‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R319 
New end use prod-
uct containing 
up to three reg-
istered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
12,626
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R318 
50 (new) New end use prod-
uct containing 
four or more 
registered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
up to 3 target 
pests. (2)(3) 
13,252
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R321 
51 (new) New end use prod-
uct containing 
four or more 
registered active 
ingredients 
never before 
registered as 
this combination 
in a formulated 
product; new 
product label is 
identical or sub-
stantially simi-
lar to the labels 
of currently reg-
istered products 
which separately 
contain the re-
spective compo-
nent active in-
gredients; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; re-
quires review of 
data package 
within RD only; 
includes data 
and/or waivers 
of data for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
4 to 7 target 
pests. (2)(3) 
17,252
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R315 
New end-use, on- 
animal product, 
registered 
source of active 
ingredient(s), 
with the sub-
mission of data 
and/or waivers 
for only: 
∑ animal safety 
and 
∑ pest(s) requiring 
efficacy (4) and/ 
or 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging. (2) 
(3) 
9,820
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R316 
53 (new) New end-use or 
manufacturing 
product with 
registered 
source(s) of ac-
tive ingre-
dient(s) includ-
ing products 
containing two 
or more reg-
istered active 
ingredients pre-
viously com-
bined in other 
registered prod-
ucts; excludes 
products requir-
ing or citing an 
animal safety 
study; and re-
quires review of 
data and/or 
waivers for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 3 
and up to 7 tar-
get pests. (2)(3) 
11,301
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R317 
54 (new) New end-use or 
manufacturing 
product with 
registered 
source(s) of ac-
tive ingre-
dient(s) includ-
ing products 
containing 2 or 
more registered 
active ingredi-
ents previously 
combined in 
other registered 
products; ex-
cludes products 
requiring or cit-
ing an animal 
safety study; 
and requires re-
view of data 
and/or waivers 
for only: 
∑ product chem-
istry and/or 
∑ acute toxicity 
and/or 
∑ child resistant 
packaging and/ 
or 
∑ pest(s) requiring 
efficacy (4) - for 
greater than 7 
target pests. 
(2)(3) 
15,301 
R320 
New product; new 
physical form; 
requires data 
review in 
science divi-
sions. (2)(3) 
13,226
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R331 
New product; re-
pack of identical 
registered end- 
use product as a 
manufacturing- 
use product, or 
identical reg-
istered manu-
facturing-use 
product as an 
end use prod-
uct; same reg-
istered uses 
only. (2)(3) 
2,530 
R332 
New manufac-
turing-use prod-
uct; registered 
active ingre-
dient; unregis-
tered source of 
active ingre-
dient; submis-
sion of com-
pletely new ge-
neric data pack-
age; registered 
uses only; re-
quires review in 
RD and science 
divisions. (2)(3) 
283,215
‘‘TABLE 4. — REGISTRATION DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R333 
New product; 
MUP or End 
use product 
with unregis-
tered source of 
active ingre-
dient; requires 
science data re-
view; new phys-
ical form; etc. 
Cite-all or selec-
tive data cita-
tion where ap-
plicant owns all 
required data. 
(2)(3) 
19,838 
R334 
New product; 
MUP or End 
use product 
with unregis-
tered source of 
the active ingre-
dient; requires 
science data re-
view; new phys-
ical form; etc. 
Selective data 
citation. (2)(3) 
23,100 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
(2) An application for a new end-use product using a source of active ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant a draft accepted label, including any changes made by the Agency that 
differ from the applicant-submitted label and relevant supporting data reviewed 
by the Agency. The applicant will notify the Agency that the applicant either (a) 
agrees to all of the terms associated with the draft accepted label as amended by 
the Agency and requests that it be issued as the accepted final Agency-stamped 
label; or (b) does not agree to one or more of the terms of the draft accepted 
label as amended by the Agency and requests additional time to resolve the dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant agrees to all of the terms of the accepted label as in (a), including upon 
resolution of differences in (b), the Agency shall provide an accepted final Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
(4) For the purposes of classifying proposed registration actions into PRIA 
categories, ‘‘pest(s) requiring efficacy’’ are: public health pests listed in PR No-
tice 2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests 
(e.g. termites, carpenter ants, wood-boring beetles) and certain invasive species 
(e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/re-
fined as invasive pest needs arise. To determine the number of pests for the 
PRIA categories, pests have been placed into groups (general; e.g., cockroaches) 
and pest specific (specifically a test species). If seeking a label claim against a 
pest group (general), use the group listing below and each group will count as 1. 
