[Congressional Record Volume 163, Number 48 (Monday, March 20, 2017)]
[House]
[Pages H2190-H2208]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PESTICIDE REGISTRATION ENHANCEMENT ACT OF 2017
Mr. RODNEY DAVIS of Illinois. Madam Speaker, I move to suspend the
rules and pass the bill (H.R. 1029) 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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1029
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pesticide
Registration Enhancement Act of 2017''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Extension and modification of maintenance fee authority.
Sec. 3. Reregistration and Expedited Processing Fund.
Sec. 4. Experimental use permits for pesticides.
Sec. 5. Pesticide registration service fees.
Sec. 6. Revision of tables regarding covered pesticide registration
applications and other covered actions and their
corresponding registration service fees.
SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE FEE
AUTHORITY.
(a) Maintenance Fee.--Section 4(i)(1) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-
1(i)(1)) is amended--
(1) in subparagraph (C), by striking ``an aggregate amount
of $27,800,000 for each of fiscal years 2013 through 2017''
and inserting ``an average amount of $31,000,000 for each of
fiscal years 2017 through 2023'';
(2) in subparagraph (D)--
(A) in clause (i), by striking ``$115,500 for each of
fiscal years 2013 through 2017'' and inserting ``$129,400 for
each of fiscal years 2017 through 2023''; and
(B) in clause (ii), by striking ``$184,800 for each of
fiscal years 2013 through 2017'' and inserting ``$207,000 for
each of fiscal years 2017 through 2023'';
(3) in subparagraph (E)(i)--
(A) in subclause (I), by striking ``$70,600 for each of
fiscal years 2013 through 2017'' and inserting ``$79,100 for
each of fiscal years 2017 through 2023''; and
(B) in subclause (II), by striking ``$122,100 for each of
fiscal years 2013 through 2017'' and inserting ``$136,800 for
each of fiscal years 2017 through 2023''; and
(4) in subparagraph (I), by striking ``2017'' and inserting
``2023''.
(b) Prohibition on Other Fees.--Section 4(i)(2) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a-1(i)(2)) is amended--
(1) by striking ``during the period beginning on the date
of enactment of this section and ending on September 30,
2019'' and inserting ``until September 30, 2025''; and
(2) by inserting after ``registration of a pesticide under
this Act'' the following: ``or any other action covered under
a table specified in section 33(b)(3),''.
(c) Extension of Prohibition on Tolerance Fees.--Section
408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 346a(m)(3)) is amended by striking ``2017'' and
inserting ``2023''.
SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.
(a) Authorized Use of Fund.--Section 4(k)(2)(A) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a-1(k)(2)(A)) is amended--
(1) in the first sentence, by striking ``the fund'' and
inserting ``the Reregistration and Expedited Processing
Fund'';
(2) by striking ``paragraph (3),'' in the first sentence
and all that follows through the second sentence and
inserting the following: ``paragraph (3), to offset the costs
of registration review under section 3(g), including the
costs associated with any review under the Endangered Species
Act of 1973 (16 U.S.C. 1531 et. seq.) required as part of the
registration review, to offset the costs associated with
tracking and implementing registration review decisions,
including registration review decisions designed to reduce
risk, for the purposes specified in paragraphs (4) and (5),
and to enhance the information systems capabilities to
improve the tracking of pesticide registration decisions.'';
(3) in clause (i), by striking ``are allocated solely'' and
all that follows through ``3(g);'' and inserting the
following: ``are allocated solely for the purposes specified
in the first sentence of this subparagraph;''; and
(4) in clause (ii), by striking ``necessary to achieve''
and all that follows through ``3(g);'' and inserting the
following: ``necessary to achieve the purposes specified in
the first sentence of this subparagraph;''.
(b) Set-aside for Review of Inert Ingredients and Expedited
Processing of Similar Applications.--Section 4(k)(3)(A) of
the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136a-1(k)(3)(A)) is amended, in the matter preceding
clause (i), by striking ``The Administrator shall use'' and
all that follows through ``personnel and resources--'' and
inserting the following: ``For each of fiscal years 2017
through 2023, the Administrator shall use between \1/9\ and
\1/8\ of the maintenance fees collected in such fiscal year
to obtain sufficient personnel and resources--''.
(c) Set-aside for Expedited Rulemaking and Guidance
Development for Certain Purposes.--Paragraph (4) of section
4(k) of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136a-1(k)) is amended to read as follows:
``(4) Expedited rulemaking and guidance development for
certain product performance data requirements.--
``(A) Set-aside.--For each of fiscal years 2017 through
2021, the Administrator shall use not more than $500,000 of
the amounts made available to the Administrator in the
Reregistration and Expedited Processing Fund for the
activities described in subparagraph (B).
``(B) Products claiming efficacy against invertebrate pests
of significant public health or economic importance.--The
Administrator shall use amounts made available under
subparagraph (A) to develop, receive comments with respect
to, finalize, and implement the necessary rulemaking and
guidance for product performance data requirements to
evaluate products claiming efficacy against the following
invertebrate pests of significant public health or economic
importance (in order of importance):
``(i) Bed bugs.
``(ii) Premise (including crawling insects, flying insects,
and baits).
``(iii) Pests of pets (including pet pests controlled by
spot-ons, collars, shampoos, powders, dips).
``(iv) Fire ants.
``(C) Deadlines for guidance.--The Administrator shall
develop, and publish guidance required by subparagraph (B)
with respect to claims of efficacy against pests described in
such subparagraph as follows:
``(i) With respect to bed bugs, issue final guidance not
later than June 30, 2017.
``(ii) With respect to pests specified in clause (ii) of
such subparagraph--
``(I) submit draft guidance to the Scientific Advisory
Panel and for public comment not later than June 30, 2018;
and
``(II) complete any response to comments received with
respect to such draft guidance and finalize the guidance not
later than September 30, 2020.
``(iii) With respect to pests specified in clauses (iii)
and (iv) of such subparagraph--
``(I) submit to the Scientific Advisory Panel and for
public comment draft guidance not later than June 30, 2019;
and
``(II) complete any response to comments received with
respect to such draft guidance and finalize the guidance not
later than March 31, 2021.
``(D) Revision.--The Administrator shall revise the
guidance required by subparagraph (B) from time-to-time, but
shall permit applicants and registrants sufficient time to
obtain data that meet the requirements specified in such
revised guidance.
``(E) Deadline for product performance data requirements.--
The Administrator shall, not later than September 30, 2021,
issue regulations prescribing product performance data
requirements for any pesticide intended for preventing,
destroying, repelling, or mitigating any invertebrate pest of
significant public health or economic importance specified in
clauses (i) through (iv) of subparagraph (B).''.
(d) Set-aside for Good Laboratory Practices Inspections.--
Section 4(k) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
(1) by redesignating paragraphs (5) and (6) as paragraphs
(6) and (7), respectively;
(2) by inserting after paragraph (4) the following new
paragraph:
``(5) Good laboratory practices inspections.--
[[Page H2191]]
``(A) Set-aside.--For each of fiscal years 2017 through
2023, the Administrator shall use not more than $500,000 of
the amounts made available to the Administrator in the
Reregistration and Expedited Processing Fund for the
activities described in subparagraph (B).
``(B) Activities.--The Administrator shall use amounts made
available under subparagraph (A) for enhancements to the good
laboratory practices standards compliance monitoring program
established under part 160 of title 40 of the Code of Federal
Regulations (or successor regulations), with respect to
laboratory inspections and data audits conducted in support
of pesticide product registrations under this Act. As part of
such monitoring program, the Administrator shall make
available to each laboratory inspected under such program in
support of such registrations a preliminary summary of
inspection observations not later than 60 days after the date
on which such an inspection is completed.''; and
(3) in paragraph (7), as so redesignated, by striking ``
paragraphs (2), (3), and (4)'' and inserting `` paragraphs
(2), (3), (4), and (5)''.
SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.
