S483 ENR: Pesticide Registration Improvement Extension Act of 2018
U.S. Senate
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.
Short title; table of contents
(a)
This Act may be cited as the Pesticide Registration Improvement Extension Act of 2018
.
(b)
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.
2.
Extension and modification of maintenance
fee authority
(a)
Section 4(i)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(1)) is amended—
(1)
in subparagraph (C), by striking an aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017
and inserting an average amount of $31,000,000 for each of fiscal years 2019 through 2023
;
(2)
in subparagraph (D)— (A) in clause (i), by striking $115,500 for each of fiscal years 2013 through 2017
and inserting $129,400 for each of fiscal years 2019 through 2023
; and
(B)
in clause (ii), by striking $184,800 for each of fiscal years 2013 through 2017
and inserting $207,000 for each of fiscal years 2019 through 2023
;
(3)
in subparagraph (E)(i)— (A) in subclause (I), by striking $70,600 for each of fiscal years 2013 through 2017
and inserting $79,100 for each of fiscal years 2019 through 2023
; and
(B)
in subclause (II), by striking $122,100 for each of fiscal years 2013 through 2017
and inserting $136,800 for each of fiscal years 2019 through 2023
; and
(4)
in subparagraph (I), by striking 2017..
and inserting 2023.
.
(b)
Prohibition on other fees
Section 4(i)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(2)) is amended—
(1)
by striking the date of enactment of this section and ending on September 30, 2019
and inserting the effective date of the Pesticide Registration Improvement Extension Act of 2018 and ending on September 30, 2025
; and
(2)
by inserting after registration of a pesticide under this Act
the following: or any other action covered under a table specified in section 33(b)(3),
.
(c)
Extension of prohibition on tolerance
fees
Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking 2017
and inserting 2023
.
3.
Reregistration and Expedited Processing
Fund
(a)
Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(2)(A)) is amended—
(1)
in the first sentence, by striking the fund
and inserting the Reregistration and Expedited Processing Fund
;
(2)
by striking paragraph (3),
in the first sentence and all that follows through the period at the end of the second sentence and inserting the following: paragraph (3), to offset the costs of registration review under section 3(g), including the costs associated with any review under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part of the registration review, to offset the costs associated with tracking and implementing registration review decisions, including registration review decisions designed to reduce risk, for the purposes specified in paragraphs (4) and (5), and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions.
;
(3)
in clause (i), by striking are allocated solely
and all that follows through 3(g);
and inserting the following: are allocated solely for the purposes specified in the first sentence of this subparagraph;
; and
(4)
in clause (ii), by striking necessary to achieve
and all that follows through 3(g);
and inserting the following: necessary to achieve the purposes specified in the first sentence of this subparagraph;
.
(b)
Set-Aside for review of inert
ingredients and expedited processing of similar
applications
Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is amended, in the matter preceding clause (i), by striking The Administrator shall use
and all that follows through personnel and resources—
and inserting the following: For each of fiscal years 2018 through 2023, the Administrator shall use between 1/9 and 1/8 of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources—
.
(c)
Set-Aside for Expedited Rulemaking and
Guidance Development for certain purposes
Paragraph (4) of section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended to read as follows:
(4)
Expedited rulemaking and
guidance development for certain product
performance data
requirements
(A)
For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).
(B)
Products claiming efficacy
against invertebrate pests of
significant public health or economic
importance
The Administrator shall use amounts made available under subparagraph (A) to develop, receive comments with respect to, finalize, and implement the necessary rulemaking and guidance for product performance data requirements to evaluate products claiming efficacy against the following invertebrate pests of significant public health or economic importance (in order of importance):
(i)
Bed bugs. (ii) Premise (including crawling insects, flying insects, and baits).
(iii)
Pests of pets (including pet pests controlled by spot-ons, collars, shampoos, powders, or dips).
(iv)
Fire ants. (C) 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)
The Administrator shall revise the guidance required by subparagraph (B) from time to time, but shall permit applicants and registrants sufficient time to obtain data that meet the requirements specified in such revised guidance.
(E)
Deadline for product
performance data requirements
The Administrator shall, not later than September 30, 2021, issue regulations prescribing product performance data requirements for any pesticide intended for preventing, destroying, repelling, or mitigating any invertebrate pest of significant public health or economic importance specified in clauses (i) through (iv) of subparagraph (B).
.
(d)
Set-Aside for Good laboratory practices
inspections
Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended—
(1)
by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively;
(2)
by inserting after paragraph (4) the following new paragraph:
(5)
Good laboratory practices
inspections
(A)
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)
The Administrator shall use amounts made available under subparagraph (A) for enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations), with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under this Act. As part of such monitoring program, the Administrator shall make available to each laboratory inspected under such program in support of such registrations a preliminary summary of inspection observations not later than 60 days after the date on which such an inspection is completed.
; and
(3)
in paragraph (7), as so redesignated, by striking paragraphs (2), (3), and (4)
and inserting paragraphs (2), (3), (4), and (5)
.
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
.
5.
Pesticide registration service fees
(a)
Extension and modification of fee
authority
Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
(1)
in paragraph (2)— (A) in the heading, by striking pesticide registration
; and
(B)
in subparagraph (A), by inserting or for any other action covered by a table specified in paragraph (3)
after covered by this Act that is received by the Administrator on or after the effective date of the Pesticide Registration Improvement Act of 2003
;
(2)
in paragraph (5)— (A) in the heading, by striking pesticide registration applications
and inserting covered applications
; and
(B)
by striking pesticide registration application
both places it appears and inserting covered application
;
(3)
in paragraph (6)— (A) in subparagraph (A)—
(i)
by striking pesticide registration
; and
(ii)
by striking October 1, 2013, and ending on September 30, 2015
and inserting October 1, 2019, and ending on September 30, 2021
;
(B)
in subparagraph (B)— (i) by striking pesticide registration
; and
(ii)
by striking 2015
each place it appears and inserting 2021
; and
(C)
in subparagraph (C), by striking revised registration service fee schedules
and inserting service fee schedules revised pursuant to this paragraph
;
(4)
in paragraph (7)— (A) in subparagraph (A)—
(i)
by striking covered pesticide registration
and inserting covered application
; and
(ii)
by inserting before the period at the end the following: , except that no waiver or fee reduction shall be provided in connection with a request for a letter of certification (commonly referred to as a Gold Seal letter)
; and
(B)
in subparagraph (F)(i), by striking pesticide registration
; and
(5)
in paragraph (8)— (A) in subparagraph (A), by striking pesticide registration
;
(B)
in subparagraph (B)(i), by striking pesticide registration
; and
(C)
in subparagraph (C)— (i) in clause (i), by striking pesticide registration
and inserting covered
; and
(ii)
in clause (ii)(I), by striking pesticide registration
and inserting covered
.
(b)
Pesticide registration fund set-Asides
for worker protection, partnership grants, and pesticide
safety
education
Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)(3)(B)) is amended—
(1)
in the heading, by inserting , partnership grants, and pesticide safety education
after Worker protection
;
(2)
in clause (i)— (A) by striking 2017
and inserting 2023
; and
(B)
by inserting before the period at the end the following:, with an emphasis on field-worker populations in the United States
;
(3)
in clause (ii), by striking 2017
and inserting 2023
; and
(4)
in clause (iii), by striking 2017
and inserting 2023
.
(c)
Reforms To reduce decision time review
periods
Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amended—
(1)
by striking Pesticide Registration Improvement Extension Act of 2012
and inserting Pesticide Registration Improvement Extension Act of 2018
; and
(2)
by inserting at the end the following new sentence: Such reforms shall include identifying opportunities for streamlining review processes for applications for a new active ingredient or a new use and providing prompt feedback to applicants during such review process.
.
(d)
Decision time review periods
Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—
(1)
in paragraph (1)— (A) by striking Pesticide Registration Improvement Extension Act of 2012
and inserting Pesticide Registration Improvement Extension Act of 2018
; and
(B)
by inserting after covered pesticide registration actions
the following: or for any other action covered by a table specified in subsection (b)(3)
;
(2)
in paragraph (3), by striking subparagraph (C) and inserting the following new subparagraph:
(C)
applications for any other action covered by a table specified in subsection (b)(3).
; and
(3)
in paragraph (4)(A)— (A) by striking a pesticide registration application
and inserting a covered application
; and
(B)
by striking covered pesticide registration application
and inserting covered application
.
