H. R. 2617—1597 
(3) Where the action involves approval of a new or amended label, on or before the 
end date of the decision review time, the Agency shall provide to the applicant a 
draft accepted label, including any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the Agency. The 
applicant will notify the Agency that the applicant either (a) agrees to all of the 
terms associated with the draft accepted label as amended by the Agency and re-
quests that it be issued as the accepted final Agency-stamped label; or (b) does not 
agree to one or more of the terms of the draft accepted label as amended by the 
Agency and requests additional time to resolve the difference(s); or (c) withdraws 
the application without prejudice for subsequent resubmission, but forfeits the asso-
ciated 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 pro-
vide an accepted final Agency-stamped label to the registrant within 2 business 
days following the registrant’s written or electronic confirmation of agreement to the 
Agency. 
(4) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 12. — BIOPESTICIDES AND POLLUTION 
PREVENTION DIVISION (BPPD) — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B630 
128 
First food use; peti-
tion to establish/ 
amend a tolerance 
exemption. (2) (4) 
(5) 
18,296 
B640 
129 
First food use; peti-
tion to establish/ 
amend a tolerance. 
(2) (4) (5) 
27,443 
B644 
130 
New use, no change to 
an established toler-
ance or tolerance 
exemption (includes 
non-food uses). (3) 
(4) (5) 
18,296 
B645 
131 
New use; Experi-
mental Use Permit; 
petition to establish 
a permanent or 
temporary tolerance 
or tolerance exemp-
tion. (4) (5) 
18,296 
B646 
132 
New use; Experi-
mental Use Permit; 
non-food use (in-
cludes crop de-
struct). (4) (5) 
9,151 
(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.
H. R. 2617—1598 
(2) All requests for new uses (food and/or nonfood) contained in any application 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 re-
view period as the new active ingredient or first food use application. The applica-
tion 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 submitted in the new active in-
gredient 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 associ-
ated applications that are submitted together will be subject to the new active ingre-
dient 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 applica-
tion for another new product containing the same active ingredient or an amend-
ment 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 in-
gredient. In the case of a first food use application, until that first food use is ap-
proved, 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 required by the Agency, and (b) 
is submitted by the applicant at the applicant’s initiative to support the application 
after completion of the preliminary technical screening, and (c) is not itself a cov-
ered 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 prod-
uct registration and new inert approval(s) that is submitted in the new use applica-
tion 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 amendments in the application, then review 
of one new product application is covered by the new use fee. All such associated ap-
plications 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 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 appro-
priate fee is due for each type of new use and the longest decision review time ap-
plies 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 ap-
plicant at the applicant’s initiative to support the application after completion of the 
preliminary technical 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 Agency. The 
applicant will notify the Agency that the applicant either (a) agrees to all of the 
terms associated with the draft accepted label as amended by the Agency and re-
quests that it be issued as the accepted final Agency-stamped label; or (b) does not 
agree to one or more of the terms of the draft accepted label as amended by the 
Agency and requests additional time to resolve the difference(s); or (c) withdraws 
the application without prejudice for subsequent resubmission, but forfeits the asso-
ciated 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 pro-
vide an accepted final Agency-stamped label to the registrant within 2 business 
days following the registrant’s written or electronic confirmation of agreement to the 
Agency. 
(5) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension.
H. R. 2617—1599 
‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION 
PREVENTION DIVISION (BPPD) — NEW PRODUCTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B660 
133 
New product; reg-
istered source of ac-
tive ingredient(s); 
identical or sub-
stantially similar in 
composition and use 
to a registered prod-
uct; no change in an 
established toler-
ance or tolerance 
exemption; no data 
submission or data 
matrix (or submis-
sion of product 
chemistry data 
only). (2) (3) 
1,833 
B670 
134 
New product; reg-
istered source of ac-
tive ingredient(s); 
no change in an es-
tablished tolerance 
or tolerance exemp-
tion; (including non- 
food); Must address 
Product-Specific 
Data Requirements. 
(2) (3) 
7,322 
B672 
135 
New product; unregis-
tered source of at 
least one active in-
gredient (or reg-
istered source with 
new generic data 
package); no change 
in an established 
tolerance or toler-
ance exemption (in-
cluding non-food); 
must address Prod-
uct-Specific and Ge-
neric Data Require-
ments. (2) (3) 
13,069
H. R. 2617—1600 
‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVEN-
TION DIVISION (BPPD) — NEW PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B673 
136 
New product; unregis-
tered source of ac-
tive ingredient(s); 
citation of Technical 
Grade Active Ingre-
dient (TGAI) data 
previously reviewed 
and accepted by the 
Agency; requires an 
Agency determina-
tion that the cited 
data support the 
new product. (2) (3) 
7,322 
B674 
137 
New product; repack 
of identical reg-
istered end-use 
product or repack of 
an end-use product 
as a manufacturing- 
use product; same 
registered uses 
only. (2) (3) 
1,833 
B677 
138 
New end-use non-food 
animal product with 
submission of two 
or more target ani-
mal safety studies; 
includes data and/or 
waivers of data for 
only: 
1. product chemistry 
and/or 
2. acute toxicity and/ 
or 
3. public health pest 
efficacy and/or 
4. animal safety stud-
ies and/or 
5. child resistant 
packaging. (2) (3) 
12,643 
(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 ingredient 
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.
H. R. 2617—1601 
(3) Where the action involves approval of a new or amended label, on or before the 
end date of the decision review time, the Agency shall provide to the applicant a 
draft accepted label, including any changes made by the Agency that differ from the 
applicant-submitted label and relevant supporting data reviewed by the Agency. The 
applicant will notify the Agency that the applicant either (a) agrees to all of the 
terms associated with the draft accepted label as amended by the Agency and re-
quests that it be issued as the accepted final Agency-stamped label; or (b) does not 
agree to one or more of the terms of the draft accepted label as amended by the 
Agency and requests additional time to resolve the difference(s); or (c) withdraws 
the application without prejudice for subsequent resubmission, but forfeits the asso-
ciated 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 pro-
vide an accepted final Agency-stamped label to the registrant within 2 business 
days following the registrant’s written or electronic confirmation of agreement to the 
Agency. 
‘‘TABLE 14. — BIOPESTICIDES AND POLLUTION 
PREVENTION DIVISION (BPPD) — AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B621 
139 
Amendment; Experi-
mental Use Permit; 
no change to an es-
tablished temporary 
or permanent toler-
ance or tolerance 
exemption. (3) (4) 
7,322 
B622 
140 
Amendment; Experi-
mental Use Permit; 
petition to amend a 
permanent or tem-
porary tolerance or 
tolerance exemp-
tion. (3) (4) 
18,296 
B641 
141 
Amendment; changes 
to an established 
tolerance or toler-
ance exemption. (4) 
18,296 
B680 
142 
Amendment; reg-
istered sources of 
active ingredient(s); 
no new use(s); no 
changes to an es-
tablished tolerance 
or tolerance exemp-
tion; requires data 
submission. (2) (3) 
7,322