33. Pesticide registration service fees

SEC. 33. [7 U.S.C. 136w–8] PESTICIDE REGISTRATION SERVICE FEES.

(a) DEFINITION OF COSTS.—In this section, the term ‘‘costs’’,
when used with respect to review and decisionmaking pertaining to
an application for which registration service fees are paid under
this section, means—
(1) costs to the extent that—
(A) officers and employees provide direct support for
the review and decisionmaking for covered pesticide appli

cations, associated tolerances, and corresponding risk and
benefits information and analyses;
(B) persons and organizations under contract with the
Administrator engage in the review of the applications,
and corresponding risk and benefits information and as

sessments; and
(C) advisory committees and other accredited persons
or organizations, on the request of the Administrator, en

gage in the peer review of risk or benefits information as

sociated with covered pesticide applications;
(2) costs of management of information, and the acquisi

tion, maintenance, and repair of computer and telecommuni

cation resources (including software), used to support review of
pesticide applications, associated tolerances, and corresponding
risk and benefits information and analyses; and
(3) costs of collecting registration service fees under sub

sections (b) and (c) and reporting, auditing, and accounting
under this section.
(b) F
EES
.—
(1) I
N
GENERAL
.—Effective beginning on the effective date
of the Pesticide Registration Improvement Act of 2003, the Ad
-ministrator shall assess and collect covered pesticide registra

tion service fees in accordance with this section.
(2) C
OVERED
PESTICIDE
REGISTRATION
APPLICATIONS
.—
(A) I
N
GENERAL
.—An application for the registration of
a pesticide covered by this Act that is received by the Ad

ministrator on or after the effective date of the Pesticide
Registration Improvement Act of 2003 shall be subject to
a registration service fee under this section.
(B) E
XISTING
APPLICATIONS
.—
(i) I
N
GENERAL
.—Subject to clause (ii), an applica

tion for the registration of a pesticide that was sub

mitted to the Administrator before the effective date of
the Pesticide Registration Improvement Act of 2003
and is pending on that effective date shall be subject
to a service fee under this section if the application is
for the registration of a new active ingredient that is
not listed in the Registration Division 2003 Work Plan
of the Office of Pesticide Programs of the Environ

mental Protection Agency.
(ii) T
OLERANCE
OR
EXEMPTION
FEES
.—The amount
of any fee otherwise payable for an application de

scribed in clause (i) under this section shall be reduced
by the amount of any fees paid to support the related
petition for a pesticide tolerance or exemption under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(C) D
OCUMENTATION
.—An application subject to a reg

istration service fee under this section shall be submitted
with documentation certifying—
(i) payment of the registration service fee; or
(ii) payment of at least 25 percent of the registra

tion service fee and a request for a waiver from or re

duction of the remaining amount of the registration
service fee.
(D) P
AYMENT
.—The registration service fee required
under this subsection shall be due upon submission of the
application.
(E) A
PPLICATIONS
SUBJECT
TO
ADDITIONAL
FEES
.—An
application may be subject to additional fees if—
(i) the applicant identified the incorrect registra

tion service fee and decision review period;
(ii) after review of a waiver request, the Adminis

trator denies the waiver request; or
(iii) after review of the application, the Adminis

trator determines that a different registration service
fee and decision review period apply to the application.
(F) E
FFECT
OF
FAILURE
TO
PAY
FEES
.—The Adminis

trator shall reject any application submitted without the
required registration service fee.
(G) N
ON

REFUNDABLE
PORTION
OF
FEES
.—
(i) I
N
GENERAL
.—The Administrator shall retain
25 percent of the applicable registration service fee.(ii) L
IMITATION
.—Any waiver, refund, credit or
other reduction in the registration service fee shall not
exceed 75 percent of the registration service fee.
(H) C
OLLECTION
OF
UNPAID
FEES
.—In any case in
which the Administrator does not receive payment of a
registration service fee (or applicable portion of the reg

istration service fee) by the date that is 30 days after the
fee is due, the fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37
of title 31, United States Code.
(3) S
CHEDULE
OF
COVERED
APPLICATIONS
AND
REGISTRA

TION
SERVICE
FEES
.—Subject to paragraph (6), the schedule of
covered pesticide registration applications and corresponding
registration service fees shall be as follows:

(1) A decision review time that would otherwise end on a Saturday, Sunday, or fed

eral 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 re

view 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 reg

istration and new inert approval that is submitted in the new active ingredient appli

cation 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 de

cision 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 screen

ing, 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 applica

tion.

(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 appli

cant-submitted label and relevant supporting data reviewed by the Agency. The appli

cant will notify the Agency that the applicant either (a) agrees to all of the terms as

sociated 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 writ

ten or electronic confirmation of agreement to the Agency.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or fed

eral 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 re

view 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 reg

istration and new inert approval that is submitted in the new active ingredient appli

cation 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 de

cision 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 screen

ing, 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 applica

tion.
(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 appli

cant-submitted label and relevant supporting data reviewed by the Agency. The appli

cant will notify the Agency that the applicant either (a) agrees to all of the terms as

sociated 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 writ

ten 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 ap

proval. 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 sepa

rate new-use application, subject to a separate registration service fee and new deci

sion 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 initia

tive 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.

(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 appli

cant-submitted label and relevant supporting data reviewed by the Agency. The appli

cant will notify the Agency that the applicant either (a) agrees to all of the terms as

sociated 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 writ

ten or electronic confirmation of agreement to the Agency.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or fed

eral holiday, will be extended to end on the next business day.
*ERR93*(2) An application for a new end-use product using a source of active in

gredient 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 unreg

istered 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 appli

cant-submitted label and relevant supporting data reviewed by the Agency. The appli

cant will notify the Agency that the applicant either (a) agrees to all of the terms as

sociated 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 writ

ten or electronic confirmation of agreement to the Agency.