(e)
Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
(1)
in paragraph (1) by striking 2017
and inserting 2023
; and
(2)
in paragraph (2)— (A) in subparagraph (D), by striking clause (i) and inserting the following new clause:
(i)
the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—
(I)
the number of cases cancelled;
(II)
the number of cases requiring risk mitigation measures;
(III)
the number of cases removing risk mitigation measures;
(IV)
the number of cases with no risk mitigation needed; and
(V)
the number of cases in which risk mitigation has been fully implemented;
;
(B)
in subparagraph (G)— (i) in clause (i)—
(I)
by striking section 4(k)(4)
and inserting paragraphs (4) and (5) of section 4(k)
; and
(II)
by striking that section
and inserting such paragraphs
;
(ii)
by striking clauses (ii), (iii), (iv), (v), and (vi);
(iii)
by inserting after clause (i) the following new clause:
(ii)
implementing enhancements to—
(I)
the electronic tracking of covered applications;
(II)
the electronic tracking of conditional registrations;
(III)
the endangered species database;
(IV)
the electronic review of labels submitted with covered applications; and
(V)
the electronic review and assessment of confidential statements of formula submitted with covered applications; and
; and
(iv)
by redesignating clause (vii) as clause (iii);
(C)
in subparagraph (I), by striking and
at the end;
(D)
in subparagraph (J), by striking the period at the end and inserting a semicolon; and
(E)
by adding at the end the following new subparagraphs:
(K)
a review of the progress made in developing, updating, and implementing product performance test guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and, by regulation, prescribing product performance data requirements for such pesticide products registered under section 3;
(L)
a review of the progress made in the priority review and approval of new pesticides to control invertebrate public health pests that may transmit vector-borne disease for use in the United States, including each territory or possession of the United States, and United States military installations globally;
(M)
a review of the progress made in implementing enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations);
(N)
the number of approvals for active ingredients, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency; and
(O)
with respect to funds in the Pesticide Registration Fund reserved under subsection (c)(3), a review that includes—
(i)
a description of the amount and use of such funds—
(I)
to carry out activities relating to worker protection under clause (i) of subsection (c)(3)(B);
(II)
to award partnership grants under clause (ii) of such subsection; and
(III)
to carry out the pesticide safety education program under clause (iii) of such subsection;
(ii)
an evaluation of the appropriateness and effectiveness of the activities, grants, and program described in clause (i);
(iii)
a description of how stakeholders are engaged in the decision to fund such activities, grants, and program; and
(iv)
with respect to activities relating to worker protection carried out under subparagraph (B)(i) of such subsection, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.
.
(f)
Termination of effectiveness
Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
(1)
in paragraph (1), by striking 2017
and inserting 2023
; and
(2)
in paragraph (2)— (A) in subparagraph (A)—
(i)
by striking Fiscal year 2018.—During fiscal year 2018
and inserting Fiscal year 2024.—During fiscal year 2024
; and
(ii)
by striking 2017
and inserting 2023
;
(B)
in subparagraph (B)— (i) by striking Fiscal year 2019.—During fiscal year 2019
and inserting Fiscal year 2025.—During fiscal year 2025
; and
(ii)
by striking 2017
and inserting 2023
;
(C)
in subparagraph (C), by striking September 30, 2019.—Effective September 30, 2019
and inserting September 30, 2025.—Effective September 30, 2025
; and
(D)
in subparagraph (D), by striking 2017
both places it appears and inserting 2023
.
6.
Revision of tables regarding covered
pesticide registration applications and other covered actions and
their
corresponding registration service fees
Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended to read as follows:
(3)
Schedule of covered applications and
other actions and their registration service fees
Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:
TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE INGREDIENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
R010
1
New Active Ingredient, Food use. (2)(3)
24
753,082
R020
2
New Active Ingredient, Food use; reduced risk.
(2)(3)
18
627,568
R040
3
New Active Ingredient, Food use; Experimental Use Permit
application;
establish temporary tolerance; submitted before
application for
registration; credit 45% of fee toward new
active ingredient
application that follows. (3)
18
462,502
R060
4
New Active Ingredient, Non-food use; outdoor.
(2)(3)
21
523,205
R070
5
New Active Ingredient, Non-food use; outdoor; reduced risk.
(2)(3)
16
436,004
R090
6
New Active Ingredient, Non-food use; outdoor; Experimental
Use Permit
application; submitted before application for
registration;
credit 45% of fee toward new active ingredient
application that
follows. (3)
16
323,690
R110
7
New Active Ingredient, Non-food use; indoor. (2)(3)
20
290,994
R120
8
New Active Ingredient, Non-food use; indoor; reduced risk.
(2)(3)
14
242,495
R121
9
New Active Ingredient, Non-food use; indoor; Experimental
Use Permit
application; submitted before application for
registration;
credit 45% of fee toward new active ingredient
application that
follows. (3)
18
182,327
R122
10
Enriched isomer(s) of registered mixed-isomer active
ingredient. (2)(3)
18
317,128
R123
11
New Active Ingredient, Seed treatment only; includes
agricultural and
non-agricultural seeds; residues not
expected in raw
agricultural commodities. (2)(3)
18
471,861
R125
12
New Active Ingredient, Seed treatment; Experimental Use
Permit application;
submitted before application for
registration;
credit 45% of fee toward new active ingredient
application that
follows. (3)
16
323,690
TABLE 2. — REGISTRATION DIVISION — NEW USES
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(4) Amendment
applications to add
the new use(s) to registered product
labels are covered
by the base fee for the new use(s). All
items in the
covered application must be submitted together
in one package.
Each application for an additional new
product
registration and new inert approval(s) that is
submitted in the
new use application package is subject to
the registration
service fee for a new product or a new
inert approval.
However, if a new use application only
proposes to
register the new use for a new product and there
are no amendments
in the application, then review of one new
product application
is covered by the new use fee. All such
associated
applications that are submitted together will be
subject to the new
use decision review time. Any application
for a new product
or an amendment to the proposed labeling
(a) submitted
subsequent to submission of the new use
application and (b)
prior to conclusion of its decision
review time and (c)
containing the same new uses, will be
deemed a separate
new-use application, subject to a separate
registration
service fee and new decision review time for a
new use. If the
new-use application includes non-food
(indoor and/or
outdoor), and food (outdoor and/or indoor)
uses, the
appropriate fee is due for each type of new use
and the longest
decision review time applies to all of the
new uses requested
in the application. Any information that
(a) was neither
requested nor required by the Agency, and
(b) is submitted by
the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screen, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new use
application.
R130
13
First food use; indoor; food/food handling. (2) (3)
21
191,444
R140
14
Additional food use; Indoor; food/food handling. (3)
(4)
15
44,672
R150
15
First food use. (2)(3)
21
317,104
R155
16 (new)
First food use, Experimental Use Permit application; a.i.
registered for
non-food outdoor use. (3)(4)
21
264,253
R160
17
First food use; reduced risk. (2)(3)
16
264,253
R170
18
Additional food use. (3) (4)
15
79,349
R175
19
Additional food uses covered within a crop group resulting
from the conversion
of existing approved crop group(s) to
one or more revised
crop groups. (3)(4)
10
66,124
R180
20
Additional food use; reduced risk. (3)(4)
10
66,124
R190
21
Additional food uses; 6 or more submitted in one
application. (3)(4)
15
476,090
R200
22
Additional Food Use; 6 or more submitted in one
application;
Reduced Risk. (3)(4)
10
396,742
R210
23
Additional food use; Experimental Use Permit application;
establish temporary
tolerance; no credit toward new use
registration.
(3)(4)
12
48,986
R220
24
Additional food use; Experimental Use Permit application;
crop destruct
basis; no credit toward new use registration.
(3)(4)
6
19,838
R230
25
Additional use; non-food; outdoor. (3) (4)
15
31,713
R240
26
Additional use; non-food; outdoor; reduced risk.
(3)(4)
10
26,427
R250
27
Additional use; non-food; outdoor; Experimental Use Permit
application; no
credit toward new use registration.
(3)(4)
6
19,838
R251
28
Experimental Use Permit application which requires no
changes to the
tolerance(s); non-crop destruct basis.
(3)
8
19,838
R260
29
New use; non-food; indoor. (3) (4)
12
15,317
R270
30
New use; non-food; indoor; reduced risk. (3)(4)
9
12,764
R271
31
New use; non-food; indoor; Experimental Use Permit
application; no
credit toward new use registration.
