject to the registration service fee for a new product or a new inert approval. 
All such associated applications that are submitted together will be subject to the 
new active ingredient or first food use decision review time. In the case of a new 
active ingredient application, until that new active ingredient is approved, any 
subsequent application for another new product containing the same active ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient application, subject to the registration service fee and decision review 
time for a new active ingredient. In the case of a first food use application, until 
that first food use is approved, any subsequent application for an additional new 
food use or uses will be subject to the registration service fee and decision review 
time for a first food use. Any information that (a) was neither requested nor re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
(3) Amendment applications to add the new use(s) to registered product labels 
are covered by the base fee for the new use(s). All items in the covered application 
must be submitted together in one package. Each application for an additional 
new product registration and new inert approval(s) that is submitted in the new 
use application package is subject to the registration service fee for a new product 
or a new inert approval. However, if a new use application only proposes to reg-
ister the new use for a new product and there are no amendments in the applica-
tion, then review of one new product application is covered by the new use fee. All 
such associated applications that are submitted together will be subject to the new 
use decision review time. Any application for a new product or an amendment to 
the proposed labeling (a) submitted subsequent to submission of the new use appli-
cation and (b) prior to conclusion of its decision review time and (c) containing 
the same new uses, will be deemed a separate new-use application, subject to a 
separate registration service fee and new decision review time for a new use. If the 
new-use application includes non-food (indoor and/or outdoor), and food (outdoor 
and/or indoor) uses, the appropriate fee is due for each type of new use and the 
longest decision review time applies to all of the new uses requested in the applica-
tion. Any information that (a) was neither requested nor required by the Agency, 
and (b) is submitted by the applicant at the applicant’s initiative to support the 
application after completion of the technical deficiency screen, and (c) is not itself 
a covered registration application, must be assessed 25% of the full registration 
service fee for the new use application. 
(4) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B652 
124 
New product; reg-
istered source of 
active ingredient; 
requires petition 
to amend estab-
lished tolerance or 
tolerance exemp-
tion; requires 1) 
submission of 
product specific 
data; or 2) cita-
tion of previously 
reviewed and ac-
cepted data; or 3) 
submission or ci-
tation of data gen-
erated at govern-
ment expense; or 
4) submission or 
citation of sci-
entifically-sound 
rationale based on 
publicly available 
literature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining 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) 
Registra-
tion 
Service Fee 
($) 
B660 
125 
New product; reg-
istered source of 
active ingre-
dient(s); identical 
or substantially 
similar in com-
position and use 
to a registered 
product. No data 
review, or only 
product chemistry 
data; cite-all data 
citation, or selec-
tive data citation 
where applicant 
owns all required 
data or authoriza-
tion from data 
owner is dem-
onstrated. Cat-
egory includes 
100% re-package 
of registered end- 
use or manufac-
turing-use product 
that requires no 
data submission 
or data matrix. 
For microbial pes-
ticides, the active 
ingredient(s) must 
not be re-isolated. 
(2)(3) 
1,278 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B670 
126 
New product; reg-
istered source of 
active ingre-
dient(s); requires: 
1) submission of 
product specific 
data; or 2) cita-
tion of previously 
reviewed and ac-
cepted data; or 3) 
submission or ci-
tation of data gen-
erated at govern-
ment expense; or 
4) submission or 
citation of a sci-
entifically-sound 
rationale based on 
publicly available 
literature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining 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) 
Registra-
tion 
Service Fee 
($) 
B671 
127 
New product; unreg-
istered source of 
active ingre-
dient(s); requires a 
petition to amend 
an established tol-
erance or tolerance 
exemption; re-
quires: 1) submis-
sion of product 
specific data; or 2) 
citation of pre-
viously reviewed 
and accepted data; 
or 3) submission 
or citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on publicly 
available lit-
erature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining why 
the data require-
ment does not 
apply. (2)(3) 
12,764 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B672 
128 
New product; unreg-
istered source of 
active ingre-
dient(s); non-food 
use or food use re-
quires: 1) submis-
sion of product 
specific data; or 2) 
citation of pre-
viously reviewed 
and accepted data; 
or 3) submission 
or citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on publicly 
available lit-
erature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining 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) 
Registra-
tion 
Service Fee 
($) 
B673 
129 
New product MUP/ 
EP; unregistered 
source of active in-
gredient(s); cita-
tion of Technical 
Grade Active In-
gredient (TGAI) 
data previously re-
viewed and accept-
ed by the Agency. 
