Attachment E -- Pesticide Registration Enhancement Act of 2018 (PRIA 4)

PUBLIC LAW 116–8—MAR. 8, 2019

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PESTICIDE REGISTRATION IMPROVEMENT
EXTENSION ACT OF 2018

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133 STAT. 484

PUBLIC LAW 116–8—MAR. 8, 2019

Public Law 116–8
116th Congress
An Act
Mar. 8, 2019
[S. 483]
Pesticide
Registration
Improvement
Extension Act
of 2018.
7 USC 136 note.

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,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(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:
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

1.
2.
3.
4.
5.
6.

Short title; table of contents.
Extension and modification of maintenance fee authority.
Reregistration and Expedited Processing Fund.
Experimental use permits for pesticides.
Pesticide registration service fees.
Revision of tables regarding covered pesticide registration applications and
other covered actions and their corresponding registration service fees.
Sec. 7. Agricultural worker protection standard; certification of pesticide applicators.

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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 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.’’.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 485

(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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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 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.—

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133 STAT. 486

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘(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

Evaluation.

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

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Publication.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 487

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)’’.

Deadline.

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’’.

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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)—

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133 STAT. 488

PUBLIC LAW 116–8—MAR. 8, 2019
(A) in the heading, by striking ‘‘PESTICIDE REGISTRAand inserting ‘‘COVERED APPLICATIONS’’;

TION APPLICATIONS’’

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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—

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 489

(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—

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133 STAT. 490

‘‘(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

Reviews.

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Evaluation.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 491

‘‘(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’’.

Summary.

SEC. 6. REVISION OF TABLES REGARDING COVERED PESTICIDE REGISTRATION APPLICATIONS AND OTHER COVERED ACTIONS
AND THEIR CORRESPONDING REGISTRATION SERVICE FEES.

Extension.
Notification.
Time period.
Deadline.

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

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R010

1

New Active Ingredient, Food
use. (2)(3)

24

753,082

R020

2

New Active Ingredient, Food
use; reduced
risk. (2)(3)

18

627,568

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133 STAT. 492

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE
INGREDIENTS—Continued

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EPA
No.

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06:03 Sep 30, 2019

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R040

3

New Active Ingredient, Food
use; Experimental Use
Permit application; establish temporary
tolerance; submitted before
application for
registration;
credit 45% of
fee toward
new active ingredient application that follows. (3)

18

462,502

R060

4

New Active Ingredient, Nonfood use; outdoor. (2)(3)

21

523,205

R070

5

New Active Ingredient, Nonfood use; outdoor; reduced
risk. (2)(3)

16

436,004

R090

6

New Active Ingredient, Nonfood use; outdoor; Experimental Use
Permit application; submitted before
application for
registration;
credit 45% of
fee toward
new active ingredient application that follows. (3)

16

323,690

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 493

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE
INGREDIENTS—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R110

7

New Active Ingredient, Nonfood use; indoor. (2)(3)

20

290,994

R120

8

New Active Ingredient, Nonfood use; indoor; reduced
risk. (2)(3)

14

242,495

R121

9

New Active Ingredient, Nonfood use; indoor; Experimental Use
Permit application; submitted before
application for
registration;
credit 45% of
fee toward
new active ingredient application that follows. (3)

18

182,327

R122

10

Enriched isomer(s) of registered mixedisomer active
ingredient.
(2)(3)

18

317,128

R123

11

New Active Ingredient, Seed
treatment
only; includes
agricultural
and non-agricultural seeds;
residues not
expected in
raw agricultural commodities. (2)(3)

18

471,861

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133 STAT. 494

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE
INGREDIENTS—Continued
EPA
No.
R125

New
CR
No.
12

Decision
Review
Time
(Months)(1)

Action

New Active Ingredient, Seed
treatment; Experimental
Use Permit
application;
submitted before application for registration; credit 45% of fee
toward new
active ingredient application that follows. (3)

16

Registration
Service Fee
($)
323,690

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 495

(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

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R130

13

First food use;
indoor; food/
food handling.
(2) (3)

21

191,444

R140

14

Additional food
use; Indoor;
food/food handling. (3) (4)

15

44,672

R150

15

First food use.
(2)(3)

21

317,104

R155

16 (new)

First food use,
Experimental
Use Permit
application;
a.i. registered
for non-food
outdoor use.
(3)(4)

21

264,253

R160

17

First food use;
reduced risk.
(2)(3)

16

264,253

R170

18

Additional food
use. (3) (4)

15

79,349

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133 STAT. 496

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES—
Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R175

19

Additional food
uses covered
within a crop
group resulting from the
conversion of
existing approved crop
group(s) to one
or more revised crop
groups. (3)(4)

10

66,124

R180

20

Additional food
use; reduced
risk. (3)(4)

