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U.S. Code as of:
01/03/05
Section 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 applications,
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 assessments;
and
(C) advisory committees and other accredited persons or
organizations, on the request of the Administrator, engage in
the peer review of risk or benefits information associated with
covered pesticide applications;
(2) costs of management of information, and the acquisition,
maintenance, and repair of computer and telecommunication
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
subsections (b) and (c) of this section and reporting, auditing,
and accounting under this section.
(b) Fees
(1) In general
Effective beginning on the effective date of the Pesticide
Registration Improvement Act of 2003, the Administrator shall
assess and collect covered pesticide registration service fees in
accordance with this section.
(2) Covered pesticide registration applications
(A) In general
An application for the registration of a pesticide covered by
this subchapter that is received by the Administrator 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) Existing applications
(i) In general
Subject to clause (ii), an application for the registration
of a pesticide that was submitted 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
Environmental Protection Agency.
(ii) Tolerance or exemption fees
The amount of any fee otherwise payable for an application
described 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) Documentation
An application subject to a registration service fee under
this section shall be submitted with documentation certifying -
(i) payment of the registration service fee; or
(ii) a request for a waiver from or reduction of the
registration service fee.
(3) Schedule of covered applications and registration service
fees
(A) In general
Not later than 30 days after the effective date of the
Pesticide Registration Improvement Act of 2003, the
Administrator shall publish in the Federal Register a schedule
of covered pesticide registration applications and
corresponding registration service fees.
(B) Report
Subject to paragraph (6), the schedule shall be the same as
the applicable schedule appearing in the Congressional Record
on pages S11631 through S11633, dated September 17, 2003.
(4) Pending pesticide registration applications
(A) In general
An applicant that submitted a registration application to the
Administrator before the effective date of the Pesticide
Registration Improvement Act of 2003, but that is not required
to pay a registration service fee under paragraph (2)(B), may,
on a voluntary basis, pay a registration service fee in
accordance with paragraph (2)(B).
(B) Voluntary fee
The Administrator may not compel payment of a registration
service fee for an application described in subparagraph (A).
(C) Documentation
An application for which a voluntary registration service fee
is paid under this paragraph shall be submitted with
documentation certifying -
(i) payment of the registration service fee; or
(ii) a request for a waiver from or reduction of the
registration service fee.
(5) Resubmission of pesticide registration applications
If a pesticide registration application is submitted by a
person that paid the fee for the application under paragraph (2),
is determined by the Administrator to be complete, and is not
approved or is withdrawn (without a waiver or refund), the
submission of the same pesticide registration application by the
same person (or a licensee, assignee, or successor of the person)
shall not be subject to a fee under paragraph (2).
(6) Fee adjustment
Effective for a covered pesticide registration application
received on or after October 1, 2005, the Administrator shall -
(A) increase by 5 percent the service fee payable for the
application under paragraph (3); and
(B) publish in the Federal Register the revised registration
service fee schedule.
(7) Waivers and reductions
(A) In general
An applicant for a covered pesticide registration may request
the Administrator to waive or reduce the amount of a
registration service fee payable under this section under the
circumstances described in subparagraphs (D) through (G).
(B) Documentation
(i) In general
A request for a waiver from or reduction of the
registration service fee shall be accompanied by appropriate
documentation demonstrating the basis for the waiver or
reduction.
(ii) Certification
The applicant shall provide to the Administrator a written
certification, signed by a responsible officer, that the
documentation submitted to support the waiver or reduction
request is accurate.
(iii) Inaccurate documentation
An application shall be subject to the applicable
registration service fee payable under paragraph (3) if, at
any time, the Administrator determines that -
(I) the documentation supporting the waiver or reduction
request is not accurate; or
(II) based on the documentation or any other information,
the waiver or reduction should not have been granted or
should not be granted.
(C) Determination to grant or deny request
As soon as practicable, but not later than 60 days, after the
date on which the Administrator receives a request for a waiver
or reduction of a registration service fee under this
paragraph, the Administrator shall -
(i) determine whether to grant or deny the request; and
(ii) notify the applicant of the determination.
