[116th Congress Public Law 8]
[From the U.S. Government Publishing Office]
[[Page 483]]
PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2018
[[Page 133 STAT. 484]]
Public Law 116-8
116th Congress
An Act
To enact into law a bill by reference. <<NOTE: Mar. 8, 2019 - [S.
483]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Pesticide
Registration Improvement Extension Act of 2018.>>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title <<NOTE: 7 USC 136 note.>> .--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. 1. Short title; table of contents.
Sec. 2. Extension and modification of maintenance fee authority.
Sec. 3. Reregistration and Expedited Processing Fund.
Sec. 4. Experimental use permits for pesticides.
Sec. 5. Pesticide registration service fees.
Sec. 6. Revision of tables regarding covered pesticide registration
applications and other covered actions and their
corresponding registration service fees.
Sec. 7. Agricultural worker protection standard; certification of
pesticide applicators.
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.''.
[[Page 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''.
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.--
[[Page 133 STAT. 486]]
``(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 <<NOTE: Evaluation.>> .--The
Administrator shall use amounts made available under
subparagraph (A) to develop, receive comments with
respect to, finalize, and implement the necessary
rulemaking and guidance for product performance data
requirements to evaluate products claiming efficacy
against the following invertebrate pests of significant
public health or economic importance (in order of
importance):
``(i) Bed bugs.
``(ii) Premise (including crawling insects,
flying insects, and baits).
``(iii) Pests of pets (including pet pests
controlled by spot-ons, collars, shampoos,
powders, or dips).
``(iv) Fire ants.
``(C) Deadlines for
guidance <<NOTE: Publication.>> .--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
[[Page 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. <<NOTE: Deadline.>> As part of such monitoring
program, the Administrator shall make available to each
laboratory inspected under such program in support of
such registrations a preliminary summary of inspection
observations not later than 60 days after the date on
which such an inspection is completed.''; and
(3) in paragraph (7), as so redesignated, by striking
``paragraphs (2), (3), and (4)'' and inserting ``paragraphs (2),
(3), (4), and (5)''.
SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.
Section 5(a) of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136c(a)) is amended--
(1) by striking ``permit for a pesticide.'' and inserting
``permit for a pesticide. An application for an experimental use
permit for a covered application under section 33(b) shall
conform with the requirements of that section.''; and
(2) by inserting ``(or in the case of an application for an
experimental use permit for a covered application under section
33(b), not later than the last day of the applicable timeframe
for such application specified in such section)'' after ``all
required supporting data''.
SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.
(a) Extension and Modification of Fee Authority.--Section 33(b) of
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(b)) is amended--
(1) in paragraph (2)--
(A) in the heading, by striking ``pesticide
registration''; and
(B) in subparagraph (A), by inserting ``or for any
other action covered by a table specified in paragraph
(3)'' after ``covered by this Act that is received by
the Administrator on or after the effective date of the
Pesticide Registration Improvement Act of 2003'';
(2) in paragraph (5)--
[[Page 133 STAT. 488]]
(A) in the heading, by striking ``pesticide
registration applications'' and inserting ``covered
applications''; and
(B) by striking ``pesticide registration
application'' both places it appears and inserting
``covered application'';
(3) in paragraph (6)--
(A) in subparagraph (A)--
(i) by striking ``pesticide registration'';
and
(ii) by striking ``October 1, 2013, and ending
on September 30, 2015'' and inserting ``October 1,
2019, and ending on September 30, 2021'';
(B) in subparagraph (B)--
(i) by striking ``pesticide registration'';
and
(ii) by striking ``2015'' each place it
appears and inserting ``2021''; and
(C) in subparagraph (C), by striking ``revised
registration service fee schedules'' and inserting
``service fee schedules revised pursuant to this
paragraph'';
(4) in paragraph (7)--
(A) in subparagraph (A)--
(i) by striking ``covered pesticide
registration'' and inserting ``covered
application''; and
(ii) by inserting before the period at the end
the following: ``, except that no waiver or fee
reduction shall be provided in connection with a
request for a letter of certification (commonly
referred to as a Gold Seal letter)''; and
(B) in subparagraph (F)(i), by striking ``pesticide
registration''; and
(5) in paragraph (8)--
(A) in subparagraph (A), by striking ``pesticide
registration'';
(B) in subparagraph (B)(i), by striking ``pesticide
registration''; and
(C) in subparagraph (C)--
(i) in clause (i), by striking ``pesticide
registration'' and inserting ``covered''; and
(ii) in clause (ii)(I), by striking
``pesticide registration'' and inserting
``covered''.
(b) Pesticide Registration Fund Set-Asides for Worker Protection,
Partnership Grants, and Pesticide Safety Education.--Section 33(c)(3)(B)
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(c)(3)(B)) is amended--
(1) in the heading, by inserting ``, partnership grants, and
pesticide safety education'' after ``Worker protection'';
(2) in clause (i)--
(A) by striking ``2017'' and inserting ``2023''; and
(B) by inserting before the period at the end the
following:``, with an emphasis on field-worker
populations in the United States'';
(3) in clause (ii), by striking ``2017'' and inserting
``2023''; and
(4) in clause (iii), by striking ``2017'' and inserting
``2023''.
(c) Reforms To Reduce Decision Time Review Periods.--Section 33(e)
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(e)) is amended--
[[Page 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--
[[Page 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) <<NOTE: Reviews.>> 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) <<NOTE: Evaluation.>> 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
[[Page 133 STAT. 491]]
``(iv) <<NOTE: Summary.>> with respect to
activities relating to worker protection carried
out under subparagraph (B)(i) of such subsection,
a summary of the analyses from stakeholders,
including from worker community-based
organizations, on the appropriateness and
effectiveness of such activities.''.