(3)(4)
6
9,725
R273
32
Additional use; seed treatment; limited uptake into Raw
Agricultural
Commodities; includes crops with established
tolerances (e.g.,
for soil or foliar application); includes
food and/or
non-food uses. (3)(4)
12
50,445
R274
33
Additional uses; seed treatment only; 6 or more submitted
in one application;
limited uptake into raw agricultural
commodities;
includes crops with established tolerances
(e.g., for soil or
foliar application); includes food and/or
non-food uses.
(3)(4)
12
302,663
TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER
TOLERANCES
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service
Fee ($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(4) Amendment
applications to add
the revised use pattern(s) to registered
product labels are
covered by the base fee for the category.
All items in the
covered application must be submitted
together in one
package. Each application for an additional
new product
registration and new inert approval(s) that is
submitted in the
amendment application package is subject to
the registration
service fee for a new product or a new
inert approval.
However, if an amendment application only
proposes to
register the amendment for a new product and
there are no
amendments in the application, then review of
one new product
application is covered by the base fee. All
such associated
applications that are submitted together
will be subject to
the category decision review
time.
R280
34
Establish import tolerance; new active ingredient or first
food use. (2)
21
319,072
R290
35
Establish Import tolerance; Additional new food
use.
15
63,816
R291
36
Establish import tolerances; additional food uses; 6 or
more crops
submitted in one petition.
15
382,886
R292
37
Amend an established tolerance (e.g., decrease or increase)
and/or harmonize
established tolerances with Codex MRLs;
domestic or import;
applicant-initiated.
11
45,341
R293
38
Establish tolerance(s) for inadvertent residues in one
crop;
applicant-initiated.
12
53,483
R294
39
Establish tolerances for inadvertent residues; 6 or more
crops submitted in
one application;
applicant-initiated.
12
320,894
R295
40
Establish tolerance(s) for residues in one rotational crop
in response to a
specific rotational crop application;
submission of
corresponding label amendments which specify
the necessary
plant-back restrictions; applicant-initiated.
(3) (4)
15
66,124
R296
41
Establish tolerances for residues in rotational crops in
response to a
specific rotational crop petition; 6 or more
crops submitted in
one application; submission of
corresponding label
amendments which specify the necessary
plant-back
restrictions; applicant-initiated. (3)
(4)
15
396,742
R297
42
Amend 6 or more established tolerances (e.g., decrease or
increase) in one
petition; domestic or import;
applicant-initiated.
11
272,037
R298
43
Amend an established tolerance (e.g., decrease or
increase); domestic
or import; submission of corresponding
amended labels
(requiring science review). (3) (4)
13
58,565
R299
44
Amend 6 or more established tolerances (e.g., decrease or
increase); domestic
or import; submission of corresponding
amended labels
(requiring science review). (3) (4)
13
285,261
TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) An application for
a new end-use
product using a source of active ingredient
that (a) is not yet
registered but (b) has an application
pending with the
Agency for review, will be considered an
application for a
new product with an unregistered source of
active ingredient.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(4) For the purposes
of classifying
proposed registration actions into PRIA
categories,
“pest(s) requiring efficacy” are: public health
pests listed in PR
Notice 2002–1, livestock pests (e.g. Horn
flies, Stable
flies), wood-destroying pests (e.g. termites,
carpenter ants,
wood-boring beetles) and certain invasive
species (e.g. Asian
Longhorned beetle, Emerald Ashborer).
This list may be
updated/refined as invasive pest needs
arise. To determine
the number of pests for the PRIA
categories, pests
have been placed into groups (general;
e.g., cockroaches)
and pest specific (specifically a test
species). If
seeking a label claim against a pest group
(general), use the
group listing below and each group will
count as 1. The
general pests groups are: mites, dust mites,
chiggers, ticks,
hard ticks, soft ticks, cattle ticks,
scorpions, spiders,
centipedes, lice, fleas, cockroaches,
keds, bot flies,
screwworms, filth flies, blow flies, house
flies, flesh flies,
mosquitoes, biting flies, horse flies,
stable flies, deer
flies, sand flies, biting midges, black
flies, true bugs,
bed bugs, stinging bees, wasps, yellow
jackets, hornets,
ants (excluding carpenter ants), fire and
harvester ants,
wood destroying beetles, carpenter ants,
termites,
subterranean termites, dry wood termites, arboreal
termites, damp wood
termites and invasive species. If
seeking a claim
against a specific pest without a general
claim then each
specific pest will count as 1.
R300
45
New
product; or similar
combination product (already registered)
to an identical or
substantially similar in composition and
use to a registered
product; registered source of active
ingredient; no data
review on acute toxicity, efficacy or
CRP – only product
chemistry data; cite-all data citation,
or selective data
citation where applicant owns all required
data, or applicant
submits specific authorization letter
from data owner.
Category also includes 100% re-package of
registered end-use
or manufacturing-use product that
requires no data
submission nor data matrix. (2)(3)
4
1,582
R301
46
New product; or similar combination product (already
registered) to an
identical or substantially similar in
composition and use
to a registered product; registered
source of active
ingredient; selective data citation only
for data on product
chemistry and/or acute toxicity and/or
public health pest
efficacy (identical data citation and
claims to cited
product(s)), where applicant does not own
all required data
and does not have a specific authorization
letter from data
owner. (2)(3)
4
1,897
R310
47
New end-use or manufacturing-use product with registered
source(s) of active
ingredient(s); includes products
containing two or
more registered active ingredients
previously combined
in other registered products; excludes
products requiring
or citing an animal safety study;
requires review of
data package within RD only; includes
data and/or waivers
of data for only:• product
chemistry and/or• acute toxicity
and/or• child resistant packaging
and/or• pest(s) requiring efficacy (4) - for up
to 3 target pests.
(2)(3)
7
7,301
R314
48
New end use product containing up to three registered
active ingredients
never before registered as this
combination in a
formulated product; new product label is
identical or
substantially similar to the labels of
currently
registered products which separately contain the
respective
component active ingredients; excludes products
requiring or citing
an animal safety study; requires review
of data package
within RD only; includes data and/or waivers
of data for only:• product chemistry
and/or• acute toxicity and/or •
child resistant
packaging and/or• pest(s)
requiring efficacy
(4) - for up to 3 target pests.
(2)(3)
8
8,626
R319
49
New end use product containing up to three registered
active ingredients
never before registered as this
combination in a
formulated product; new product label is
identical or
substantially similar to the labels of
currently
registered products which separately contain the
respective
component active ingredients; excludes products
requiring or citing
an animal safety study; requires review
of data package
within RD only; includes data and/or waivers
of data for only:• product chemistry
and/or• acute toxicity and/or •
child resistant
packaging and/or• pest(s)
requiring efficacy
(4) - for 4 to 7 target pests.
(2)(3)
10
12,626
R318
50 (new)
New end use product containing four or more registered
active ingredients
never before registered as this
combination in a
formulated product; new product label is
identical or
substantially similar to the labels of
currently
registered products which separately contain the
respective
component active ingredients; excludes products
requiring or citing
an animal safety study; requires review
of data package
within RD only; includes data and/or waivers
of data for only:• product chemistry
and/or• acute toxicity and/or• child
resistant packaging
and/or• pest(s) requiring
efficacy (4) - for
up to 3 target pests. (2)(3)
9
13,252
R321
51 (new)
New end use product containing four or more registered
active ingredients
never before registered as this
combination in a
formulated product; new product label is
identical or
substantially similar to the labels of
currently
registered products which separately contain the
respective
component active ingredients; excludes products
requiring or citing
an animal safety study; requires review
of data package
within RD only; includes data and/or waivers
of data for only:• product chemistry
and/or• acute toxicity and/or• child
resistant packaging
and/or• pest(s) requiring
efficacy (4) - for
4 to 7 target pests. (2)(3)
11
17,252
R315
52
New end-use, on-animal product, registered source of active
ingredient(s), with
the submission of data and/or waivers
for only:• animal safety and•
pest(s) requiring
efficacy (4) and/or• product
chemistry and/or• acute toxicity and/or
• child resistant packaging. (2) (3)
9
9,820
R316
53 (new)
New end-use or manufacturing product with registered
source(s) of active
ingredient(s) including products
containing two or
more registered active ingredients
previously combined
in other registered products; excludes
products requiring
or citing an animal safety study; and
requires review of
data and/or waivers for
only:• product chemistry and/or•
acute toxicity
and/or • child resistant
packaging and/or• pest(s) requiring efficacy (4)
- for greater than
3 and up to 7 target pests.