(D) Minor uses
(i) In general
The Administrator may waive or reduce a registration
service fee for an application for minor uses for a
pesticide.
(ii) Supporting documentation
An applicant requesting a waiver under this subparagraph
shall provide supporting documentation that demonstrates, to
the satisfaction of the Administrator, that anticipated
revenues from the uses that are the subject of the
application would be insufficient to justify imposition of
the full application fee.
(E) IR-4 waiver
The Administrator shall waive the registration service fee
for an application if the Administrator determines that -
(i) the application is solely associated with a tolerance
petition submitted in connection with the Inter-Regional
Project Number 4 (IR-4) as described in section 450i(e) of
this title; and
(ii) the waiver is in the public interest.
(F) Small businesses
(i) In general
The Administrator shall waive 50 percent of the
registration service fees payable by an entity for a covered
pesticide registration application under this section if the
entity is a small business (as defined in section
136a-1(i)(5)(E)(ii) of this title) at the time of
application.
(ii) Waiver of fees
The Administrator shall waive all of the registration
service fees payable by an entity under this section if the
entity -
(I) is a small business (as defined in section
136a-1(i)(5)(E)(ii) of this title) at the time of
application; and
(II) has average annual global gross revenues described
in section 136a-1(i)(5)(E)(ii)(I)(bb) of this title that
does not exceed $10,000,000, at the time of application.
(iii) Formation for waiver
The Administrator shall not grant a waiver under this
subparagraph if the Administrator determines that the entity
submitting the application has been formed or manipulated
primarily for the purpose of qualifying for the waiver.
(iv) Documentation
An entity requesting a waiver under this subparagraph shall
provide to the Administrator -
(I) documentation demonstrating that the entity is a
small business (as defined in section 136a-1(i)(5)(E)(ii)
of this title) at the time of application; and
(II) if the entity is requesting a waiver of all
registration service fees payable under this section,
documentation demonstrating that the entity has an average
annual global gross revenues described in section
136a-1(i)(5)(E)(ii)(I)(bb) of this title that does not
exceed $10,000,000, at the time of application.
(G) Federal and State agency exemptions
An agency of the Federal Government or a State government
shall be exempt from covered registration service fees under
this section.
(8) Refunds
(A) Early withdrawals
If, during the first 60 days after the beginning of the
applicable decision time review period under subsection (f)(3)
of this section, a covered pesticide registration application
is withdrawn by the applicant, the Administrator shall refund
all but 10 percent of the total registration service fee
payable under paragraph (3) for the application.
(B) Withdrawals after the first 60 days of decision review time
period
(i) In general
If a covered pesticide registration application is
withdrawn after the first 60 days of the applicable decision
time review period, the Administrator shall determine what
portion, if any, of the total registration service fee
payable under paragraph (3) for the application may be
refunded based on the proportion of the work completed at the
time of withdrawal.
(ii) Timing
The Administrator shall -
(I) make the determination described in clause (i) not
later than 90 days after the date the application is
withdrawn; and
(II) provide any refund as soon as practicable after the
determination.
(C) Discretionary refunds
(i) In general
In the case of a pesticide registration application that
has been filed with the Administrator and has not been
withdrawn by the applicant, but for which the Administrator
has not yet made a final determination, the Administrator may
refund a portion of a covered registration service fee if the
Administrator determines that the refund is justified.
(ii) Basis
The Administrator may provide a refund for an application
under this subparagraph -
(I) on the basis that, in reviewing the application, the
Administrator has considered data submitted in support of
another pesticide registration application; or
(II) on the basis that the Administrator completed
portions of the review of the application before the
effective date of this section.
(D) Credited fees
In determining whether to grant a refund under this
paragraph, the Administrator shall take into account any
portion of the registration service fees credited under
paragraph (2) or (4).
(c) Pesticide Registration Fund
(1) Establishment
There is established in the Treasury of the United States a
Pesticide Registration Fund to be used in carrying out this
section (referred to in this section as the "Fund"), consisting
of -
(A) such amounts as are deposited in the Fund under paragraph
(2);
(B) any interest earned on investment of amounts in the Fund
under paragraph (4); and
(C) any proceeds from the sale or redemption of investments
held in the Fund.