The general pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft 
ticks, cattle ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, 
bot flies, screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, 
biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black 
flies, true bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (ex-
cluding carpenter ants), fire and harvester ants, wood destroying beetles, car-
penter ants, termites, subterranean termites, dry wood termites, arboreal ter-
mites, damp wood termites and invasive species. If seeking a claim against a 
specific pest without a general claim then each specific pest will count as 1. 
‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R340 
Amendment requiring 
data review within 
RD (e.g., changes 
to precautionary 
label statements); 
includes adding/ 
modifying pest(s) 
claims for up to 2 
target pests, ex-
cludes products re-
quiring or citing an 
animal safety 
study. (2)(3)(4) 
4,988
‘‘TABLE 5. — REGISTRATION DIVISION — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R341 
(New) 
Amendment requiring 
data review within 
RD (e.g., changes 
to precautionary 
label statements), 
includes adding/ 
modifying pest(s) 
claims for greater 
than 2 target 
pests, excludes 
products requiring 
or citing an animal 
safety study. 
(2)(3)(4) 
5,988 
R345 
Amending on-animal 
products previously 
registered, with the 
submission of data 
and/or waivers for 
only: 
∑ animal safety and 
∑ pest(s) requiring ef-
ficacy (4) and/or 
∑ product chemistry 
and/or 
∑ acute toxicity and/ 
or 
∑ child resistant 
packaging. (2)(3) 
8,820 
R350 
Amendment requiring 
data review in 
science divisions 
(e.g., changes to 
REI, or PPE, or 
PHI, or use rate, 
or number of appli-
cations; or add aer-
ial application; or 
modify GW/SW ad-
visory statement). 
(2)(3) 
13,226
‘‘TABLE 5. — REGISTRATION DIVISION — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R351 
Amendment adding a 
new unregistered 
source of active in-
gredient. (2)(3) 
13,226 
R352 
Amendment adding 
already approved 
uses; selective 
method of support; 
does not apply if 
the applicant owns 
all cited data. (2) 
(3) 
13,226 
R371 
Amendment to Ex-
perimental Use 
Permit; (does not 
include extending a 
permit’s time pe-
riod). (3) 
10,090 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
(2) (a) EPA-initiated amendments shall not be charged registration service 
fees. (b) Registrant-initiated fast-track amendments are to be completed within 
the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to reg-
istration service fees. (c) Registrant-initiated fast-track amendments handled by 
the Antimicrobials Division are to be completed within the timelines specified in 
FIFRA Section 3(h) and are not subject to registration service fees. (d) Reg-
istrant initiated amendments submitted by notification under PR Notices, such 
as PR Notice 98-10, continue under PR Notice timelines and are not subject to 
registration service fees. (e) Submissions with data and requiring data review 
are subject to registration service fees. 
(3) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant a draft accepted label, including any changes made by the Agency that 
differ from the applicant-submitted label and relevant supporting data reviewed 
by the Agency. The applicant will notify the Agency that the applicant either (a) 
agrees to all of the terms associated with the draft accepted label as amended by 
the Agency and requests that it be issued as the accepted final Agency-stamped 
label; or (b) does not agree to one or more of the terms of the draft accepted 
label as amended by the Agency and requests additional time to resolve the dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant agrees to all of the terms of the accepted label as in (a), including upon 
resolution of differences in (b), the Agency shall provide an accepted final Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA 
categories, ‘‘pest(s) requiring efficacy’’ are: public health pests listed in PR No-
tice 2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests 
(e.g. termites, carpenter ants, wood-boring beetles) and certain invasive species 
(e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/re-
fined as invasive pest needs arise. To determine the number of pests for the 
PRIA categories, pests have been placed into groups (general; e.g., cockroaches) 
and pest specific (specifically a test species). If seeking a label claim against a 
pest group (general), use the group listing below and each group will count as 1. 
The general pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft 
ticks, cattle ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, 
bot flies, screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, 
biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black 
flies, true bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (ex-
cluding carpenter ants), fire and harvester ants, wood destroying beetles, car-
penter ants, termites, subterranean termites, dry wood termites, arboreal ter-
mites, damp wood termites and invasive species. If seeking a claim against a 
specific pest without a general claim then each specific pest will count as 1. 
‘‘TABLE 6. — REGISTRATION DIVISION — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
R124 
Conditional Rul-
ing on Pre-ap-
plication Study 
Waivers; appli-
cant-initiated. 
2,530 
R272 
Review of Study 
Protocol appli-
cant-initiated; 
excludes 
DART, pre-reg-
istration con-
ference, Rapid 
Response re-
view, DNT pro-
tocol review, 
protocol need-
ing HSRB re-
view. 