Section 5(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136c(a)) is amended--
(1) by striking ``permit for a pesticide.'' and inserting
``permit for a pesticide. An application for an experimental
use permit for a covered application under section 33(b)
shall conform with the requirements of that section.''; and
(2) by inserting ``(or in the case of an application for an
experimental use permit for a covered application under
section 33(b), not later than the last day of the applicable
timeframe for such application specified in such section)''
after ``all required supporting data''.
SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.
(a) Extension and Modification of Fee Authority.--Section
33(b) of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136w-8(b)) is amended--
(1) in paragraph (2)--
(A) in the heading, by striking ``pesticide registration'';
and
(B) in subparagraph (A), by inserting ``or for any other
action covered by a table specified in paragraph (3)'' after
``covered by this Act that is received by the Administrator
on or after the effective date of the Pesticide Registration
Improvement Act of 2003'';
(2) in paragraph (5)--
(A) in the heading, by striking ``pesticide registration
applications'' and inserting ``covered application''; and
(B) by striking ``pesticide registration application'' both
places it appears and inserting ``covered application'';
(3) in paragraph (6)--
(A) in subparagraph (A)--
(i) by striking ``pesticide registration''; and
(ii) by striking ``October 1, 2013, and ending on September
30, 2015'' and inserting ``October 1, 2019, and ending on
September 30, 2021'';
(B) in subparagraph (B)--
(i) by striking ``pesticide registration''; and
(ii) by striking ``2015'' both places in appears, and
inserting ``2021''; and
(C) in subparagraph (C), by striking ``revised registration
service fee schedules'' and inserting ``service fee schedules
revised pursuant to this paragraph'';
(4) in paragraph (7)--
(A) in subparagraph (A)--
(i) by striking ``covered pesticide registration'' and
inserting ``covered application''; and
(ii) by inserting before the period at the end the
following: ``, except that no waiver or fee reduction shall
be provided in connection with a request for a letter of
certification (commonly referred to as a Gold Seal letter)'';
and
(B) in subparagraph (F)(i), by striking ``pesticide
registration''; and
(5) in paragraph (8)--
(A) in subparagraph (A), by striking ``pesticide
registration'';
(B) in subparagraph (B)(i), by striking ``pesticide
registration''; and
(C) in subparagraph (C)--
(i) in clause (i), by striking ``pesticide registration''
and inserting ``covered''; and
(ii) in clause (ii)(I), by striking ``pesticide
registration'' and inserting ``covered''.
(b) Pesticide Registration Fund Set-asides for Worker
Protection, Partnership Grants, and Pesticide Safety
Education.--Section 33(c)(3)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is
amended--
(1) in the heading, by inserting ``, partnership grants,
and pesticide safety education'' after ``Worker protection'';
(2) in clause (i)--
(A) by striking ``2017'' and inserting ``2023''; and
(B) by inserting before the period at the end the
following:``, with an emphasis on field-worker populations in
the United States'';
(3) in clause (ii), by striking ``2017'' and inserting
``2023''; and
(4) in clause (iii), by striking ``2017'' and inserting
``2023''.
(c) Reforms to Reduce Decision Time Review Periods.--
Section 33(e) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136w-8(e)) is amended--
(1) by striking ``Pesticide Registration Improvement
Extension Act of 2012'' and inserting ``Pesticide
Registration Enhancement Act of 2017''; and
(2) by inserting at the end the following new sentence:
``Such reforms shall include identifying opportunities for
streamlining review processes for applications for a new
active ingredient or a new use and providing prompt feedback
to applicants during such review process.''.
(d) Decision Time Review Periods.--Section 33(f) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(f)(1)) is amended--
(1) in paragraph (1)--
(A) by striking ``Pesticide Registration Improvement
Extension Act of 2012'' and inserting ``Pesticide
Registration Enhancement Act of 2017''; and
(B) by inserting after ``covered pesticide registration
actions'' the following: ``or for any other action covered by
a table specified in subsection (b)(3)'';
(2) in paragraph (3), by striking subparagraph (C) and
inserting the following new subparagraph:
``(C) applications for any other action covered by a table
specified in subsection (b)(3).''; and
(3) in paragraph (4)(A)--
(A) by striking ``a pesticide registration application''
and inserting ``a covered application''; and
(B) by striking ``covered pesticide registration
application'' and inserting ``covered application''.
(e) Reporting Requirements.--Section 33(k) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(k)) is amended--
(1) in paragraph (1) by striking ``2017'' and inserting
``2023''; and
(2) in paragraph (2)--
(A) in subparagraph (D), by striking clause (i) and
inserting the following new clause:
``(i) the number of pesticides or pesticide cases reviewed
and the number of registration review decisions completed,
including--
``(I) the number of cases cancelled;
``(II) the number of cases requiring risk mitigation
measures;
``(III) the number of cases removing risk mitigation
measures;
``(IV) the number of cases with no risk mitigation needed;
and
``(V) the number of cases in which risk mitigation has been
fully implemented;'';
(B) in subparagraph (G)--
(i) in clause (i)--
(I) by striking ``section 4(k)(4)'' and inserting
``paragraphs (4) and (5) of section 4(k)''; and
(II) by striking ``that section'' and inserting ``such
paragraphs'';
(ii) by striking clauses (ii), (iii), (iv), (v), and (vi);
(iii) by inserting after clause (i) the following new
clause:
``(ii) implementing enhancements to--
``(I) the electronic tracking of covered applications;
``(II) the electronic tracking of conditional
registrations;
``(III) the endangered species database;
``(IV) the electronic review of labels submitted with
covered applications; and
``(V) the electronic review and assessment of confidential
statements of formula submitted with covered applications;
and''; and
(iv) by redesignating clause (vii) as clause (iii);
(C) in subparagraph (I), by striking ``and'' at the end;
(D) in subparagraph (J), by striking the period at the end
and inserting a semicolon; and
(E) by adding at the end the following new subparagraphs:
``(K) a review of the progress made in developing,
updating, and implementing product performance test
guidelines for pesticide products that are intended to
control invertebrate pests of significant public health
importance and, by regulation, prescribing product
performance data requirements for such pesticide products
registered under section 3;
``(L) a review of the progress made in the priority review
and approval of new pesticides to control vector-born public
health pests for use in the United States, including each
territory or possession of the United States, and United
States military installations globally;
``(M) a review of the progress made in implementing
enhancements to the good laboratory practices standards
compliance monitoring program established under part 160 of
title 40 of the Code of Federal Regulations (or successor
regulations);
``(N) the number of approvals for active ingredients, new
uses, and pesticide end use products granted in connection
with the Design for the Environment program (or any successor
program) of the Environmental Protection Agency; and
``(O) with respect to funds in the Pesticide Registration
Fund reserved under subsection (c)(3), a review that
includes--
``(i) a description of the amount and use of such funds--
``(I) to carry out activities relating to worker protection
under clause (i) of subsection (c)(3)(B);
``(II) to award partnership grants under clause (ii) of
such subsection; and
``(III) to carry out the pesticide safety education program
under clause (iii) of such subsection;
``(ii) an evaluation of the appropriateness and
effectiveness of the activities, grants, and program
described in clause (i);
[[Page H2192]]
``(iii) a description of how stakeholders are engaged in
the decision to fund such activities, grants, and program;
and
``(iv) with respect to activities relating to worker
protection carried out under subparagraph (B)(i) of such
subsection, a summary of the analyses from stakeholders,
including from worker community-based organizations, on the
appropriateness and effectiveness of such activities.''.
(f) Termination of Effectiveness.--Section 33(m) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(m)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``Fiscal year 2018.--During fiscal year
2018'' and inserting ``Fiscal year 2024.--During fiscal year
2024''; and
(ii) by striking ``2017'' and inserting ``2023'';
(B) in subparagraph (B)--
(i) by striking ``Fiscal year 2019.--During fiscal year
2019'' and inserting ``Fiscal year 2025.--During fiscal year
2025''; and
(ii) by striking ``2017'' and inserting ``2023'';
(C) in subparagraph (C), by striking ``September 30,
2019.--Effective September 30, 2019'' and inserting
``September 30, 2025.--Effective September 30, 2025''; and
(D) in subparagraph (D), by striking ``2017'' both places
it appears and inserting ``2023''.