(2) Deposits in Fund
Subject to paragraph (4), the Administrator shall deposit fees
collected under this section in the Fund.
(3) Expenditures from Fund
(A) In general
Subject to subparagraphs (B) and (C) and paragraph (4), the
Administrator may make expenditures from the Fund -
(i) to cover the costs associated with the review and
decisionmaking pertaining to all applications for which
registration service fees have been paid under this section;
and
(ii) to otherwise carry out this section.
(B) Worker protection
For each of fiscal years 2004 through 2008, the Administrator
shall use approximately 1/17 of the amount in the Fund (but
not more than $1,000,000, and not less than $750,000, for any
fiscal year) to enhance current scientific and regulatory
activities related to worker protection.
(C) New inert ingredients
For each of fiscal years 2004 and 2005, the Administrator
shall use approximately 1/34 of the amount in the Fund (but
not to exceed $500,000 for any fiscal year) for the review and
evaluation of new inert ingredients.
(4) Collections and appropriations Acts
The fees authorized by this section and amounts deposited in
the Fund -
(A) shall be collected and made available for obligation only
to the extent provided in advance in appropriations Acts; and
(B) shall be available without fiscal year limitation.
(5) Unused funds
Amounts in the Fund not currently needed to carry out this
section shall be -
(A) maintained readily available or on deposit;
(B) invested in obligations of the United States or
guaranteed by the United States; or
(C) invested in obligations, participations, or other
instruments that are lawful investments for fiduciary, trust,
or public funds.
(d) Assessment of fees
(1) Definition of covered functions
In this subsection, the term "covered functions" means
functions of the Office of Pesticide Programs of the
Environmental Protection Agency, as identified in key programs
and projects of the final operating plan for the Environmental
Protection Agency submitted as part of the budget process for
fiscal year 2002, regardless of any subsequent transfer of 1 or
more of the functions to another office or agency or the
subsequent transfer of a new function to the Office of Pesticide
Programs.
(2) Minimum amount of appropriations
For fiscal years 2004, 2005, and 2006 only, registration
service fees may not be assessed for a fiscal year under this
section unless the amount of appropriations for salaries,
contracts, and expenses for the functions (as in existence in
fiscal year 2002) of the Office of Pesticide Programs of the
Environmental Protection Agency for the fiscal year (excluding
the amount of any fees appropriated for the fiscal year) are
equal to or greater than the amount of appropriations for covered
functions for fiscal year 2002 (excluding the amount of any fees
appropriated for the fiscal year).
(3) Use of fees
Registration service fees authorized by this section shall be
available, in the aggregate, only to defray increases in the
costs associated with the review and decisionmaking for the
review of pesticide registration applications and associated
tolerances (including increases in the number of full-time
equivalent positions in the Environmental Protection Agency
engaged in those activities) over the costs for fiscal year 2002,
excluding costs paid from fees appropriated for the fiscal year.
(4) Compliance
The requirements of paragraph (2) shall have been considered to
have been met for any fiscal year if the amount of appropriations
for salaries, contracts, and expenses for the functions (as in
existence in fiscal year 2002) of the Office of Pesticide
Programs of the Environmental Protection Agency for the fiscal
year (excluding the amount of any fees appropriated for the
fiscal year) is not more than 3 percent below the amount of
appropriations for covered functions for fiscal year 2002
(excluding the amount of any fees appropriated for the fiscal
year).
(5) Subsequent authority
If the Administrator does not assess registration service fees
under subsection (b) of this section during any portion of a
fiscal year as the result of paragraph (2) and is subsequently
permitted to assess the fees under subsection (b) of this section
during the fiscal year, the Administrator shall assess and
collect the fees, without any modification in rate, at any time
during the fiscal year, notwithstanding any provisions of
subsection (b) of this section relating to the date fees are to
be paid.
(e) Reforms to reduce decision time review periods
To the maximum extent practicable consistent with the degrees of
risk presented by pesticides and the type of review appropriate to
evaluate risks, the Administrator shall identify and evaluate
reforms to the pesticide registration process under this subchapter
with the goal of reducing decision review periods in effect on the
effective date of the Pesticide Registration Improvement Act of
2003 for pesticide registration actions for covered pesticide
registration applications (including reduced risk applications).