Requires an Agen-
cy determination 
that the cited data 
supports the new 
product. (2)(3) 
5,107 
B674 
130 
New product MUP; 
Repack of iden-
tical registered 
end-use product as 
a manufacturing- 
use product; same 
registered uses 
only. (2)(3) 
1,278 
B675 
131 
New Product MUP; 
registered source of 
active ingredient; 
submission of com-
pletely new generic 
data package; reg-
istered uses only. 
(2)(3) 
9,118 
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‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B676 
132 
New product; more 
than one active in-
gredient where one 
active ingredient 
is an unregistered 
source; product 
chemistry data 
must be submitted; 
requires: 1) sub-
mission of product 
specific data, and 
2) citation of pre-
viously reviewed 
and accepted data; 
or 3) submission 
or citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on publicly 
available lit-
erature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining 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) 
Registra-
tion 
Service Fee 
($) 
B677 
133 
New end-use non- 
food animal prod-
uct with submis-
sion of two or 
more target ani-
mal safety studies; 
includes data and/ 
or waivers of data 
for only: 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ public health pest 
efficacy and/or 
∑ animal safety 
studies and/or 
∑ child resistant 
packaging. (2)(3) 
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 before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
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‘‘TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Reg-
istration 
Service 
Fee 
($) 
B621 
134 
Amendment; Experimental Use 
Permit; no change to an estab-
lished temporary tolerance or 
tolerance exemption. (3) 
5,107 
B622 
135 
Amendment; Experimental Use 
Permit; petition to amend an 
established or temporary toler-
ance or tolerance exemption. 
(3) 
12,764 
B641 
136 
Amendment of an established tol-
erance or tolerance exemption. 
12,764 
B680 
137 
Amendment; registered sources of 
active ingredient(s); no new 
use(s); no changes to an estab-
lished tolerance or tolerance ex-
emption. Requires data sub-
mission. (2)(3) 
5,107 
B681 
138 
Amendment; unregistered source 
of active ingredient(s). Re-
quires data submission. (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 prod-
uct that includes submission of 
target animal safety data; pre-
viously registered. (2)(3) 
8,820 
B685 
141 
(new) 
Amendment; add a new bio-
chemical unregistered source of 
active ingredient or a new mi-
crobial production site. Re-
quires submission of analysis 
of samples data and source/ 
production site-specific manu-
facturing 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. 
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initi-
ated 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 requiring data 
review are subject to registration service fees. 
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(3) Where the action involves approval of a new or amended label, on or before the end date of the 
decision review time, the Agency shall provide to the applicant a draft accepted label, including any 
changes made by the Agency that differ from the applicant-submitted label and relevant supporting 
data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees 
to all of the terms associated with the draft accepted label as amended by the Agency and requests that 
it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the 
terms of the draft accepted label as amended by the Agency and requests additional time to resolve the 
difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but for-
feits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 
calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If 
the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of dif-
ferences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant with-
in 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) 
Registra-
tion 
Service Fee 
($) 
B690 
142 
New active ingre-
dient; food or 
non-food use. 
(2)(6) 
2,554 
B700 
143 
Experimental Use 
Permit applica-
tion; new active 
ingredient or 
new use. (6) 
1,278 
B701 
144 
Extend or amend 
Experimental 
Use Permit. (6) 
1,278 
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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B710 
145 
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 change in an 
established toler-
ance or tolerance 
exemption. 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 requires 
no data submis-
sion or data ma-
trix. (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) 
Registra-
tion 
Service Fee 
($) 
B720 
146 
New product; reg-
istered source of 
active ingre-
dient(s); re-
quires: 1) sub-
mission of prod-
uct specific data; 
or 2) citation of 
previously re-
viewed and ac-
cepted data; or 
3) submission or 
citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on pub-
licly available 
literature or 
other relevant 
information that 
addresses the 
data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to 
be waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why 
the data require-
ment does not 
apply. (3)(6) 
1,278 
B721 
147 
New product; un-
registered source 
of active ingre-
dient. (3)(6) 
2,676 
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‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B722 
148 
New use and/or 
amendment; pe-
tition to estab-
lish a tolerance 
or tolerance ex-
emption. 
(4)(5)(6) 
2,477 
B730 
149 
Label amendment 
requiring data 
submission. 