10

66,124

R190

21

Additional food
uses; 6 or
more submitted in one
application.
(3)(4)

15

476,090

R200

22

Additional Food
Use; 6 or more
submitted in
one application; Reduced
Risk. (3)(4)

10

396,742

R210

23

Additional food
use; Experimental Use
Permit application; establish temporary
tolerance; no
credit toward
new use registration. (3)(4)

12

48,986

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 497

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES—
Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R220

24

Additional food
use; Experimental Use
Permit application; crop
destruct basis;
no credit toward new use
registration.
(3)(4)

6

19,838

R230

25

Additional use;
non-food; outdoor. (3) (4)

15

31,713

R240

26

Additional use;
non-food; outdoor; reduced
risk. (3)(4)

10

26,427

R250

27

Additional use;
non-food; outdoor; Experimental Use
Permit application; no
credit toward
new use registration. (3)(4)

6

19,838

R251

28

Experimental
Use Permit
application
which requires
no changes to
the tolerance(s); noncrop destruct
basis. (3)

8

19,838

R260

29

New use; nonfood; indoor.
(3) (4)

12

15,317

R270

30

New use; nonfood; indoor;
reduced risk.
(3)(4)

9

12,764

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133 STAT. 498

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES—
Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R271

31

New use; nonfood; indoor;
Experimental
Use Permit
application; no
credit toward
new use registration. (3)(4)

6

9,725

R273

32

Additional use;
seed treatment; 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)

12

50,445

R274

33

Additional uses;
seed treatment
only; 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 nonfood uses.
(3)(4)

12

302,663

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 499

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(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.

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133 STAT. 500

PUBLIC LAW 116–8—MAR. 8, 2019

(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

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R280

34

Establish import
tolerance; new
active ingredient or first
food use. (2)

21

319,072

R290

35

Establish Import
tolerance; Additional new
food use.

15

63,816

R291

36

Establish import
tolerances; additional food
uses; 6 or
more crops
submitted in
one petition.

15

382,886

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 501

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND
OTHER TOLERANCES—Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R292

37

Amend an established tolerance (e.g., decrease or increase) and/or
harmonize established tolerances with
Codex MRLs;
domestic or
import; applicant-initiated.

11

45,341

R293

38

Establish tolerance(s) for inadvertent residues in one
crop; applicant-initiated.

12

53,483

R294

39

Establish tolerances for inadvertent residues; 6 or
more crops
submitted in
one application; applicant-initiated.

12

320,894

R295

40

Establish tolerance(s) for residues in 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)

15

66,124

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133 STAT. 502

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND
OTHER TOLERANCES—Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R296

41

Establish tolerances for residues in 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)

15

396,742

R297

42

Amend 6 or
more established tolerances (e.g., decrease or increase) in one
petition; domestic or import; applicant-initiated.

11

272,037

R298

43

Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding
amended labels (requiring
science review). (3) (4)

13

58,565

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 503

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND
OTHER TOLERANCES—Continued
EPA
No.
R299

New
CR
No.
44

Decision
Review
Time
(Months)(1)

Action

Amend 6 or
more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding
amended labels (requiring
science review). (3) (4)

13

Registration
Service Fee
($)
285,261

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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133 STAT. 504

PUBLIC LAW 116–8—MAR. 8, 2019

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 505

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPA
No.

dkrause on DSKBC28HB2PROD with PUBLAWS

R300

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
45

Jkt 089139

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

4

1,582

New product; or
similar 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% repackage of registered end-use
or manufacturing-use
product that requires no data
submission nor
data matrix.
(2)(3)

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133 STAT. 506

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R301

VerDate Sep 11 2014

06:03 Sep 30, 2019

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New
CR
No.
46

Frm 00024

Action

New product; or
similar 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)

Fmt 6580

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

4

1,897

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 507

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

dkrause on DSKBC28HB2PROD with PUBLAWS

R310

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
47

Jkt 089139

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

7

7,301

New end-use or
manufacturinguse 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)

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133 STAT. 508

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R314

VerDate Sep 11 2014

06:03 Sep 30, 2019

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PO 00008

New
CR
No.
48

Frm 00026

Action

New end use
product containing up 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)

Fmt 6580

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

8

8,626

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 509

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R319

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
49

Jkt 089139

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

10

12,626

New end use
product containing up 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)

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133 STAT. 510

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R318

VerDate Sep 11 2014

06:03 Sep 30, 2019

Jkt 089139

PO 00008

New
CR
No.
50
(new)

Frm 00028

Action

New end use
product containing 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)

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

9

13,252

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 511

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R321

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
51
(new)

Jkt 089139

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

11

17,252

New end use
product containing 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)