(f) Decision time review periods
(1) In general
Not later than 30 days after the effective date of the
Pesticide Registration Improvement Act of 2003, the Administrator
shall publish in the Federal Register a schedule of decision
review periods for covered pesticide registration actions and
corresponding registration service fees under this subchapter.
(2) Report
The schedule shall be the same as the applicable schedule
appearing in the Congressional Record on pages S11631 through
S11633, dated September 17, 2003.
(3) Applications subject to decision time review periods
The decision time review periods specified in paragraph (1)
shall apply to -
(A) covered pesticide registration applications subject to
registration service fees under subsection (b)(2) of this
section;
(B) covered pesticide registration applications for which an
applicant has voluntarily paid registration service fees under
subsection (b)(4) of this section; and
(C) covered pesticide registration applications listed in the
Registration Division 2003 Work Plan of the Office of Pesticide
Programs of the Environmental Protection Agency.
(4) Start of decision time review period
(A) In general
Except as provided in subparagraphs (C), (D), and (E), in the
case of a pesticide registration application accompanied by the
registration service fee required under this section, the
decision time review period begins 21 days after the date on
which the Administrator receives the covered pesticide
registration application.
(B) Completeness of application
In conducting an initial screening of an application, the
Administrator shall determine -
(i) whether -
(I) the applicable registration service fee has been
paid; or
(II) the application contains a waiver or refund request;
and
(ii) whether the application -
(I) contains all necessary forms, data, draft labeling,
and, documentation certifying payment of any registration
service fee required under this section; or
(II) establishes a basis for any requested waiver or
reduction.
(C) Applications with waiver or reduction requests
(i) In general
In the case of an application submitted with a request for
a waiver or reduction of registration service fees under
subsection (b)(7) of this section, the decision time review
period shall be determined in accordance with this
subparagraph.
(ii) Request granted with no additional fees required
If the Administrator grants the waiver or reduction request
and no additional fee is required, the decision time review
period begins on the earlier of -
(I) the date on which the Administrator grants the
request; or
(II) the date that is 60 days after the date of receipt
of the application.
(iii) Request granted with additional fees required
If the Administrator grants the waiver or reduction
request, in whole or in part, but an additional registration
service fee is required, the decision time review period
begins on the date on which the Administrator receives
certification of payment of the applicable registration
service fee.
(iv) Request denied
If the Administrator denies the waiver or reduction
request, the decision time review period begins on the date
on which the Administrator receives certification of payment
of the applicable registration service fee.
(D) Pending applications
(i) In general
The start of the decision time review period for
applications described in clause (ii) shall be the date on
which the Administrator receives certification of payment of
the applicable registration service fee.
(ii) Applications
Clause (i) applies to -
(I) covered pesticide registration applications for which
voluntary fees have been paid under subsection (b)(4) of
this section; and
(II) covered pesticide registration applications received
on or after the effective date of the Pesticide
Registration Improvement Act of 2003 but submitted without
the applicable registration service fee required under this
section due to the inability of the Administrator to assess
fees under subsection (d)(1) of this section.
(E) 2003 work plan
In the case of a covered pesticide registration application
listed in the Registration Division 2003 Work Plan of the
Office of Pesticide Programs of the Environmental Protection
Agency, the decision time review period begins on the date that
is 30 days after the effective date of the Pesticide
Registration Improvement Act of 2003.
(5) Extension of decision time review period
The Administrator and the applicant may mutually agree in
writing to extend a decision time review period under this
subsection.
(g) Judicial review
(1) In general
Any applicant adversely affected by the failure of the
Administrator to make a determination on the application of the
applicant for registration of a new active ingredient or new use
for which a registration service fee is paid under this section
may obtain judicial review of the failure solely under this
section.
(2) Scope
(A) In general
In an action brought under this subsection, the only issue on
review is whether the Administrator failed to make a
determination on the application specified in paragraph (1) by
the end of the applicable decision time review period required
under subsection (f) of this section for the application.
