1.This Act may be cited as the
Pesticide Registration Improvement
Extension Act of 2012
.
2.Pesticide registration improvement
(a)
(1)Section 4(i) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)) is amended—
(A)in paragraph (5)—
(i)in subparagraph (C), by striking
aggregate amount of
and all that follows through the end of the
subparagraph and inserting aggregate amount of $27,800,000 for each of
fiscal years 2013 through 2017.
;
(ii)in subparagraph (D)—
(I)in clause (i), by striking shall
be
and all that follows through the semicolon and inserting
shall be $115,500 for each of fiscal years 2013 through 2017;
;
and
(II)in clause (ii), by striking shall
be
and all that follows through the period and inserting shall
be $184,800 for each of fiscal years 2013 through 2017.
;
(iii)in subparagraph (E)(i)—
(I)in subclause (I), by striking shall
be
and all that follows through the semicolon and inserting
shall be $70,600 for each of fiscal years 2013 through 2017;
;
and
(II)in subclause (II), by striking shall
be
and all that follows through the period and inserting shall
be $122,100 for each of fiscal years 2013 through 2017.
;
(iv)in subparagraph (F)—
(I)by striking paragraph (3)
and inserting this paragraph
; and
(II)by striking Humans
and
inserting Human
;
(v)by redesignating subparagraphs (F) through
(H) as subparagraphs (G) through (I), respectively;
(vi)by inserting after subparagraph (E) the
following:
(F)Fee reduction for certain small
businesses
(i)In this subparagraph, the term
qualified small business entity means a corporation, partnership,
or unincorporated business that—
(I)has 500 or fewer employees;
(II)during the 3-year period prior to the most
recent maintenance fee billing cycle, had an average annual global gross
revenue from all sources that did not exceed $10,000,000; and
(III)holds not more than 5 pesticide
registrations under this paragraph.
(ii)Except as provided in clause (iii), the
Administrator shall waive 25 percent of the fee under this paragraph applicable
to the first registration of any qualified small business entity under this
paragraph.
(iii)The Administrator shall not grant a waiver
under clause (ii) to a qualified small business entity if the Administrator
determines that the entity has been formed or manipulated primarily for the
purpose of qualifying for the waiver.
;
and
(vii)in subparagraph (I) (as redesignated by
clause (v)), by striking 2012
and inserting
2017
;
(B)in paragraph (6)—
(i)by striking 2014
and
inserting 2019
; and
(ii)by striking paragraphs (1) through
(5)
and inserting paragraph (1)
;
(C)by striking paragraphs (1), (2), (3), (4),
and (7); and
(D)by redesignating paragraphs (5) and (6) as
paragraphs (1) and (2), respectively.
(2)
(A)Section 4 of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a–1) is amended—
(i)in subsection (d)(5)(B)(ii)(III), by
striking subsection (i)(1)
and inserting this
section
;
(ii)in subsection (j), by striking
subsection (i)(5)
and inserting subsection
(i)(1)
; and
(iii)in subsection (k)(5)—
(I)in the first sentence, by striking
subsection (i)(5)(C)(ii)
and inserting subsection
(i)(1)(C)(ii)
; and
(II)in the third and sixth sentences, by
striking subsection (i)(5)(C)
each place it appears and
inserting subsection (i)(1)(C)
.
(B)Section 33(b)(7)(F) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(7)(F)) is
amended—
(i)by striking section
4(i)(5)(E)(ii)
each place it appears in clauses (i), (ii)(I), and
(iv)(I) and inserting section 4(i)(1)(E)(ii)
;
(ii)by striking section
4(i)(5)(E)(ii)(I)(bb)
each place it appears in clauses (ii)(II) and
(iv)(II) and inserting section 4(i)(1)(E)(ii)(I)(bb)
; and
(iii)in clause (iv)(II)—
(I)by striking applicable.
and
inserting applicable
; and
(II)by striking revenues
and
inserting revenue
.
(3)Extension of prohibition on tolerance
feesSection 408(m)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by
striking September 30, 2012
and inserting September 30,
2017
.