(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 deci-
sion time review period as the new active ingredient or first food use application. 
The application must be received by the agency in one package. The base fee for 
the category covers a maximum of five new products. Each application for an ad-
ditional new product registration and new inert approval that is submitted in the 
new active ingredient application package or first food use application package is 
subject to the registration service fee for a new product or a new inert approval. 
All such associated applications that are submitted together will be subject to the 
new active ingredient or first food use decision review time. In the case of a new 
active ingredient application, until that new active ingredient is approved, any 
subsequent application for another new product containing the same active ingre-
dient or an amendment to the proposed labeling will be deemed a new active in-
gredient application, subject to the registration service fee and decision review 
time for a new active ingredient. In the case of a first food use application, until 
that first food use is approved, any subsequent application for an additional new 
food use or uses will be subject to the registration service fee and decision review 
time for a first food use. Any information that (a) was neither requested nor re-
quired by the Agency, and (b) is submitted by the applicant at the applicant’s ini-
tiative to support the application after completion of the technical deficiency 
screening, and (c) is not itself a covered registration application, must be assessed 
25% of the full registration service fee for the new active ingredient or first food 
use application. 
(3) 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. 
(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 registra-
tion service fees. (c) Registrant-initiated fast-track amendments handled by the 
Antimicrobials Division are to be completed within the timelines specified in 
FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant 
initiated amendments submitted by notification under PR Notices, such as PR 
Notice 98-10, continue under PR Notice timelines and are not subject to registra-
tion service fees. (e) Submissions with data and requiring data review are subject 
to registration service fees. 
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(5) Amendment applications to add the new use(s) to registered product labels 
are covered by the base fee for the new use(s). All items in the covered application 
must be submitted together in one package. Each application for an additional 
new product registration and new inert approval(s) that is submitted in the new 
use application package is subject to the registration service fee for a new product 
or a new inert approval. However, if a new use application only proposes to reg-
ister the new use for a new product and there are no amendments in the applica-
tion, then review of one new product application is covered by the new use fee. All 
such associated applications that are submitted together will be subject to the new 
use decision review time. Any application for a new product or an amendment to 
the proposed labeling (a) submitted subsequent to submission of the new use appli-
cation and (b) prior to conclusion of its decision review time and (c) containing 
the same new uses, will be deemed a separate new-use application, subject to a 
separate registration service fee and new decision review time for a new use. If the 
new-use application includes non-food (indoor and/or outdoor), and food (outdoor 
and/or indoor) uses, the appropriate fee is due for each type of new use and the 
longest decision review time applies to all of the new uses requested in the applica-
tion. Any information that (a) was neither requested nor required by the Agency, 
and (b) is submitted by the applicant at the applicant’s initiative to support the 
application after completion of the technical deficiency screen, and (c) is not itself 
a covered registration application, must be assessed 25% of the full registration 
service fee for the new use application. 
(6) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B614 
150 
Pre-application; 
Conditional Rul-
ing on ration-
ales for address-
ing a data re-
quirement in 
lieu of data; ap-
plicant-initi-
ated; applies to 
one rationale at 
a time. 
2,530 
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‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B615 
151 
Rebuttal of agency 
reviewed pro-
tocol, applicant 
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. 
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B740 
153 
Experimental Use Per-
mit application; no 
petition for toler-
ance/tolerance ex-
emption. Includes: 
1. non-food/feed use(s) 
for a new (2) or reg-
istered (3) PIP (12); 
2. food/feed use(s) for a 
new or registered 
PIP with crop de-
struct (12); 
3. food/feed use(s) for a 
new or registered 
PIP in which an es-
tablished tolerance/ 
tolerance exemption 
exists for the in-
tended use(s). 