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133 STAT. 512

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R315

VerDate Sep 11 2014

06:03 Sep 30, 2019

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New
CR
No.
52

Frm 00030

Action

New end-use, onanimal product,
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)

Fmt 6580

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

9

9,820

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 513

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

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R316

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
53
(new)

Jkt 089139

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

9

11,301

New end-use or
manufacturing
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)

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133 STAT. 514

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued

dkrause on DSKBC28HB2PROD with PUBLAWS

EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R317

54
(new)

New end-use or
manufacturing
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)

10

15,301

R320

55

New product; new
physical form;
requires data
review in
science divisions. (2)(3)

12

13,226

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 515

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R331

56

New product; repack of identical 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)

3

2,530

R332

57

New manufacturing-use
product; 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)

24

283,215

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133 STAT. 516

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS—
Continued
EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

R333

58

New product;
MUP or End
use 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)

10

19,838

R334

59

New product;
MUP or End
use product
with unregistered source of
the active ingredient; requires science
data review;
new physical
form; etc. Selective data citation. (2)(3)

11

23,100

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 517

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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133 STAT. 518

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R340

60

Amendment requiring data review
within RD (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)

4

4,988

R341

61
(New)

Amendment requiring data review
within RD (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)

6

5,988

R345

62

Amending on-animal
products previously 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)

7

8,820

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 519

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS—
Continued
EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R350

63

Amendment requiring data review in
science 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)

9

13,226

R351

64

Amendment adding
a new unregistered source of active ingredient.
(2)(3)

8

13,226

R352

65

Amendment adding
already approved
uses; selective
method of support;
does not apply if
the applicant owns
all cited data. (2)
(3)

8

13,226

R371

66

Amendment to Experimental Use
Permit; (does not
include extending
a permit’s time period). (3)

6

10,090

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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133 STAT. 520

PUBLIC LAW 116–8—MAR. 8, 2019

(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
EPA
No.

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R124

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CR
No.
67

Frm 00038

Decision
Review
Time
(Months)(1)

Action

Conditional Ruling on Pre-application Study
Waivers; applicant-initiated.

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Registration
Service Fee
($)
2,530

PUBL008

PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 521

‘‘TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS—
Continued
EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

R272

68

Review of Study
Protocol applicant-initiated;
excludes
DART, pre-registration conference, Rapid
Response review, DNT protocol review,
protocol needing HSRB review.

3

2,530

R275

69

Rebuttal of agency reviewed
protocol, applicant initiated.

3

2,530

R370

70

Cancer reassessment; applicant-initiated.

18

198,250

(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
EPA
No.

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A380

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
71

Jkt 089139

Decision
Review
Time
(Months)(1)

Action

New Active Ingredient; Indirect
Food use; establish tolerance or tolerance exemption
if required.
(2)(3)

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($)
137,841

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133 STAT. 522

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE
INGREDIENTS—Continued
EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

A390

72

New Active Ingredient; Direct
Food use; establish tolerance or tolerance exemption
if required.
(2)(3)

24

229,733

A410

73

New Active Ingredient Non-food
use.(2)(3)

21

229,733

A431

74

New Active Ingredient, Non-food
use; low-risk.
(2)(3)

12

80,225

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 523

(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.

dkrause on DSKBC28HB2PROD with PUBLAWS

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES

VerDate Sep 11 2014

Decision
Review
Time
(Months)(1)

EPA
No.

New
CR
No.

A440

75

New Use, Indirect
Food Use, establish tolerance or tolerance exemption.
(2)(3)(4)

21

31,910

A441

76

Additional Indirect food uses;
establish tolerances or tolerance exemptions
if required; 6 or
more submitted
in one application. (3)(4)(5)

21

114,870

A450

77

New use, Direct
food use, establish tolerance or
tolerance exemption.
(2)(3)(4)

21

95,724

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133 STAT. 524

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES—
Continued
Decision
Review
Time
(Months)(1)

EPA
No.

New
CR
No.

A451

78

Additional Direct
food uses; establish tolerances
or tolerance exemptions if required; 6 or
more submitted
in one application. (3)(4)(5)

21

182,335

A500

79

New use, nonfood. (4)(5)

12

31,910

A501

80

New use, nonfood; 6 or more
submitted in
one application.
(4)(5)

15

76,583

Action

Registration
Service Fee
($)

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 525

dkrause on DSKBC28HB2PROD with PUBLAWS

(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.

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133 STAT. 526

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS
AND AMENDMENTS
EPA
No.

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A530

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New
CR
No.
81

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Action

New product,
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 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)

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Review
Time
(Months)(1)

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Service Fee
($)

4

1,278

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 527

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS
AND AMENDMENTS—Continued
EPA
No.