(2)(3)
9
11,301
R317
54 (new)
New end-use or manufacturing product with registered
source(s) of active
ingredient(s) including products
containing 2 or
more registered active ingredients
previously combined
in other registered products; excludes
products requiring
or citing an animal safety study; and
requires review of
data and/or waivers for
only:• product chemistry and/or•
acute toxicity
and/or • child resistant
packaging and/or• pest(s) requiring efficacy (4)
- for greater than
7 target pests. (2)(3)
10
15,301
R320
55
New product; new physical form; requires data review in
science divisions.
(2)(3)
12
13,226
R331
56
New product; repack of identical registered end-use product
as a
manufacturing-use product, or identical registered
manufacturing-use
product as an end use product; same
registered uses
only. (2)(3)
3
2,530
R332
57
New manufacturing-use product; registered active
ingredient;
unregistered source of active ingredient;
submission of
completely new generic data package;
registered uses
only; requires review in RD and science
divisions. (2)(3)
24
283,215
R333
58
New product; MUP or End use product with unregistered
source of active
ingredient; requires science data review;
new physical form;
etc. Cite-all or selective data citation
where applicant
owns all required data. (2)(3)
10
19,838
R334
59
New product; MUP or End use product with unregistered
source of the
active ingredient; requires science data
review; new
physical form; etc. Selective data citation.
(2)(3)
11
23,100
TABLE 5. — REGISTRATION DIVISION — AMENDMENTS
EPA No.
New CR
No.
Action
Decision Review Time
(Months)(1)
Registration Service
Fee ($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) (a) EPA-initiated
amendments shall
not be charged registration service fees.
(b)
Registrant-initiated fast-track amendments are to be
completed within
the timelines specified in FIFRA Section
3(c)(3)(B) and are
not subject to registration service fees.
(c)
Registrant-initiated fast-track amendments handled by
the Antimicrobials
Division are to be completed within the
timelines specified
in FIFRA Section 3(h) and are not
subject to
registration service fees. (d) Registrant
initiated
amendments submitted by notification under PR
Notices, such as PR
Notice 98–10, continue under PR Notice
timelines and are
not subject to registration service fees.
(e) Submissions
with data and requiring data review are
subject to
registration service fees.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(4) For the purposes
of classifying
proposed registration actions into PRIA
categories,
“pest(s) requiring efficacy” are: public health
pests listed in PR
Notice 2002–1, livestock pests (e.g. Horn
flies, Stable
flies), wood-destroying pests (e.g. termites,
carpenter ants,
wood-boring beetles) and certain invasive
species (e.g. Asian
Longhorned beetle, Emerald Ashborer).
This list may be
updated/refined as invasive pest needs
arise. To determine
the number of pests for the PRIA
categories, pests
have been placed into groups (general;
e.g., cockroaches)
and pest specific (specifically a test
species). If
seeking a label claim against a pest group
(general), use the
group listing below and each group will
count as 1. The
general pests groups are: mites, dust mites,
chiggers, ticks,
hard ticks, soft ticks, cattle ticks,
scorpions, spiders,
centipedes, lice, fleas, cockroaches,
keds, bot flies,
screwworms, filth flies, blow flies, house
flies, flesh flies,
mosquitoes, biting flies, horse flies,
stable flies, deer
flies, sand flies, biting midges, black
flies, true bugs,
bed bugs, stinging bees, wasps, yellow
jackets, hornets,
ants (excluding carpenter ants), fire and
harvester ants,
wood destroying beetles, carpenter ants,
termites,
subterranean termites, dry wood termites, arboreal
termites, damp wood
termites and invasive species. If
seeking a claim
against a specific pest without a general
claim then each
specific pest will count as 1.
R340
60
Amendment requiring data review within RD (e.g., changes to
precautionary label
statements); includes adding/modifying
pest(s) claims for
up to 2 target pests, excludes products
requiring or citing
an animal safety study.
(2)(3)(4)
4
4,988
R341
61 (New)
Amendment requiring data review within RD (e.g., changes to
precautionary label
statements), includes adding/modifying
pest(s) claims for
greater than 2 target pests, excludes
products requiring
or citing an animal safety study.
(2)(3)(4)
6
5,988
R345
62
Amending on-animal products previously registered, with the
submission of data
and/or waivers for only: •
animal safety and• pest(s) requiring efficacy
(4) and/or• product chemistry
and/or• acute toxicity and/or •
child resistant
packaging. (2)(3)
7
8,820
R350
63
Amendment requiring data review in science divisions (e.g.,
changes to REI, or
PPE, or PHI, or use rate, or number of
applications; or
add aerial application; or modify GW/SW
advisory
statement). (2)(3)
9
13,226
R351
64
Amendment adding a new unregistered source of active
ingredient. (2)(3)
8
13,226
R352
65
Amendment adding already approved uses; selective method of
support; does not
apply if the applicant owns all cited
data. (2) (3)
8
13,226
R371
66
Amendment to Experimental Use Permit; (does not include
extending a
permit's time period). (3)
6
10,090
TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS
EPA No.
New CR
No.
Action
Decision Review Time
(Months)(1)
Registration Service
Fee ($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
R124
67
Conditional Ruling on Pre-application Study Waivers;
applicant-initiated.
6
2,530
R272
68
Review of Study Protocol applicant-initiated; excludes
DART,
pre-registration conference, Rapid Response review,
DNT protocol
review, protocol needing HSRB review.
3
2,530
R275
69
Rebuttal of agency reviewed protocol, applicant
initiated.
3
2,530
R370
70
Cancer reassessment; applicant-initiated.
18
198,250
TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service
Fee ($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
A380
71
New Active Ingredient; Indirect Food use; establish
tolerance or
tolerance exemption if required. (2)(3)
24
137,841
A390
72
New Active Ingredient; Direct Food use; establish tolerance
or tolerance
exemption if required. (2)(3)
24
229,733
A410
73
New Active Ingredient Non-food use.(2)(3)
21
229,733
A431
74
New Active Ingredient, Non-food use; low-risk.
(2)(3)
12
80,225
TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service
Fee ($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) If EPA data rules
are amended to
newly require clearance under section 408 of
the FFDCA for an
ingredient of an antimicrobial product
where such
ingredient was not previously subject to such a
clearance, then
review of the data for such clearance of
such product is not
subject to a registration service fee
for the tolerance
action for two years from the effective
date of the rule.
(4) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(5) Amendment
applications to add
the new use(s) to registered product
labels are covered
by the base fee for the new use(s). All
items in the
covered application must be submitted together
in one package.
Each application for an additional new
product
registration and new inert approval(s) that is
submitted in the
new use application package is subject to
the registration
service fee for a new product or a new
inert approval.
However, if a new use application only
proposes to
register the new use for a new product and there
are no amendments
in the application, then review of one new
product application
is covered by the new use fee. All such
associated
applications that are submitted together will be
subject to the new
use decision review time. Any application
for a new product
or an amendment to the proposed labeling
(a) submitted
subsequent to submission of the new use
application and (b)
prior to conclusion of its decision
review time and (c)
containing the same new uses, will be
deemed a separate
new-use application, subject to a separate
registration
service fee and new decision review time for a
new use. If the
new-use application includes non-food
(indoor and/or
outdoor), and food (outdoor and/or indoor)
uses, the
appropriate fee is due for each type of new use
and the longest
decision review time applies to all of the
new uses requested
in the application. Any information that
(a) was neither
requested nor required by the Agency, and
(b) is submitted by
the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screen, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new use
application.
A440
75
New Use, Indirect Food Use, establish tolerance or
tolerance
exemption. (2)(3)(4)
21
31,910
A441
76
Additional Indirect food uses; establish tolerances or
tolerance
exemptions if required; 6 or more submitted in one
application.
(3)(4)(5)
21
114,870
A450
77
New use, Direct food use, establish tolerance or tolerance
exemption.
(2)(3)(4)
21
95,724
A451
78
Additional Direct food uses; establish tolerances or
tolerance
exemptions if required; 6 or more submitted in one
application.
(3)(4)(5)
21
182,335
A500
79
New use, non-food. (4)(5)
12
31,910
A501
80
New use, non-food; 6 or more submitted in one application.
(4)(5)
15
76,583
TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND
AMENDMENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) An application for
a new end-use
product using a source of active ingredient
that (a) is not yet
registered but (b) has an application
pending with the
Agency for review, will be considered an
application for a
new product with an unregistered source of
active ingredient.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(4)(a) EPA-initiated
amendments shall
not be charged registration service fees.
