[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 483 Enrolled Bill (ENR)]
S.483
One Hundred Sixteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and nineteen
An Act
To enact into law a bill by reference.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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(a) Short Title.--This Act may be cited as the ``Pesticide
Registration Improvement Extension Act of 2018''.
(b) Table of Contents.--The table of contents for this Act is as
follows:

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applications and other covered actions and their corresponding
registration service fees.

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(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 2019 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 2019 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 2019 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 2019 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 2019 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 ``the date of enactment of this section and
ending on September 30, 2019'' and inserting ``the effective date
of the Pesticide Registration Improvement Extension Act of 2018 and
ending on 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''.

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(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 period at the end of 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
2018 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 2018 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) 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, or 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 30 days after the effective date of the
Pesticide Registration Improvement Extension Act of 2018.
``(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, 2019.
``(iii) With respect to pests specified in clauses
(iii) and (iv) of such subparagraph--
``(I) submit draft guidance to the Scientific
Advisory Panel and for public comment 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.--
``(A) Set-aside.--For each of fiscal years 2018 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)''.

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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''.

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(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 applications''; 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'' each place it 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 Improvement
Extension Act of 2018''; 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)) is
amended--
(1) in paragraph (1)--
(A) by striking ``Pesticide Registration Improvement
Extension Act of 2012'' and inserting ``Pesticide Registration
Improvement Extension Act of 2018''; 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 invertebrate public
health pests that may transmit vector-borne disease 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);
``(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''.

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Pesticide Registration Improvement Extension Act of 2018 — S. 483

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