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A531

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New
CR
No.
82

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Action

New product;
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,
where applicant does not
own all required data
and does not
have a specific
authorization
letter from
data owner.
(2)(3)

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Time
(Months)(1)

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Service Fee
($)

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133 STAT. 528

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS
AND AMENDMENTS—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A532

83

New product;
identical or
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)

5

5,107

A540

84

New end use
product;
FIFRA
§2(mm) uses
only; up to 25
public health
organisms.
(2)(3)(5)(6)

5

5,107

A541

85 (new)

New end use
product;
FIFRA
§2(mm) uses
only; 26–50
public health
organisms.
(2)(3)(5)(6)

7

8,500

A542

86 (new)

New end use
product;
FIFRA
§2(mm) uses
only; ≥ 51 public health organisms.
(2)(3)(5)

10

15,000

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 529

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS
AND AMENDMENTS—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A550

87

New end-use
product; uses
other than
FIFRA
§2(mm); nonFQPA product.
(2)(3)(5)

9

13,226

A560

88

New manufacturing use
product; registered active
ingredient; selective data citation. (2)(3)

6

12,596

A565

89 (new)

New manufacturing-use
product; registered active
ingredient; unregistered
source of active ingredient; submission of new generic data
package; registered uses
only; requires
science review.
(2)(3)

12

18,234

A570

90

Label amendment requiring data review; up to 25
public health
organisms.
(3)(4)(5)(6)

4

3,831

A573

91 (new)

Label amendment requiring data review; 26–50
public health
organisms.
(2)(3)(5)(7)

6

6,350

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133 STAT. 530

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS
AND AMENDMENTS—Continued
EPA
No.

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

Label amendment requiring data review; ≥ 51
public health
organisms.
(2)(3)(5)(7)

9

11,000

New Product or
amendment
requiring data
review for risk
assessment by
Science
Branch (e.g.,
changes to
REI, or PPE,
or use rate).
(2)(3)(4)

9

13,226

New
CR
No.

A574

92 (new)

A572

93

Action

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(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 531

(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 of 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 of 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
EPA
No.

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A520

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CR
No.
94

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Action

Experimental
Use Permit
application,
non-food use.
(2)

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

9

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133 STAT. 532

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A521

95

Review of public
health efficacy
study 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.

4

4,726

A522

96

Review of public
health efficacy
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.

12

12,156

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 533

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A537

97 (new)

New Active Ingredient/New
Use, 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.

18

153,156

A538

98 (new)

New Active Ingredient/New
Use, 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.

18

95,724

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133 STAT. 534

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A539

99 (new)

New Active Ingredient/New
Use, Experimental Use
Permit application;
Nonfood use.
Credit 45% of
fee toward
new active ingredient/new
use application that follows.

15

92,163

A529

100

Amendment to
Experimental
Use Permit;
requires data
review or risk
assessment.
(2)

9

11,429

A523

101

Review of protocol other
than a public
health efficacy
study (i.e.,
Toxicology or
Exposure Protocols).

9

12,156

A571

102

Science reassessment: Cancer
risk, refined
ecological risk,
and/or endangered species;
applicant-initiated.

18

95,724

A533

103
(new)

Exemption from
the requirement of an Experimental
Use Permit.
(2)

4

2,482

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 535

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS—Continued
EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

A534

104
(new)

Rebuttal of
agency reviewed protocol, applicant initiated.

4

4,726

A535

105
(new)

Conditional Ruling on Pre-application
Study Waiver
or Data Bridging Argument;
applicant-initiated.

6

2,409

A536

106
(new)

Conditional Ruling on Pre-application Direct Food, Indirect Food,
Nonfood use
determination;
applicant-initiated.

4

2,482

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(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.

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133 STAT. 536

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE
INGREDIENTS

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B580

107

New active ingredient; food
use; petition
to establish a
tolerance.
(2)(3)

20

51,053

B590

108

New active ingredient; food
use; petition
to establish a
tolerance exemption. (2)(3)

18

31,910

B600

109

New active ingredient; nonfood use. (2)(3)

13

19,146

B610

110

New active ingredient; Experimental
Use Permit
application;
petition to establish a temporary tolerance or temporary tolerance exemption. (3)

10

12,764

B611

111

New active ingredient; Experimental
Use Permit
application;
petition to establish permanent tolerance
exemption. (3)

12

12,764

B612

112

New active ingredient; no
change to a
permanent tolerance exemption. (2)(3)

10

17,550

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 537

‘‘TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE
INGREDIENTS—Continued

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EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B613

113

New active ingredient; petition to convert
a temporary
tolerance or a
temporary tolerance exemption to a permanent tolerance or tolerance exemption. (2)(3)

11

17,550

B620

114

New active ingredient; Experimental
Use Permit
application;
non-food use
including crop
destruct. (3)

7

6,383

(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.