SEC. 6. REVISION OF TABLES REGARDING COVERED PESTICIDE
REGISTRATION APPLICATIONS AND OTHER COVERED
ACTIONS AND THEIR CORRESPONDING REGISTRATION
SERVICE FEES.
Paragraph (3) of section 33(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is
amended to read as follows:
``(3) Schedule of covered applications and other actions
and their registration service fees.--Subject to paragraph
(6), the schedule of registration applications and other
covered actions and their corresponding registration service
fees shall be as follows:
``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
R010 1 New Active Ingredient, Food use. 24 753,082
(2)(3)
----------------------------------------------------------------------------------------------------------------
R020 2 New Active Ingredient, Food use; 18 627,568
reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
R040 3 New Active Ingredient, Food use; 18 462,502
Experimental Use Permit application;
establish temporary tolerance;
submitted before application for
registration; credit 45% of fee
toward new active ingredient
application that follows. (3)
----------------------------------------------------------------------------------------------------------------
R060 4 New Active Ingredient, Non-food use; 21 523,205
outdoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
R070 5 New Active Ingredient, Non-food use; 16 436,004
outdoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
R090 6 New Active Ingredient, Non-food use; 16 323,690
outdoor; Experimental Use Permit
application; submitted before
application for registration; credit
45% of fee toward new active
ingredient application that follows.
(3)
----------------------------------------------------------------------------------------------------------------
R110 7 New Active Ingredient, Non-food use; 20 290,994
indoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
R120 8 New Active Ingredient, Non-food use; 14 242,495
indoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
R121 9 New Active Ingredient, Non-food use; 18 182,327
indoor; Experimental Use Permit
application; submitted before
application for registration; credit
45% of fee toward new active
ingredient application that follows.
(3)
----------------------------------------------------------------------------------------------------------------
R122 10 Enriched isomer(s) of registered mixed- 18 317,128
isomer active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
R123 11 New Active Ingredient, Seed treatment 18 471,861
only; includes agricultural and non-
agricultural seeds; residues not
expected in raw agricultural
commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------
R125 12 New Active Ingredient, Seed treatment; 16 323,690
Experimental Use Permit application;
submitted before application for
registration; credit 45% of fee
toward new active ingredient
application that follows. (3)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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 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 agreement to the Agency.
``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
R130 13 First food use; indoor; food/food 21 191,444
handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
R140 14 Additional food use; Indoor; food/food 15 44,672
handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
R150 15 First food use. (2)(3) 21 317,104
----------------------------------------------------------------------------------------------------------------
[[Page H2193]]
R155 16 (new) First food use, Experimental Use 21 264,253
Permit application; a.i. registered
for non-food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
R160 17 First food use; reduced risk. (2)(3) 16 264,253
----------------------------------------------------------------------------------------------------------------
R170 18 Additional food use. (3) (4) 15 79,349
----------------------------------------------------------------------------------------------------------------
R175 19 Additional food uses covered within a 10 66,124
crop group resulting from the
conversion of existing approved crop
group(s) to one or more revised crop
groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
R180 20 Additional food use; reduced risk. 10 66,124
(3)(4)
----------------------------------------------------------------------------------------------------------------
R190 21 Additional food uses; 6 or more 15 476,090
submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
R200 22 Additional Food Use; 6 or more 10 396,742
submitted in one application; Reduced
Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
R210 23 Additional food use; Experimental Use 12 48,986
Permit application; establish
temporary tolerance; no credit toward
new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R220 24 Additional food use; Experimental Use 6 19,838
Permit application; crop destruct
basis; no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R230 25 Additional use; non-food; outdoor. (3) 15 31,713
(4)
----------------------------------------------------------------------------------------------------------------
R240 26 Additional use; non-food; outdoor; 10 26,427
reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
R250 27 Additional use; non-food; outdoor; 6 19,838
Experimental Use Permit application;
no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R251 28 Experimental Use Permit application 8 19,838
which requires no changes to the
tolerance(s); non-crop destruct
basis. (3)
----------------------------------------------------------------------------------------------------------------
R260 29 New use; non-food; indoor. (3) (4) 12 15,317
----------------------------------------------------------------------------------------------------------------
R270 30 New use; non-food; indoor; reduced 9 12,764
risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
R271 31 New use; non-food; indoor; 6 9,725
Experimental Use Permit application;
no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R273 32 Additional use; seed treatment; 12 50,445
limited uptake into Raw Agricultural
Commodities; includes crops with
established tolerances (e.g., for
soil or foliar application); includes
food and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
R274 33 Additional uses; seed treatment only; 12 302,663
6 or more submitted in one
application; limited uptake into raw
agricultural commodities; includes
crops with established tolerances
(e.g., for soil or foliar
application); includes food and/or
non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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 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 agreement to the Agency.
(4) 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 product registration and new inert approval(s) that is submitted in the new
use application 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 applications 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 appropriate fee is due for each type
of new use and the longest decision review time applies 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
applicant at the applicant's initiative to support the application after completion of the technical
deficiency 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.
``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
R280 34 Establish import tolerance; new active 21 319,072
ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
R290 35 Establish Import tolerance; Additional 15 63,816
new food use.
----------------------------------------------------------------------------------------------------------------
[[Page H2194]]
R291 36 Establish import tolerances; 15 382,886
additional food uses; 6 or more crops
submitted in one petition.
----------------------------------------------------------------------------------------------------------------
R292 37 Amend an established tolerance (e.g., 11 45,341
decrease or increase) and/or
harmonize established tolerances with
Codex MRLs; domestic or import;
applicant-initiated.
----------------------------------------------------------------------------------------------------------------
R293 38 Establish tolerance(s) for inadvertent 12 53,483
residues in one crop; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
R294 39 Establish tolerances for inadvertent 12 320,894
residues; 6 or more crops submitted
in one application; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
R295 40 Establish tolerance(s) for residues in 15 66,124
one rotational crop in response to a
specific rotational crop application;
submission of corresponding label
amendments which specify the
necessary plant-back restrictions;
applicant-initiated. (3) (4)
----------------------------------------------------------------------------------------------------------------
R296 41 Establish tolerances for residues in 15 396,742
rotational crops in response to a
specific rotational crop petition; 6
or more crops submitted in one
application; submission of
corresponding label amendments which
specify the necessary plant-back
restrictions; applicant-initiated.
(3) (4)
----------------------------------------------------------------------------------------------------------------
R297 42 Amend 6 or more established tolerances 11 272,037
(e.g., decrease or increase) in one
petition; domestic or import;
applicant-initiated.
----------------------------------------------------------------------------------------------------------------
R298 43 Amend an established tolerance (e.g., 13 58,565
decrease or increase); domestic or
import; submission of corresponding
amended labels (requiring science
review). (3) (4)
----------------------------------------------------------------------------------------------------------------
R299 44 Amend 6 or more established tolerances 13 285,261
(e.g., decrease or increase);
domestic or import; submission of
corresponding amended labels
(requiring science review). (3) (4)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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 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 agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
base fee for the category. All items in the covered application must be submitted together in one package.
Each application for an additional new product registration and new inert approval(s) that is submitted in the
amendment application package is subject to the registration service fee for a new product or a new inert
approval. However, if an amendment application only proposes to register the amendment for a new product and
there are no amendments in the application, then review of one new product application is covered by the base
fee. All such associated applications that are submitted together will be subject to the category decision
review time.