(4)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—
(i)by inserting , to enhance the
information systems capabilities to improve the tracking of pesticide
registration decisions,
after paragraph (3)
each place
it appears; and
(ii)in clause (i)—
(I)by inserting offset
before
the costs of reregistration
; and
(II)by striking in the same portion as
appropriated funds
.
(B)Expedited processing of similar
applicationsSection
4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a–1(k)(3)(A)) is amended—
(i)in the matter preceding clause (i), by
striking 2008 through 2012, between 1/8 and
1/7
and inserting 2013 through 2017,
between 1/9 and 1/8
;
(ii)in clause (i), by striking
new
; and
(iii)in clause (ii), by striking any
application
and all that follows through that—
and
inserting any application that—
.
(C)Enhancements of information technology
systems for improvement in review of pesticide applicationsSection 4(k) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended—
(i)by redesignating paragraphs (4) and (5) as
paragraphs (5) and (6), respectively;
(ii)by inserting after paragraph (3) the
following:
(4)Enhancements of information technology
systems for improvement in review of pesticide applications
(A)For each of fiscal years 2013 through 2017,
the Administrator shall use not more than $800,000 of the amounts made
available to the Administrator in the Reregistration and Expedited Processing
Fund for the activities described in subparagraph (B).
(B)The Administrator shall use amounts made
available from the Reregistration and Expedited Processing Fund to improve the
information systems capabilities for the Office of Pesticide Programs to
enhance tracking of pesticide registration decisions, which shall
include—
(i)the electronic tracking of—
(I)registration submissions; and
(II)the status of conditional
registrations;
(ii)enhancing the database for information
regarding endangered species assessments for registration review;
(iii)implementing the capability to
electronically review labels submitted with registration actions; and
(iv)acquiring and implementing the capability
to electronically assess and evaluate confidential statements of formula
submitted with registration actions.
;
and
(iii)in the first sentence of paragraph (6) (as
redesignated by clause (i)), by striking to carry out the goals
established under subsection (l)
and inserting for the purposes
described in paragraphs (2), (3), and (4) and to carry out the goals
established under subsection (l)
.
(b)Pesticide Registration Service
Fees
(1)Section 33(b) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is
amended—
(A)by striking paragraph (3) and inserting the
following:
(3)Schedule of covered applications and
registration service feesSubject to paragraph (6), the schedule of
covered pesticide registration applications and corresponding registration
service fees shall be as follows:
TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE
INGREDIENTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(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.
R0101New Active Ingredient, Food use (2)
(3)24569,221
R0202New Active Ingredient, Food use; reduced risk (2)
(3)18569,221
R0403New 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)18419,502
R0604New Active Ingredient, Non-food use; outdoor (2)
(3)21395,467
R0705New Active Ingredient, Non-food use; outdoor; reduced
risk (2) (3)16395,467
R0906New Active Ingredient, Non-food use; outdoor;
Experimental Use Permit application; submitted before application for
registration; credit 45% of fee toward new active ingredient (3)16293,596
R1107New Active Ingredient, Non-food use; indoor (2)
(3)20219,949
R1208New Active Ingredient, Non-food use; indoor; reduced
risk (2) (3)14219,949
R1219New 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)18165,375
R12210Enriched isomer(s) of registered mixed-isomer active
ingredient (2) (3)18287,643
R12311New Active Ingredient, Seed treatment only; includes
agricultural and non-agricultural seeds; residues not expected in raw
agricultural commodities (2) (3)18427,991
R125New12New 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)16293,596
TABLE 2. — REGISTRATION DIVISION — NEW USES
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
R13013First food use; indoor;
food/food handling (2) (3)21173,644
R14014Additional food use; Indoor; food/food handling (3)
(4)1540,518
R15015First food use (2) (3)21239,684
R16016First food use; reduced risk (2) (3)16239,684
R17017Additional food use (3) (4)1559,976
R175New18Additional 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)1059,976
R18019Additional food use; reduced risk (3) (4)1059,976
R19020Additional food uses; 6 or more submitted in one
application (3) (4)15359,856
R20021Additional food uses; 6 or more submitted in one
application; reduced risk (3) (4)10359,856
R21022Additional food use; Experimental Use Permit
application; establish temporary tolerance; no credit toward new use
registration (3) (4)1244,431