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133 STAT. 538

PUBLIC LAW 116–8—MAR. 8, 2019

(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

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B630

115

First food use;
petition to establish a tolerance exemption. (2)(4)

13

12,764

B631

116

New food use;
petition to
amend an established tolerance. (3)(4)

12

12,764

B640

117

First food use;
petition to establish a tolerance. (2)(4)

19

19,146

B643

118

New Food use;
petition to
amend an established tolerance exemption. (3)(4)

10

12,764

B642

119

First food use;
indoor; food/
food handling.
(2)(4)

12

31,910

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 539

‘‘TABLE 12. — BIOPESTICIDES DIVISION — NEW USES—
Continued
EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B644

120

New use, no
change to an
established
tolerance or
tolerance exemption. (3)(4)

8

12,764

B650

121

New use; nonfood. (3)(4)

7

6,383

B645

122
(new)

New food use;
Experimental
Use Permit
application;
petition to
amend or add
a tolerance exemption. (4)

12

12,764

B646

123
(new)

New use; nonfood use including crop
destruct; Experimental
Use Permit
application. (4)

7

6,383

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(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.

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133 STAT. 540

PUBLIC LAW 116–8—MAR. 8, 2019

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(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 541

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(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.

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133 STAT. 542

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW PRODUCTS
EPA
No.

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B652

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New
CR
No.
124

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Decision
Review
Time
(Months)(1)

Action

New product; registered source
of active 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 scientificallysound 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 scientificallysound rationale
explaining why
the data requirement does
not apply. (2)(3)

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Service Fee
($)
12,764

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 543

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.

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B660

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New
CR
No.
125

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Decision
Review
Time
(Months)(1)

Action

New product; registered source
of active 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)

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133 STAT. 544

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.

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B670

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CR
No.
126

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Decision
Review
Time
(Months)(1)

Action

New product; registered source
of 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 scientificallysound 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 scientificallysound rationale
explaining why
the data requirement does
not apply. (2)(3)

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 545

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.

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B671

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New
CR
No.
127

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Decision
Review
Time
(Months)(1)

Action

New product; unregistered
source of 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 scientificallysound 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 scientificallysound rationale
explaining why
the data requirement does
not apply. (2)(3)

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133 STAT. 546

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.

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B672

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CR
No.
128

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Decision
Review
Time
(Months)(1)

Action

New product; unregistered
source of 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 scientificallysound 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 scientificallysound rationale
explaining why
the data requirement does
not apply. (2)(3)

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($)
9,118

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 547

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued

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EPA
No.

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New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B673

129

New product
MUP/EP; unregistered
source 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)

10

5,107

B674

130

New product
MUP; Repack of
identical registered end-use
product as a
manufacturinguse product;
same registered
uses only. (2)(3)

4

1,278

B675

131

New Product
MUP; registered source
of active ingredient; submission of completely new generic data package; registered
uses only. (2)(3)

10

9,118

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133 STAT. 548

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.

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B676

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CR
No.
132

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Decision
Review
Time
(Months)(1)

Action

New product;
more than one
active 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 scientificallysound 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 scientificallysound rationale
explaining why
the data requirement does
not apply. (2)(3)

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9,118

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 549

‘‘TABLE 13. — BIOPESTICIDES DIVISION — NEW
PRODUCTS—Continued
EPA
No.
B677

New
CR
No.
133

Decision
Review
Time
(Months)(1)

Action

New end-use nonfood animal
product with
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)

10

Registration
Service Fee
($)
8,820

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(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.

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133 STAT. 550

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS

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EPA
No.

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06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service
Fee
($)

B621

134

Amendment; Experimental Use Permit;
no change to an established temporary
tolerance or tolerance
exemption. (3)

7

5,107

B622

135

Amendment; Experimental Use Permit;
petition to amend an
established or temporary tolerance or
tolerance exemption.
(3)

11

12,764

B641

136

Amendment of an established tolerance or tolerance exemption.

13

12,764

B680

137

Amendment; registered
sources of active ingredient(s); no new
use(s); no changes to
an established tolerance or tolerance exemption. Requires
data submission.
(2)(3)

5

5,107

B681

138

Amendment; unregistered source of active
ingredient(s). Requires data submission. (2)(3)

7

6,079

B683

139

Label amendment; requires review/update
of previous risk assessment(s) without
data submission (e.g.,
labeling changes to
REI, PPE, PHI). (2)(3)

6

5,107

B684

140

Amending non-food animal product that includes submission of
target animal safety
data; previously registered. (2)(3)

8

8,820

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 551

‘‘TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS—
Continued

EPA
No.

B685

New
CR
No.
141
(new)

Action

Amendment; add a new
biochemical unregistered source of active
ingredient or a new
microbial production
site. Requires submission of analysis of
samples data and
source/production sitespecific manufacturing process description. (3)

Decision
Review
Time
(Months)(1)

Registration
Service
Fee
($)

5

5,107

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(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.

