† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B670 
126 
New product; reg-
istered source of 
active ingre-
dient(s); requires: 
1) submission of 
product specific 
data; or 2) cita-
tion of previously 
reviewed and ac-
cepted data; or 3) 
submission or ci-
tation of data gen-
erated at govern-
ment expense; or 
4) submission or 
citation of a sci-
entifically-sound 
rationale based on 
publicly available 
literature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining why 
the data require-
ment does not 
apply. (2)(3) 
5,107
† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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
† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B672 
128 
New product; unreg-
istered source of 
active ingre-
dient(s); non-food 
use or food use re-
quires: 1) submis-
sion of product 
specific data; or 2) 
citation of pre-
viously reviewed 
and accepted data; 
or 3) submission 
or citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on publicly 
available lit-
erature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining why 
the data require-
ment does not 
apply. (2)(3) 
9,118
† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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
† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B676 
132 
New product; more 
than one active in-
gredient where one 
active ingredient 
is an unregistered 
source; product 
chemistry data 
must be submitted; 
requires: 1) sub-
mission of product 
specific data, and 
2) citation of pre-
viously reviewed 
and accepted data; 
or 3) submission 
or citation of data 
generated at gov-
ernment expense; 
or 4) submission 
or citation of a 
scientifically- 
sound rationale 
based on publicly 
available lit-
erature or other 
relevant informa-
tion that addresses 
the data require-
ment; or 5) sub-
mission of a re-
quest for a data 
requirement to be 
waived supported 
by a scientifically- 
sound rationale 
explaining why 
the data require-
ment does not 
apply. (2)(3) 
9,118
† HR 1029 EAS 
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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.
† HR 1029 EAS 
‘‘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.
† HR 1029 EAS 
(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
† HR 1029 EAS 
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
B710 
145 
New product; reg-
istered source of 
active ingre-
dient(s); iden-
tical or substan-
tially similar in 
composition and 
use to a reg-
istered product; 
no change in an 
established toler-
ance or tolerance 
exemption. No 
data review, or 
only product 
chemistry data; 
cite-all data ci-
tation, or selec-
tive data cita-
tion where ap-
plicant owns all 
required data or 
authorization 
from data owner 
is demonstrated. 
Category in-
cludes 100% re- 
package of reg-
istered end-use 
or manufac-
turing-use prod-
uct that requires 
no data submis-
sion or data ma-
trix. (3)(6) 
1,278
† HR 1029 EAS 
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
Registra-
tion 
Service Fee 
($) 
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