(f) Termination of Effectiveness.--Section 33(m) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is
amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``Fiscal year 2018.--During
fiscal year 2018'' and inserting ``Fiscal year
2024.--During fiscal year 2024''; and
(ii) by striking ``2017'' and inserting
``2023'';
(B) in subparagraph (B)--
(i) by striking ``Fiscal year 2019.--During
fiscal year 2019'' and inserting ``Fiscal year
2025.--During fiscal year 2025''; and
(ii) by striking ``2017'' and inserting
``2023'';
(C) in subparagraph (C), by striking ``September 30,
2019.--Effective September 30, 2019'' and inserting
``September 30, 2025.--Effective September 30, 2025'';
and
(D) in subparagraph (D), by striking ``2017'' both
places it appears and inserting ``2023''.
SEC. 6. <<NOTE: Extension. Notification. Time period. Deadline.>>
REVISION OF TABLES REGARDING COVERED PESTICIDE
REGISTRATION APPLICATIONS AND OTHER COVERED
ACTIONS AND THEIR CORRESPONDING REGISTRATION
SERVICE FEES.
Paragraph (3) of section 33(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended to read
as follows:
``(3) Schedule of covered applications and other actions and
their registration service fees.--Subject to paragraph (6), the
schedule of registration applications and other covered actions
and their corresponding registration service fees shall be as
follows:
``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R010 1 New Active Ingredient, Food use. 24 753,082
(2)(3)
----------------------------------------------------------------------------------------------------------------
R020 2 New Active Ingredient, Food use; 18 627,568
reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 492]]
R040 3 New Active Ingredient, Food use; 18 462,502
Experimental Use Permit application;
establish temporary tolerance;
submitted before application for
registration; credit 45% of fee
toward new active ingredient
application that follows. (3)
----------------------------------------------------------------------------------------------------------------
R060 4 New Active Ingredient, Non-food use; 21 523,205
outdoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
R070 5 New Active Ingredient, Non-food use; 16 436,004
outdoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
R090 6 New Active Ingredient, Non-food use; 16 323,690
outdoor; Experimental Use Permit
application; submitted before
application for registration; credit
45% of fee toward new active
ingredient application that follows.
(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 493]]
R110 7 New Active Ingredient, Non-food use; 20 290,994
indoor. (2)(3)
----------------------------------------------------------------------------------------------------------------
R120 8 New Active Ingredient, Non-food use; 14 242,495
indoor; reduced risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
R121 9 New Active Ingredient, Non-food use; 18 182,327
indoor; Experimental Use Permit
application; submitted before
application for registration; credit
45% of fee toward new active
ingredient application that follows.
(3)
----------------------------------------------------------------------------------------------------------------
R122 10 Enriched isomer(s) of registered mixed- 18 317,128
isomer active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
R123 11 New Active Ingredient, Seed treatment 18 471,861
only; includes agricultural and non-
agricultural seeds; residues not
expected in raw agricultural
commodities. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 494]]
R125 12 New Active Ingredient, Seed treatment; 16 323,690
Experimental Use Permit application;
submitted before application for
registration; credit 45% of fee
toward new active ingredient
application that follows. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page 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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R130 13 First food use; indoor; food/food 21 191,444
handling. (2) (3)
----------------------------------------------------------------------------------------------------------------
R140 14 Additional food use; Indoor; food/food 15 44,672
handling. (3) (4)
----------------------------------------------------------------------------------------------------------------
R150 15 First food use. (2)(3) 21 317,104
----------------------------------------------------------------------------------------------------------------
R155 16 (new) First food use, Experimental Use 21 264,253
Permit application; a.i. registered
for non-food outdoor use. (3)(4)
----------------------------------------------------------------------------------------------------------------
R160 17 First food use; reduced risk. (2)(3) 16 264,253
----------------------------------------------------------------------------------------------------------------
R170 18 Additional food use. (3) (4) 15 79,349
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 496]]
R175 19 Additional food uses covered within a 10 66,124
crop group resulting from the
conversion of existing approved crop
group(s) to one or more revised crop
groups. (3)(4)
----------------------------------------------------------------------------------------------------------------
R180 20 Additional food use; reduced risk. 10 66,124
(3)(4)
----------------------------------------------------------------------------------------------------------------
R190 21 Additional food uses; 6 or more 15 476,090
submitted in one application. (3)(4)
----------------------------------------------------------------------------------------------------------------
R200 22 Additional Food Use; 6 or more 10 396,742
submitted in one application; Reduced
Risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
R210 23 Additional food use; Experimental Use 12 48,986
Permit application; establish
temporary tolerance; no credit toward
new use registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 497]]
R220 24 Additional food use; Experimental Use 6 19,838
Permit application; crop destruct
basis; no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R230 25 Additional use; non-food; outdoor. (3) 15 31,713
(4)
----------------------------------------------------------------------------------------------------------------
R240 26 Additional use; non-food; outdoor; 10 26,427
reduced risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
R250 27 Additional use; non-food; outdoor; 6 19,838
Experimental Use Permit application;
no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R251 28 Experimental Use Permit application 8 19,838
which requires no changes to the
tolerance(s); non-crop destruct
basis. (3)
----------------------------------------------------------------------------------------------------------------
R260 29 New use; non-food; indoor. (3) (4) 12 15,317
----------------------------------------------------------------------------------------------------------------
R270 30 New use; non-food; indoor; reduced 9 12,764
risk. (3)(4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 498]]
R271 31 New use; non-food; indoor; 6 9,725
Experimental Use Permit application;
no credit toward new use
registration. (3)(4)
----------------------------------------------------------------------------------------------------------------
R273 32 Additional use; seed treatment; 12 50,445
limited uptake into Raw Agricultural
Commodities; includes crops with
established tolerances (e.g., for
soil or foliar application); includes
food and/or non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
R274 33 Additional uses; seed treatment only; 12 302,663
6 or more submitted in one
application; limited uptake into raw
agricultural commodities; includes
crops with established tolerances
(e.g., for soil or foliar
application); includes food and/or
non-food uses. (3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
[[Page 133 STAT. 499]]
(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.