R22023Additional food use; Experimental Use Permit
application; crop destruct basis; no credit toward new use registration (3)
(4)617,993
R23024Additional use; non-food; outdoor (3) (4)1523,969
R24025Additional use; non-food; outdoor; reduced risk (3)
(4)1023,969
R25026Additional use; non-food; outdoor; Experimental Use
Permit application; no credit toward new use registration (3) (4)617,993
R251New27Experimental Use Permit
application which requires no changes to the tolerance(s); non-crop destruct
basis (3)817,993
R26028New use; non-food; indoor (3) (4)1211,577
R27029New use; non-food; indoor; reduced risk (3)
(4)911,577
R27130New use; non-food; indoor; Experimental Use Permit
application; no credit toward new use registration (3) (4)68,820
R27331Additional use; seed treatment; limited uptake into raw
agricultural commodities; includes crops with established tolerances (e.g., for
soil or foliar application); includes food or non-food uses (3)
(4)1245,754
R27432Additional 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)12274,523
TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER
TOLERANCES
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
R28033Establish import
tolerance; new active ingredient or first food use (2)21289,407
R29034Establish import tolerance; additional food
use1557,882
R29135Establish import tolerances; additional food uses; 6 or
more crops submitted in one petition 15347,288
R29236Amend an established tolerance (e.g., decrease or
increase); domestic or import; applicant-initiated 1141,124
R29337Establish tolerance(s) for inadvertent residues in one
crop; applicant-initiated 1248,510
R29438Establish tolerances for inadvertent residues; 6 or
more crops submitted in one application; applicant-initiated 12291,060
R29539Establish tolerance(s) for residues in one rotational
crop in response to a specific rotational crop application; applicant-initiated
1559,976
R29640Establish tolerances for residues in rotational crops
in response to a specific rotational crop petition; 6 or more crops submitted
in one application; applicant-initiated 15359,856
R297New41Amend 6 or more
established tolerances (e.g., decrease or increase) in one petition; domestic
or import; applicant-initiated 11246,744
R298New42Amend an established
tolerance (e.g., decrease or increase); domestic or import; submission of
amended labels (requiring science review) in addition to those associated with
the amended tolerance; applicant-initiated (3)1353,120
R299New43Amend 6 or more
established tolerances (e.g., decrease or increase); domestic or import;
submission of amended labels (requiring science review) in addition to those
associated with the amended tolerance; applicant-initiated (3)13258,740
TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
R30044New 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)41,434
R30145New 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, where applicant does not own all required data and does
not have a specific authorization letter from data owner. (2) (3)41,720
R31046New 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; 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 • public health pest efficacy and/or
• child resistant packaging. (2) (3) 74,807
R314New47New end use product
containing two 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; 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
• public health pest efficacy and/or • child resistant
packaging. (2) (3)86,009
R315New48New 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) 98,000
R32049New product; new physical form; requires data review in
science divisions (2) (3)1211,996
R33150New product; repack of identical registered end-use
product as a manufacturing-use product; same registered uses only (2)
(3)32,294
R33251New 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)24256,883
R333New52New 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)1017,993
R334New53New 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)1117,993
TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO
REGISTRATION
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
R34054Amendment requiring data
review within RD (e.g., changes to precautionary label statements) (2) (3)
4
3,617
R345New55Amending non-food animal
product that includes submission of target animal safety data; previously
registered (2) (3)78,000
R35056Amendment 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)911,996
R351New57Amendment adding a new
unregistered source of active ingredient. (2) (3)811,996
R352New58Amendment adding already
approved uses; selective method of support; does not apply if the applicant
owns all cited data (2) (3)811,996
R37159Amendment to Experimental Use Permit; (does not include
extending a permit's time period) (3)69,151
TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(1) A decision
review time that would otherwise end on a Saturday, Sunday, or federal holiday,
will be extended to end on the next business day.
