[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3552 Engrossed in Senate (ES)]
112th CONGRESS
2d Session
S. 3552
_______________________________________________________________________
AN ACT
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pesticide Registration Improvement
Extension Act of 2012''.
SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT.
(a) Maintenance Fees.--
(1) Fees.--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) Definition.--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) Waiver.--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) Limitation.--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) Conforming amendments.--
(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 fees.--Section
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) Source and use.--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 applications.--
Section 4(k)(3)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a-
1(k)(3)(A)) is amended--
(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 applications.--
Section 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) In general.--For each of fiscal years 2013
through 2017, the Administrator shall use not more than
$800,000 of the amounts made available to the
Administrator in the Reregistration and Expedited
Processing Fund for the activities described in
subparagraph (B).
``(B) Activities.--The Administrator shall use
amounts made available from the Reregistration and
Expedited Processing Fund to improve the information
systems capabilities for the Office of Pesticide
Programs to enhance tracking of pesticide registration
decisions, which shall include--
``(i) the electronic tracking of--
``(I) registration submissions; and
``(II) the status of conditional
registrations;
``(ii) enhancing the database for
information regarding endangered species
assessments for registration review;
``(iii) implementing the capability to
electronically review labels submitted with
registration actions; and
``(iv) acquiring and implementing the
capability to electronically assess and
evaluate confidential statements of formula
submitted with registration actions.''; and
(iii) in the first sentence of paragraph
(6) (as redesignated by clause (i)), by
striking ``to carry out the goals established
under subsection (l)'' and inserting ``for the
purposes described in paragraphs (2), (3), and
(4) and to carry out the goals established
under subsection (l)''.
(b) Pesticide Registration Service Fees.--
(1) Amount of fees.--Section 33(b) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(b)) is amended--
(A) by striking paragraph (3) and inserting the
following:
``(3) Schedule of covered applications and registration
service fees.--Subject to paragraph (6), the schedule of
covered pesticide registration applications and corresponding
registration service fees shall be as follows:
``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R010 1 New Active Ingredient, Food use (2) (3) 24 569,221
----------------------------------------------------------------------------------------------------------------
R020 2 New Active Ingredient, Food use; reduced 18 569,221
risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R040 3 New Active Ingredient, Food use; 18 419,502
Experimental Use Permit application;
establish temporary tolerance; submitted
before application for registration;
credit 45% of fee toward new active
ingredient application that follows (3)
----------------------------------------------------------------------------------------------------------------
R060 4 New Active Ingredient, Non-food use; 21 395,467
outdoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R070 5 New Active Ingredient, Non-food use; 16 395,467
outdoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R090 6 New Active Ingredient, Non-food use; 16 293,596
outdoor; Experimental Use Permit
application; submitted before application
for registration; credit 45% of fee
toward new active ingredient (3)
----------------------------------------------------------------------------------------------------------------
R110 7 New Active Ingredient, Non-food use; 20 219,949
indoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R120 8 New Active Ingredient, Non-food use; 14 219,949
indoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R121 9 New Active Ingredient, Non-food use; 18 165,375
indoor; Experimental Use Permit
application; submitted before application
for registration; credit 45% of fee
toward new active ingredient application
that follows (3)
----------------------------------------------------------------------------------------------------------------
R122 10 Enriched isomer(s) of registered mixed- 18 287,643
isomer active ingredient (2) (3)
----------------------------------------------------------------------------------------------------------------
R123 11 New Active Ingredient, Seed treatment 18 427,991
only; includes agricultural and non-
agricultural seeds; residues not expected
in raw agricultural commodities (2) (3)
----------------------------------------------------------------------------------------------------------------
R125 12 New Active Ingredient, Seed treatment; 16 293,596
New Experimental Use Permit application;
submitted before application for
registration; credit 45% of fee toward
new active ingredient application that
follows (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R130 13 First food use; indoor; food/food handling 21 173,644
(2) (3)
----------------------------------------------------------------------------------------------------------------