[[Page 133 STAT. 500]]
(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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R280 34 Establish import tolerance; new active 21 319,072
ingredient or first food use. (2)
----------------------------------------------------------------------------------------------------------------
R290 35 Establish Import tolerance; Additional 15 63,816
new food use.
----------------------------------------------------------------------------------------------------------------
R291 36 Establish import tolerances; 15 382,886
additional food uses; 6 or more crops
submitted in one petition.
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 501]]
R292 37 Amend an established tolerance (e.g., 11 45,341
decrease or increase) and/or
harmonize established tolerances with
Codex MRLs; domestic or import;
applicant-initiated.
----------------------------------------------------------------------------------------------------------------
R293 38 Establish tolerance(s) for inadvertent 12 53,483
residues in one crop; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
R294 39 Establish tolerances for inadvertent 12 320,894
residues; 6 or more crops submitted
in one application; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
R295 40 Establish tolerance(s) for residues in 15 66,124
one rotational crop in response to a
specific rotational crop application;
submission of corresponding label
amendments which specify the
necessary plant-back restrictions;
applicant-initiated. (3) (4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 502]]
R296 41 Establish tolerances for residues in 15 396,742
rotational crops in response to a
specific rotational crop petition; 6
or more crops submitted in one
application; submission of
corresponding label amendments which
specify the necessary plant-back
restrictions; applicant-initiated.
(3) (4)
----------------------------------------------------------------------------------------------------------------
R297 42 Amend 6 or more established tolerances 11 272,037
(e.g., decrease or increase) in one
petition; domestic or import;
applicant-initiated.
----------------------------------------------------------------------------------------------------------------
R298 43 Amend an established tolerance (e.g., 13 58,565
decrease or increase); domestic or
import; submission of corresponding
amended labels (requiring science
review). (3) (4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 503]]
R299 44 Amend 6 or more established tolerances 13 285,261
(e.g., decrease or increase);
domestic or import; submission of
corresponding amended labels
(requiring science review). (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page 133 STAT. 504]]
(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.
[[Page 133 STAT. 505]]
``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
New CR Decision Review Time Registration Service Fee
EPA No. No. Action (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R300 45 New product; or similar 4 1,582
combination product (already
registered) to an identical or
substantially similar in
composition and use to a
registered product; registered
source of active ingredient; no
data review on acute toxicity,
efficacy or CRP - only product
chemistry data; cite-all data
citation, or selective data
citation where applicant owns
all required data, or applicant
submits specific authorization
letter from data owner. Category
also includes 100% re-package of
registered end-use or
manufacturing-use product that
requires no data submission nor
data matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 506]]
R301 46 New product; or similar 4 1,897
combination product (already
registered) to an identical or
substantially similar in
composition and use to a
registered product; registered
source of active ingredient;
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy (identical
data citation and claims to
cited product(s)), where
applicant does not own all
required data and does not have
a specific authorization letter
from data owner. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 507]]
R310 47 New end-use or manufacturing-use 7 7,301
product with registered
source(s) of active
ingredient(s); includes products
containing two or more
registered active ingredients
previously combined in other
registered products; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 508]]
R314 48 New end use product containing up 8 8,626
to three registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 509]]
R319 49 New end use product containing up 10 12,626
to three registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for 4 to 7 target
pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 510]]
R318 50 (new) New end use product containing 9 13,252
four or more registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for up to 3
target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 511]]
R321 51 (new) New end use product containing 11 17,252
four or more registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; excludes
products requiring or citing an
animal safety study; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for 4 to 7 target
pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 512]]
R315 52 New end-use, on-animal product, 9 9,820
registered source of active
ingredient(s), with the
submission of data and/or
waivers for only:
<bullet> animal safety and
<bullet> pest(s) requiring
efficacy (4) and/or
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging. (2) (3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 513]]
R316 53 (new) New end-use or manufacturing 9 11,301
product with registered
source(s) of active
ingredient(s) including products
containing two or more
registered active ingredients
previously combined in other
registered products; excludes
products requiring or citing an
animal safety study; and
requires review of data and/or
waivers for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for greater than
3 and up to 7 target pests.
(2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 514]]
R317 54 (new) New end-use or manufacturing 10 15,301
product with registered
source(s) of active
ingredient(s) including products
containing 2 or more registered
active ingredients previously
combined in other registered
products; excludes products
requiring or citing an animal
safety study; and requires
review of data and/or waivers
for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant
packaging and/or
<bullet> pest(s) requiring
efficacy (4) - for greater than
7 target pests. (2)(3)
----------------------------------------------------------------------------------------------------------------
R320 55 New product; new physical form; 12 13,226
requires data review in science
divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 515]]
R331 56 New product; repack of identical 3 2,530
registered end-use product as a
manufacturing-use product, or
identical registered
manufacturing-use product as an
end use product; same registered
uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
R332 57 New manufacturing-use product; 24 283,215
registered active ingredient;
unregistered source of active
ingredient; submission of
completely new generic data
package; registered uses only;
requires review in RD and
science divisions. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 516]]
R333 58 New product; MUP or End use 10 19,838
product with unregistered source
of active ingredient; requires
science data review; new
physical form; etc. Cite-all or
selective data citation where
applicant owns all required
data. (2)(3)
----------------------------------------------------------------------------------------------------------------
R334 59 New product; MUP or End use 11 23,100
product with unregistered source
of the active ingredient;
requires science data review;
new physical form; etc.
Selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
[[Page 133 STAT. 517]]
(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.