R12460Conditional Ruling on
Preapplication Study Waivers; applicant-initiated62,294
R27261Review of Study Protocol applicant-initiated; excludes
DART, pre-registration conference, Rapid Response review, DNT protocol review,
protocol needing HSRB review32,294
R275New62Rebuttal of agency
reviewed protocol, applicant initiated32,294
R37063Cancer reassessment; applicant-initiated18179,818
TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE
INGREDIENTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(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.
A38064Food use; establish
tolerance exemption (2) (3)24104,187
A39065Food use; establish tolerance (2) (3)24173,644
A40066Non-food use; outdoor; FIFRA §2(mm) uses (2)
(3)1886,823
A41067Non-food use; outdoor; uses other than FIFRA §2(mm) (2)
(3)21173,644
A42068Non-food use; indoor; FIFRA §2(mm) uses (2)
(3)1857,882
A43069Non-food use; indoor; uses other than FIFRA §2(mm) (2)
(3)2086,823
A43170Non-food use; indoor; low-risk, low-toxicity food-grade
active ingredient(s); efficacy testing for public health claims required under
GLP and following DIS/TSS or AD-approved study protocol (2) (3)1260,638
TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
A44071First food use;
establish tolerance exemption (2) (3) (4) 21 28,942
A45072First food use; establish tolerance (2) (3)
(4)2186,823
A46073Additional food use; establish tolerance exemption (3)
(4) (5)1511,577
A47074Additional food use; establish tolerance (3) (4)
(5)1528,942
A471New75Additional food uses;
establish tolerances; 6 or more submitted in one application (3) (4)
(5)15173,652
A48076Additional use; non-food; outdoor; FIFRA §2(mm) uses
(4) (5)917,365
A481New77Additional non-food
outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4)
(5)9104,190
A49078Additional use; non-food; outdoor; uses other than
FIFRA §2(mm) (4) (5)1528,942
A491New79Additional non-food;
outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application
(4) (5)15173,652
A50080Additional use; non-food, indoor, FIFRA §2(mm) uses (4)
(5)911,577
A501New81Additional non-food;
indoor; FIFRA §2(mm) uses; 6 or more submitted in one application (4)
(5)969,462
A51082Additional use; non-food; indoor; uses other than FIFRA
§2(mm) (4) (5)1211,577
A511New83Additional non-food;
indoor; uses other than FIFRA §2(mm); 6 or more submitted in one application
(4) (5)1269,462
TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND
AMENDMENTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
A53084New 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 when applicant owns all required data, or applicant
submits specific authorization letter for 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)41,159
A53185New 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)41,654
A53286New 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)54,631
A54087New end use product; FIFRA §2(mm) uses only (2)
(3)54,631
A55088New end-use product; uses other than FIFRA §2(mm);
non-FQPA product (2) (3)74,631
A56089New manufacturing-use product; registered active
ingredient; selective data citation (2) (3)1217,365
A57090Label amendment requiring data review (3)
(4)43,474
A572New91New 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)911,996
TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE
PERMITS AND OTHER TYPE OF ACTIONS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
A52092Experimental Use Permit
application, Non-Food Use (2)95,789
A52193Review 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
132,250
A52294Review 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 21211,025
A524New95New Active Ingredient,
Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of
fee toward new active ingredient application that follows. (2)18138,916
A525New96New Active Ingredient,
Experimental Use Permit application; Food Use Requires Tolerance Exemption.
Credit 45% of fee toward new active ingredient application that follows.
(2)1883,594
A526New97New Active Ingredient,
Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee
toward new active ingredient application that follows. (2)1586,823
A527New98New Active Ingredient,
Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee
toward new active ingredient application that follows. (2)1558,000
A528New99Experimental Use Permit
application, Food Use; Requires Tolerance or Tolerance Exemption
(2)1520,260
A529New100Amendment to Experimental Use Permit;
requires data review or risk assessment (2)910,365
A523New101Review of protocol other than a
public health efficacy study (i.e., Toxicology or Exposure
Protocols)911,025
A571New102Science reassessment: Cancer risk,
refined ecological risk, and/or endangered species;
applicant-initiated1886,823
TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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, except where the new inert approval decision review time is greater than
that for the new active ingredient, in which case the associated new active
ingredient will be subject to the new inert approval 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.