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133 STAT. 552

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B690

142

New active ingredient; food
or non-food
use. (2)(6)

7

2,554

B700

143

Experimental
Use Permit
application;
new active ingredient or
new use. (6)

7

1,278

B701

144

Extend or
amend Experimental Use
Permit. (6)

4

1,278

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 553

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP—Continued
EPA
No.

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B710

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06:03 Sep 30, 2019

New
CR
No.
145

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Decision
Review
Time
(Months)(1)

Action

New product;
registered
source of 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)

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133 STAT. 554

PUBLIC LAW 116–8—MAR. 8, 2019

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP—Continued
EPA
No.

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B720

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New
CR
No.
146

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Decision
Review
Time
(Months)(1)

Action

New product;
registered
source of 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
scientificallysound 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
scientificallysound rationale explaining
why the data
requirement
does not
apply. (3)(6)

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($)
1,278

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 555

‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP—Continued
EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B721

147

New product;
unregistered
source of active ingredient. (3)(6)

7

2,676

B722

148

New use and/or
amendment;
petition to establish a tolerance or tolerance exemption. (4)(5)(6)

7

2,477

B730

149

Label amendment requiring data submission. (4)(6)

5

1,278

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(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.

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133 STAT. 556

PUBLIC LAW 116–8—MAR. 8, 2019

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(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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 557

‘‘TABLE 16. — BIOPESTICIDES DIVISION — OTHER ACTIONS
EPA
No.

New
CR
No.

Decision
Review
Time
(Months)(1)

Action

Registration
Service Fee
($)

B614

150

Pre-application;
Conditional
Ruling on rationales for
addressing a
data requirement in lieu of
data; applicant-initiated;
applies to one
rationale at a
time.

3

2,530

B615

151

Rebuttal of
agency reviewed protocol, applicant initiated.

3

2,530

B682

152

Protocol review;
applicant initiated; excludes
time for HSRB
review.

3

2,432

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(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.

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133 STAT. 558

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP
EPA
No.
B740

New
CR
No.
153

Action

Experimental Use
Permit application; no petition
for tolerance/tolerance exemption. Includes:

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

6

95,724

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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)

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 559

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued
EPA
No.
B741

New
CR
No.
154
(new)

Action

Experimental Use
Permit application; no petition
for tolerance/tolerance exemption. Includes:

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

12

159,538

9

127,630

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)

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B750

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06:03 Sep 30, 2019

155

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Experimental Use
Permit application; with a 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)

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133 STAT. 560

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B770

156

Experimental Use
Permit application; new (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)

15

191,444

B771

157

Experimental Use
Permit application; new (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)

10

127,630

B772

158

Application to
amend or extend
an Experimental
Use Permit; no
petition since the
established tolerance/tolerance
exemption for
the active ingredient is unaffected. (12)

3

12,764

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 561

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B773

159

Application to
amend or extend
an Experimental
Use Permit; with
petition to extend a temporary
tolerance/tolerance exemption
for the active ingredient. (12)

5

31,910

B780

160

Registration application; new (2)
PIP; non-food/
feed. (12)

12

159,537

B790

161

Registration application; new (2)
PIP; non-food/
feed; SAP review.
(5)(12)

18

223,351

B800

162

Registration application; new (2)
PIP; with petition to establish
permanent tolerance/tolerance
exemption for
the active ingredient based on
an existing temporary tolerance/
tolerance exemption. (12)

13

172,300

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133 STAT. 562

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B810

163

Registration application; new (2)
PIP; with petition to establish
permanent tolerance/tolerance
exemption for
the active ingredient based on
an existing temporary tolerance/
tolerance exemption. SAP review.
(5)(12)

19

236,114

B820

164

Registration application; new (2)
PIP; with petition to establish
or amend a permanent tolerance/tolerance
exemption of an
active ingredient.
(12)

15

204,208

B840

165

Registration application; new (2)
PIP; with petition to establish
or amend a permanent tolerance/tolerance
exemption of an
active ingredient.
SAP review.
(5)(12)

21

268,022

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 563

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B851

166

Registration application; new event
of a previously
registered PIP
active ingredient(s); no petition since permanent tolerance/
tolerance exemption is already
established for
the active ingredient(s). (12)

9

127,630

B870

167

Registration application; registered
(3) PIP; new
product; new use;
no petition since
a permanent tolerance/tolerance
exemption is already established
for the active ingredient(s). (4)
(12)

9

38,290

B880

168

Registration application; registered
(3) 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)

9

31,910

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133 STAT. 564

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B881

169

Registration application; registered
(3) 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)

15

95,724

B882

170
(new)