[[Page 133 STAT. 518]]
``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R340 60 Amendment requiring data review within RD 4 4,988
(e.g., changes to precautionary label
statements); includes adding/modifying
pest(s) claims for up to 2 target pests,
excludes products requiring or citing an
animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
R341 61 (New) Amendment requiring data review within RD 6 5,988
(e.g., changes to precautionary label
statements), includes adding/modifying
pest(s) claims for greater than 2 target
pests, excludes products requiring or
citing an animal safety study. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
R345 62 Amending on-animal products previously 7 8,820
registered, with the submission of data
and/or waivers for only:
<bullet> animal safety and
<bullet> pest(s) requiring efficacy (4) and/
or
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> child resistant packaging. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 519]]
R350 63 Amendment requiring data review in science 9 13,226
divisions (e.g., changes to REI, or PPE,
or PHI, or use rate, or number of
applications; or add aerial application;
or modify GW/SW advisory statement).
(2)(3)
----------------------------------------------------------------------------------------------------------------
R351 64 Amendment adding a new unregistered source 8 13,226
of active ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
R352 65 Amendment adding already approved uses; 8 13,226
selective method of support; does not
apply if the applicant owns all cited
data. (2) (3)
----------------------------------------------------------------------------------------------------------------
R371 66 Amendment to Experimental Use Permit; (does 6 10,090
not include extending a permit's time
period). (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
[[Page 133 STAT. 520]]
(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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
R124 67 Conditional Ruling on Pre-application 6 2,530
Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 521]]
R272 68 Review of Study Protocol applicant- 3 2,530
initiated; excludes DART, pre-
registration conference, Rapid
Response review, DNT protocol review,
protocol needing HSRB review.
----------------------------------------------------------------------------------------------------------------
R275 69 Rebuttal of agency reviewed protocol, 3 2,530
applicant initiated.
----------------------------------------------------------------------------------------------------------------
R370 70 Cancer reassessment; applicant- 18 198,250
initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
A380 71 New Active Ingredient; Indirect Food use; 24 137,841
establish tolerance or tolerance
exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 522]]
A390 72 New Active Ingredient; Direct Food use; 24 229,733
establish tolerance or tolerance
exemption if required. (2)(3)
----------------------------------------------------------------------------------------------------------------
A410 73 New Active Ingredient Non-food use.(2)(3) 21 229,733
----------------------------------------------------------------------------------------------------------------
A431 74 New Active Ingredient, Non-food use; low- 12 80,225
risk. (2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page 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.
``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
A440 75 New Use, Indirect Food Use, 21 31,910
establish tolerance or tolerance
exemption. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
A441 76 Additional Indirect food uses; 21 114,870
establish tolerances or tolerance
exemptions if required; 6 or more
submitted in one application.
(3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A450 77 New use, Direct food use, 21 95,724
establish tolerance or tolerance
exemption. (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 524]]
A451 78 Additional Direct food uses; 21 182,335
establish tolerances or tolerance
exemptions if required; 6 or more
submitted in one application.
(3)(4)(5)
----------------------------------------------------------------------------------------------------------------
A500 79 New use, non-food. (4)(5) 12 31,910
----------------------------------------------------------------------------------------------------------------
A501 80 New use, non-food; 6 or more 15 76,583
submitted in one application.
(4)(5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page 133 STAT. 525]]
(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.
[[Page 133 STAT. 526]]
``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
A530 81 New product, identical or 4 1,278
substantially similar in composition
and use to a registered product; no
data review or only product chemistry
data; cite all data citation or
selective data citation where
applicant owns all required data; or
applicant submits specific
authorization letter from data owner.
Category also includes 100% re-
package of registered end-use or
manufacturing use product that
requires no data submission nor data
matrix. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 527]]
A531 82 New product; identical or 4 1,824
substantially similar in composition
and use to a registered product;
registered source of active
ingredient: selective data citation
only for data on product chemistry
and/or acute toxicity and/or public
health pest efficacy, where applicant
does not own all required data and
does not have a specific
authorization letter from data owner.
(2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 528]]
A532 83 New product; identical or 5 5,107
substantially similar in composition
and use to a registered product;
registered active ingredient;
unregistered source of active
ingredient; cite-all data citation
except for product chemistry; product
chemistry data submitted. (2)(3)
----------------------------------------------------------------------------------------------------------------
A540 84 New end use product; FIFRA Sec. 2(mm) 5 5,107
uses only; up to 25 public health
organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
A541 85 (new) New end use product; FIFRA Sec. 2(mm) 7 8,500
uses only; 26-50 public health
organisms. (2)(3)(5)(6)
----------------------------------------------------------------------------------------------------------------
A542 86 (new) New end use product; FIFRA Sec. 2(mm) 10 15,000
uses only; $ 51 public health
organisms. (2)(3)(5)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 529]]
A550 87 New end-use product; uses other than 9 13,226
FIFRA Sec. 2(mm); non-FQPA product.
(2)(3)(5)
----------------------------------------------------------------------------------------------------------------
A560 88 New manufacturing use product; 6 12,596
registered active ingredient;
selective data citation. (2)(3)
----------------------------------------------------------------------------------------------------------------
A565 89 (new) New manufacturing-use product; 12 18,234
registered active ingredient;
unregistered source of active
ingredient; submission of new generic
data package; registered uses only;
requires science review. (2)(3)
----------------------------------------------------------------------------------------------------------------
A570 90 Label amendment requiring data 4 3,831
review; up to 25 public health
organisms. (3)(4)(5)(6)
----------------------------------------------------------------------------------------------------------------
A573 91 (new) Label amendment requiring data 6 6,350
review; 26-50 public health
organisms. (2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 530]]
A574 92 (new) Label amendment requiring data 9 11,000
review; $ 51 public health organisms.
(2)(3)(5)(7)
----------------------------------------------------------------------------------------------------------------
A572 93 New Product or amendment requiring 9 13,226
data review for risk assessment by
Science Branch (e.g., changes to REI,
or PPE, or use rate). (2)(3)(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
[[Page 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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
A520 94 Experimental Use Permit application, 9 6,383
non-food use. (2)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 532]]
A521 95 Review of public health efficacy study 4 4,726
protocol within AD, per AD Internal
Guidance for the Efficacy Protocol
Review Process; Code will also
include review of public health
efficacy study protocol and data
review for devices making pesticidal
claims; applicant-initiated; Tier 1.