``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
New CR Decision Review Time FY'17 & FY'18 Registration
EPA No. No. Action (Months)(1) Service Fee ($)
----------------------------------------------------------------------------------------------------------------
R300 45 New product; or similar 4 1,582
combination product (already
registered) to an identical or
substantially similar in
composition and use to a
registered product; registered
source of active ingredient; no
data review on acute toxicity,
efficacy or CRP - only product
chemistry data; cite-all data
citation, or selective data
citation where applicant owns
all required data, or applicant
submits specific authorization
letter from data owner. Category
also includes 100% re-package of
registered end-use or
manufacturing-use product that
requires no data submission nor
data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
R301 46 New product; or similar 4 1,897
combination product (already
registered) to an identical or
substantially similar in
composition and use to a
registered product; registered
source of active ingredient;
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy (identical
data citation and claims to
cited product(s)), where
applicant does not own all
required data and does not have
a specific authorization letter
from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page H2195]]
R310 47 New end-use or manufacturing-use 7 7,301
product with registered
source(s) of active
ingredient(s); includes products
containing two or more
registered active ingredients
previously combined in other
registered products; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R314 48 New end use product containing up 8 8,626
to three registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R319 49 New end use product containing up 10 12,626
to three registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for 4 to 7 target
pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R318 50 (new) New end use product containing 9 13,252
four or more registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R321 51 (new) New end use product containing 11 17,252
four or more registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for 4 to 7 target
pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R315 52 New end-use, on-animal product, 9 9,820
registered source of active
ingredient(s), with the
submission of data and/or
waivers for only:
animal safety and
pest(s) requiring
efficacy (4) and/or
product chemistry and/or
acute toxicity and/or
child resistant
packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------
[[Page H2196]]
R316 53 (new) New end-use or manufacturing 9 11,301
product with registered
source(s) of active
ingredient(s) including products
containing two or more
registered active ingredients
previously combined in other
registered products; excludes
products requiring or citing an
animal safety study; and
requires review of data and/or
waivers for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for greater than
3 and up to 7 target pests.
(2)(3)
----------------------------------------------------------------------------------------------------------------
R317 54 (new) New end-use or manufacturing 10 15,301
product with registered
source(s) of active
ingredient(s) including products
containing 2 or more registered
active ingredients previously
combined in other registered
products; excludes products
requiring or citing an animal
safety study; and requires
review of data and/or waivers
for only:
product chemistry and/or
acute toxicity and/or
child resistant
packaging and/or
pest(s) requiring
efficacy (4) - for greater than
7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R320 55 New product; new physical form; 12 13,226
requires data review in science
divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
R331 56 New product; repack of identical 3 2,530
registered end-use product as a
manufacturing-use product, or
identical registered
manufacturing-use product as an
end use product; same registered
uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
R332 57 New manufacturing-use product; 24 283,215
registered active ingredient;
unregistered source of active
ingredient; submission of
completely new generic data
package; registered uses only;
requires review in RD and
science divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
R333 58 New product; MUP or End use 10 19,838
product with unregistered source
of active ingredient; requires
science data review; new
physical form; etc. Cite-all or
selective data citation where
applicant owns all required
data. (2)(3)
----------------------------------------------------------------------------------------------------------------
R334 59 New product; MUP or End use 11 23,100
product with unregistered source
of the active ingredient;
requires science data review;
new physical form; etc.
Selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
(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.
(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 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 agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
(general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
a pest group (general), use the group listing below and each group will count as 1. The general pests groups
are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
a general claim then each specific pest will count as 1.
``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
R340 60 Amendment requiring data review within RD 4 4,988
(e.g., changes to precautionary label
statements); includes adding/modifying
pest(s) claims for up to 2 target pests,
excludes products requiring or citing an
animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
R341 61 (New) Amendment requiring data review within RD 6 5,988
(e.g., changes to precautionary label
statements), includes adding/modifying
pest(s) claims for greater than 2 target
pests, excludes products requiring or
citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
[[Page H2197]]
R345 62 Amending on-animal products previously 7 8,820
registered, with the submission of data
and/or waivers for only:
animal safety and
pest(s) requiring efficacy (4) and/
or
product chemistry and/or
acute toxicity and/or
child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------
R350 63 Amendment requiring data review in science 9 13,226
divisions (e.g., changes to REI, or PPE,
or PHI, or use rate, or number of
applications; or add aerial application;
or modify GW/SW advisory statement).
(2)(3)
----------------------------------------------------------------------------------------------------------------
R351 64 Amendment adding a new unregistered source 8 13,226
of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
R352 65 Amendment adding already approved uses; 8 13,226
selective method of support; does not
apply if the applicant owns all cited
data. (2) (3)
----------------------------------------------------------------------------------------------------------------
R371 66 Amendment to Experimental Use Permit; (does 6 10,090
not include extending a permit's time
period). (3)
----------------------------------------------------------------------------------------------------------------
(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-initiated 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 amendments 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 amendments 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.
(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 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 agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
efficacy'' are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable
flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest
needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
(general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
a pest group (general), use the group listing below and each group will count as 1. The general pests groups
are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
a general claim then each specific pest will count as 1.
``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
R124 67 Conditional Ruling on Pre-application 6 2,530
Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
R272 68 Review of Study Protocol applicant- 3 2,530
initiated; excludes DART, pre-
registration conference, Rapid
Response review, DNT protocol review,
protocol needing HSRB review.
----------------------------------------------------------------------------------------------------------------
R275 69 Rebuttal of agency reviewed protocol, 3 2,530
applicant initiated.
----------------------------------------------------------------------------------------------------------------
R370 70 Cancer reassessment; applicant- 18 198,250
initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
A380 71 New Active Ingredient; Indirect Food use; 24 137,841
establish tolerance or tolerance
exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
A390 72 New Active Ingredient; Direct Food use; 24 229,733
establish tolerance or tolerance
exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
A410 73 New Active Ingredient Non-food use.(2)(3) 21 229,733
----------------------------------------------------------------------------------------------------------------
A431 74 New Active Ingredient, Non-food use; low- 12 80,225
risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page H2198]]
(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 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 agreement to the Agency.
``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
A440 75 New Use, Indirect Food Use, 21 31,910
establish tolerance or
tolerance exemption.
(2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A441 76 Additional Indirect food 21 114,870
uses; establish tolerances
or tolerance exemptions if
required; 6 or more
submitted in one
application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A450 77 New use, Direct food use, 21 95,724
establish tolerance or
tolerance exemption.
(2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A451 78 Additional Direct food uses; 21 182,335
establish tolerances or
tolerance exemptions if
required; 6 or more
submitted in one
application. (3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A500 79 New use, non-food. (4)(5) 12 31,910
----------------------------------------------------------------------------------------------------------------
A501 80 New use, non-food; 6 or more 15 76,583
submitted in one
application. (4)(5)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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 ingredient 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) 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 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 agreement to the Agency.
(5) 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 product registration and new inert approval(s) that is submitted in the new
use application 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 applications 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 appropriate fee is due for each type
of new use and the longest decision review time applies 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
applicant at the applicant's initiative to support the application after completion of the technical
deficiency 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.
``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
A530 81 New product, identical or 4 1,278
substantially similar in composition
and use to a registered product; no
data review or only product chemistry
data; cite all data citation or
selective data citation where
applicant owns all required data; or
applicant submits specific
authorization letter from data owner.
Category also includes 100% re-
package of registered end-use or
manufacturing use product that
requires no data submission nor data
matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
A531 82 New product; identical or 4 1,824
substantially similar in composition
and use to a registered product;
registered source of active
ingredient: selective data citation
only for data on product chemistry
and/or acute toxicity and/or public
health pest efficacy, where applicant
does not own all required data and
does not have a specific
authorization letter from data owner.
(2)(3)
----------------------------------------------------------------------------------------------------------------
A532 83 New product; identical or 5 5,107
substantially similar in composition
and use to a registered product;
registered active ingredient;
unregistered source of active
ingredient; cite-all data citation
except for product chemistry; product
chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
A540 84 New end use product; FIFRA Sec. 2(mm) 5 5,107
uses only; up to 25 public health
organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
[[Page H2199]]
A541 85 (new) New end use product; FIFRA Sec. 2(mm) 7 8,500
uses only; 26-50 public health
organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
A542 86 (new) New end use product; FIFRA Sec. 2(mm) 10 15,000
uses only; $ 51 public health
organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
A550 87 New end-use product; uses other than 9 13,226
FIFRA Sec. 2(mm); non-FQPA product.