2,530 
R275 
Rebuttal of agen-
cy reviewed 
protocol, appli-
cant initiated. 
2,530 
R370 
Cancer reassess-
ment; appli-
cant-initiated. 
198,250 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day.
‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW 
ACTIVE INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A380 
New Active Ingre-
dient; Indirect 
Food use; es-
tablish tolerance 
or tolerance ex-
emption if re-
quired. (2)(3) 
137,841 
A390 
New Active Ingre-
dient; Direct 
Food use; es-
tablish tolerance 
or tolerance ex-
emption if re-
quired. (2)(3) 
229,733 
A410 
New Active Ingre-
dient Non-food 
use.(2)(3) 
229,733 
A431 
New Active Ingre-
dient, Non-food 
use; low-risk. 
(2)(3) 
80,225 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion for a new active ingredient or a first food use are covered by the base fee 
for that new active ingredient or first food use application and retain the same 
decision time review period as the new active ingredient or first food use applica-
tion. The application must be received by the agency in one package. The base 
fee for the category covers a maximum of five new products. Each application 
for an additional new product registration and new inert approval that is sub-
mitted in the new active ingredient application package or first food use applica-
tion package is subject to the registration service fee for a new product or a new 
inert approval. All such associated applications that are submitted together will 
be subject to the new active ingredient or first food use decision review time. In 
the case of a new active ingredient application, until that new active ingredient 
is approved, any subsequent application for another new product containing the 
same active ingredient or an amendment to the proposed labeling will be deemed 
a new active ingredient application, subject to the registration service fee and 
decision review time for a new active ingredient. In the case of a first food use 
application, until that first food use is approved, any subsequent application for 
an additional new food use or uses will be subject to the registration service fee 
and decision review time for a first food use. Any information that (a) was nei-
ther requested nor required by the Agency, and (b) is submitted by the applicant 
at the applicant’s initiative to support the application after completion of the 
technical deficiency screening, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the new active 
ingredient or first food use application.
(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
‘‘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.
(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.
‘‘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
‘‘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 
($) 
A531 
New product; 
identical or 
substantially 
similar in 
composition 
and use to a 
registered 
product; reg-
istered source 
of active in-
gredient: selec-
tive data cita-
tion only for 
data on prod-
uct chemistry 
and/or acute 
toxicity and/or 
public health 
pest efficacy, 
where appli-
cant does not 
own all re-
quired data 
and does not 
have a specific 
authorization 
letter from 
data owner. 
(2)(3) 
1,824
‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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
‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A542 
86 (new) 
New end use 
product; 
FIFRA 
§2(mm) uses 
only; ≥ 51 
public health 
organisms. 
(2)(3)(5) 
15,000 
A550 
New end-use 
product; uses 
other than 
FIFRA 
§2(mm); non- 
FQPA prod-
uct. (2)(3)(5) 
13,226 
A560 
New manufac-
turing use 
product; reg-
istered active 
ingredient; se-
lective data ci-
tation. (2)(3) 
12,596 
A565 
89 (new) 
New manufac-
turing-use 
product; reg-
istered active 
ingredient; un-
registered 
source of ac-
tive ingre-
dient; submis-
sion of new 
generic data 
package; reg-
istered uses 
only; requires 
science review. 
(2)(3) 
18,234
‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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.
(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 
($) 
A520 
Experimental 
Use Permit 
application, 
non-food use. 
(2) 
6,383
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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
‘‘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 
($) 
A537 
97 (new) 
New Active In-
gredient/New 
Use, Experi-
mental Use 
Permit appli-
cation; Direct 
food use; Es-
tablish toler-
ance or toler-
ance exemp-
tion if re-
quired. Credit 
45% of fee to-
ward new ac-
tive ingre-
dient/new use 
application 
that follows. 
153,156 
A538 
98 (new) 
New Active In-
gredient/New 
Use, Experi-
mental Use 
Permit appli-
cation; Indi-
rect food use; 
Establish tol-
erance or tol-
erance exemp-
tion if re-
quired Credit 
45% of fee to-
ward new ac-
tive ingre-
dient/new use 
application 
that follows. 
95,724
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Contin-
ued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
A533 
103 (new) Exemption from 
the require-
ment of an 
Experimental 
Use Permit. 
(2) 
2,482 
A534 
104 (new) Rebuttal of 
agency re-
viewed pro-
tocol, appli-
cant initiated. 