(4)(12) 
95,724 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B741 
154 
(new) 
Experimental Use Per-
mit application; no 
petition for toler-
ance/tolerance ex-
emption. Includes: 
1. non-food/feed use(s) 
for a new (2) or reg-
istered (3) PIP; 
2. food/feed use(s) for a 
new or registered 
PIP with crop de-
struct; 
3. food/feed use(s) for a 
new or registered 
PIP in which an es-
tablished tolerance/ 
tolerance exemption 
exists for the in-
tended use(s); 
SAP Review. (12) 
159,538 
B750 
155 
Experimental Use Per-
mit application; 
with a petition to 
establish a tem-
porary or perma-
nent tolerance/toler-
ance exemption for 
the active ingre-
dient. Includes 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) 
Registra-
tion 
Service Fee 
($) 
B770 
156 
Experimental Use Per-
mit application; 
new (2) PIP; with 
petition to establish 
a temporary toler-
ance/tolerance ex-
emption for the ac-
tive ingredient; 
credit 75% of B771 
fee toward registra-
tion application for 
a new active ingre-
dient that follows; 
SAP review. (5)(12) 
191,444 
B771 
157 
Experimental Use Per-
mit application; 
new (2) PIP; with 
petition to establish 
a temporary toler-
ance/tolerance ex-
emption for the ac-
tive ingredient; 
credit 75% of B771 
fee toward registra-
tion application for 
a new active ingre-
dient that follows. 
(12) 
127,630 
B772 
158 
Application to amend 
or extend an Exper-
imental Use Permit; 
no petition since the 
established toler-
ance/tolerance ex-
emption for the ac-
tive ingredient is 
unaffected. (12) 
12,764 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B773 
159 
Application to amend 
or extend an Exper-
imental Use Permit; 
with petition to ex-
tend a temporary 
tolerance/tolerance 
exemption 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 es-
tablish permanent 
tolerance/tolerance 
exemption for the 
active ingredient 
based on an existing 
temporary toler-
ance/tolerance ex-
emption. (12) 
172,300 
B810 
163 
Registration applica-
tion; new (2) PIP; 
with petition to es-
tablish permanent 
tolerance/tolerance 
exemption for the 
active ingredient 
based on an existing 
temporary toler-
ance/tolerance ex-
emption. SAP re-
view. (5)(12) 
236,114 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B820 
164 
Registration applica-
tion; new (2) PIP; 
with petition to es-
tablish or amend a 
permanent toler-
ance/tolerance ex-
emption of an active 
ingredient. (12) 
204,208 
B840 
165 
Registration applica-
tion; new (2) PIP; 
with petition to es-
tablish or amend a 
permanent toler-
ance/tolerance ex-
emption of an active 
ingredient. SAP re-
view. (5)(12) 
268,022 
B851 
166 
Registration applica-
tion; new event of a 
previously registered 
PIP active ingre-
dient(s); no petition 
since permanent tol-
erance/tolerance ex-
emption is already 
established for the 
active ingredient(s). 
(12) 
127,630 
B870 
167 
Registration applica-
tion; registered (3) 
PIP; new product; 
new use; no petition 
since a permanent 
tolerance/tolerance 
exemption is al-
ready established for 
the active ingre-
dient(s). (4) (12) 
38,290 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B880 
168 
Registration applica-
tion; registered (3) 
PIP; new product or 
new terms of reg-
istration; additional 
data submitted; no 
petition since a per-
manent tolerance/ 
tolerance exemption 
is already estab-
lished for the active 
ingredient(s). (6) 
(7) (12) 
31,910 
B881 
169 
Registration applica-
tion; registered (3) 
PIP; new product or 
new terms of reg-
istration; additional 
data submitted; no 
petition since a per-
manent tolerance/ 
tolerance exemption 
is already estab-
lished for the active 
ingredient(s). SAP 
review. (5)(6)(7)(12) 
95,724 
B882 
170 
(new) 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acreage 
cap and time-lim-
ited registration; 
with petition to es-
tablish a permanent 
tolerance/tolerance 
exemption 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) 
Registra-
tion 
Service Fee 
($) 
B883 
171 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acreage 
cap and time-lim-
ited registration; 
with petition to es-
tablish a permanent 
tolerance/tolerance 
exemption for the 
active ingredient 
based on an existing 
temporary toler-
ance/tolerance ex-
emption. (8) (12) 
127,630 
B884 
172 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acreage 
cap and time-lim-
ited registration; 
with petition to es-
tablish a permanent 
tolerance/tolerance 
exemption for the 
active ingredient. 
(8)(12) 
159,537 
B885 
173 
Registration applica-
tion; registered (3) 
PIP, seed increase; 
breeding stack of 
previously approved 
PIPs, same crop; no 
petition since a per-
manent tolerance/ 
tolerance exemption 
is already estab-
lished for the active 
ingredient(s). 
(9)(12) 
31,910 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B886 
174 
(new) 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acreage 
cap and time-lim-
ited registration; 
with petition to es-
tablish a permanent 
tolerance/tolerance 
exemption for the 
active ingredient. 