R140 14 Additional food use; Indoor; food/food 15 40,518
handling (3) (4)
----------------------------------------------------------------------------------------------------------------
R150 15 First food use (2) (3) 21 239,684
----------------------------------------------------------------------------------------------------------------
R160 16 First food use; reduced risk (2) (3) 16 239,684
----------------------------------------------------------------------------------------------------------------
R170 17 Additional food use (3) (4) 15 59,976
----------------------------------------------------------------------------------------------------------------
R175 18 Additional food uses covered within a crop 10 59,976
New group resulting from the conversion of
existing approved crop group(s) to one or
more revised crop groups. (3) (4)
----------------------------------------------------------------------------------------------------------------
R180 19 Additional food use; reduced risk (3) (4) 10 59,976
----------------------------------------------------------------------------------------------------------------
R190 20 Additional food uses; 6 or more submitted 15 359,856
in one application (3) (4)
----------------------------------------------------------------------------------------------------------------
R200 21 Additional food uses; 6 or more submitted 10 359,856
in one application; reduced risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R210 22 Additional food use; Experimental Use 12 44,431
Permit application; establish temporary
tolerance; no credit toward new use
registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R220 23 Additional food use; Experimental Use 6 17,993
Permit application; crop destruct basis;
no credit toward new use registration (3)
(4)
----------------------------------------------------------------------------------------------------------------
R230 24 Additional use; non-food; outdoor (3) (4) 15 23,969
----------------------------------------------------------------------------------------------------------------
R240 25 Additional use; non-food; outdoor; reduced 10 23,969
risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R250 26 Additional use; non-food; outdoor; 6 17,993
Experimental Use Permit application; no
credit toward new use registration (3)
(4)
----------------------------------------------------------------------------------------------------------------
R251 27 Experimental Use Permit application which 8 17,993
New requires no changes to the tolerance(s);
non-crop destruct basis (3)
----------------------------------------------------------------------------------------------------------------
R260 28 New use; non-food; indoor (3) (4) 12 11,577
----------------------------------------------------------------------------------------------------------------
R270 29 New use; non-food; indoor; reduced risk 9 11,577
(3) (4)
----------------------------------------------------------------------------------------------------------------
R271 30 New use; non-food; indoor; Experimental 6 8,820
Use Permit application; no credit toward
new use registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R273 31 Additional use; seed treatment; limited 12 45,754
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)
----------------------------------------------------------------------------------------------------------------
R274 32 Additional uses; seed treatment only; 6 or 12 274,523
more submitted in one application;
limited uptake into raw agricultural
commodities; includes crops with
established tolerances (e.g., for soil or
foliar application); includes food and/or
non-food uses (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(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.
``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R280 33 Establish import tolerance; new active 21 289,407
ingredient or first food use (2)
----------------------------------------------------------------------------------------------------------------
R290 34 Establish import tolerance; additional 15 57,882
food use
----------------------------------------------------------------------------------------------------------------
R291 35 Establish import tolerances; additional 15 347,288
food uses; 6 or more crops submitted in
one petition
----------------------------------------------------------------------------------------------------------------
R292 36 Amend an established tolerance (e.g., 11 41,124
decrease or increase); domestic or
import; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293 37 Establish tolerance(s) for inadvertent 12 48,510
residues in one crop; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R294 38 Establish tolerances for inadvertent 12 291,060
residues; 6 or more crops submitted in
one application; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R295 39 Establish tolerance(s) for residues in one 15 59,976
rotational crop in response to a specific
rotational crop application; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R296 40 Establish tolerances for residues in 15 359,856
rotational crops in response to a
specific rotational crop petition; 6 or
more crops submitted in one application;
applicant-initiated
----------------------------------------------------------------------------------------------------------------
R297 41 Amend 6 or more established tolerances 11 246,744
New (e.g., decrease or increase) in one
petition; domestic or import; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R298 42 Amend an established tolerance (e.g., 13 53,120