B580103New active ingredient; food use;
petition to establish a tolerance (2) 1946,305
B590104New active ingredient; food use; petition to establish
a tolerance exemption (2)1728,942
B600105New active ingredient; non-food use (2) 1317,365
B610106New active ingredient; Experimental Use Permit
application; petition to establish a temporary tolerance or temporary tolerance
exemption 1011,577
B611New107New active ingredient; Experimental
Use Permit application; petition to establish permanent tolerance
exemption1211,577
B612New108New active ingredient; no change to a
permanent tolerance exemption (2)1015,918
B613New109New active ingredient; petition to
convert a temporary tolerance or a temporary tolerance exemption to a permanent
tolerance or tolerance exemption (2)1115,918
B620110New active ingredient; Experimental Use Permit
application; non-food use including crop destruct75,789
TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
B630111First food use; petition to establish
a tolerance exemption (2)1311,577
B631112New food use; petition to amend an established
tolerance (3)1211,577
B640113First food use; petition to establish a tolerance (2)
1917,365
B643New114New Food use; petition to amend
tolerance exemption (3)1011,577
B642New115First food use; indoor; food/food
handling (2)1228,942
B644New116New use, no change to an established
tolerance or tolerance exemption (3)811,577
B650117New use; non-food (3)75,789
TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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.
B652New118New 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)1311,577
B660119New 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.
For microbial pesticides, the active ingredient(s) must not be re-isolated.
(2)41,159
B670120New product; registered source of active ingredient(s);
no change in 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)74,631
B671121New 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)1711,577
B672122New product; unregistered source of active
ingredient(s); non-food use or food use with a tolerance or tolerance exemption
previously established for the 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)138,269
B673New123New 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)104,631
B674New124New product MUP; Repack of identical
registered end-use product as a manufacturing-use product; same registered uses
only (2)41,159
B675New125New Product MUP; registered source of
active ingredient; submission of completely new generic data package;
registered uses only. (2)108,269
B676New126New 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) 138,269
B677New127New 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) 108,000
TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(1) A decision
review time that would otherwise end on a Saturday, Sunday, or federal holiday,
will be extended to end on the next business day. (2) (a)
EPA-initiated amendments shall not be charged registration service fees. (b)
Registrant-initiated fast-track amendments are to be completed within the
timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to
registration service fees. (c) Registrant-initiated fast-track amendments
handled by the Antimicrobials Division are to be completed within the timelines
specified in FIFRA Section 3(h) and are not subject to registration service
fees. (d) Registrant initiated amendments submitted by notification under PR
Notices, such as PR Notice 98–10, continue under PR Notice timelines and are
not subject to registration service fees. (e) Submissions with data and
requiring data review are subject to registration service fees.
B621128Amendment; Experimental Use Permit;
no change to an established temporary tolerance or tolerance
exemption.74,631
B622New129Amendment; Experimental Use Permit;
petition to amend an established or temporary tolerance or tolerance
exemption.1111,577
B641130Amendment of an established tolerance or tolerance
exemption. 1311,577
B680131Amendment; registered source of active ingredient(s);
no new use(s); no changes to an established tolerance or tolerance exemption.
Requires data submission. (2) 54,631
B681132Amendment; unregistered source of active ingredient(s).
Requires data submission. (2) 75,513
B683New133Label amendment; requires
review/update of previous risk assessment(s) without data submission (e.g.,
labeling changes to REI, PPE, PHI). (2) 64,631
B684New134Amending non-food animal product that
includes submission of target animal safety data; previously registered (2)
88,000
TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(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, except where the new inert approval decision review time is greater than
that for the new active ingredient, in which case the associated new active
ingredient will be subject to the new inert approval 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.
B690135New active ingredient; food or
non-food use. (2)72,316
B700136Experimental Use Permit application; new active
ingredient or new use. 71,159
B701137Extend or amend Experimental Use Permit.41,159
B710138New 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) 41,159
B720139New 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)51,159
B721140New product; unregistered source of active ingredient.