(2)(3)(5)
----------------------------------------------------------------------------------------------------------------
A560 88 New manufacturing use product; 6 12,596
registered active ingredient;
selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
A565 89 (new) New manufacturing-use product; 12 18,234
registered active ingredient;
unregistered source of active
ingredient; submission of new generic
data package; registered uses only;
requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
A570 90 Label amendment requiring data 4 3,831
review; up to 25 public health
organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
A573 91 (new) Label amendment requiring data 6 6,350
review; 26-50 public health
organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
A574 92 (new) Label amendment requiring data 9 11,000
review; $ 51 public health organisms.
(2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
A572 93 New Product or amendment requiring 9 13,226
data review for risk assessment by
Science Branch (e.g., changes to REI,
or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(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.
(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 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 agreement to the Agency.
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated 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 amendments 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 amendments 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.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
original decision review time period will result in reclassification of both the original and subsequent
submission into the appropriate new category based on the sum of the number or organisms in both submissions.
A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
either A570 or A573, additional organisms submitted for the same product before expiration of the first
submission's original decision review time period will result in reclassification of both the original and
subsequent submission into the appropriate new category based on the sum of the number or organisms in both
submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
fee of the new category.
``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
A520 94 Experimental Use Permit application, 9 6,383
non-food use. (2)
----------------------------------------------------------------------------------------------------------------
A521 95 Review of public health efficacy study 4 4,726
protocol within AD, per AD Internal
Guidance for the Efficacy Protocol
Review Process; Code will also
include review of public health
efficacy study protocol and data
review for devices making pesticidal
claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
A522 96 Review of public health efficacy 12 12,156
study protocol outside AD by members
of AD Efficacy Protocol Review Expert
Panel; Code will also include review
of public health efficacy study
protocol and data review for devices
making pesticidal claims; applicant-
initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
A537 97 (new) New Active Ingredient/New Use, 18 153,156
Experimental Use Permit application;
Direct food use; Establish tolerance
or tolerance exemption if required.
Credit 45% of fee toward new active
ingredient/new use application that
follows.
----------------------------------------------------------------------------------------------------------------
A538 98 (new) New Active Ingredient/New Use, 18 95,724
Experimental Use Permit application;
Indirect food use; Establish
tolerance or tolerance exemption if
required Credit 45% of fee toward new
active ingredient/new use application
that follows.
----------------------------------------------------------------------------------------------------------------
A539 99 (new) New Active Ingredient/New Use, 15 92,163
Experimental Use Permit application;
Nonfood use. Credit 45% of fee toward
new active ingredient/new use
application that follows.
----------------------------------------------------------------------------------------------------------------
A529 100 Amendment to Experimental Use Permit; 9 11,429
requires data review or risk
assessment. (2)
----------------------------------------------------------------------------------------------------------------
A523 101 Review of protocol other than a 9 12,156
public health efficacy study (i.e.,
Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
A571 102 Science reassessment: Cancer risk, 18 95,724
refined ecological risk, and/or
endangered species; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
A533 103 (new) Exemption from the requirement of an 4 2,482
Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------
[[Page H2200]]
A534 104 (new) Rebuttal of agency reviewed protocol, 4 4,726
applicant initiated.
----------------------------------------------------------------------------------------------------------------
A535 105 (new) Conditional Ruling on Pre-application 6 2,409
Study Waiver or Data Bridging
Argument; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
A536 106 (new) Conditional Ruling on Pre-application 4 2,482
Direct Food, Indirect Food, Nonfood
use determination; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
(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) 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 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 agreement to the Agency.
``TABLE 11. -- BIOPESTICIDES DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B580 107 New active ingredient; food use; 20 51,053
petition to establish a tolerance.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B590 108 New active ingredient; food use; 18 31,910
petition to establish a tolerance
exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
B600 109 New active ingredient; non-food use. 13 19,146
(2)(3)
----------------------------------------------------------------------------------------------------------------
B610 110 New active ingredient; Experimental 10 12,764
Use Permit application; petition to
establish a temporary tolerance or
temporary tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
B611 111 New active ingredient; Experimental 12 12,764
Use Permit application; petition to
establish permanent tolerance
exemption. (3)
----------------------------------------------------------------------------------------------------------------
B612 112 New active ingredient; no change to a 10 17,550
permanent tolerance exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
B613 113 New active ingredient; petition to 11 17,550
convert a temporary tolerance or a
temporary tolerance exemption to a
permanent tolerance or tolerance
exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
B620 114 New active ingredient; Experimental 7 6,383
Use Permit application; non-food use
including crop destruct. (3)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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 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 agreement to the Agency.
``TABLE 12. -- BIOPESTICIDES DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B630 115 First food use; petition to establish 13 12,764
a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
B631 116 New food use; petition to amend an 12 12,764
established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
B640 117 First food use; petition to establish 19 19,146
a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
B643 118 New Food use; petition to amend an 10 12,764
established tolerance exemption.
(3)(4)
----------------------------------------------------------------------------------------------------------------
B642 119 First food use; indoor; food/food 12 31,910
handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
B644 120 New use, no change to an established 8 12,764
tolerance or tolerance exemption.
(3)(4)
----------------------------------------------------------------------------------------------------------------
B650 121 New use; non-food. (3)(4) 7 6,383
----------------------------------------------------------------------------------------------------------------
[[Page H2201]]
B645 122 (new) New food use; Experimental Use Permit 12 12,764
application; petition to amend or add
a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
B646 123 (new) New use; non-food use including crop 7 6,383
destruct; Experimental Use Permit
application. (4)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered 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 product registration and new inert approval(s) that is submitted in the new
use application 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 applications 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 appropriate fee is due for each type
of new use and the longest decision review time applies 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
applicant at the applicant's initiative to support the application after completion of the technical
deficiency 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 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 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 agreement to the Agency.
``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B652 124 New product; registered source of active 13 12,764
ingredient; requires petition to amend
established tolerance or tolerance
exemption; requires 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of scientifically-
sound rationale based on publicly
available literature or other relevant
information that addresses the data
requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
B660 125 New product; registered source of active 4 1,278
ingredient(s); identical or
substantially similar in composition and
use to a registered product. No data
review, or only product chemistry data;
cite-all data citation, or selective
data citation where applicant owns all
required data or authorization from data
owner is demonstrated. Category includes
100% re-package of registered end-use or
manufacturing-use product that requires
no data submission or data matrix. For
microbial pesticides, the active
ingredient(s) must not be re-isolated.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B670 126 New product; registered source of active 7 5,107
ingredient(s); requires: 1) submission
of product specific data; or 2) citation
of previously reviewed and accepted
data; or 3) submission or citation of
data generated at government expense; or
4) submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
B671 127 New product; unregistered source of 17 12,764
active ingredient(s); requires a
petition to amend an established
tolerance or tolerance exemption;
requires: 1) submission of product
specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
B672 128 New product; unregistered source of 13 9,118
active ingredient(s); non-food use or
food use requires: 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
B673 129 New product MUP/EP; unregistered source 10 5,107
of active ingredient(s); citation of
Technical Grade Active Ingredient (TGAI)
data previously reviewed and accepted by
the Agency. Requires an Agency
determination that the cited data
supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
B674 130 New product MUP; Repack of identical 4 1,278
registered end-use product as a
manufacturing-use product; same
registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page H2202]]
B675 131 New Product MUP; registered source of 10 9,118
active ingredient; submission of
completely new generic data package;
registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
B676 132 New product; more than one active 13 9,118
ingredient where one active ingredient
is an unregistered source; product
chemistry data must be submitted;
requires: 1) submission of product
specific data, and 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
B677 133 New end-use non-food animal product with 10 8,820
submission of two or more target animal
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)
----------------------------------------------------------------------------------------------------------------
(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.