Registration application; new (2)
PIP, seed increase with negotiated acreage
cap and timelimited 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)

15

191,444

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 565

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B883

171

Registration application; new (2)
PIP, seed increase with negotiated acreage
cap and timelimited registration; with petition to establish
a permanent tolerance/tolerance
exemption for
the active ingredient based on
an existing temporary tolerance/
tolerance exemption. (8) (12)

9

127,630

B884

172

Registration application; new (2)
PIP, seed increase with negotiated acreage
cap and timelimited registration; with petition to establish
a permanent tolerance/tolerance
exemption for
the active ingredient. (8)(12)

12

159,537

B885

173

Registration application; registered
(3) 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)

6

31,910

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133 STAT. 566

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B886

174
(new)

Registration application; new (2)
PIP, seed increase with negotiated acreage
cap and timelimited registration; with petition to establish
a permanent tolerance/tolerance
exemption for
the active ingredient. SAP Review. (8) (12)

18

223,351

B890

175

Application to
amend a seed increase registration; converts
registration to
commercial registration; no petition since permanent tolerance/
tolerance exemption is already
established for
the active ingredient(s). (12)

9

63,816

B891

176

Application to
amend a seed increase 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)

15

127,630

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 567

‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B900

177

Application to
amend a registration, including actions such
as extending an
expiration date,
modifying an
IRM plan, or
adding an insect
to be controlled.
(10)(11)(12)

6

12,764

B901

178

Application to
amend a registration, including actions such
as extending an
expiration date,
modifying an
IRM plan, or
adding an insect
to be controlled.
SAP review. (10)
(11) (12)

12

76,578

B902

179

PIP Protocol review.

3

6,383

B903

180

Inert ingredient
tolerance exemption; e.g., a
marker such as
NPT II; reviewed
in BPPD.

6

63,816

B904

181

Import tolerance or
tolerance exemption; processed
commodities/food
only (inert or active ingredient).

9

127,630

B905

182
(new)

SAP Review.

6

63,816

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133 STAT. 568

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 17. — BIOPESTICIDES DIVISION — PIP—Continued

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EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

B906

183
(new)

Petition to establish a temporary
tolerance/tolerance exemption
for one or more
active ingredients.

3

31,907

B907

184
(new)

Petition to establish a temporary
tolerance/tolerance exemption
for one or more
active ingredients based on an
existing temporary tolerance/
tolerance exemption.

3

12,764

B908

185
(new)

Petition to establish a temporary
tolerance/tolerance exemption
for one or more
active ingredients or inert ingredients.

3

44,671

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently
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).

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 569

(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

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

I001

186

Approval of new
food use inert
ingredient.
(2)(3)

13

27,000

I002

187

Amend currently
approved inert
ingredient tolerance or exemption from
tolerance; new
data. (2)

11

7,500

I003

188

Amend currently
approved inert
ingredient tolerance or exemption from
tolerance; no
new data. (2)

9

3,308

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133 STAT. 570

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 18. — INERT INGREDIENTS—Continued

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EPA
No.

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

I004

189

Approval of new
non-food use
inert ingredient. (2)

6

11,025

I005

190

Amend currently
approved nonfood use inert
ingredient with
new use pattern; new data.
(2)

6

5,513

I006

191

Amend currently
approved nonfood use inert
ingredient with
new use pattern; no new
data. (2)

3

3,308

I007

192

Approval of substantially similar non-food
use inert ingredients when
original inert is
compositionally
similar with
similar use
pattern. (2)

4

1,654

I008

193

Approval of new
or amended
polymer inert
ingredient, food
use. (2)

5

3,749

I009

194

Approval of new
or amended
polymer inert
ingredient,
non-food use.
(2)

4

3,087

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 571

‘‘TABLE 18. — INERT INGREDIENTS—Continued

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

I010

195

Petition to amend
a single tolerance exemption
descriptor, or
single non-food
use descriptor,
to add ≤ 10
CASRNs; no
new data. (2)

6

1,654

I011

196
(new)

Approval of new
food use
safener with
tolerance or exemption from
tolerance. (2)(8)

24

597,683

I012

197
(new)

Approval of new
non-food use
safener. (2)(8)

21

415,241

I013

198
(new)

Approval of additional food use
for previously
approved
safener with
tolerance or exemption from
tolerance. (2)

15

62,975

I014

199
(new)

Approval of additional non-food
use for previously approved safener.
(2)

15

25,168

I015

200
(new)

Approval of new
generic data for
previously approved food use
safener. (2)

24

269,728

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133 STAT. 572

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 18. — INERT INGREDIENTS—Continued
EPA
No.

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I016

New
CR
No.
201
(new)

Action

Approval of
amendment(s)
to tolerance
and label for
previously approved safener.
(2)

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

13

55,776

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) If another covered application is submitted that depends upon an 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.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 573

(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

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EPA
No.