SAP Review. (8) 
(12) 
223,351 
B890 
175 
Application to amend 
a seed increase reg-
istration; converts 
registration to com-
mercial registration; 
no petition since 
permanent toler-
ance/tolerance ex-
emption is already 
established for the 
active ingredient(s). 
(12) 
63,816 
B891 
176 
Application to amend 
a seed increase reg-
istration; converts 
registration to a 
commercial registra-
tion; no petition 
since a permanent 
tolerance/tolerance 
exemption already 
established for the 
active ingredient(s); 
SAP review. (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) 
Registra-
tion 
Service Fee 
($) 
B900 
177 
Application to amend 
a registration, in-
cluding actions such 
as extending an ex-
piration date, modi-
fying an IRM plan, 
or adding an insect 
to be controlled. 
(10)(11)(12) 
12,764 
B901 
178 
Application to amend 
a registration, in-
cluding actions such 
as extending an ex-
piration date, modi-
fying an IRM plan, 
or adding an insect 
to be controlled. 
SAP review. (10) 
(11) (12) 
76,578 
B902 
179 
PIP Protocol review. 
6,383 
B903 
180 
Inert ingredient toler-
ance exemption; e.g., 
a marker such as 
NPT II; reviewed in 
BPPD. 
63,816 
B904 
181 
Import tolerance or 
tolerance exemption; 
processed commod-
ities/food only (inert 
or active ingre-
dient). 
127,630 
B905 
182 
(new) 
SAP Review. 
63,816 
B906 
183 
(new) 
Petition to establish a 
temporary toler-
ance/tolerance ex-
emption for one or 
more active ingredi-
ents. 
31,907 
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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B907 
184 
(new) 
Petition to establish a 
temporary toler-
ance/tolerance ex-
emption for one or 
more active ingredi-
ents based on an ex-
isting temporary 
tolerance/tolerance 
exemption. 
12,764 
B908 
185 
(new) 
Petition to establish a 
temporary toler-
ance/tolerance ex-
emption for one or 
more active ingredi-
ents or inert ingre-
dients. 
44,671 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
(2) New PIP = a PIP with an active ingredient that has not been registered. 
(3) Registered PIP = a PIP with an active ingredient that is currently reg-
istered. 
(4) Transfer registered PIP through conventional breeding for new food/feed use, 
such as from field corn to sweet corn. 
(5) The scientific data involved in this category are complex. EPA often seeks 
technical advice from the Scientific Advisory Panel on risks that pesticides pose to 
wildlife, farm workers, pesticide applicators, non-target species, as well as insect 
resistance, and novel scientific issues surrounding new technologies. The scientists 
of the SAP neither make nor recommend policy decisions. They provide advice on 
the science used to make these decisions. Their advice is invaluable to the EPA as 
it strives to protect humans and the environment from risks posed by pesticides. 
Due to the time it takes to schedule and prepare for meetings with the SAP, addi-
tional time and costs are needed. 
(6) Registered PIPs stacked through conventional breeding. 
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend). 
(8) The negotiated acreage cap will depend upon EPA’s determination of the 
potential environmental exposure, risk(s) to non-target organisms, and the risk of 
targeted pest developing resistance to the pesticidal substance. The uncertainty of 
these risks may reduce the allowable acreage, based upon the quantity and type of 
non-target organism data submitted and the lack of insect resistance management 
data, which is usually not required for seed-increase registrations. Registrants are 
encouraged to consult with EPA prior to submission of a registration application 
in this category. 
(9) Application can be submitted prior to or concurrently with an application 
for commercial registration. 
(10) For example, IRM plan modifications that are applicant-initiated. 
(11) EPA-initiated amendments shall not be charged fees. 
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178 
(12) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
‘‘TABLE 18. — INERT INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
I001 
186 
Approval of new 
food use inert in-
gredient. (2)(3) 
27,000 
I002 
187 
Amend currently ap-
proved inert in-
gredient tolerance 
or exemption from 
tolerance; new 
data. (2) 
7,500 
I003 
188 
Amend currently ap-
proved inert in-
gredient tolerance 
or exemption from 
tolerance; no new 
data. (2) 
3,308 
I004 
189 
Approval of new 
non-food use inert 
ingredient. (2) 
11,025 
I005 
190 
Amend currently ap-
proved non-food 
use inert ingre-
dient with new 
use pattern; new 
data. (2) 
5,513 
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179 
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
I006 
191 
Amend currently ap-
proved non-food 
use inert ingre-
dient with new 
use pattern; no 
new data. (2) 
3,308 
I007 
192 
Approval of substan-
tially similar 
non-food use inert 
ingredients when 
original inert is 
compositionally 
similar with simi-
lar use pattern. 