(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 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 agreement to the Agency.
``TABLE 14. -- BIOPESTICIDES DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B621 134 Amendment; Experimental Use Permit; no 7 5,107
change to an established temporary
tolerance or tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
B622 135 Amendment; Experimental Use Permit; 11 12,764
petition to amend an established or
temporary tolerance or tolerance
exemption. (3)
----------------------------------------------------------------------------------------------------------------
B641 136 Amendment of an established tolerance or 13 12,764
tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680 137 Amendment; registered sources of active 5 5,107
ingredient(s); no new use(s); no changes
to an established tolerance or tolerance
exemption. Requires data submission.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B681 138 Amendment; unregistered source of active 7 6,079
ingredient(s). Requires data submission.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B683 139 Label amendment; requires review/update 6 5,107
of previous risk assessment(s) without
data submission (e.g., labeling changes
to REI, PPE, PHI). (2)(3)
----------------------------------------------------------------------------------------------------------------
B684 140 Amending non-food animal product that 8 8,820
includes submission of target animal
safety data; previously registered.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B685 141 (new) Amendment; add a new biochemical 5 5,107
unregistered source of active ingredient
or a new microbial production site.
Requires submission of analysis of
samples data and source/production site-
specific manufacturing process
description. (3)
----------------------------------------------------------------------------------------------------------------
(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-initiated 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 amendments 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 amendments 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.
(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 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 agreement to the Agency.
[[Page H2203]]
``TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B690 142 New active ingredient; food or non- 7 2,554
food use. (2)(6)
----------------------------------------------------------------------------------------------------------------
B700 143 Experimental Use Permit application; 7 1,278
new active ingredient or new use. (6)
----------------------------------------------------------------------------------------------------------------
B701 144 Extend or amend Experimental Use 4 1,278
Permit. (6)
----------------------------------------------------------------------------------------------------------------
B710 145 New product; registered source of 4 1,278
active ingredient(s); identical or
substantially similar in composition
and use to a registered product; no
change in an established tolerance or
tolerance exemption. No data review,
or only product chemistry data; cite-
all data citation, or selective data
citation where applicant owns all
required data or authorization from
data owner is demonstrated. Category
includes 100% re-package of
registered end-use or manufacturing-
use product that requires no data
submission or data matrix. (3)(6)
----------------------------------------------------------------------------------------------------------------
B720 146 New product; registered source of 5 1,278
active ingredient(s); requires: 1)
submission of product specific data;
or 2) citation of previously reviewed
and accepted data; or 3) submission
or citation of data generated at
government expense; or 4) submission
or citation of a scientifically-sound
rationale based on publicly available
literature or other relevant
information that addresses the data
requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the
data requirement does not apply.
(3)(6)
----------------------------------------------------------------------------------------------------------------
B721 147 New product; unregistered source of 7 2,676
active ingredient. (3)(6)
----------------------------------------------------------------------------------------------------------------
B722 148 New use and/or amendment; petition to 7 2,477
establish a tolerance or tolerance
exemption. (4)(5)(6)
----------------------------------------------------------------------------------------------------------------
B730 149 Label amendment requiring data 5 1,278
submission. (4)(6)
----------------------------------------------------------------------------------------------------------------
(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) 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 review period as the new active ingredient or first food use application. The
application 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 ingredient 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 associated applications that
are submitted together will be subject to the new active ingredient 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
application for another new product containing the same active ingredient or an amendment 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 ingredient. In the case of a first food use application, until that
first food use is approved, 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 technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(3) 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.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated 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 amendments 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 amendments 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.
(5) 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 product registration and new inert approval(s) that is submitted in the new
use application 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 applications 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 appropriate fee is due for each type
of new use and the longest decision review time applies 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
applicant at the applicant's initiative to support the application after completion of the technical
deficiency 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.
(6) 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 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 agreement to the Agency.
``TABLE 16. -- BIOPESTICIDES DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B614 150 Pre-application; Conditional Ruling on 3 2,530
rationales for addressing a data
requirement in lieu of data;
applicant-initiated; applies to one
rationale at a time.
----------------------------------------------------------------------------------------------------------------
B615 151 Rebuttal of agency reviewed protocol, 3 2,530
applicant initiated.
----------------------------------------------------------------------------------------------------------------
B682 152 Protocol review; applicant initiated; 3 2,432
excludes time for HSRB review.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
[[Page H2204]]
``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
B740 153 Experimental Use Permit application; no 6 95,724
petition for tolerance/tolerance
exemption. Includes:
...........................................
1. non-food/feed use(s) for a new (2) or
registered (3) PIP (12);
2. food/feed use(s) for a new or registered
PIP with crop destruct (12);
3. food/feed use(s) for a new or registered
PIP in which an established tolerance/
tolerance exemption exists for the
intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
B741 154 Experimental Use Permit application; no 12 159,538
(new) petition for tolerance/tolerance
exemption. Includes:
...........................................
1. non-food/feed use(s) for a new (2) or
registered (3) PIP;
2. food/feed use(s) for a new or registered
PIP with crop destruct;
3. food/feed use(s) for a new or registered
PIP in which an established tolerance/
tolerance exemption exists for the
intended use(s);
SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
B750 155 Experimental Use Permit application; with a 9 127,630
petition to establish a temporary or
permanent tolerance/tolerance exemption
for the active ingredient. Includes new
food/feed use for a registered (3) PIP.
(4)(12)
----------------------------------------------------------------------------------------------------------------
B770 156 Experimental Use Permit application; new 15 191,444
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows;
SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B771 157 Experimental Use Permit application; new 10 127,630
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows.
(12)
----------------------------------------------------------------------------------------------------------------
B772 158 Application to amend or extend an 3 12,764
Experimental Use Permit; no petition since
the established tolerance/tolerance
exemption for the active ingredient is
unaffected. (12)
----------------------------------------------------------------------------------------------------------------
B773 159 Application to amend or extend an 5 31,910
Experimental Use Permit; with petition to
extend a temporary tolerance/tolerance
exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
B780 160 Registration application; new (2) PIP; non- 12 159,537
food/feed. (12)
----------------------------------------------------------------------------------------------------------------
B790 161 Registration application; new (2) PIP; non- 18 223,351
food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B800 162 Registration application; new (2) PIP; with 13 172,300
petition to establish permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------
B810 163 Registration application; new (2) PIP; with 19 236,114
petition to establish permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. SAP review.
(5)(12)
----------------------------------------------------------------------------------------------------------------
B820 164 Registration application; new (2) PIP; with 15 204,208
petition to establish or amend a permanent
tolerance/tolerance exemption of an active
ingredient. (12)
----------------------------------------------------------------------------------------------------------------
B840 165 Registration application; new (2) PIP; with 21 268,022
petition to establish or amend a permanent
tolerance/tolerance exemption of an active
ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B851 166 Registration application; new event of a 9 127,630
previously registered PIP active
ingredient(s); no petition since permanent
tolerance/tolerance exemption is already
established for the active ingredient(s).
(12)
----------------------------------------------------------------------------------------------------------------
B870 167 Registration application; registered (3) 9 38,290
PIP; new product; new use; no petition
since a permanent tolerance/tolerance
exemption is already established for the
active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
B880 168 Registration application; registered (3) 9 31,910
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
B881 169 Registration application; registered (3) 15 95,724
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). SAP review.
(5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
B882 170 Registration application; new (2) PIP, seed 15 191,444
(new) increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption; SAP Review.