New 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)
----------------------------------------------------------------------------------------------------------------
R299 43 Amend 6 or more established tolerances 13 258,740
New (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)
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R300 44 New product; or similar combination 4 1,434
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)
----------------------------------------------------------------------------------------------------------------
R301 45 New product; or similar combination 4 1,720
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)
----------------------------------------------------------------------------------------------------------------
R310 46 New end-use or manufacturing-use product 7 4,807
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:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> public health pest efficacy and/
or
<bullet> child resistant packaging. (2)
(3)
----------------------------------------------------------------------------------------------------------------
R314 47 New end use product containing two or more 8 6,009
New 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:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> public health pest efficacy and/
or
<bullet> child resistant packaging. (2)
(3)
----------------------------------------------------------------------------------------------------------------
R315 48 New end-use non-food animal product with 9 8,000
New submission of two or more target animal
safety studies; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> public health pest efficacy and/
or
<bullet> animal safety studies and/or
<bullet> child resistant packaging (2) (3)
----------------------------------------------------------------------------------------------------------------
R320 49 New product; new physical form; requires 12 11,996
data review in science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R331 50 New product; repack of identical 3 2,294
registered end-use product as a
manufacturing-use product; same
registered uses only (2) (3)
----------------------------------------------------------------------------------------------------------------
R332 51 New manufacturing-use product; registered 24 256,883
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)
----------------------------------------------------------------------------------------------------------------
R333 52 New product; MUP or End use product with 10 17,993
New unregistered source of active ingredient;
requires science data review; new
physical form; etc. Cite-all or selective
data citation where applicant owns all
required data. (2) (3)
----------------------------------------------------------------------------------------------------------------
R334 53 New product; MUP or End use product with 11 17,993
New unregistered source of the active
ingredient; requires science data review;
new physical form; etc. Selective data
citation. (2) (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring data review within RD 4 3,617
(e.g., changes to precautionary label
statements) (2) (3)
----------------------------------------------------------------------------------------------------------------
R345 55 Amending non-food animal product that 7 8,000
New includes submission of target animal
safety data; previously registered (2)
(3)
----------------------------------------------------------------------------------------------------------------
R350 56 Amendment requiring data review in science 9 11,996
divisions (e.g., changes to REI, or PPE,
or PHI, or use rate, or number of
applications; or add aerial application;
or modify GW/SW advisory statement) (2)
(3)
----------------------------------------------------------------------------------------------------------------
R351 57 Amendment adding a new unregistered source 8 11,996
New of active ingredient. (2) (3)
----------------------------------------------------------------------------------------------------------------
R352 58 Amendment adding already approved uses; 8 11,996
New selective method of support; does not
apply if the applicant owns all cited
data (2) (3)
----------------------------------------------------------------------------------------------------------------
R371 59 Amendment to Experimental Use Permit; 6 9,151
(does not include extending a permit's
time period) (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
R124 60 Conditional Ruling on Preapplication Study 6 2,294
Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R272 61 Review of Study Protocol applicant- 3 2,294
initiated; excludes DART, pre-
registration conference, Rapid Response
review, DNT protocol review, protocol
needing HSRB review
----------------------------------------------------------------------------------------------------------------
R275 62 Rebuttal of agency reviewed protocol, 3 2,294
New applicant initiated
----------------------------------------------------------------------------------------------------------------
R370 63 Cancer reassessment; applicant-initiated 18 179,818
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
A380 64 Food use; establish tolerance exemption 24 104,187
(2) (3)
----------------------------------------------------------------------------------------------------------------
A390 65 Food use; establish tolerance (2) (3) 24 173,644
