100 
‘‘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 
($) 
M005 
206 
New Product: Com-
bination, Con-
tains a combina-
tion of active in-
gredients from a 
registered and/or 
unregistered 
source; conven-
tional, anti-
microbial and/or 
biopesticide. Re-
quires coordina-
tion with other 
regulatory divi-
sions to conduct 
review of data, 
label and/or 
verify the valid-
ity of existing 
data as cited. 
Only existing 
uses for each ac-
tive ingredient 
in the combina-
tion product. 
(6)(7) 
22,050 
M006 
207 
Request for up to 5 
letters of certifi-
cation (Gold 
Seal) for one ac-
tively registered 
product (ex-
cludes dis-
tributor prod-
ucts). (8) 
277 
M007 
208 
Request to extend 
Exclusive Use of 
data as provided 
by FIFRA Sec-
tion 
3(c)(1)(F)(ii). 
5,513 
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101 
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS 
ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M008 
209 
Request to grant 
Exclusive Use of 
data as provided 
by FIFRA Sec-
tion 
3(c)(1)(F)(vi) 
for a minor use, 
when a FIFRA 
Section 2(ll)(2) 
determination is 
required. 
1,654 
M009 
210 
(new) 
Non-FIFRA Regu-
lated Determina-
tion: Applicant 
initiated, per 
product. 
2,363 
M010 
211 
(new) 
Conditional ruling 
on pre-applica-
tion, product 
substantial simi-
larity. 
2,363 
M011 
212 
(new) 
Label amendment 
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. 
(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 multiple in-
gredients 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 decision 
review times for the associated actions run concurrently, but will end at the date 
of the latest review time. 
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102 
(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 decision re-
view 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 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. 
(8) Due to low fee and short time frame this category is not eligible for small 
business waivers. Gold seal applies to one registered product. 
(9) This category includes amendments the sole purpose of which is to add DfE 
(or equivalent terms that do not use ‘‘safe’’ or derivatives of ‘‘safe’’) logos to a 
label. DfE is a voluntary program. A label bearing a DfE logo is not considered 
an Agency endorsement because the ingredients in the qualifying product must 
meet objective, scientific criteria established and widely publicized by EPA.’’. 
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Union Calendar No. 29 
115TH CONGRESS 
1ST SESSION 
H. R. 1029 
[Report No. 115–49, Part I] 
A BILL 
To amend the Federal Insecticide, Fungicide, and 
Rodenticide Act to improve pesticide registration 
and other activities under the Act, to extend and 
modify fee authorities, and for other purposes. 
MARCH 20, 2017 
Reported from the Committee on Agriculture with an 
amendment 
MARCH 20, 2017 
The Committee on Energy and Commerce discharged; 
committed to the Committee of the Whole House on 
the State of the Union and ordered to be printed 
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