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‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B906 
183 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients. 
31,907 
B907 
184 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients based 
on an existing 
temporary toler-
ance/tolerance ex-
emption. 
12,764 
B908 
185 
(new) 
Petition to establish 
a temporary toler-
ance/tolerance ex-
emption for one 
or more active in-
gredients or inert 
ingredients. 
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 in-
sect resistance, and novel scientific issues surrounding new technologies. The sci-
entists 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, additional 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). 
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(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 uncer-
tainty 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 reg-
istration 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. 
(12) 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 18. — INERT INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I001 
186 
Approval of new 
food use inert 
ingredient. 
(2)(3) 
27,000 
I002 
187 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; new data. 
(2) 
7,500 
I003 
188 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; no new 
data. (2) 
3,308 
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‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I004 
189 
Approval of new 
non-food use 
inert ingredient. 
(2) 
11,025 
I005 
190 
Amend currently 
approved non- 
food use inert 
ingredient with 
new use pattern; 
new data. (2) 
5,513 
I006 
191 
Amend currently 
approved non- 
food use inert 
ingredient with 
new use pattern; 
no new data. (2) 
3,308 
I007 
192 
Approval of sub-
stantially similar 
non-food use 
inert ingredients 
when original 
inert is 
compositionally 
similar with 
similar use pat-
tern. (2) 
1,654 
I008 
193 
Approval of new or 
amended poly-
mer inert ingre-
dient, food use. 
(2) 
3,749 
I009 
194 
Approval of new or 
amended poly-
mer inert ingre-
dient, non-food 
use. (2) 
3,087 
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‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I010 
195 
Petition to amend 
a single toler-
ance exemption 
descriptor, or 
single 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 
I013 
198 
(new) 
Approval of addi-
tional food use 
for previously 
approved 
safener with tol-
erance or ex-
emption from 
tolerance. (2) 
62,975 
I014 
199 
(new) 
Approval of addi-
tional non-food 
use for pre-
viously approved 
safener. (2) 
25,168 
I015 
200 
(new) 
Approval of new 
generic data for 
previously ap-
proved food use 
safener. (2) 
269,728 
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‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I016 
201 
(new) 
Approval of 
amendment(s) 
to tolerance and 
label for pre-
viously approved 
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 mul-
tiple ingredients 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 de-
cision 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 deci-
sion review 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 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. 
(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. 
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