(2) 
1,654 
I008 
193 
Approval of new or 
amended polymer 
inert ingredient, 
food use. (2) 
3,749 
I009 
194 
Approval of new or 
amended polymer 
inert ingredient, 
non-food use. (2) 
3,087 
I010 
195 
Petition to amend a 
single tolerance 
exemption 
descriptor, or sin-
gle non-food use 
descriptor, to add 
≤ 10 CASRNs; no 
new data. (2) 
1,654 
I011 
196 
(new) 
Approval of new 
food use safener 
with tolerance or 
exemption from 
tolerance. (2)(8) 
597,683 
I012 
197 
(new) 
Approval of new 
non-food use 
safener. (2)(8) 
415,241 
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180 
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
I013 
198 
(new) 
Approval of addi-
tional food use for 
previously ap-
proved safener 
with tolerance or 
exemption from 
tolerance. (2) 
62,975 
I014 
199 
(new) 
Approval of addi-
tional non-food 
use for previously 
approved safener. 
(2) 
25,168 
I015 
200 
(new) 
Approval of new ge-
neric data for pre-
viously approved 
food use safener. 
(2) 
269,728 
I016 
201 
(new) 
Approval of amend-
ment(s) to toler-
ance and label for 
previously ap-
proved safener. (2) 
55,776 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
(2) If another covered application is submitted that depends upon an applica-
tion to approve an inert ingredient, each application will be subject to its respec-
tive registration service fee. The decision review time line for both submissions will 
be the longest of the associated applications. If the application covers multiple in-
gredients grouped by EPA into one chemical class, a single registration service fee 
will be assessed for approval of those ingredients. 
(3) If EPA data rules are amended to newly require clearance under section 
408 of the FFDCA for an ingredient of an antimicrobial product where such in-
gredient was not previously subject to such a clearance, then review of the data for 
such clearance of such product is not subject to a registration service fee for the 
tolerance action for two years from the effective date of the rule. 
(4) Any other covered application that is associated with and dependent on the 
HSRB review will be subject to its separate registration service fee. The decision 
review times for the associated actions run concurrently, but will end at the date 
of the latest review time. 
(5) Any other covered application that is associated with and dependent on the 
SAP review will be subject to its separate registration service fee. The decision re-
view time for the associated action will be extended by the decision review time for 
the SAP review. 
(6) An application for a new end-use product using a source of active ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient. 
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181 
(7) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
(8) If a new safener is submitted in the same package as a new active ingre-
dient, and that new active ingredient is determined to be reduced risk, then the 
safener would get the same reduced timeframe as the new active ingredient. 
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
M001 
202 
Study protocol re-
quiring Human 
Studies Review 
Board review as 
defined in 40 
CFR Part 26 in 
support of an 
active ingre-
dient. (4) 
7,938 
M002 
203 
Completed study 
requiring 
Human Studies 
Review Board 
review as de-
fined in 40 CFR 
Part 26 in sup-
port of an active 
ingredient. (4) 
7,938 
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182 
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
M003 
204 
External technical 
peer review of 
new active in-
gredient, prod-
uct, or amend-
ment (e.g., con-
sultation with 
FIFRA Sci-
entific Advisory 
Panel) for an 
action with a 
decision time-
frame of less 
than 12 months. 
Applicant initi-
ated request 
based on a re-
quirement of the 
Administrator, 
as defined by 
FIFRA § 25(d), 
in support of a 
novel active in-
gredient, or 
unique use pat-
tern or applica-
tion technology. 
Excludes PIP 
active ingredi-
ents. (5) 
63,945 
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184 
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
M005 
206 
New Product: Com-
bination, Con-
tains a combina-
tion of active in-
gredients from a 
registered and/or 
unregistered 
source; conven-
tional, anti-
microbial and/or 
biopesticide. Re-
quires coordina-
tion with other 
regulatory divi-
sions to conduct 
review of data, 
label and/or 
verify the valid-
ity of existing 
data as cited. 
Only existing 
uses for each ac-
tive ingredient 
in the combina-
tion product. 