(3) 72,426
B722141New use and/or amendment; petition to establish a
tolerance or tolerance exemption. (4) (5)72,246
B730142Label amendment requiring data submission.
(4)51,159
TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
OTHER ACT
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(1) A decision
review time that would otherwise end on a Saturday, Sunday, or federal holiday,
will be extended to end on the next business day.
B614New143Conditional Ruling on
Preapplication Study Waivers; applicant-initiated32,294
B615New144Rebuttal of agency reviewed protocol,
applicant initiated32,294
B682145Protocol review; applicant initiated; excludes time for
HSRB review32,205
TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION —
PLANT INCORPORATED PROTECTANTS (PIPS)
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService Fee($)
(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.
B740146Experimental 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). (4)
686,823
B750147Experimental 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)9115,763
B770148Experimental 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)15173,644
B771149Experimental 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.10115,763
B772150Application to amend or extend an Experimental Use
Permit; no petition since the established tolerance/tolerance exemption for the
active ingredient is unaffected.311,577
B773151Application to amend or extend an Experimental Use
Permit; with petition to extend a temporary tolerance/tolerance exemption for
the active ingredient.528,942
B780152Registration application; new (2) PIP;
non-food/feed.12144,704
B790153Registration application; new (2) PIP; non-food/feed;
SAP review. (5)18202,585
B800154Registration application; new (2) PIP; with petition to
establish permanent tolerance/tolerance exemption for the active ingredient
based on an existing temporary tolerance/tolerance exemption.12231,585
B810155Registration 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)18289,407
B820156Registration application; new (2) PIP; with petition to
establish or amend a permanent tolerance/tolerance exemption of an active
ingredient.15289,407
B840157Registration application; new (2) PIP; with petition to
establish or amend a permanent tolerance/tolerance exemption of an active
ingredient. SAP review. (5)21347,288
B851158Registration 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). 9115,763
B870159Registration 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)934,729
B880160Registration 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)928,942
B881161Registration 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)1586,823
B883New162Registration 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)9115,763
B884New163Registration 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)12144,704
B885New164Registration 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)986,823
B890165Application 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).957,882
B891166Application 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)15115,763
B900167Application 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)611,577
B901168Application 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)1269,458
B902169PIP protocol review35,789
B903170Inert ingredient tolerance exemption; e.g., a marker
such as NPT II; reviewed in BPPD.657,882
B904171Import tolerance or tolerance exemption; processed
commodities/food only (inert or active ingredient).9115,763
TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND
MISCELLANEOUS ACTIONS
EPANo.NewCRNo.ActionDecisionReview Time(Months)
(1)RegistrationService 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 associated with and dependent upon a pending application
for an inert ingredient action, each application will be subject to its
respective registration service fee. The decision review time for the other
associated covered application will be extended to match the PRIA due date of
the pending inert ingredient action, unless the PRIA due date for the other
associated covered action is further out, in which case it will be subject to
its own decision review time. 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.
I001172Approval of new food use inert
ingredient (2) (3) 1218,000
I002New173Amend currently approved inert
ingredient tolerance or exemption from tolerance; new data (2)105,000
I003New174Amend currently approved inert
ingredient tolerance or exemption from tolerance; no new data (2)83,000
I004New175Approval of new non-food use inert
ingredient (2)810,000
I005New176Amend currently approved non-food use
inert ingredient with new use pattern; new data (2)85,000
I006New177Amend currently approved non-food use
inert ingredient with new use pattern; no new data (2)63,000
I007New178Approval of substantially similar
non-food use inert ingredients when original inert is compositionally similar
with similar use pattern (2)41,500
I008New179Approval of new polymer inert
ingredient, food use (2)53,400
I009New180Approval of new polymer inert
ingredient, non food use (2)42,800
I010New181Petition to amend a tolerance
exemption descriptor to add one or more CASRNs; no new data (2)61,500
M001New182Study protocol requiring Human
Studies Review Board review as defined in 40 CFR 26 in support of an active
ingredient (4)97,200
M002New183Completed study requiring Human
Studies Review Board review as defined in 40 CFR 26 in support of an active
ingredient (4)97,200
M003New184External 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)1258,000
M004New185External 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)1858,000
M005New186New 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)920,000
M006New187Request for up to 5 letters of
certification (Gold Seal) for one actively registered product.1250
M007New188Request to extend Exclusive Use of
data as provided by FIFRA Section 3(c)(1)(F)(ii)125,000
M008New189Request 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 required101,500
;
(B)in paragraph (6)—
(i)in subparagraph (A)—
(I)by striking October 1, 2008
and inserting October 1, 2013
; and
(II)by striking September 30,
2010
and inserting September 30, 2015
; and
(ii)in subparagraph (B)—
(I)by striking October 1, 2010
and inserting October 1, 2015
; and
(II)by striking September 30,
2010
and inserting September 30, 2015
; and
(C)in paragraph (8)(C)(ii)—
(i)in subclause (I), by striking
or
at the end;
(ii)in subclause (II), by striking the period
at the end and inserting ; or
; and
(iii)by adding at the end the following:
(III)on the basis that the Administrator
rejected the application under subsection
(f)(4)(B).
