‘‘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 
($) 
B881 
169 
Registration applica-
tion; registered 
(3) PIP; new 
product or new 
terms of registra-
tion; additional 
data submitted; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). SAP re-
view. 
(5)(6)(7)(12) 
95,724 
B882 
170 
(new) 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient based 
on an existing 
temporary toler-
ance/tolerance ex-
emption; SAP Re-
view. (8)(12) 
191,444
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B883 
171 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient based 
on an existing 
temporary toler-
ance/tolerance ex-
emption. (8) (12) 
127,630 
B884 
172 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient. 
(8)(12) 
159,537 
B885 
173 
Registration applica-
tion; registered 
(3) PIP, seed in-
crease; breeding 
stack of pre-
viously approved 
PIPs, same crop; 
no petition since a 
permanent toler-
ance/tolerance ex-
emption is already 
established for 
the active ingre-
dient(s). (9)(12) 
31,910
‘‘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 
($) 
B886 
174 
(new) 
Registration applica-
tion; new (2) PIP, 
seed increase with 
negotiated acre-
age cap and time- 
limited registra-
tion; with petition 
to establish a per-
manent tolerance/ 
tolerance exemp-
tion for the active 
ingredient. SAP 
Review. (8) (12) 
223,351 
B890 
175 
Application to 
amend a seed in-
crease registra-
tion; converts reg-
istration to com-
mercial registra-
tion; no petition 
since permanent 
tolerance/toler-
ance exemption is 
already estab-
lished for the ac-
tive ingredient(s). 
(12) 
63,816 
B891 
176 
Application to 
amend a seed in-
crease registra-
tion; converts reg-
istration to a 
commercial reg-
istration; no peti-
tion since a per-
manent tolerance/ 
tolerance exemp-
tion already es-
tablished for the 
active ingre-
dient(s); SAP re-
view. (5)(12) 
127,630
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B900 
177 
Application to 
amend a registra-
tion, including ac-
tions such as ex-
tending an expira-
tion date, modi-
fying an IRM 
plan, or adding 
an insect to be 
controlled. 
(10)(11)(12) 
12,764 
B901 
178 
Application to 
amend a registra-
tion, including ac-
tions such as ex-
tending an expira-
tion date, modi-
fying an IRM 
plan, or adding 
an insect to be 
controlled. SAP 
review. (10) (11) 
(12) 
76,578 
B902 
179 
PIP Protocol review. 
6,383 
B903 
180 
Inert ingredient tol-
erance exemption; 
e.g., a marker 
such as NPT II; 
reviewed in 
BPPD. 
63,816 
B904 
181 
Import tolerance or 
tolerance exemp-
tion; processed 
commodities/food 
only (inert or ac-
tive ingredient). 
127,630 
B905 
182 
(new) 
SAP Review. 
63,816
(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 
($) 
I001 
186 
Approval of new 
food use inert 
ingredient. 
(2)(3) 
27,000 
I002 
187 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; new data. 
(2) 
7,500 
I003 
188 
Amend currently 
approved inert 
ingredient toler-
ance or exemp-
tion from toler-
ance; no new 
data. (2) 
3,308
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
I010 
195 
Petition to amend 
a single toler-
ance exemption 
descriptor, or 
single non-food 
use descriptor, 
to add ≤ 10 
CASRNs; no 
new data. (2) 
1,654 
I011 
196 
(new) 
Approval of new 
food use safener 
with tolerance 
or exemption 
from tolerance. 
(2)(8) 
597,683 
I012 
197 
(new) 
Approval of new 
non-food use 
safener. (2)(8) 
415,241 
I013 
198 
(new) 
Approval of addi-
tional food use 
for previously 
approved 
safener with tol-
erance or ex-
emption from 
tolerance. (2) 
62,975 
I014 
199 
(new) 
Approval of addi-
tional non-food 
use for pre-
viously approved 
safener. (2) 
25,168 
I015 
200 
(new) 
Approval of new 
generic data for 
previously ap-
proved food use 
safener. (2) 
269,728
‘‘TABLE 18. — INERT INGREDIENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
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.
100 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M001 
202 
Study protocol 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient. (4) 
7,938 
M002 
203 
Completed study 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient. (4) 
7,938
101 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M003 
204 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
less than 12 
months. Appli-
cant initiated 
request based 
on a require-
ment of the 
Administrator, 
as defined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945
102 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M004 
205 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
greater than 
12 months. 
Applicant ini-
tiated request 
based on a re-
quirement of 
the Adminis-
trator, as de-
fined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945
103 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M005 
206 
New Product: 
Combination, 
Contains a 
combination of 
active ingredi-
ents from a 
registered and/ 
or unregis-
tered source; 
conventional, 
antimicrobial 
and/or biopes-
ticide. Re-
quires coordi-
nation with 
other regu-
latory divi-
sions to con-
duct review of 
data, label 
and/or verify 
the validity of 
existing data 
as cited. Only 
existing uses 
for each active 
ingredient in 
the combina-
tion product. 
(6)(7) 
22,050 
M006 
207 
Request for up 
to 5 letters of 
certification 
(Gold Seal) 
for one ac-
tively reg-
istered prod-
uct (excludes 
distributor 
products). (8) 
277
104 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M007 
208 
Request to ex-
tend Exclusive 
Use of data as 
provided by 
FIFRA Sec-
tion 
3(c)(1)(F)(ii). 
5,513 
M008 
209 
Request to grant 
Exclusive Use 
of data as pro-
vided by 
FIFRA Sec-
tion 
3(c)(1)(F)(vi) 
for a minor 
use, when a 
FIFRA Sec-
tion 2(ll)(2) 
determination 
is required. 
1,654 
M009 
210 (new) Non-FIFRA 
Regulated De-
termination: 
Applicant ini-
tiated, per 
product. 
2,363 
M010 
211 (new) Conditional rul-
ing on pre-ap-
plication, 
product sub-
stantial simi-
larity. 
2,363 
M011 
212 (new) Label amend-
ment to add 
the DfE logo; 
requires data 
review; no 
other label 
changes. (9) 
3,648 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day.