----------------------------------------------------------------------------------------------------------------
A522 96 Review of public health efficacy 12 12,156
study protocol outside AD by members
of AD Efficacy Protocol Review Expert
Panel; Code will also include review
of public health efficacy study
protocol and data review for devices
making pesticidal claims; applicant-
initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 533]]
A537 97 (new) New Active Ingredient/New Use, 18 153,156
Experimental Use Permit application;
Direct food use; Establish tolerance
or tolerance exemption if required.
Credit 45% of fee toward new active
ingredient/new use application that
follows.
----------------------------------------------------------------------------------------------------------------
A538 98 (new) New Active Ingredient/New Use, 18 95,724
Experimental Use Permit application;
Indirect food use; Establish
tolerance or tolerance exemption if
required Credit 45% of fee toward new
active ingredient/new use application
that follows.
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 534]]
A539 99 (new) New Active Ingredient/New Use, 15 92,163
Experimental Use Permit application;
Nonfood use. Credit 45% of fee toward
new active ingredient/new use
application that follows.
----------------------------------------------------------------------------------------------------------------
A529 100 Amendment to Experimental Use Permit; 9 11,429
requires data review or risk
assessment. (2)
----------------------------------------------------------------------------------------------------------------
A523 101 Review of protocol other than a 9 12,156
public health efficacy study (i.e.,
Toxicology or Exposure Protocols).
----------------------------------------------------------------------------------------------------------------
A571 102 Science reassessment: Cancer risk, 18 95,724
refined ecological risk, and/or
endangered species; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
A533 103 (new) Exemption from the requirement of an 4 2,482
Experimental Use Permit. (2)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 535]]
A534 104 (new) Rebuttal of agency reviewed protocol, 4 4,726
applicant initiated.
----------------------------------------------------------------------------------------------------------------
A535 105 (new) Conditional Ruling on Pre-application 6 2,409
Study Waiver or Data Bridging
Argument; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
A536 106 (new) Conditional Ruling on Pre-application 4 2,482
Direct Food, Indirect Food, Nonfood
use determination; applicant-
initiated.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
[[Page 133 STAT. 536]]
``TABLE 11. -- BIOPESTICIDES DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B580 107 New active ingredient; food use; 20 51,053
petition to establish a tolerance.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B590 108 New active ingredient; food use; 18 31,910
petition to establish a tolerance
exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
B600 109 New active ingredient; non-food use. 13 19,146
(2)(3)
----------------------------------------------------------------------------------------------------------------
B610 110 New active ingredient; Experimental 10 12,764
Use Permit application; petition to
establish a temporary tolerance or
temporary tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
B611 111 New active ingredient; Experimental 12 12,764
Use Permit application; petition to
establish permanent tolerance
exemption. (3)
----------------------------------------------------------------------------------------------------------------
B612 112 New active ingredient; no change to a 10 17,550
permanent tolerance exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 537]]
B613 113 New active ingredient; petition to 11 17,550
convert a temporary tolerance or a
temporary tolerance exemption to a
permanent tolerance or tolerance
exemption. (2)(3)
----------------------------------------------------------------------------------------------------------------
B620 114 New active ingredient; Experimental 7 6,383
Use Permit application; non-food use
including crop destruct. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
[[Page 133 STAT. 538]]
(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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B630 115 First food use; petition to establish 13 12,764
a tolerance exemption. (2)(4)
----------------------------------------------------------------------------------------------------------------
B631 116 New food use; petition to amend an 12 12,764
established tolerance. (3)(4)
----------------------------------------------------------------------------------------------------------------
B640 117 First food use; petition to establish 19 19,146
a tolerance. (2)(4)
----------------------------------------------------------------------------------------------------------------
B643 118 New Food use; petition to amend an 10 12,764
established tolerance exemption.
(3)(4)
----------------------------------------------------------------------------------------------------------------
B642 119 First food use; indoor; food/food 12 31,910
handling. (2)(4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 539]]
B644 120 New use, no change to an established 8 12,764
tolerance or tolerance exemption.
(3)(4)
----------------------------------------------------------------------------------------------------------------
B650 121 New use; non-food. (3)(4) 7 6,383
----------------------------------------------------------------------------------------------------------------
B645 122 (new) New food use; Experimental Use Permit 12 12,764
application; petition to amend or add
a tolerance exemption. (4)
----------------------------------------------------------------------------------------------------------------
B646 123 (new) New use; non-food use including crop 7 6,383
destruct; Experimental Use Permit
application. (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
[[Page 133 STAT. 540]]
(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.
[[Page 133 STAT. 541]]
(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.
[[Page 133 STAT. 542]]
``TABLE 13. -- BIOPESTICIDES DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B652 124 New product; registered source of active 13 12,764
ingredient; requires petition to amend
established tolerance or tolerance
exemption; requires 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of scientifically-
sound rationale based on publicly
available literature or other relevant
information that addresses the data
requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 543]]
B660 125 New product; registered source of active 4 1,278
ingredient(s); identical or
substantially similar in composition and
use to a registered product. No data
review, or only product chemistry data;
cite-all data citation, or selective
data citation where applicant owns all
required data or authorization from data
owner is demonstrated. Category includes
100% re-package of registered end-use or
manufacturing-use product that requires
no data submission or data matrix. For
microbial pesticides, the active
ingredient(s) must not be re-isolated.