(b)
Registrant-initiated fast-track amendments are to be
completed within
the timelines specified in FIFRA Section
3(c)(3)(B) and are
not subject to registration service fees.
(c)
Registrant-initiated fast-track amendments handled by
the Antimicrobials
Division are to be completed within the
timelines specified
in FIFRA Section 3(h) and are not
subject to
registration service fees. (d) Registrant
initiated
amendments submitted by notification under PR
Notices, such as PR
Notice 98–10, continue under PR Notice
timelines and are
not subject to registration service fees.
(e) Submissions
with data and requiring data review are
subject to
registration service fees.
(5) The applicant must
identify the
substantially similar product if opting to use
cite-all or the
selective method to support acute toxicity
data requirements.
(6) Once a submission
for a new product
with public health organisms has been
submitted and
classified in either A540 or A541, additional
organisms submitted
for the same product before expiration
of the first
submission’s original decision review time
period will result
in reclassification of both the original
and subsequent
submission into the appropriate new category
based on the sum of
the number 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.
A530
81
New product,
identical or substantially similar in
composition and use
to a registered product; no data review
or only product
chemistry data; cite all data citation or
selective data
citation where applicant owns all required
data; or applicant
submits specific authorization letter
from data owner.
Category also includes 100% re-package of
registered end-use
or manufacturing use product that
requires no data
submission nor data matrix. (2)(3)
4
1,278
A531
82
New product;
identical or substantially similar in
composition and use
to a registered product; registered
source of active
ingredient: selective data citation only
for data on product
chemistry and/or acute toxicity and/or
public health pest
efficacy, where applicant does not own
all required data
and does not have a specific authorization
letter from data
owner. (2)(3)
4
1,824
A532
83
New product; identical or substantially similar in
composition and use
to a registered product; registered
active ingredient;
unregistered source of active ingredient;
cite-all data
citation except for product chemistry; product
chemistry data
submitted. (2)(3)
5
5,107
A540
84
New end use
product; FIFRA §2(mm) uses only; up to 25 public
health organisms.
(2)(3)(5)(6)
5
5,107
A541
85 (new)
New end use
product; FIFRA §2(mm) uses only; 26–50 public
health organisms.
(2)(3)(5)(6)
7
8,500
A542
86 (new)
New end use
product; FIFRA §2(mm) uses only; ≥ 51 public
health organisms.
(2)(3)(5)
10
15,000
A550
87
New end-use
product; uses other than FIFRA §2(mm); non-FQPA
product. (2)(3)(5)
9
13,226
A560
88
New manufacturing
use product; registered active ingredient;
selective data
citation. (2)(3)
6
12,596
A565
89 (new)
New
manufacturing-use product; registered active ingredient;
unregistered source
of active ingredient; submission of new
generic data
package; registered uses only; requires science
review. (2)(3)
12
18,234
A570
90
Label amendment
requiring data review; up to 25 public
health organisms.
(3)(4)(5)(6)
4
3,831
A573
91 (new)
Label amendment
requiring data review; 26–50 public health
organisms.
(2)(3)(5)(7)
6
6,350
A574
92 (new)
Label amendment
requiring data review; ≥ 51 public health
organisms.
(2)(3)(5)(7)
9
11,000
A572
93
New Product or amendment requiring data review for risk
assessment by
Science Branch (e.g., changes to REI, or PPE,
or use rate).
(2)(3)(4)
9
13,226
TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND
OTHER ACTIONS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(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.
A520
94
Experimental Use
Permit application, non-food use. (2)
9
6,383
A521
95
Review of public health efficacy study protocol within AD,
per AD Internal
Guidance for the Efficacy Protocol Review
Process; Code will
also include review of public health
efficacy study
protocol and data review for devices making
pesticidal claims;
applicant-initiated; Tier 1.
4
4,726
A522
96
Review of public
health efficacy study protocol outside AD
by members of AD
Efficacy Protocol Review Expert Panel; Code
will also include
review of public health efficacy study
protocol and data
review for devices making pesticidal
claims;
applicant-initiated; Tier 2.
12
12,156
A537
97 (new)
New Active
Ingredient/New Use, Experimental Use Permit
application; Direct
food use; Establish tolerance or
tolerance exemption
if required. Credit 45% of fee toward
new active
ingredient/new use application that
follows.
18
153,156
A538
98 (new)
New Active
Ingredient/New Use, Experimental Use Permit
application;
Indirect food use; Establish tolerance or
tolerance exemption
if required Credit 45% of fee toward new
active
ingredient/new use application that follows.
18
95,724
A539
99 (new)
New Active
Ingredient/New Use, Experimental Use Permit
application;
Nonfood use. Credit 45% of fee toward new
active
ingredient/new use application that follows.
15
92,163
A529
100
Amendment to
Experimental Use Permit; requires data review
or risk assessment.
(2)
9
11,429
A523
101
Review of protocol
other than a public health efficacy study
(i.e., Toxicology
or Exposure Protocols).
9
12,156
A571
102
Science
reassessment: Cancer risk, refined ecological risk,
and/or endangered
species; applicant-initiated.
18
95,724
A533
103 (new)
Exemption from the requirement of an Experimental Use
Permit. (2)
4
2,482
A534
104 (new)
Rebuttal of agency
reviewed protocol, applicant initiated.
4
4,726
A535
105 (new)
Conditional Ruling
on Pre-application Study Waiver or Data
Bridging Argument;
applicant-initiated.
6
2,409
A536
106 (new)
Conditional Ruling on Pre-application Direct Food, Indirect
Food, Nonfood use
determination;
applicant-initiated.
4
2,482
TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE INGREDIENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
B580
107
New active ingredient; food use; petition to establish a
tolerance. (2)(3)
20
51,053
B590
108
New active
ingredient; food use; petition to establish a
tolerance
exemption. (2)(3)
18
31,910
B600
109
New active
ingredient; non-food use. (2)(3)
13
19,146
B610
110
New active
ingredient; Experimental Use Permit application;
petition to
establish a temporary tolerance or temporary
tolerance
exemption. (3)
10
12,764
B611
111
New active
ingredient; Experimental Use Permit application;
petition to
establish permanent tolerance exemption.
(3)
12
12,764
B612
112
New active
ingredient; no change to a permanent tolerance
exemption. (2)(3)
10
17,550
B613
113
New active
ingredient; petition to convert a temporary
tolerance or a
temporary tolerance exemption to a permanent
tolerance or
tolerance exemption. (2)(3)
11
17,550
B620
114
New active
ingredient; Experimental Use Permit application;
non-food use
including crop destruct. (3)
7
6,383
TABLE 12. — BIOPESTICIDES DIVISION — NEW USES
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) Amendment
applications to add
the new use(s) to registered product
labels are covered
by the base fee for the new use(s). All
items in the
covered application must be submitted together
in one package.
Each application for an additional new
product
registration and new inert approval(s) that is
submitted in the
new use application package is subject to
the registration
service fee for a new product or a new
inert approval.
However, if a new use application only
proposes to
register the new use for a new product and there
are no amendments
in the application, then review of one new
product application
is covered by the new use fee. All such
associated
applications that are submitted together will be
subject to the new
use decision review time. Any application
for a new product
or an amendment to the proposed labeling
(a) submitted
subsequent to submission of the new use
application and (b)
prior to conclusion of its decision
review time and (c)
containing the same new uses, will be
deemed a separate
new-use application, subject to a separate
registration
service fee and new decision review time for a
new use. If the
new-use application includes non-food
(indoor and/or
outdoor), and food (outdoor and/or indoor)
uses, the
appropriate fee is due for each type of new use
and the longest
decision review time applies to all of the
new uses requested
in the application. Any information that
(a) was neither
requested nor required by the Agency, and
(b) is submitted by
the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screen, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new use
application.
(4) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
B630
115
First food use;
petition to establish a tolerance exemption.
(2)(4)
13
12,764
B631
116
New food use;
petition to amend an established tolerance.
(3)(4)
12
12,764
B640
117
First food use; petition to establish a tolerance. (2)(4)
19
19,146
B643
118
New Food use; petition to amend an established tolerance
exemption. (3)(4)
10
12,764
B642
119
First food use; indoor; food/food handling. (2)(4)
12
31,910
B644
120
New use, no change to an established tolerance or tolerance
exemption. (3)(4)
8
12,764
B650
121
New use; non-food. (3)(4)
7
6,383
B645
122 (new)
New food use;
Experimental Use Permit application; petition
to amend or add a
tolerance exemption. (4)
12
12,764
B646
123 (new)
New use; non-food use including crop destruct; Experimental
Use Permit
application. (4)
7
6,383
TABLE 13. — BIOPESTICIDES DIVISION — NEW PRODUCTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(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.