----------------------------------------------------------------------------------------------------------------
A400 66 Non-food use; outdoor; FIFRA Sec. 2(mm) 18 86,823
uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A410 67 Non-food use; outdoor; uses other than 21 173,644
FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A420 68 Non-food use; indoor; FIFRA Sec. 2(mm) 18 57,882
uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A430 69 Non-food use; indoor; uses other than 20 86,823
FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A431 70 Non-food use; indoor; low-risk, low- 12 60,638
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)
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
A440 71 First food use; establish tolerance 21 28,942
exemption (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
A450 72 First food use; establish tolerance (2) 21 86,823
(3) (4)
----------------------------------------------------------------------------------------------------------------
A460 73 Additional food use; establish tolerance 15 11,577
exemption (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A470 74 Additional food use; establish tolerance 15 28,942
(3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A471 75 Additional food uses; establish 15 173,652
New tolerances; 6 or more submitted in one
application (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A480 76 Additional use; non-food; outdoor; FIFRA 9 17,365
Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A481 77 Additional non-food outdoor uses; FIFRA 9 104,190
New Sec. 2(mm) uses; 6 or more submitted in
one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A490 78 Additional use; non-food; outdoor; uses 15 28,942
other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A491 79 Additional non-food; outdoor; uses other 15 173,652
New than FIFRA Sec. 2(mm); 6 or more
submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A500 80 Additional use; non-food, indoor, FIFRA 9 11,577
Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A501 81 Additional non-food; indoor; FIFRA Sec. 9 69,462
New 2(mm) uses; 6 or more submitted in one
application (4) (5)
----------------------------------------------------------------------------------------------------------------
A510 82 Additional use; non-food; indoor; uses 12 11,577
other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A511 83 Additional non-food; indoor; uses other 12 69,462
New than FIFRA Sec. 2(mm); 6 or more
submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time. In
the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
application for another new product containing the same active ingredient or an amendment to the proposed
labeling will be deemed a new active ingredient application, subject to the registration service fee and
decision review time for a new active ingredient. In the case of a first food use application, until that
first food use is approved, any subsequent application for an additional new food use or uses will be subject
to the registration service fee and decision review time for a first food use. Any information that (a) was
neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
initiative to support the application after completion of the technical deficiency screening, and (c) is not
itself a covered registration application, must be assessed 25% of the full registration service fee for the
new active ingredient or first food use application.
(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.
``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
A530 84 New product; identical or substantially 4 1,159
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)
----------------------------------------------------------------------------------------------------------------
A531 85 New product; identical or substantially 4 1,654
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)
----------------------------------------------------------------------------------------------------------------
A532 86 New product; identical or substantially 5 4,631
similar in composition and use to a
registered product; registered active
ingredient; unregistered source of active
ingredient; cite-all data citation except
for product chemistry; product chemistry
data submitted (2) (3)
----------------------------------------------------------------------------------------------------------------
A540 87 New end use product; FIFRA Sec. 2(mm) uses 5 4,631
only (2) (3)
----------------------------------------------------------------------------------------------------------------
A550 88 New end-use product; uses other than FIFRA 7 4,631
Sec. 2(mm); non-FQPA product (2) (3)
----------------------------------------------------------------------------------------------------------------
A560 89 New manufacturing-use product; registered 12 17,365
active ingredient; selective data
citation (2) (3)
----------------------------------------------------------------------------------------------------------------
A570 90 Label amendment requiring data review (3) 4 3,474
(4)
----------------------------------------------------------------------------------------------------------------
A572 91 New Product or amendment requiring data 9 11,996
New review for risk assessment by Science
Branch (e.g., changes to REI, or PPE, or
use rate) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
but (b) has an application pending with the Agency for review, will be considered an application for a new
product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
(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.