4,726 
A535 
105 (new) Conditional Rul-
ing on Pre-ap-
plication 
Study Waiver 
or Data 
Bridging Ar-
gument; appli-
cant-initiated. 
2,409 
A536 
106 (new) Conditional Rul-
ing on Pre-ap-
plication Di-
rect Food, In-
direct Food, 
Nonfood use 
determination; 
applicant-initi-
ated. 
2,482 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant a draft accepted label, including any changes made by the Agency that 
differ from the applicant-submitted label and relevant supporting data reviewed 
by the Agency. The applicant will notify the Agency that the applicant either (a) 
agrees to all of the terms associated with the draft accepted label as amended by 
the Agency and requests that it be issued as the accepted final Agency-stamped 
label; or (b) does not agree to one or more of the terms of the draft accepted 
label as amended by the Agency and requests additional time to resolve the dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant agrees to all of the terms of the accepted label as in (a), including upon 
resolution of differences in (b), the Agency shall provide an accepted final Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 
INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B580 
107 
New active in-
gredient; food 
use; petition to 
establish a tol-
erance. (2)(3) 
51,053 
B590 
108 
New active in-
gredient; food 
use; petition to 
establish a tol-
erance exemp-
tion. (2)(3) 
31,910 
B600 
109 
New active in-
gredient; non- 
food use. 
(2)(3) 
19,146 
B610 
110 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
petition to es-
tablish a tem-
porary toler-
ance or tem-
porary toler-
ance exemp-
tion. (3) 
12,764
‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE 
INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B611 
111 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
petition to es-
tablish perma-
nent tolerance 
exemption. (3) 
12,764 
B612 
112 
New active in-
gredient; no 
change to a 
permanent tol-
erance exemp-
tion. (2)(3) 
17,550 
B613 
113 
New active in-
gredient; peti-
tion to convert 
a temporary 
tolerance or a 
temporary tol-
erance exemp-
tion to a per-
manent toler-
ance or toler-
ance exemp-
tion. (2)(3) 
17,550 
B620 
114 
New active in-
gredient; Ex-
perimental 
Use Permit 
application; 
non-food use 
including crop 
destruct. (3) 
6,383 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day.
(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
‘‘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.
(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.
‘‘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
‘‘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 
($) 
B660 
125 
New product; reg-
istered source of 
active ingre-
dient(s); iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product. 
No data review, 
or only product 
chemistry data; 
cite-all data ci-
tation, or selec-
tive data cita-
tion where ap-
plicant owns all 
required data or 
authorization 
from data owner 
is demonstrated. 
Category in-
cludes 100% re- 
package of reg-
istered end-use 
or manufac-
turing-use prod-
uct that re-
quires no data 
submission or 
data matrix. 
For microbial 
pesticides, the 
active ingre-
dient(s) must 
not be re-iso-
lated. (2)(3) 
1,278
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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
‘‘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 
($) 
B672 
128 
New product; un-
registered 
source of active 
ingredient(s); 
non-food use or 
food use re-
quires: 1) sub-
mission of prod-
uct specific 
data; or 2) cita-
tion of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
9,118
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B673 
129 
New product 
MUP/EP; un-
registered 
source of active 
ingredient(s); ci-
tation of Tech-
nical Grade Ac-
tive Ingredient 
(TGAI) data 
previously re-
viewed and ac-
cepted by the 
Agency. Re-
quires an Agen-
cy determina-
tion that the 
cited data sup-
ports the new 
product. (2)(3) 
5,107 
B674 
130 
New product 
MUP; Repack 
of identical reg-
istered end-use 
product as a 
manufacturing- 
use product; 
same registered 
uses only. (2)(3) 
1,278 
B675 
131 
New Product 
MUP; registered 
source of active 
ingredient; sub-
mission of com-
pletely new ge-
neric data pack-
age; registered 
uses only. (2)(3) 
9,118
‘‘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 
($) 
B676 
132 
New product; 
more than one 
active ingredient 
where one active 
ingredient is an 
unregistered 
source; product 
chemistry data 
must be sub-
mitted; requires: 
1) submission of 
product specific 
data, and 2) ci-
tation of pre-
viously reviewed 
and accepted 
data; or 3) sub-
mission or cita-
tion of data 
generated at 
government ex-
pense; or 4) 
submission or 
citation of a sci-
entifically-sound 
rationale based 
on publicly 
available lit-
erature or other 
relevant infor-
mation that ad-
dresses the data 
requirement; or 
5) submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a sci-
entifically-sound 
rationale ex-
plaining why the 
data require-
ment does not 
apply. (2)(3) 
9,118
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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.
‘‘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.