B652
124
New product; registered source of active ingredient;
requires petition
to amend established tolerance or
tolerance
exemption; requires 1) submission of product
specific data; or
2) citation of previously reviewed and
accepted data; or
3) submission or citation of data
generated at
government expense; or 4) submission or
citation of
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)
13
12,764
B660
125
New product;
registered source of active ingredient(s);
identical or
substantially similar in composition and use to
a registered
product. No data review, or only product
chemistry data;
cite-all data citation, or selective data
citation where
applicant owns all required data or
authorization from
data owner is demonstrated. Category
includes 100%
re-package of registered end-use or
manufacturing-use
product that requires no data submission
or data matrix. For
microbial pesticides, the active
ingredient(s) must
not be re-isolated. (2)(3)
4
1,278
B670
126
New product;
registered source of active ingredient(s);
requires: 1)
submission of product specific data; or 2)
citation of
previously reviewed and accepted data; or 3)
submission or
citation of data generated at government
expense; or 4)
submission or citation of a
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)
7
5,107
B671
127
New product;
unregistered source of active ingredient(s);
requires a petition
to amend an established tolerance or
tolerance
exemption; requires: 1) submission of product
specific data; or
2) citation of previously reviewed and
accepted data; or
3) submission or citation of data
generated at
government expense; or 4) submission or
citation of a
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)
17
12,764
B672
128
New product;
unregistered source of active ingredient(s);
non-food use or
food use requires: 1) submission of product
specific data; or
2) citation of previously reviewed and
accepted data; or
3) submission or citation of data
generated at
government expense; or 4) submission or
citation of a
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)
13
9,118
B673
129
New product MUP/EP;
unregistered source of active
ingredient(s);
citation of Technical Grade Active Ingredient
(TGAI) data
previously reviewed and accepted by the Agency.
Requires an Agency
determination that the cited data
supports the new
product. (2)(3)
10
5,107
B674
130
New product MUP;
Repack of identical registered end-use
product as a
manufacturing-use product; same registered uses
only. (2)(3)
4
1,278
B675
131
New Product MUP;
registered source of active ingredient;
submission of
completely new generic data package;
registered uses
only. (2)(3)
10
9,118
B676
132
New product; more
than one active ingredient where one
active ingredient
is an unregistered source; product
chemistry data must
be submitted; requires: 1) submission of
product specific
data, and 2) citation of previously
reviewed and
accepted data; or 3) submission or citation of
data generated at
government expense; or 4) submission or
citation of a
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)
13
9,118
B677
133
New end-use non-food animal product with submission of two
or more target
animal safety studies; includes data and/or
waivers of data for
only:• product chemistry
and/or• acute toxicity and/or•
public health pest
efficacy and/or• animal
safety studies
and/or • child resistant
packaging. (2)(3)
10
8,820
TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(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.
B621
134
Amendment; Experimental Use Permit; no change to an
established
temporary tolerance or tolerance exemption.
(3)
7
5,107
B622
135
Amendment; Experimental Use Permit; petition to amend an
established or
temporary tolerance or tolerance exemption.
(3)
11
12,764
B641
136
Amendment of an established tolerance or tolerance
exemption.
13
12,764
B680
137
Amendment;
registered sources of active ingredient(s); no
new use(s); no
changes to an established tolerance or
tolerance
exemption. Requires data submission. (2)(3)
5
5,107
B681
138
Amendment;
unregistered source of active ingredient(s).
Requires data
submission. (2)(3)
7
6,079
B683
139
Label amendment;
requires review/update of previous risk
assessment(s)
without data submission (e.g., labeling
changes to REI,
PPE, PHI). (2)(3)
6
5,107
B684
140
Amending non-food
animal product that includes submission of
target animal
safety data; previously registered.
(2)(3)
8
8,820
B685
141 (new)
Amendment; add a
new biochemical unregistered source of
active ingredient
or a new microbial production site.
Requires submission
of analysis of samples data and
source/production
site-specific manufacturing process
description. (3)
5
5,107
TABLE 15. — BIOPESTICIDES DIVISION — SCLP
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) All requests for
new uses (food
and/or nonfood) contained in any application
for a new active
ingredient or a first food use are covered
by the base fee for
that new active ingredient or first food
use application and
retain the same decision time review
period as the new
active ingredient or first food use
application. The
application must be received by the agency
in one package. The
base fee for the category covers a
maximum of five new
products. Each application for an
additional new
product registration and new inert approval
that is submitted
in the new active ingredient application
package or first
food use application package is subject to
the registration
service fee for a new product or a new
inert approval. All
such associated applications that are
submitted together
will be subject to the new active
ingredient or first
food use decision review time. In the
case of a new
active ingredient application, until that new
active ingredient
is approved, any subsequent application
for another new
product containing the same active
ingredient or an
amendment to the proposed labeling will be
deemed a new active
ingredient application, subject to the
registration
service fee and decision review time for a new
active ingredient.
In the case of a first food use
application, until
that first food use is approved, any
subsequent
application for an additional new food use or
uses will be
subject to the registration service fee and
decision review
time for a first food use. Any information
that (a) was
neither requested nor required by the Agency,
and (b) is
submitted by the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screening, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new active
ingredient or first
food use application.
(3) An application for
a new end-use
product using a source of active ingredient
that (a) is not yet
registered but (b) has an application
pending with the
Agency for review, will be considered an
application for a
new product with an unregistered source of
active ingredient.
(4) (a) EPA-initiated
amendments shall
not be charged registration service fees.
(b)
Registrant-initiated fast-track amendments are to be
completed within
the timelines specified in FIFRA Section
3(c)(3)(B) and are
not subject to registration service fees.
(c)
Registrant-initiated fast-track amendments handled by
the Antimicrobials
Division are to be completed within the
timelines specified
in FIFRA Section 3(h) and are not
subject to
registration service fees. (d) Registrant
initiated
amendments submitted by notification under PR
Notices, such as PR
Notice 98–10, continue under PR Notice
timelines and are
not subject to registration service fees.
(e) Submissions
with data and requiring data review are
subject to
registration service fees.
(5) Amendment
applications to add
the new use(s) to registered product
labels are covered
by the base fee for the new use(s). All
items in the
covered application must be submitted together
in one package.
Each application for an additional new
product
registration and new inert approval(s) that is
submitted in the
new use application package is subject to
the registration
service fee for a new product or a new
inert approval.
However, if a new use application only
proposes to
register the new use for a new product and there
are no amendments
in the application, then review of one new
product application
is covered by the new use fee. All such
associated
applications that are submitted together will be
subject to the new
use decision review time. Any application
for a new product
or an amendment to the proposed labeling
(a) submitted
subsequent to submission of the new use
application and (b)
prior to conclusion of its decision
review time and (c)
containing the same new uses, will be
deemed a separate
new-use application, subject to a separate
registration
service fee and new decision review time for a
new use. If the
new-use application includes non-food
(indoor and/or
outdoor), and food (outdoor and/or indoor)
uses, the
appropriate fee is due for each type of new use
and the longest
decision review time applies to all of the
new uses requested
in the application. Any information that
(a) was neither
requested nor required by the Agency, and
(b) is submitted by
the applicant at the applicant’s
initiative to
support the application after completion of
the technical
deficiency screen, and (c) is not itself a
covered
registration application, must be assessed 25% of
the full
registration service fee for the new use
application.
(6) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
B690
142
New active ingredient; food or non-food use. (2)(6)
7
2,554
B700
143
Experimental Use
Permit application; new active ingredient
or new use. (6)
7
1,278
B701
144
Extend or amend
Experimental Use Permit. (6)
4
1,278
B710
145
New product;
registered source of active ingredient(s);
identical or
substantially similar in composition and use to
a registered
product; no change in an established tolerance
or tolerance
exemption. No data review, or only product
chemistry data;
cite-all data citation, or selective data
citation where
applicant owns all required data or
authorization from
data owner is demonstrated. Category
includes 100%
re-package of registered end-use or
manufacturing-use
product that requires no data submission
or data matrix.
(3)(6)
4
1,278
B720
146
New product;
registered source of active ingredient(s);
requires: 1)
submission of product specific data; or 2)
citation of
previously reviewed and accepted data; or 3)
submission or
citation of data generated at government
expense; or 4)
submission or citation of a
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)
5
1,278
B721
147
New product;
unregistered source of active ingredient.