(2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 544]]
B670 126 New product; registered source of active 7 5,107
ingredient(s); requires: 1) submission
of product specific data; or 2) citation
of previously reviewed and accepted
data; or 3) submission or citation of
data generated at government expense; or
4) submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 545]]
B671 127 New product; unregistered source of 17 12,764
active ingredient(s); requires a
petition to amend an established
tolerance or tolerance exemption;
requires: 1) submission of product
specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 546]]
B672 128 New product; unregistered source of 13 9,118
active ingredient(s); non-food use or
food use requires: 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 547]]
B673 129 New product MUP/EP; unregistered source 10 5,107
of active ingredient(s); citation of
Technical Grade Active Ingredient (TGAI)
data previously reviewed and accepted by
the Agency. Requires an Agency
determination that the cited data
supports the new product. (2)(3)
----------------------------------------------------------------------------------------------------------------
B674 130 New product MUP; Repack of identical 4 1,278
registered end-use product as a
manufacturing-use product; same
registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
B675 131 New Product MUP; registered source of 10 9,118
active ingredient; submission of
completely new generic data package;
registered uses only. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 548]]
B676 132 New product; more than one active 13 9,118
ingredient where one active ingredient
is an unregistered source; product
chemistry data must be submitted;
requires: 1) submission of product
specific data, and 2) citation of
previously reviewed and accepted data;
or 3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 549]]
B677 133 New end-use non-food animal product with 10 8,820
submission of two or more target animal
safety studies; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> public health pest efficacy and/
or
<bullet> animal safety studies and/or
<bullet> child resistant packaging.
(2)(3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
[[Page 133 STAT. 550]]
``TABLE 14. -- BIOPESTICIDES DIVISION -- AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B621 134 Amendment; Experimental Use Permit; no 7 5,107
change to an established temporary
tolerance or tolerance exemption. (3)
----------------------------------------------------------------------------------------------------------------
B622 135 Amendment; Experimental Use Permit; 11 12,764
petition to amend an established or
temporary tolerance or tolerance
exemption. (3)
----------------------------------------------------------------------------------------------------------------
B641 136 Amendment of an established tolerance or 13 12,764
tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680 137 Amendment; registered sources of active 5 5,107
ingredient(s); no new use(s); no changes
to an established tolerance or tolerance
exemption. Requires data submission.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B681 138 Amendment; unregistered source of active 7 6,079
ingredient(s). Requires data submission.
(2)(3)
----------------------------------------------------------------------------------------------------------------
B683 139 Label amendment; requires review/update 6 5,107
of previous risk assessment(s) without
data submission (e.g., labeling changes
to REI, PPE, PHI). (2)(3)
----------------------------------------------------------------------------------------------------------------
B684 140 Amending non-food animal product that 8 8,820
includes submission of target animal
safety data; previously registered.
(2)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 551]]
B685 141 (new) Amendment; add a new biochemical 5 5,107
unregistered source of active ingredient
or a new microbial production site.
Requires submission of analysis of
samples data and source/production site-
specific manufacturing process
description. (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
[[Page 133 STAT. 552]]
``TABLE 15. -- BIOPESTICIDES DIVISION -- SCLP
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B690 142 New active ingredient; food or non- 7 2,554
food use. (2)(6)
----------------------------------------------------------------------------------------------------------------
B700 143 Experimental Use Permit application; 7 1,278
new active ingredient or new use. (6)
----------------------------------------------------------------------------------------------------------------
B701 144 Extend or amend Experimental Use 4 1,278
Permit. (6)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 553]]
B710 145 New product; registered source of 4 1,278
active ingredient(s); identical or
substantially similar in composition
and use to a registered product; no
change in an established tolerance or
tolerance exemption. No data review,
or only product chemistry data; cite-
all data citation, or selective data
citation where applicant owns all
required data or authorization from
data owner is demonstrated. Category
includes 100% re-package of
registered end-use or manufacturing-
use product that requires no data
submission or data matrix. (3)(6)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 554]]
B720 146 New product; registered source of 5 1,278
active ingredient(s); requires: 1)
submission of product specific data;
or 2) citation of previously reviewed
and accepted data; or 3) submission
or citation of data generated at
government expense; or 4) submission
or citation of a scientifically-sound
rationale based on publicly available
literature or other relevant
information that addresses the data
requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the
data requirement does not apply.
(3)(6)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 555]]
B721 147 New product; unregistered source of 7 2,676
active ingredient. (3)(6)
----------------------------------------------------------------------------------------------------------------
B722 148 New use and/or amendment; petition to 7 2,477
establish a tolerance or tolerance
exemption. (4)(5)(6)
----------------------------------------------------------------------------------------------------------------
B730 149 Label amendment requiring data 5 1,278
submission. (4)(6)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
[[Page 133 STAT. 556]]
(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.
[[Page 133 STAT. 557]]
``TABLE 16. -- BIOPESTICIDES DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B614 150 Pre-application; Conditional Ruling on 3 2,530
rationales for addressing a data
requirement in lieu of data;
applicant-initiated; applies to one
rationale at a time.
----------------------------------------------------------------------------------------------------------------
B615 151 Rebuttal of agency reviewed protocol, 3 2,530
applicant initiated.
----------------------------------------------------------------------------------------------------------------
B682 152 Protocol review; applicant initiated; 3 2,432
excludes time for HSRB review.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
[[Page 133 STAT. 558]]
``TABLE 17. -- BIOPESTICIDES DIVISION -- PIP
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
B740 153 Experimental Use Permit application; no 6 95,724
petition for tolerance/tolerance
exemption. Includes:
...........................................
1. non-food/feed use(s) for a new (2) or
registered (3) PIP (12);
2. food/feed use(s) for a new or registered
PIP with crop destruct (12);
3. food/feed use(s) for a new or registered
PIP in which an established tolerance/
tolerance exemption exists for the
intended use(s). (4)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 559]]
B741 154 Experimental Use Permit application; no 12 159,538
(new) petition for tolerance/tolerance
exemption. Includes:
...........................................
1. non-food/feed use(s) for a new (2) or
registered (3) PIP;
2. food/feed use(s) for a new or registered
PIP with crop destruct;
3. food/feed use(s) for a new or registered
PIP in which an established tolerance/
tolerance exemption exists for the
intended use(s);
SAP Review. (12)
----------------------------------------------------------------------------------------------------------------
B750 155 Experimental Use Permit application; with a 9 127,630
petition to establish a temporary or
permanent tolerance/tolerance exemption
for the active ingredient. Includes new
food/feed use for a registered (3) PIP.