.
(2)Pesticide registration fundSection 33(c)(3)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)(3)(B)) is
amended—
(A)in clause (i), by striking 2008
through 2012
and inserting 2013 through 2017
;
(B)in clause (ii), by striking
grants
and all that follows through the end of the clause and
inserting grants, for each of fiscal years 2013 through 2017,
$500,000.
; and
(C)in clause (iii), by striking 2008
through 2012
and inserting 2013 through 2017
.
(3)Section 33(d) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)) is amended—
(A)in paragraph (2), by striking
2002
each place it appears and inserting
2012
;
(B)by striking paragraph (4); and
(C)by redesignating paragraph (5) as paragraph
(4).
(4)Reforms to reduce decision time review
periodsSection 33(e) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is
amended by striking Pesticide Registration Improvement Act of
2003
and inserting Pesticide
Registration Improvement Extension Act of 2012
.
(5)Decision time review periodsSection 33(f) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—
(A)in paragraph (1), by striking
Pesticide Registration Improvement Renewal Act, the Administrator shall
publish in the Federal Register
and inserting Pesticide Registration Improvement Extension Act of
2012, the Administrator shall make publicly
available
;
(B)in paragraph (2), by striking
appearing in the Congressional Record on pages S10409
and all
that follows through the period and inserting provided under subsection
(b)(3).
; and
(C)in paragraph (4)—
(i)in subparagraph (A), by inserting
and fee
before the period; and
(ii)in subparagraph (B)—
(I)by striking (B)
Completeness of
application
and all that follows through Not
later
in clause (i) and inserting the following:
(B)Initial content and preliminary technical
screenings
(i)
(I)Not
later
;
(II)in clause (i) (as so designated) by adding
at the end the following:
(II)Preliminary technical
screeningAfter conducting
the initial content screening described in subclause (I) and in accordance with
clause (iv), the Administrator shall conduct a preliminary technical
screening—
- (aa)not later than 45 days after the date on
which the decision time review period begins (for applications with decision
time review periods of not more than 180 days); and
- (bb)not later than 90 days after the date on
which the decision time review period begins (for applications with decision
time review periods greater than 180
days).
;
(III)by striking clause (ii) and inserting the
following:
(ii)
(I)If the Administrator determines at any time
before the Administrator completes the preliminary technical screening under
clause (i)(II) that the application failed the initial content or preliminary
technical screening and the applicant does not correct the failure before the
date that is 10 business days after the applicant receives a notification of
the failure, the Administrator shall reject the application.
(II)The Administrator shall make every effort
to provide a written notification of a rejection under subclause (I) during the
10-day period that begins on the date the Administrator completes the
preliminary technical
screening.
;
(IV)in clause (iii)—
- (aa)in the heading, by inserting
initial
content
before screening
;
- (bb)in the matter preceding subclause (I), by
inserting
content
after initial
; and
- (cc)in subclause (II), by striking
contains
and inserting appears to contain
;
and
(V)by adding at the end the following:
(iv)Requirements of preliminary technical
screeningIn conducting a
preliminary technical screening of an application, the Administrator shall
determine if—
(I)the application and the data and
information submitted with the application are accurate and complete;
and
(II)the application, data, and information are
consistent with the proposed labeling and any proposal for a tolerance or
exemption from the requirement for a tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to
full review under the standards of this Act, could result in the granting of
the
application.