(3)(6)
7
2,676
B722
148
New use and/or amendment; petition to establish a tolerance
or tolerance
exemption. (4)(5)(6)
7
2,477
B730
149
Label amendment requiring data submission. (4)(6)
5
1,278
TABLE 16. — BIOPESTICIDES DIVISION — OTHER ACTIONS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
B614
150
Pre-application; Conditional Ruling on rationales for
addressing a data
requirement in lieu of data;
applicant-initiated; applies to one rationale at a
time.
3
2,530
B615
151
Rebuttal of agency reviewed protocol, applicant
initiated.
3
2,530
B682
152
Protocol review; applicant initiated; excludes time for
HSRB review.
3
2,432
TABLE 17. — BIOPESTICIDES DIVISION — PIP
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) New PIP = a PIP
with an active
ingredient that has not been
registered.
(3) Registered PIP = a
PIP with an active
ingredient that is currently
registered.
(4) Transfer
registered PIP
through conventional breeding for new
food/feed use, such
as from field corn to sweet
corn.
(5) The scientific
data involved in
this category are complex. EPA often seeks
technical advice
from the Scientific Advisory Panel on risks
that pesticides
pose to wildlife, farm workers, pesticide
applicators,
non-target species, as well as insect
resistance, and
novel scientific issues surrounding new
technologies. The
scientists of the SAP neither make nor
recommend policy
decisions. They provide advice on the
science used to
make these decisions. Their advice is
invaluable to the
EPA as it strives to protect humans and
the environment
from risks posed by pesticides. Due to the
time it takes to
schedule and prepare for meetings with the
SAP, additional
time and costs are needed.
(6) Registered PIPs
stacked through
conventional breeding.
(7) Deployment of a
registered PIP with
a different IRM plan (e.g., seed
blend).
(8) The negotiated
acreage cap will
depend upon EPA's determination of the
potential
environmental exposure, risk(s) to non-target
organisms, and the
risk of targeted pest developing
resistance to the
pesticidal substance. The uncertainty of
these risks may
reduce the allowable acreage, based upon the
quantity and type
of non-target organism data submitted and
the lack of insect
resistance management data, which is
usually not
required for seed-increase registrations.
Registrants are
encouraged to consult with EPA prior to
submission of a
registration application in this
category.
(9) Application can be
submitted prior to
or concurrently with an application for
commercial
registration.
(10) For example, IRM
plan modifications
that are applicant-initiated.
(11) EPA-initiated
amendments shall
not be charged fees.
(12) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
B740
153
Experimental Use Permit application; no 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)
6
95,724
B741
154 (new)
Experimental Use Permit application; no 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)
12
159,538
B750
155
Experimental Use Permit application; with a petition to
establish a
temporary or permanent tolerance/tolerance
exemption for the
active ingredient. Includes new food/feed
use for a
registered (3) PIP. (4)(12)
9
127,630
B770
156
Experimental Use Permit application; new (2) PIP; with
petition to
establish a temporary tolerance/tolerance
exemption for the
active ingredient; credit 75% of B771 fee
toward registration
application for a new active ingredient
that follows; SAP
review. (5)(12)
15
191,444
B771
157
Experimental Use Permit application; new (2) PIP; with
petition to
establish a temporary tolerance/tolerance
exemption for the
active ingredient; credit 75% of B771 fee
toward registration
application for a new active ingredient
that follows. (12)
10
127,630
B772
158
Application to amend or extend an Experimental Use Permit;
no petition since
the established tolerance/tolerance
exemption for the
active ingredient is unaffected.
(12)
3
12,764
B773
159
Application to amend or extend an Experimental Use Permit;
with petition to
extend a temporary tolerance/tolerance
exemption for the
active ingredient. (12)
5
31,910
B780
160
Registration application; new (2) PIP; non-food/feed.
(12)
12
159,537
B790
161
Registration application; new (2) PIP; non-food/feed; SAP
review. (5)(12)
18
223,351
B800
162
Registration application; new (2) PIP; with petition to
establish permanent
tolerance/tolerance exemption for the
active ingredient
based on an existing temporary
tolerance/tolerance
exemption. (12)
13
172,300
B810
163
Registration application; new (2) PIP; with petition to
establish permanent
tolerance/tolerance exemption for the
active ingredient
based on an existing temporary
tolerance/tolerance
exemption. SAP review. (5)(12)
19
236,114
B820
164
Registration application; new (2) PIP; with petition to
establish or amend
a permanent tolerance/tolerance exemption
of an active
ingredient. (12)
15
204,208
B840
165
Registration application; new (2) PIP; with petition to
establish or amend
a permanent tolerance/tolerance exemption
of an active
ingredient. SAP review. (5)(12)
21
268,022
B851
166
Registration application; new event of a previously
registered PIP
active ingredient(s); no petition since
permanent
tolerance/tolerance exemption is already
established for the
active ingredient(s). (12)
9
127,630
B870
167
Registration application; registered (3) PIP; new product;
new use; no
petition since a permanent tolerance/tolerance
exemption is
already established for the active
ingredient(s). (4)
(12)
9
38,290
B880
168
Registration application; registered (3) PIP; new product
or new terms of
registration; additional data submitted; no
petition since a
permanent tolerance/tolerance exemption is
already established
for the active ingredient(s). (6) (7)
(12)
9
31,910
B881
169
Registration application; registered (3) PIP; new product
or new terms of
registration; additional data submitted; no
petition since a
permanent tolerance/tolerance exemption is
already established
for the active ingredient(s). SAP
review.
(5)(6)(7)(12)
15
95,724
B882
170 (new)
Registration application; new (2) PIP, seed increase with
negotiated acreage
cap and 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)
15
191,444
B883
171
Registration application; new (2) PIP, seed 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)
9
127,630
B884
172
Registration application; new (2) PIP, seed increase with
negotiated acreage
cap and time-limited registration; with
petition to
establish a permanent tolerance/tolerance
exemption for the
active ingredient. (8)(12)
12
159,537
B885
173
Registration application; registered (3) PIP, seed
increase; breeding
stack of previously approved PIPs, same
crop; no petition
since a permanent tolerance/tolerance
exemption is
already established for the active
ingredient(s).
(9)(12)
6
31,910
B886
174 (new)
Registration application; new (2) PIP, seed 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)
18
223,351
B890
175
Application to amend a seed increase registration; converts
registration to
commercial registration; no petition since
permanent
tolerance/tolerance exemption is already
established for the
active ingredient(s). (12)
9
63,816
B891
176
Application to amend a seed increase registration; converts
registration to a
commercial registration; no petition since
a permanent
tolerance/tolerance exemption already
established for the
active ingredient(s); SAP review.
(5)(12)
15
127,630
B900
177
Application to amend a registration, including actions such
as extending an
expiration date, modifying an IRM plan, or
adding an insect to
be controlled. (10)(11)(12)
6
12,764
B901
178
Application to amend a registration, including actions such
as extending an
expiration date, modifying an IRM plan, or
adding an insect to
be controlled. SAP review. (10) (11)
(12)
12
76,578
B902
179
PIP Protocol review.
3
6,383
B903
180
Inert ingredient tolerance exemption; e.g., a marker such
as NPT II; reviewed
in BPPD.
6
63,816
B904
181
Import tolerance or tolerance exemption; processed
commodities/food
only (inert or active ingredient).
9
127,630
B905
182 (new)
SAP Review.
6
63,816
B906
183 (new)
Petition to establish a temporary tolerance/tolerance
exemption for one
or more active ingredients.
3
31,907
B907
184 (new)
Petition to establish a temporary tolerance/tolerance
exemption for one
or more active ingredients based on an
existing temporary
tolerance/tolerance exemption.
3
12,764
B908
185 (new)
Petition to establish a temporary tolerance/tolerance
exemption for one
or more active ingredients or inert
ingredients.
3
44,671
TABLE 18. — INERT INGREDIENTS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) If another covered
application is
submitted that depends upon an application to
approve an inert
ingredient, each application will be
subject to its
respective registration service fee. The
decision review
time line for both submissions will be the
longest of the
associated applications. If the application
covers multiple
ingredients grouped by EPA into one chemical
class, a single
registration service fee will be assessed
for approval of
those ingredients.
(3) If EPA data rules
are amended to
newly require clearance under section 408 of
the FFDCA for an
ingredient of an antimicrobial product
where such
ingredient was not previously subject to such a
clearance, then
review of the data for such clearance of
such product is not
subject to a registration service fee
for the tolerance
action for two years from the effective
date of the rule.