(4)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 560]]
B770 156 Experimental Use Permit application; new 15 191,444
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows;
SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B771 157 Experimental Use Permit application; new 10 127,630
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows.
(12)
----------------------------------------------------------------------------------------------------------------
B772 158 Application to amend or extend an 3 12,764
Experimental Use Permit; no petition since
the established tolerance/tolerance
exemption for the active ingredient is
unaffected. (12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 561]]
B773 159 Application to amend or extend an 5 31,910
Experimental Use Permit; with petition to
extend a temporary tolerance/tolerance
exemption for the active ingredient. (12)
----------------------------------------------------------------------------------------------------------------
B780 160 Registration application; new (2) PIP; non- 12 159,537
food/feed. (12)
----------------------------------------------------------------------------------------------------------------
B790 161 Registration application; new (2) PIP; non- 18 223,351
food/feed; SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
B800 162 Registration application; new (2) PIP; with 13 172,300
petition to establish permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. (12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 562]]
B810 163 Registration application; new (2) PIP; with 19 236,114
petition to establish permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. SAP review.
(5)(12)
----------------------------------------------------------------------------------------------------------------
B820 164 Registration application; new (2) PIP; with 15 204,208
petition to establish or amend a permanent
tolerance/tolerance exemption of an active
ingredient. (12)
----------------------------------------------------------------------------------------------------------------
B840 165 Registration application; new (2) PIP; with 21 268,022
petition to establish or amend a permanent
tolerance/tolerance exemption of an active
ingredient. SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 563]]
B851 166 Registration application; new event of a 9 127,630
previously registered PIP active
ingredient(s); no petition since permanent
tolerance/tolerance exemption is already
established for the active ingredient(s).
(12)
----------------------------------------------------------------------------------------------------------------
B870 167 Registration application; registered (3) 9 38,290
PIP; new product; new use; no petition
since a permanent tolerance/tolerance
exemption is already established for the
active ingredient(s). (4) (12)
----------------------------------------------------------------------------------------------------------------
B880 168 Registration application; registered (3) 9 31,910
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). (6) (7) (12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 564]]
B881 169 Registration application; registered (3) 15 95,724
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). SAP review.
(5)(6)(7)(12)
----------------------------------------------------------------------------------------------------------------
B882 170 Registration application; new (2) PIP, seed 15 191,444
(new) increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption; SAP Review.
(8)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 565]]
B883 171 Registration application; new (2) PIP, seed 9 127,630
increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient based on an existing temporary
tolerance/tolerance exemption. (8) (12)
----------------------------------------------------------------------------------------------------------------
B884 172 Registration application; new (2) PIP, seed 12 159,537
increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient. (8)(12)
----------------------------------------------------------------------------------------------------------------
B885 173 Registration application; registered (3) 6 31,910
PIP, seed increase; breeding stack of
previously approved PIPs, same crop; no
petition since a permanent tolerance/
tolerance exemption is already established
for the active ingredient(s). (9)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 566]]
B886 174 Registration application; new (2) PIP, seed 18 223,351
(new) increase with negotiated acreage cap and
time-limited registration; with petition
to establish a permanent tolerance/
tolerance exemption for the active
ingredient. SAP Review. (8) (12)
----------------------------------------------------------------------------------------------------------------
B890 175 Application to amend a seed increase 9 63,816
registration; converts registration to
commercial registration; no petition since
permanent tolerance/tolerance exemption is
already established for the active
ingredient(s). (12)
----------------------------------------------------------------------------------------------------------------
B891 176 Application to amend a seed increase 15 127,630
registration; converts registration to a
commercial registration; no petition since
a permanent tolerance/tolerance exemption
already established for the active
ingredient(s); SAP review. (5)(12)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 567]]
B900 177 Application to amend a registration, 6 12,764
including actions such as extending an
expiration date, modifying an IRM plan, or
adding an insect to be controlled.
(10)(11)(12)
----------------------------------------------------------------------------------------------------------------
B901 178 Application to amend a registration, 12 76,578
including actions such as extending an
expiration date, modifying an IRM plan, or
adding an insect to be controlled. SAP
review. (10) (11) (12)
----------------------------------------------------------------------------------------------------------------
B902 179 PIP Protocol review. 3 6,383
----------------------------------------------------------------------------------------------------------------
B903 180 Inert ingredient tolerance exemption; e.g., 6 63,816
a marker such as NPT II; reviewed in BPPD.
----------------------------------------------------------------------------------------------------------------
B904 181 Import tolerance or tolerance exemption; 9 127,630
processed commodities/food only (inert or
active ingredient).
----------------------------------------------------------------------------------------------------------------
B905 182 SAP Review. 6 63,816
(new)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 568]]
B906 183 Petition to establish a temporary tolerance/ 3 31,907
(new) tolerance exemption for one or more active
ingredients.
----------------------------------------------------------------------------------------------------------------
B907 184 Petition to establish a temporary tolerance/ 3 12,764
(new) tolerance exemption for one or more active
ingredients based on an existing temporary
tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B908 185 Petition to establish a temporary tolerance/ 3 44,671
(new) tolerance exemption for one or more active
ingredients or inert ingredients.