.
(6)Section 33(k) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
(A)in paragraph (1), by striking March
1, 2014
and inserting March 1, 2017
;
(B)in paragraph (2)—
(i)in subparagraph (A)—
(I)in clause (vi)(V), by striking
and
at the end;
(II)in clause (vii)(II), by inserting
and
at the end; and
(III)by adding at the end the following:
(viii)the number of extensions of decision time
review periods agreed to under subsection (f)(5) along with a description of
the reason that the Administrator was unable to make a decision within the
initial decision time review
period;
;
(ii)in subparagraph (E), by striking
and
at the end;
(iii)in subparagraph (F), by striking the period
and inserting a semicolon; and
(iv)by adding at the end the following:
(G)a review of the progress made
toward—
(i)carrying out section 4(k)(4) and the
amounts from the Reregistration and Expedited Processing Fund used for the
purposes described in that section;
(ii)implementing systems for the electronic
tracking of registration submissions by December 31, 2013;
(iii)implementing a system for tracking the
status of conditional registrations, including making nonconfidential
information related to the conditional registrations publicly available by
December 31, 2013;
(iv)implementing enhancements to the endangered
species knowledge database, including making nonconfidential information
related to the database publicly available;
(v)implementing the capability to
electronically submit and review labels submitted with registration
actions;
(vi)acquiring and implementing the capability
to electronically assess and evaluate confidential statements of formula
submitted with registration actions by December 31, 2014; and
(vii)facilitating public participation in
certain registration actions and the registration review process by providing
electronic notification to interested parties of additions to the public
docket;
(H)the number of applications rejected by the
Administrator under the initial content and preliminary technical screening
conducted under subsection (f)(4);
(I)a review of the progress made in updating
the Pesticide Incident Data System, including progress toward making the
information contained in the System available to the public (as the
Administrator determines is appropriate); and
(J)an assessment of the public availability of
summary pesticide usage data.
;
and
(C)by adding at the end the following:
(4)
(A)In addition to the annual report described
in paragraph (1), not later than October 1, 2016, the Administrator shall
submit to the Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate a report that
includes an analysis of the impact of maintenance fees on small businesses that
have—
(i)10 or fewer employees; and
(ii)annual global gross revenue that does not
exceed $2,000,000.
(B)In conducting the analysis described in
subparagraph (A), the Administrator shall collect, and include in the report
under that subparagraph, information on—
(i)the number of small businesses described in
subparagraph (A) that are paying maintenance fees; and
(ii)the number of registrations each company
holds.
.
(7)Termination of effectivenessSection 33(m) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
(A)in paragraph (1), by striking
2012
and inserting 2017
; and
(B)in paragraph (2)—
(i)in subparagraph (A)—
(I)in the heading, by striking
2013
and inserting 2018
;
(II)by striking 2013,
and
inserting 2018,
; and
(III)by striking September 30,
2012
and inserting September 30, 2017
;
(ii)in subparagraph (B)—
(I)in the heading, by striking
2014
and inserting 2019
;
(II)by striking 2014,
and
inserting 2019,
; and
(III)by striking September 30,
2012
and inserting September 30, 2017
;
(iii)in subparagraph (C)—
(I)in the heading, by striking
2014
and inserting 2019
; and
(II)by striking September 30,
2014
and inserting September 30, 2019
; and
(iv)in subparagraph (D), by striking
2012
each place it appears and inserting
2017
.
(c)This section and the
amendments made by this section take effect on October 1, 2012.
(d)Relationship to other lawIn the case of any conflict between this
section (including the amendments made by this section) and a joint resolution
making continuing appropriations for fiscal year 2013 (including any amendments
made by such a joint resolution), this section and the amendments made by this
section shall control.
Speaker of the House of Representatives
Vice President of the United States and President of the
Senate