``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
A520 92 Experimental Use Permit application, Non- 9 5,789
Food Use (2)
----------------------------------------------------------------------------------------------------------------
A521 93 Review of public health efficacy study 3 2,250
protocol within AD, per AD Internal
Guidance for the Efficacy Protocol Review
Process; Code will also include review of
public health efficacy study protocol and
data review for devices making pesticidal
claims; applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522 94 Review of public health efficacy study 12 11,025
protocol outside AD by members of AD
Efficacy Protocol Review Expert Panel;
Code will also include review of public
health efficacy study protocol and data
review for devices making pesticidal
claims; applicant-initiated; Tier 2
----------------------------------------------------------------------------------------------------------------
A524 95 New Active Ingredient, Experimental Use 18 138,916
New Permit application; Food Use Requires
Tolerance. Credit 45% of fee toward new
active ingredient application that
follows. (2)
----------------------------------------------------------------------------------------------------------------
A525 96 New Active Ingredient, Experimental Use 18 83,594
New Permit application; Food Use Requires
Tolerance Exemption. Credit 45% of fee
toward new active ingredient application
that follows. (2)
----------------------------------------------------------------------------------------------------------------
A526 97 New Active Ingredient, Experimental Use 15 86,823
New Permit application; Non-Food, Outdoor
Use. Credit 45% of fee toward new active
ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A527 98 New Active Ingredient, Experimental Use 15 58,000
New Permit application; Non-Food, Indoor Use.
Credit 45% of fee toward new active
ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A528 99 Experimental Use Permit application, Food 15 20,260
New Use; Requires Tolerance or Tolerance
Exemption (2)
----------------------------------------------------------------------------------------------------------------
A529 100 Amendment to Experimental Use Permit; 9 10,365
New requires data review or risk assessment
(2)
----------------------------------------------------------------------------------------------------------------
A523 101 Review of protocol other than a public 9 11,025
New health efficacy study (i.e., Toxicology
or Exposure Protocols)
----------------------------------------------------------------------------------------------------------------
A571 102 Science reassessment: Cancer risk, refined 18 86,823
New ecological risk, and/or endangered
species; applicant-initiated
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
stamped label to the registrant within 2 business days following the registrant's written or electronic
confirmation of agreement to the Agency.
``TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B580 103 New active ingredient; food use; petition 19 46,305
to establish a tolerance (2)
----------------------------------------------------------------------------------------------------------------
B590 104 New active ingredient; food use; petition 17 28,942
to establish a tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B600 105 New active ingredient; non-food use (2) 13 17,365
----------------------------------------------------------------------------------------------------------------
B610 106 New active ingredient; Experimental Use 10 11,577
Permit application; petition to establish
a temporary tolerance or temporary
tolerance exemption
----------------------------------------------------------------------------------------------------------------
B611 107 New active ingredient; Experimental Use 12 11,577
New Permit application; petition to establish
permanent tolerance exemption
----------------------------------------------------------------------------------------------------------------
B612 108 New active ingredient; no change to a 10 15,918
New permanent tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B613 109 New active ingredient; petition to convert 11 15,918
New a temporary tolerance or a temporary
tolerance exemption to a permanent
tolerance or tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B620 110 New active ingredient; Experimental Use 7 5,789
Permit application; non-food use
including crop destruct
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B630 111 First food use; petition to establish a 13 11,577
tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B631 112 New food use; petition to amend an 12 11,577
established tolerance (3)
----------------------------------------------------------------------------------------------------------------
B640 113 First food use; petition to establish a 19 17,365
tolerance (2)
----------------------------------------------------------------------------------------------------------------
B643 114 New Food use; petition to amend tolerance 10 11,577
New exemption (3)
----------------------------------------------------------------------------------------------------------------
B642 115 First food use; indoor; food/food handling 12 28,942
New (2)
----------------------------------------------------------------------------------------------------------------
B644 116 New use, no change to an established 8 11,577
New tolerance or tolerance exemption (3)
----------------------------------------------------------------------------------------------------------------
B650 117 New use; non-food (3) 7 5,789
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B652 118 New product; registered source of active 13 11,577
New 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)
----------------------------------------------------------------------------------------------------------------
B660 119 New product; registered source of active 4 1,159
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)
----------------------------------------------------------------------------------------------------------------
B670 120 New product; registered source of active 7 4,631
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)
----------------------------------------------------------------------------------------------------------------
B671 121 New product; unregistered source of active 17 11,577
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)
----------------------------------------------------------------------------------------------------------------
B672 122 New product; unregistered source of active 13 8,269
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)
----------------------------------------------------------------------------------------------------------------
B673 123 New product MUP/EP; unregistered source of 10 4,631
New 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)
----------------------------------------------------------------------------------------------------------------
B674 124 New product MUP; Repack of identical 4 1,159
New registered end-use product as a
manufacturing-use product; same
registered uses only (2)
----------------------------------------------------------------------------------------------------------------
B675 125 New Product MUP; registered source of 10 8,269
New active ingredient; submission of
completely new generic data package;
registered uses only. (2)
----------------------------------------------------------------------------------------------------------------
B676 126 New product; more than one active 13 8,269
New 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)
----------------------------------------------------------------------------------------------------------------
B677 127 New end-use non-food animal product with 10 8,000
New submission of two or more target animal
safety studies; includes data and/or
waivers of data for only:
<bullet> product chemistry and/or
<bullet> acute toxicity and/or
<bullet> public health pest efficacy and/
or
<bullet> animal safety studies and/or
<bullet> child resistant packaging (2)
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES;
AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B621 128 Amendment; Experimental Use Permit; no 7 4,631
change to an established temporary
tolerance or tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B622 129 Amendment; Experimental Use Permit; 11 11,577
New petition to amend an established or
temporary tolerance or tolerance
exemption.