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
[[Page 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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
I001 186 Approval of new food use inert 13 27,000
ingredient. (2)(3)
----------------------------------------------------------------------------------------------------------------
I002 187 Amend currently approved inert 11 7,500
ingredient tolerance or exemption from
tolerance; new data. (2)
----------------------------------------------------------------------------------------------------------------
I003 188 Amend currently approved inert 9 3,308
ingredient tolerance or exemption from
tolerance; no new data. (2)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 570]]
I004 189 Approval of new non-food use inert 6 11,025
ingredient. (2)
----------------------------------------------------------------------------------------------------------------
I005 190 Amend currently approved non-food use 6 5,513
inert ingredient with new use pattern;
new data. (2)
----------------------------------------------------------------------------------------------------------------
I006 191 Amend currently approved non-food use 3 3,308
inert ingredient with new use pattern;
no new data. (2)
----------------------------------------------------------------------------------------------------------------
I007 192 Approval of substantially similar non- 4 1,654
food use inert ingredients when
original inert is compositionally
similar with similar use pattern. (2)
----------------------------------------------------------------------------------------------------------------
I008 193 Approval of new or amended polymer inert 5 3,749
ingredient, food use. (2)
----------------------------------------------------------------------------------------------------------------
I009 194 Approval of new or amended polymer inert 4 3,087
ingredient, non-food use. (2)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 571]]
I010 195 Petition to amend a single tolerance 6 1,654
exemption descriptor, or single non-
food use descriptor, to add 10 CASRNs;
no new data. (2)
----------------------------------------------------------------------------------------------------------------
I011 196 (new) Approval of new food use safener with 24 597,683
tolerance or exemption from tolerance.
(2)(8)
----------------------------------------------------------------------------------------------------------------
I012 197 (new) Approval of new non-food use safener. 21 415,241
(2)(8)
----------------------------------------------------------------------------------------------------------------
I013 198 (new) Approval of additional food use for 15 62,975
previously approved safener with
tolerance or exemption from tolerance.
(2)
----------------------------------------------------------------------------------------------------------------
I014 199 (new) Approval of additional non-food use for 15 25,168
previously approved safener. (2)
----------------------------------------------------------------------------------------------------------------
I015 200 (new) Approval of new generic data for 24 269,728
previously approved food use safener.
(2)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 572]]
I016 201 (new) Approval of amendment(s) to tolerance 13 55,776
and label for previously approved
safener. (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
each application will be subject to its respective registration service fee. The decision review time line for
both submissions will be the longest of the associated applications. If the application covers multiple
ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
the data for such clearance of such product is not subject to a registration service fee for the tolerance
action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
its separate registration service fee. The decision review times for the associated actions run concurrently,
but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
separate registration service fee. The decision review time for the associated action will be extended by the
decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
[[Page 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
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR Action Decision Review Time Service Fee
No. (Months)(1) ($)
----------------------------------------------------------------------------------------------------------------
M001 202 Study protocol requiring Human Studies 9 7,938
Review Board review as defined in 40
CFR Part 26 in support of an active
ingredient. (4)
----------------------------------------------------------------------------------------------------------------
M002 203 Completed study requiring Human 9 7,938
Studies Review Board review as
defined in 40 CFR Part 26 in support
of an active ingredient. (4)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 574]]
M003 204 External technical peer review of new 12 63,945
active ingredient, product, or
amendment (e.g., consultation with
FIFRA Scientific Advisory Panel) for
an action with a decision timeframe
of less than 12 months. Applicant
initiated request based on a
requirement of the Administrator, as
defined by FIFRA Sec. 25(d), in
support of a novel active ingredient,
or unique use pattern or application
technology. Excludes PIP active
ingredients. (5)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 575]]
M004 205 External technical peer review of new 18 63,945
active ingredient, product, or
amendment (e.g., consultation with
FIFRA Scientific Advisory Panel) for
an action with a decision timeframe
of greater than 12 months. Applicant
initiated request based on a
requirement of the Administrator, as
defined by FIFRA Sec. 25(d), in
support of a novel active ingredient,
or unique use pattern or application
technology. Excludes PIP active
ingredients. (5)
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 576]]
M005 206 New Product: Combination, Contains a 9 22,050
combination of active ingredients
from a registered and/or unregistered
source; conventional, antimicrobial
and/or biopesticide. Requires
coordination with other regulatory
divisions to conduct review of data,
label and/or verify the validity of
existing data as cited. Only existing
uses for each active ingredient in
the combination product. (6)(7)
----------------------------------------------------------------------------------------------------------------
M006 207 Request for up to 5 letters of 1 277
certification (Gold Seal) for one
actively registered product (excludes
distributor products). (8)
----------------------------------------------------------------------------------------------------------------
M007 208 Request to extend Exclusive Use of 12 5,513
data as provided by FIFRA Section
3(c)(1)(F)(ii).
----------------------------------------------------------------------------------------------------------------
[[Page 133 STAT. 577]]
M008 209 Request to grant Exclusive Use of data 15 1,654
as provided by FIFRA Section
3(c)(1)(F)(vi) for a minor use, when
a FIFRA Section 2(ll)(2)
determination is required.
----------------------------------------------------------------------------------------------------------------
M009 210 (new) Non-FIFRA Regulated Determination: 4 2,363
Applicant initiated, per product.
----------------------------------------------------------------------------------------------------------------
M010 211 (new) Conditional ruling on pre-application, 4 2,363
product substantial similarity.
----------------------------------------------------------------------------------------------------------------
M011 212 (new) Label amendment to add the DfE logo; 4 3,648
requires data review; no other label
changes. (9)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
each application will be subject to its respective registration service fee. The decision review time line for
both submissions will be the longest of the associated applications. If the application covers multiple
ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
the data for such clearance of such product is not subject to a registration service fee for the tolerance
action for two years from the effective date of the rule.
[[Page 133 STAT. 578]]
(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.''.
''.SEC. 7. <<NOTE: Time periods. Regulations.>> AGRICULTURAL
WORKER PROTECTION STANDARD; CERTIFICATION OF
PESTICIDE APPLICATORS.
(a) In General <<NOTE: 7 USC 136w note.>> .--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 <<NOTE: Deadline. Notice. Public comments. 7 USC 136w
note.>> .--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,
[[Page 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) <<NOTE: Study.>> 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) <<NOTE: Public information. Recommenda- tions.>> 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.
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.
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