(6)(7) 
22,050 
M006 
207 
Request for up to 5 
letters of certifi-
cation (Gold 
Seal) for one ac-
tively registered 
product (ex-
cludes dis-
tributor prod-
ucts). (8) 
277 
M007 
208 
Request to extend 
Exclusive Use of 
data as provided 
by FIFRA Sec-
tion 
3(c)(1)(F)(ii). 
5,513 
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185 
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
M008 
209 
Request to grant 
Exclusive Use of 
data as provided 
by FIFRA Sec-
tion 
3(c)(1)(F)(vi) 
for a minor use, 
when a FIFRA 
Section 2(ll)(2) 
determination is 
required. 
1,654 
M009 
210 
(new) 
Non-FIFRA Regu-
lated Determina-
tion: Applicant 
initiated, per 
product. 
2,363 
M010 
211 
(new) 
Conditional ruling 
on pre-applica-
tion, product 
substantial simi-
larity. 
2,363 
M011 
212 
(new) 
Label amendment 
to add the DfE 
logo; requires 
data review; no 
other label 
changes. (9) 
3,648 
(1) A decision review time that would otherwise end on a Saturday, Sunday, or 
federal holiday, will be extended to end on the next business day. 
(2) If another covered application is submitted that depends upon an applica-
tion to approve an inert ingredient, each application will be subject to its respec-
tive registration service fee. The decision review time line for both submissions will 
be the longest of the associated applications. If the application covers multiple in-
gredients grouped by EPA into one chemical class, a single registration service fee 
will be assessed for approval of those ingredients. 
(3) If EPA data rules are amended to newly require clearance under section 
408 of the FFDCA for an ingredient of an antimicrobial product where such in-
gredient was not previously subject to such a clearance, then review of the data for 
such clearance of such product is not subject to a registration service fee for the 
tolerance action for two years from the effective date of the rule. 
(4) Any other covered application that is associated with and dependent on the 
HSRB review will be subject to its separate registration service fee. The decision 
review times for the associated actions run concurrently, but will end at the date 
of the latest review time. 
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186 
(5) Any other covered application that is associated with and dependent on the 
SAP review will be subject to its separate registration service fee. The decision re-
view time for the associated action will be extended by the decision review time for 
the SAP review. 
(6) An application for a new end-use product using a source of active ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient. 
(7) Where the action involves approval of a new or amended label, on or before 
the end date of the decision review time, the Agency shall provide to the applicant 
a draft accepted label, including any changes made by the Agency that differ from 
the applicant-submitted label and relevant supporting data reviewed by the Agen-
cy. The applicant will notify the Agency that the applicant either (a) agrees to all 
of the terms associated with the draft accepted label as amended by the Agency 
and requests that it be issued as the accepted final Agency-stamped label; or (b) 
does not agree to one or more of the terms of the draft accepted label as amended 
by the Agency and requests additional time to resolve the difference(s); or (c) with-
draws the application without prejudice for subsequent resubmission, but forfeits 
the associated registration service fee. For cases described in (b), the applicant 
shall have up to 30 calendar days to reach agreement with the Agency on the final 
terms of the Agency-accepted label. If the applicant agrees to all of the terms of the 
accepted label as in (a), including upon resolution of differences in (b), the Agency 
shall provide an accepted final Agency-stamped label to the registrant within 2 
business days following the registrant’s written or electronic confirmation of agree-
ment to the Agency. 
(8) Due to low fee and short time frame this category is not eligible for small 
business waivers. Gold seal applies to one registered product. 
(9) This category includes amendments the sole purpose of which is to add DfE 
(or equivalent terms that do not use ‘‘safe’’ or derivatives of ‘‘safe’’) logos to a 
label. DfE is a voluntary program. A label bearing a DfE logo is not considered 
an Agency endorsement because the ingredients in the qualifying product must 
meet objective, scientific criteria established and widely publicized by EPA.’’. 
SEC. 7. EFFECTIVE DATE. 
The amendments made by this Act take effect on Octo-
ber 1, 2017. 
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Calendar No. 163 
115TH CONGRESS 
1ST SESSION 
H. R. 1029 
AN ACT 
To amend the Federal Insecticide, Fungicide, and 
Rodenticide Act to improve pesticide registration 
and other activities under the Act, to extend and 
modify fee authorities, and for other purposes. 
JUNE 29, 2017 
Reported with amendments 
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