----------------------------------------------------------------------------------------------------------------
B641 130 Amendment of an established tolerance or 13 11,577
tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680 131 Amendment; registered source of active 5 4,631
ingredient(s); no new use(s); no changes
to an established tolerance or tolerance
exemption. Requires data submission. (2)
----------------------------------------------------------------------------------------------------------------
B681 132 Amendment; unregistered source of active 7 5,513
ingredient(s). Requires data submission.
(2)
----------------------------------------------------------------------------------------------------------------
B683 133 Label amendment; requires review/update of 6 4,631
New previous risk assessment(s) without data
submission (e.g., labeling changes to
REI, PPE, PHI). (2)
----------------------------------------------------------------------------------------------------------------
B684 134 Amending non-food animal product that 8 8,000
New includes submission of target animal
safety data; previously registered (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) (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.
``TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B690 135 New active ingredient; food or non-food 7 2,316
use. (2)
----------------------------------------------------------------------------------------------------------------
B700 136 Experimental Use Permit application; new 7 1,159
active ingredient or new use.
----------------------------------------------------------------------------------------------------------------
B701 137 Extend or amend Experimental Use Permit. 4 1,159
----------------------------------------------------------------------------------------------------------------
B710 138 New product; registered source of active 4 1,159
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)
----------------------------------------------------------------------------------------------------------------
B720 139 New product; registered source of active 5 1,159
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)
----------------------------------------------------------------------------------------------------------------
B721 140 New product; unregistered source of active 7 2,426
ingredient. (3)
----------------------------------------------------------------------------------------------------------------
B722 141 New use and/or amendment; petition to 7 2,246
establish a tolerance or tolerance
exemption. (4) (5)
----------------------------------------------------------------------------------------------------------------
B730 142 Label amendment requiring data submission. 5 1,159
(4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
a first food use are covered by the base fee for that new active ingredient or first food use application and
retain the same decision time review period as the new active ingredient or first food use application. The
application must be received by the agency in one package. The base fee for the category covers a maximum of
five new products. Each application for an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food use application package is subject to
the registration service fee for a new product or a new inert approval. All such associated applications that
are submitted together will be subject to the new active ingredient or first food use decision review time,
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.
``TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B614 143 Conditional Ruling on Preapplication Study 3 2,294
New Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
B615 144 Rebuttal of agency reviewed protocol, 3 2,294
New applicant initiated
----------------------------------------------------------------------------------------------------------------
B682 145 Protocol review; applicant initiated; 3 2,205
excludes time for HSRB review
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
``TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
B740 146 Experimental Use Permit application; no 6 86,823
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)
----------------------------------------------------------------------------------------------------------------
B750 147 Experimental Use Permit application; with 9 115,763
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)
----------------------------------------------------------------------------------------------------------------
B770 148 Experimental Use Permit application; new 15 173,644
(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)
----------------------------------------------------------------------------------------------------------------
B771 149 Experimental Use Permit application; new 10 115,763
(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.