(8)(12)
----------------------------------------------------------------------------------------------------------------
B883 171 Registration application; new (2) PIP, seed 9 127,630
increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
B884 172 Registration application; new (2) PIP, seed 12 159,537
increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
B885 173 Registration application; registered (3) 6 31,910
PIP, seed increase; breeding stack of
previously approved PIPs, same crop; no
petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
B886 174 Registration application; new (2) PIP, seed 18 223,351
(new) increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------
[[Page H2205]]
B890 175 Application to amend a seed increase 9 63,816
registration; converts registration to
commercial registration; no petition since
permanent tolerance/tolerance exemption is
already established for the active
ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
B891 176 Application to amend a seed increase 15 127,630
registration; converts registration to a
commercial registration; no petition since
a permanent tolerance/tolerance exemption
already established for the active
ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B900 177 Application to amend a registration, 6 12,764
including actions such as extending an
expiration date, modifying an IRM plan, or
adding an insect to be controlled.
(10)(11)(12)
----------------------------------------------------------------------------------------------------------------
B901 178 Application to amend a registration, 12 76,578
including actions such as extending an
expiration date, modifying an IRM plan, or
adding an insect to be controlled. SAP
review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
B902 179 PIP Protocol review. 3 6,383
----------------------------------------------------------------------------------------------------------------
B903 180 Inert ingredient tolerance exemption; e.g., 6 63,816
a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
B904 181 Import tolerance or tolerance exemption; 9 127,630
processed commodities/food only (inert or
active ingredient).
----------------------------------------------------------------------------------------------------------------
B905 182 SAP Review. 6 63,816
(new)
----------------------------------------------------------------------------------------------------------------
B906 183 Petition to establish a temporary tolerance/ 3 31,907
(new) tolerance exemption for one or more active
ingredients.
----------------------------------------------------------------------------------------------------------------
B907 184 Petition to establish a temporary tolerance/ 3 12,764
(new) tolerance exemption for one or more active
ingredients based on an existing temporary
tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B908 185 Petition to establish a temporary tolerance/ 3 44,671
(new) tolerance exemption for one or more active
ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(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 registered.
(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 insect resistance, and novel scientific issues surrounding new technologies. The
scientists 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).
(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 uncertainty 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 registration 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 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 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 agreement to the Agency.
``TABLE 18. -- INERT INGREDIENTS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
I001 186 Approval of new food use inert 13 27,000
ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
I002 187 Amend currently approved inert ingredient 11 7,500
tolerance or exemption from tolerance;
new data. (2)
----------------------------------------------------------------------------------------------------------------
I003 188 Amend currently approved inert ingredient 9 3,308
tolerance or exemption from tolerance;
no new data. (2)
----------------------------------------------------------------------------------------------------------------
I004 189 Approval of new non-food use inert 6 11,025
ingredient. (2)
----------------------------------------------------------------------------------------------------------------
I005 190 Amend currently approved non-food use 6 5,513
inert ingredient with new use pattern;
new data. (2)
----------------------------------------------------------------------------------------------------------------
I006 191 Amend currently approved non-food use 3 3,308
inert ingredient with new use pattern;
no new data. (2)
----------------------------------------------------------------------------------------------------------------
I007 192 Approval of substantially similar non- 4 1,654
food use inert ingredients when original
inert is compositionally similar with
similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
I008 193 Approval of new or amended polymer inert 5 3,749
ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
I009 194 Approval of new or amended polymer inert 4 3,087
ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------
I010 195 Petition to amend a single tolerance 6 1,654
exemption descriptor, or single non-food
use descriptor, to add 10 CASRNs; no
new data. (2)
----------------------------------------------------------------------------------------------------------------
[[Page H2206]]
I011 196 (new) Approval of new food use safener with 24 597,683
tolerance or exemption from tolerance.
(2)(8)
----------------------------------------------------------------------------------------------------------------
I012 197 (new) Approval of new non-food use safener. 21 415,241
(2)(8)
----------------------------------------------------------------------------------------------------------------
I013 198 (new) Approval of additional food use for 15 62,975
previously approved safener with
tolerance or exemption from tolerance.
(2)
----------------------------------------------------------------------------------------------------------------
I014 199 (new) Approval of additional non-food use for 15 25,168
previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
I015 200 (new) Approval of new generic data for 24 269,728
previously approved food use safener.
(2)
----------------------------------------------------------------------------------------------------------------
I016 201 (new) Approval of amendment(s) to tolerance and 13 55,776
label for previously approved safener.
(2)
----------------------------------------------------------------------------------------------------------------
(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 application to approve an inert ingredient,
each application will be subject to its respective registration service fee. The decision review time line for
both submissions will be the longest of the associated applications. If the application covers multiple
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 ingredient 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.
(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 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 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.
(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 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 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 agreement to the Agency.
(8) If a new safener is submitted in the same package as a new active ingredient, 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.
``TABLE 19. -- EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
FY'17 & FY'18
New CR Decision Review Time Registration
EPA No. No. Action (Months)(1) Service Fee
($)
----------------------------------------------------------------------------------------------------------------
M001 202 Study protocol requiring Human Studies 9 7,938
Review Board review as defined in 40
CFR Part 26 in support of an active
ingredient. (4)
----------------------------------------------------------------------------------------------------------------
M002 203 Completed study requiring Human 9 7,938
Studies Review Board review as
defined in 40 CFR Part 26 in support
of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------
M003 204 External technical peer review of new 12 63,945
active ingredient, product, or
amendment (e.g., consultation with
FIFRA Scientific Advisory Panel) for
an action with a decision timeframe
of less than 12 months. Applicant
initiated request based on a
requirement of the Administrator, as
defined by FIFRA Sec. 25(d), in
support of a novel active ingredient,
or unique use pattern or application
technology. Excludes PIP active
ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M004 205 External technical peer review of new 18 63,945
active ingredient, product, or
amendment (e.g., consultation with
FIFRA Scientific Advisory Panel) for
an action with a decision timeframe
of greater than 12 months. Applicant
initiated request based on a
requirement of the Administrator, as
defined by FIFRA Sec. 25(d), in
support of a novel active ingredient,
or unique use pattern or application
technology. Excludes PIP active
ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M005 206 New Product: Combination, Contains a 9 22,050
combination of active ingredients
from a registered and/or unregistered
source; conventional, antimicrobial
and/or biopesticide. Requires
coordination with other regulatory
divisions to conduct review of data,
label and/or verify the validity of
existing data as cited. Only existing
uses for each active ingredient in
the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
M006 207 Request for up to 5 letters of 1 277
certification (Gold Seal) for one
actively registered product (excludes
distributor products). (8)
----------------------------------------------------------------------------------------------------------------
M007 208 Request to extend Exclusive Use of 12 5,513
data as provided by FIFRA Section
3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------
M008 209 Request to grant Exclusive Use of data 15 1,654
as provided by FIFRA Section
3(c)(1)(F)(vi) for a minor use, when
a FIFRA Section 2(ll)(2)
determination is required.
----------------------------------------------------------------------------------------------------------------
M009 210 (new) Non-FIFRA Regulated Determination: 4 2,363
Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
M010 211 (new) Conditional ruling on pre-application, 4 2,363
product substantial similarity.
----------------------------------------------------------------------------------------------------------------
[[Page H2207]]
M011 212 (new) Label amendment to add the DfE logo; 4 3,648
requires data review; no other label
changes. (9)
----------------------------------------------------------------------------------------------------------------
(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 application to approve an inert ingredient,
each application will be subject to its respective registration service fee. The decision review time line for
both submissions will be the longest of the associated applications. If the application covers multiple
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 ingredient 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.
(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 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 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.
(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 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 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 agreement 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.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Illinois (Mr. Rodney Davis) and the gentleman from California (Mr.
Panetta) each will control 20 minutes.
The Chair recognizes the gentleman from Illinois.
General Leave
Mr. RODNEY DAVIS of Illinois. Madam Speaker, I ask unanimous consent
that all Members may have 5 legislative days within which to revise and
extend their remarks and include extraneous material on the bill under
consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Illinois?
There was no objection.
Mr. RODNEY DAVIS of Illinois. Madam Speaker, I yield myself such time
as I may consume.