VerDate Sep 11 2014

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

M001

202

Study protocol
requiring
Human Studies Review
Board review
as defined in
40 CFR Part
26 in support
of an active
ingredient. (4)

9

7,938

M002

203

Completed study
requiring
Human Studies Review
Board review
as defined in
40 CFR Part
26 in support
of an active
ingredient. (4)

9

7,938

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133 STAT. 574

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS
ACTIONS—Continued
EPA
No.

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M003

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06:03 Sep 30, 2019

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CR
No.
204

Frm 00092

Action

External technical peer review of new
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 § 25(d),
in support of a
novel active
ingredient, or
unique use
pattern or application technology. Excludes PIP active ingredients. (5)

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Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

12

63,945

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 575

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS
ACTIONS—Continued
EPA
No.

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M004

VerDate Sep 11 2014

06:03 Sep 30, 2019

New
CR
No.
205

Jkt 089139

Action

External technical peer review of new
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 § 25(d),
in support of a
novel active
ingredient, or
unique use
pattern or application technology. Excludes PIP active ingredients. (5)

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Review
Time
(Months)(1)

Registration
Service Fee
($)

18

63,945

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133 STAT. 576

PUBLIC LAW 116–8—MAR. 8, 2019
‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS
ACTIONS—Continued

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EPA
No.

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New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

M005

206

New Product:
Combination,
Contains a
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)

9

22,050

M006

207

Request for up
to 5 letters of
certification
(Gold Seal) for
one actively
registered
product (excludes distributor products). (8)

1

277

M007

208

Request to extend Exclusive
Use of data as
provided by
FIFRA Section
3(c)(1)(F)(ii).

12

5,513

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 577

‘‘TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS
ACTIONS—Continued

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EPA
No.

New
CR
No.

Action

Decision
Review
Time
(Months)(1)

Registration
Service Fee
($)

M008

209

Request to grant
Exclusive Use
of data as provided by
FIFRA Section
3(c)(1)(F)(vi)
for a minor
use, when a
FIFRA Section
2(ll)(2) determination is required.

15

1,654

M009

210
(new)

Non-FIFRA Regulated Determination: Applicant initiated, per product.

4

2,363

M010

211
(new)

Conditional ruling on pre-application,
product substantial similarity.

4

2,363

M011

212
(new)

Label amendment to add
the DfE logo;
requires data
review; no
other label
changes. (9)

4

3,648

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) If another covered application is submitted that depends upon an 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.

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133 STAT. 578

PUBLIC LAW 116–8—MAR. 8, 2019

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(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.’’.
Time periods.
Regulations.

SEC. 7. AGRICULTURAL WORKER PROTECTION STANDARD; CERTIFICATION OF PESTICIDE APPLICATORS.

7 USC 136w
note.

(a) IN GENERAL.—Except as provided in subsection (b), during
the period beginning on the date of enactment of this Act and
ending not earlier than October 1, 2021, the Administrator of the
Environmental Protection Agency (referred to in this section as
the ‘‘Administrator’’)—
(1) shall carry out—
(A) the final rule of the Administrator entitled ‘‘Pesticides; Agricultural Worker Protection Standard Revisions’’
(80 Fed. Reg. 67496 (November 2, 2015)); and
(B) the final rule of the Administrator entitled ‘‘Pesticides; Certification of Pesticide Applicators’’ (82 Fed. Reg.
952 (January 4, 2017)); and
(2) shall not revise or develop revisions to the rules
described in subparagraphs (A) and (B) of paragraph (1).
(b) EXCEPTIONS.—Prior to October 1, 2021, the Administrator
may propose, and after a notice and public comment period of
not less than 90 days, promulgate revisions to the final rule
described in subsection (a)(1)(A) addressing application exclusion
zones under part 170 of title 40, Code of Federal Regulations,

Deadline.
Notice.
Public comments.
7 USC 136w
note.

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PUBLIC LAW 116–8—MAR. 8, 2019

133 STAT. 579

consistent with the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136 et seq.).
(c) GAO REPORT.—The Comptroller General of the United
States shall—
(1) conduct a study on the use of the designated representative, including the effect of that use on the availability of
pesticide application and hazard information and worker health
and safety; and
(2) not later than October 1, 2021, make publically available
a report describing the study under paragraph (1), including
any recommendations to prevent the misuse of pesticide
application and hazard information, if that misuse is identified.

Study.

Public
information.
Recommendations.

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Approved March 8, 2019.

LEGISLATIVE HISTORY—S. 483:
CONGRESSIONAL RECORD, Vol. 165 (2019):
Feb. 14, considered and passed Senate.
Feb. 25, considered and passed House, amended.
Feb. 28, Senate concurred in House amendment.

Æ

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