----------------------------------------------------------------------------------------------------------------
B772 150 Application to amend or extend an 3 11,577
Experimental Use Permit; no petition
since the established tolerance/tolerance
exemption for the active ingredient is
unaffected.
----------------------------------------------------------------------------------------------------------------
B773 151 Application to amend or extend an 5 28,942
Experimental Use Permit; with petition to
extend a temporary tolerance/tolerance
exemption for the active ingredient.
----------------------------------------------------------------------------------------------------------------
B780 152 Registration application; new (2) PIP; non- 12 144,704
food/feed.
----------------------------------------------------------------------------------------------------------------
B790 153 Registration application; new (2) PIP; non- 18 202,585
food/feed; SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B800 154 Registration application; new (2) PIP; 12 231,585
with petition to establish permanent
tolerance/tolerance exemption for the
active ingredient based on an existing
temporary tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B810 155 Registration application; new (2) PIP; 18 289,407
with petition to establish permanent
tolerance/tolerance exemption for the
active ingredient based on an existing
temporary tolerance/tolerance exemption.
SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B820 156 Registration application; new (2) PIP; 15 289,407
with petition to establish or amend a
permanent tolerance/tolerance exemption
of an active ingredient.
----------------------------------------------------------------------------------------------------------------
B840 157 Registration application; new (2) PIP; 21 347,288
with petition to establish or amend a
permanent tolerance/tolerance exemption
of an active ingredient. SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B851 158 Registration application; new event of a 9 115,763
previously registered PIP active
ingredient(s); no petition since
permanent tolerance/tolerance exemption
is already established for the active
ingredient(s).
----------------------------------------------------------------------------------------------------------------
B870 159 Registration application; registered (3) 9 34,729
PIP; new product; new use; no petition
since a permanent tolerance/tolerance
exemption is already established for the
active ingredient(s). (4)
----------------------------------------------------------------------------------------------------------------
B880 160 Registration application; registered (3) 9 28,942
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)
----------------------------------------------------------------------------------------------------------------
B881 161 Registration application; registered (3) 15 86,823
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)
----------------------------------------------------------------------------------------------------------------
B883 162 Registration application; new (2) PIP, 9 115,763
New 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)
----------------------------------------------------------------------------------------------------------------
B884 163 Registration application; new (2) PIP, 12 144,704
New seed increase with negotiated acreage cap
and time-limited registration; with
petition to establish a permanent
tolerance/tolerance exemption for the
active ingredient. (8)
----------------------------------------------------------------------------------------------------------------
B885 164 Registration application; registered (3) 9 86,823
New 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)
----------------------------------------------------------------------------------------------------------------
B890 165 Application to amend a seed increase 9 57,882
registration; converts registration to
commercial registration; no petition
since permanent tolerance/tolerance
exemption is already established for the
active ingredient(s).
----------------------------------------------------------------------------------------------------------------
B891 166 Application to amend a seed increase 15 115,763
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)
----------------------------------------------------------------------------------------------------------------
B900 167 Application to amend a registration, 6 11,577
including actions such as extending an
expiration date, modifying an IRM plan,
or adding an insect to be controlled.
(10) (11)
----------------------------------------------------------------------------------------------------------------
B901 168 Application to amend a registration, 12 69,458
including actions such as extending an
expiration date, modifying an IRM plan,
or adding an insect to be controlled. SAP
review. (10) (11)
----------------------------------------------------------------------------------------------------------------
B902 169 PIP protocol review 3 5,789
----------------------------------------------------------------------------------------------------------------
B903 170 Inert ingredient tolerance exemption; 6 57,882
e.g., a marker such as NPT II; reviewed
in BPPD.
----------------------------------------------------------------------------------------------------------------
B904 171 Import tolerance or tolerance exemption; 9 115,763
processed commodities/food only (inert or
active ingredient).
----------------------------------------------------------------------------------------------------------------
(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.
``TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No. New CR No. Action Decision Review Service Fee
Time (Months) (1) ($)
----------------------------------------------------------------------------------------------------------------
I001 172 Approval of new food use inert ingredient 12 18,000
(2) (3)
----------------------------------------------------------------------------------------------------------------
I002 173 Amend currently approved inert ingredient 10 5,000
New tolerance or exemption from tolerance;
new data (2)
----------------------------------------------------------------------------------------------------------------
I003 174 Amend currently approved inert ingredient 8 3,000
New tolerance or exemption from tolerance; no
new data (2)
----------------------------------------------------------------------------------------------------------------
I004 175 Approval of new non-food use inert 8 10,000
New ingredient (2)
----------------------------------------------------------------------------------------------------------------
I005 176 Amend currently approved non-food use 8 5,000
New inert ingredient with new use pattern;
new data (2)
----------------------------------------------------------------------------------------------------------------
I006 177 Amend currently approved non-food use 6 3,000
New inert ingredient with new use pattern; no
new data (2)
----------------------------------------------------------------------------------------------------------------
I007 178 Approval of substantially similar non-food 4 1,500
New use inert ingredients when original inert
is compositionally similar with similar
use pattern (2)
----------------------------------------------------------------------------------------------------------------
I008 179 Approval of new polymer inert ingredient, 5 3,400
New food use (2)
----------------------------------------------------------------------------------------------------------------
I009 180 Approval of new polymer inert ingredient, 4 2,800
New non food use (2)
----------------------------------------------------------------------------------------------------------------
I010 181 Petition to amend a tolerance exemption 6 1,500
New descriptor to add one or more CASRNs; no
new data (2)
----------------------------------------------------------------------------------------------------------------
M001 182 Study protocol requiring Human Studies 9 7,200
New Review Board review as defined in 40 CFR
26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M002 183 Completed study requiring Human Studies 9 7,200
New Review Board review as defined in 40 CFR
26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M003 184 External technical peer review of new 12 58,000
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 Sec. 25(d), in support
of a novel active ingredient, or unique
use pattern or application technology.
Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M004 185 External technical peer review of new 18 58,000
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 Sec. 25(d), in support
of a novel active ingredient, or unique
use pattern or application technology.
Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M005 186 New Product: Combination, Contains a 9 20,000
New combination of active ingredients from a
registered and/or unregistered source;
conventional, antimicrobial and/or
biopesticide. Requires coordination with
other regulatory divisions to conduct
review of data, label and/or verify the
validity of existing data as cited. Only
existing uses for each active ingredient
in the combination product. (6) (7)
----------------------------------------------------------------------------------------------------------------
M006 187 Request for up to 5 letters of 1 250
New certification (Gold Seal) for one
actively registered product.
----------------------------------------------------------------------------------------------------------------
M007 188 Request to extend Exclusive Use of data as 12 5,000
New provided by FIFRA Section 3(c)(1)(F)(ii)
----------------------------------------------------------------------------------------------------------------
M008 189 Request to grant Exclusive Use of data as 10 1,500
New provided by FIFRA Section 3(c)(1)(F)(vi)
for a minor use, when a FIFRA Section
2(ll)(2) determination is required
----------------------------------------------------------------------------------------------------------------
(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.'';
(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 fund.--Section 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) Assessment of fees.--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 periods.--
Section 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 periods.--Section 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) Screenings.--
``(I) Initial content.--Not
later'';
(II) in clause (i) (as so
designated) by adding at the end the
following:
``(II) Preliminary technical
screening.--After 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) Rejection.--
``(I) In general.--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) Written notification.--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 screening.--In 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) Reports.--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) Other report.--
``(A) Scope.--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) Information required.--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 effectiveness.--Section 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) Effective Date.--This section and the amendments made by this
section take effect on October 1, 2012.
(d) Relationship to Other Law.--In 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.
Passed the Senate September 13, 2012.
Attest:
Secretary.
112th CONGRESS
2d Session
S. 3552
_______________________________________________________________________
AN ACT
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.