Madam Speaker, and the gentleman from California (Mr. Panetta), my
good friend and colleague, I rise in strong support as the author of
H.R. 1029, the Pesticide Registration Enhancement Act of 2017, also
known as PRIA. It is not every day in Washington that we see a
bipartisan bill come to the House floor that is supported by both
industry and industry advocates, but PRIA is that bill, Madam Speaker.
PRIA initially passed in 2003, establishing a new section of the
Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, which
put in place a fee schedule for registering pesticides with the EPA.
More specifically, PRIA constructed time frames for when the EPA was
required to make a determination on pesticide registrations. The goal
of PRIA was to create a more predictable and effective evaluation
process for pesticide decisionmaking by coupling the collection of fees
with specific decision review periods. It also promoted shorter
decision review periods for reduced-risk pesticides.
The nature of PRIA is very technical, but the widespread benefits
across industries has gained it consistent bipartisan support. PRIA is
backed by a broad coalition comprised of the companies that rely on the
registration process and also labor and environmental advocates. Each
member of this broad coalition had a seat at the table when the
Committee on Agriculture held a roundtable discussing the merits of the
bill last month before it passed unanimously out of our House Committee
on Agriculture.
This reauthorization bill that we are considering also provides a few
modifications, including reasonable increases in registration fees,
funding for good laboratory practices, and added efforts to promote
transparency. Although it has generally been a 5-year authorization,
this bill would extend PRIA for 7 years. A lengthened reauthorization,
we believe, is appropriate because PRIA has been proven effective, it
has enjoyed widespread, bipartisan support, and to date each
reauthorization has only involved minor adjustments.
PRIA expires on September 30 of this year, and I am glad to be
presenting this bill well in advance of that expiration date because we
need to provide folks with the certainty they need to conduct their
business, educate farmworkers, and keep the communication with EPA open
and transparent. This is the fourth time PRIA has come before Congress
for reauthorization, and that is because it is working for everyone. It
has always been a bipartisan effort, and we hope to continue that
tradition. I urge my colleagues to join me in supporting this
commonsense reauthorization.
Madam Speaker, I reserve the balance of my time.
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, March 16, 2017.
Hon. K. Michael Conaway,
Chairman, Committee on Agriculture,
Washington, DC.
Dear Chairman Conaway: I write in regard to H.R. 1029,
Pesticide Registration Enhancement Act of 2017, which was
referred in addition to the Committee on Energy and Commerce.
I wanted to notify you that the Committee will forgo action
on the bill so that it may proceed expeditiously to the House
floor for consideration.
The Committee on Energy and Commerce takes this action with
our mutual understanding that by foregoing consideration of
H.R. 1029, the Committee does not waive any jurisdiction over
the subject matter contained in this or similar legislation
and will be appropriately consulted and involved as this or
similar legislation moves forward to address any remaining
issues within the Committee's jurisdiction. The Committee
also reserves the right to seek appointment of an appropriate
number of conferees to any House-Senate conference involving
this or similar legislation and asks that you support any
such request.
I would appreciate your response confirming this
understanding with respect to H.R. 1029 and ask that a copy
of our exchange of letters on this matter be included in your
committee's report on the legislation or the Congressional
Record during its consideration on the House floor.
Sincerely,
Greg Walden,
Chairman.
____
House of Representatives,
Committee on Agriculture,
Washington, DC, March 16, 2017.
Greg Walden,
Committee on Energy and Commerce,
Washington, DC.
Dear Chairman Walden: Thank you for your letter regarding
H.R. 1029, the ``Pesticide Registration Enhancement Act of
2017.'' I appreciate your support in bringing this
legislation before the House of Representatives, and
accordingly, understand that the Committee on Energy and
Commerce will forego action on the bill.
The Committee on Agriculture concurs in the mutual
understanding that by foregoing consideration of the bill at
this time, the Committee on Energy and Commerce does not
waive any jurisdiction over the subject matter contained in
this bill or similar legislation in the future. In addition,
should a conference on this bill be necessary, I would
support your request to have the Committee on Energy and
Commerce represented on the conference committee.
[[Page H2208]]
I will insert copies of this exchange in the Congressional
Record during Floor consideration. I appreciate your
cooperation regarding this legislation and look forward to
continuing to work the Committee on Energy and Commerce as
this bill moves through the legislative process.
Sincerely,
K. Michael Conaway,
Chairman.
Mr. PANETTA. Madam Speaker, I yield myself such time as I may
consume. I rise in support of H.R. 1029, the Pesticide Registration
Enhancement Act of 2017.
Once again, Madam Speaker, I stand before you to urge the passage of
H.R. 1029. As we know, the Environmental Protection Agency is
responsible for regulating the sale, use, and distribution of
pesticides. To facilitate and expedite that pesticide approval process,
pesticide manufacturers have long supplemented the EPA's annual budget.
This system allows the products to be reviewed in a timely manner,
without sacrificing environmental and safety protections. It is truly a
win-win for both manufacturers and consumers, and, as you heard Mr.
Davis speak about, it is a clear example of government at its best. It
is exactly why I enjoy working on the Committee on Agriculture. It is
exactly why I enjoy working with people such as Rodney Davis. We have a
bipartisan, effective, public-private legislative solution for a more
predictable pesticide evaluation process that literally helps
everybody.
The Pesticide Registration Enhancement Act, H.R. 1029, is an
exceptional piece of legislation not only because it is supported by a
unique coalition of pesticide registrants, environmental groups, and
agricultural labor representatives, but H.R. 1029 provides a more
effective, predictable, and transparent pesticide evaluation process.
It promotes shorter review periods for reduced-risk pesticides and
enhances scientific and regulatory activities related to farmworker
protection.
My district on the central coast of California is not only bountiful
in its agriculture, it is absolutely beautiful with its environment.
Therefore, we on the central coast work hard to find that balance of
being known as the salad bowl of the world and one of the most scenic
places in the world. That is why our agriculture producers are the most
thoughtful stewards of the land and recognize the need to protect the
environment and the natural resources.
This legislation facilitates that balance. This legislation provides
a unique coalition building and encourages the agriculture industry to
work with environmentalists. Thus, H.R. 1029 helps all of us who live
and work in our community and, ultimately, our country. That is why I
am absolutely honored to speak in this debate, humbled to share the
floor with Representative Davis, and why I urge all my colleagues to
support this bill.
Madam Speaker, I yield back the balance of my time.
Mr. RODNEY DAVIS of Illinois. Madam Speaker, I yield myself the
balance of my time.
Madam Speaker, this is exactly why we are here today in a bipartisan
way. The gentleman from California (Mr. Panetta) said it right: this
affects his industry, and it affects his home area. As he likes to say,
it is the salad bowl of America. I have been there, and I have seen the
crops they grow. The crops I grow are much different in central
Illinois, the crops that are grown by the farmers that I am proud to
represent, but they all have to have a successful PRIA reauthorization
to be able to grow those foods that we here in America continue to feed
the world with and that we see in our grocery stores and on our
supermarket shelves.
Madam Speaker, I want to say thank you because this bill is
essential, as we in central Illinois go out and take care of things
such as making sure the weeds don't pop up in our yards. Every single
small business that decides to put down product and pesticides to
ensure that lawns in central Illinois continue to prosper as the spring
and summer unfold, this is essential to their success.
This is essential to our farmers, who are looking to get their fields
ready to go plant, the stewards of the land, the best stewards of the
land, as Congressman Panetta said. It assures them that they are going
to be able to get that seed into the ground and, with the hope and
prayers of rain and moisture, that it is going to grow and that we are
still going to have a marketplace for those products.
The risk that our farmers take every single year, when they risk and
leverage their family incomes in many cases, in hopes that a seed is
going to grow and a plant is going to grow, and they are going to be
able to sell that, they need the certainty that this bill will actually
give them. That is why I am proud to be here as the author, proud to
stand with my colleagues.
Madam Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Illinois (Mr. Rodney Davis) that the House suspend the
rules and pass the bill, H.R. 1029, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________