(4) Any other covered
application that is
associated with and dependent on the
HSRB review will be
subject to its separate registration
service fee. The
decision review times for the associated
actions run
concurrently, but will end at the date of the
latest review time.
(5) Any other covered
application that is
associated with and dependent on the SAP
review will be
subject to its separate registration service
fee. The decision
review time for the associated action will
be extended by the
decision review time for the SAP
review.
(6) An application for
a new end-use
product using a source of active ingredient
that (a) is not yet
registered but (b) has an application
pending with the
Agency for review, will be considered an
application for a
new product with an unregistered source of
active ingredient.
(7) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(8) If a new safener
is submitted in the
same package as a new active ingredient,
and that new active
ingredient is determined to be reduced
risk, then the
safener would get the same reduced timeframe
as the new active
ingredient.
I001
186
Approval of new food use inert ingredient. (2)(3)
13
27,000
I002
187
Amend currently approved inert ingredient tolerance or
exemption from
tolerance; new data. (2)
11
7,500
I003
188
Amend currently approved inert ingredient tolerance or
exemption from
tolerance; no new data. (2)
9
3,308
I004
189
Approval of new non-food use inert ingredient. (2)
6
11,025
I005
190
Amend currently approved non-food use inert ingredient with
new use pattern;
new data. (2)
6
5,513
I006
191
Amend currently approved non-food use inert ingredient with
new use pattern; no
new data. (2)
3
3,308
I007
192
Approval of substantially similar non-food use inert
ingredients when
original inert is compositionally similar
with similar use
pattern. (2)
4
1,654
I008
193
Approval of new or amended polymer inert ingredient, food
use. (2)
5
3,749
I009
194
Approval of new or amended polymer inert ingredient,
non-food use. (2)
4
3,087
I010
195
Petition to amend a single tolerance exemption descriptor,
or single non-food
use descriptor, to add ≤ 10 CASRNs; no
new data. (2)
6
1,654
I011
196 (new)
Approval of new food use safener with tolerance or
exemption from
tolerance. (2)(8)
24
597,683
I012
197 (new)
Approval of new non-food use safener. (2)(8)
21
415,241
I013
198 (new)
Approval of additional food use for previously approved
safener with
tolerance or exemption from tolerance.
(2)
15
62,975
I014
199 (new)
Approval of additional non-food use for previously approved
safener. (2)
15
25,168
I015
200 (new)
Approval of new generic data for previously approved food
use safener. (2)
24
269,728
I016
201 (new)
Approval of amendment(s) to tolerance and label for
previously approved
safener. (2)
13
55,776
TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
EPA No.
New CR
No.
Action
Decision Review
Time
(Months)(1)
Registration Service Fee
($)
(1) A decision review
time that would
otherwise end on a Saturday, Sunday, or
federal holiday,
will be extended to end on the next
business day.
(2) If another covered
application is
submitted that depends upon an application to
approve an inert
ingredient, each application will be
subject to its
respective registration service fee. The
decision review
time line for both submissions will be the
longest of the
associated applications. If the application
covers multiple
ingredients grouped by EPA into one chemical
class, a single
registration service fee will be assessed
for approval of
those ingredients.
(3) If EPA data rules
are amended to
newly require clearance under section 408 of
the FFDCA for an
ingredient of an antimicrobial product
where such
ingredient was not previously subject to such a
clearance, then
review of the data for such clearance of
such product is not
subject to a registration service fee
for the tolerance
action for two years from the effective
date of the rule.
(4) Any other covered
application that is
associated with and dependent on the
HSRB review will be
subject to its separate registration
service fee. The
decision review times for the associated
actions run
concurrently, but will end at the date of the
latest review time.
(5) Any other covered
application that is
associated with and dependent on the SAP
review will be
subject to its separate registration service
fee. The decision
review time for the associated action will
be extended by the
decision review time for the SAP
review.
(6) An application for
a new end-use
product using a source of active ingredient
that (a) is not yet
registered but (b) has an application
pending with the
Agency for review, will be considered an
application for a
new product with an unregistered source of
active ingredient.
(7) Where the action
involves approval
of a new or amended label, on or before
the end date of the
decision review time, the Agency shall
provide to the
applicant a draft accepted label, including
any changes made by
the Agency that differ from the
applicant-submitted
label and relevant supporting data
reviewed by the
Agency. The applicant will notify the Agency
that the applicant
either (a) agrees to all of the terms
associated with the
draft accepted label as amended by the
Agency and requests
that it be issued as the accepted final
Agency-stamped
label; or (b) does not agree to one or more
of the terms of the
draft accepted label as amended by the
Agency and requests
additional time to resolve the
difference(s); or
(c) withdraws the application without
prejudice for
subsequent resubmission, but forfeits the
associated
registration service fee. For cases described in
(b), the applicant
shall have up to 30 calendar days to
reach agreement
with the Agency on the final terms of the
Agency-accepted
label. If the applicant agrees to all of the
terms of the
accepted label as in (a), including upon
resolution of
differences in (b), the Agency shall provide
an accepted final
Agency-stamped label to the registrant
within 2 business
days following the registrant’s written or
electronic
confirmation of agreement to the Agency.
(8) Due to low fee and
short time frame
this category is not eligible for small
business waivers.
Gold seal applies to one registered
product.
(9) This category
includes amendments
the sole purpose of which is to add DfE
(or equivalent
terms that do not use “safe” or derivatives
of “safe”) logos to
a label. DfE is a voluntary program. A
label bearing a DfE
logo is not considered an Agency
endorsement because
the ingredients in the qualifying
product must meet
objective, scientific criteria established
and widely
publicized by EPA.
M001
202
Study protocol requiring Human Studies Review Board review
as defined in 40
CFR Part 26 in support of an active
ingredient. (4)
9
7,938
M002
203
Completed study requiring Human Studies Review Board review
as defined in 40
CFR Part 26 in support of an active
ingredient. (4)
9
7,938
M003
204
External technical peer review of new active ingredient,
product, or
amendment (e.g., consultation with FIFRA
Scientific Advisory
Panel) for an action with a decision
timeframe of less
than 12 months. Applicant initiated
request based on a
requirement of the Administrator, as
defined by FIFRA §
25(d), in support of a novel active
ingredient, or
unique use pattern or application technology.
Excludes PIP active
ingredients. (5)
12
63,945
M004
205
External technical peer review of new active ingredient,
product, or
amendment (e.g., consultation with FIFRA
Scientific Advisory
Panel) for an action with a decision
timeframe of
greater than 12 months. Applicant initiated
request based on a
requirement of the Administrator, as
defined by FIFRA §
25(d), in support of a novel active
ingredient, or
unique use pattern or application technology.
Excludes PIP active
ingredients. (5)
18
63,945
M005
206
New Product: Combination, Contains a combination of active
ingredients from a
registered and/or unregistered source;
conventional,
antimicrobial and/or biopesticide. Requires
coordination with
other regulatory divisions to conduct
review of data,
label and/or verify the validity of existing
data as cited. Only
existing uses for each active ingredient
in the combination
product. (6)(7)
9
22,050
M006
207
Request for up to 5 letters of certification (Gold Seal)
for one actively
registered product (excludes distributor
products). (8)
1
277
M007
208
Request to extend Exclusive Use of data as provided by
FIFRA Section
3(c)(1)(F)(ii).
12
5,513
M008
209
Request to grant Exclusive Use of data as provided by FIFRA
Section
3(c)(1)(F)(vi) for a minor use, when a FIFRA Section
2(ll)(2)
determination is required.
15
1,654
M009
210 (new)
Non-FIFRA Regulated Determination: Applicant initiated, per
product.
4
2,363
M010
211 (new)
Conditional ruling on pre-application, product substantial
similarity.
4
2,363
M011
212 (new)
Label amendment to add the DfE logo; requires data review;
no other label
changes. (9)
4
3,648
.
7.
Agricultural worker protection standard;
certification of pesticide applicators
(a)
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)
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, consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.).
(c)
The Comptroller General of the United States shall—
(1)
conduct a study on the use of the designated representative, including the effect of that use on the availability of pesticide application and hazard information and worker health and safety; and
(2)
not later than October 1, 2021, make publically available a report describing the study under paragraph (1), including any recommendations to prevent the misuse of pesticide application and hazard information, if that misuse is identified.
Speaker of the House of Representatives
Vice President of the United States and President of the Senate