(B) Other actions
No other action authorized or required under this section
shall be judicially reviewable by a Federal or State court.
(3) Timing
(A) In general
A person may not obtain judicial review of the failure of the
Administrator to make a determination on the application
specified in paragraph (1) before the expiration of the 2-year
period that begins on the date on which the decision time
review period for the application ends.
(B) Meeting with Administrator
To be eligible to seek judicial review under this subsection,
a person seeking the review shall first request in writing, at
least 120 days before filing the complaint for judicial review,
a decision review meeting with the Administrator.
(4) Remedies
The Administrator may not be required or permitted to refund
any portion of a registration service fee paid in response to a
complaint that the Administrator has failed to make a
determination on the covered pesticide registration application
specified in paragraph (1) by the end of the applicable decision
review period.
(h) Accounting
The Administrator shall -
(1) provide an annual accounting of the registration service
fees paid to the Administrator and disbursed from the Fund, by
providing financial statements in accordance with -
(A) the Chief Financial Officers Act of 1990 (Public Law
101-576; 104 Stat. 2838) and amendments made by that Act; and
(B) the Government Management Reform Act of 1994 (Public Law
103-356; 108 Stat. 3410) and amendments made by that Act;
(2) provide an accounting describing expenditures from the Fund
authorized under subsection (c) of this section; and
(3) provide an annual accounting describing collections and
expenditures authorized under subsection (d) of this section.
(i) Auditing
(1) Financial statements of agencies
For the purpose of section 3515(c) of title 31, the Fund shall
be considered a component of an executive agency.
(2) Components
The annual audit required under sections 3515(b) and 3521 of
that title of the financial statements of activities under this
section shall include an analysis of -
(A) the fees collected under subsection (b) of this section
and disbursed;
(B) compliance with subsection (f) of this section;
(C) the amount appropriated to meet the requirements of
subsection (d)(1) of this section; and
(D) the reasonableness of the allocation of the overhead
allocation of costs associated with the review and
decisionmaking pertaining to applications under this section.
(3) Inspector General
The Inspector General of the Environmental Protection Agency
shall -
(A) conduct the annual audit required under this subsection;
and
(B) report the findings and recommendations of the audit to
the Administrator and to the appropriate committees of
Congress.
(j) Personnel levels
All full-time equivalent positions supported by fees authorized
and collected under this section shall not be counted against the
agency-wide personnel level goals of the Environmental Protection
Agency.
(k) Reports
(1) In general
Not later than March 1, 2005, and each March 1 thereafter
through March 1, 2009, the Administrator shall publish an annual
report describing actions taken under this section.
(2) Contents
The report shall include -
(A) a review of the progress made in carrying out each
requirement of subsections (e) and (f) of this section,
including -
(i) the number of applications reviewed, including the
decision times for each application specified in subsection
(f) of this section;
(ii) the number of actions pending in each category of
actions described in subsection (f)(3) of this section, as
well as the number of inert ingredients;
(iii) to the extent determined appropriate by the
Administrator and consistent with the authorities of the
Administrator and limitations on delegation of functions by
the Administrator, recommendations for -
(I) expanding the use of self-certification in all
appropriate areas of the registration process;
(II) providing for accreditation of outside reviewers and
the use of outside reviewers to conduct the review of major
portions of applications; and
(III) reviewing the scope of use of the notification
process to cover broader categories of registration
actions; and
(iv) the use of performance-based contracts, other
contracts, and procurement to ensure that -
(I) the goals of this subchapter for the timely review of
applications for registration are met; and
(II) the registration program is administered in the most
productive and cost effective manner practicable;
(B) a description of the staffing and resources relating to
the costs associated with the review and decisionmaking
pertaining to applications; and
(C) a review of the progress in meeting the timeline
requirements of section 136a-1(g) of this title.
(3) Method
The Administrator shall publish a report required by this
subsection by such method as the Administrator determines to be
the most effective for efficiently disseminating the report,
including publication of the report on the Internet site of the
Environmental Protection Agency.
(l) Savings clause
Nothing in this section affects any other duties, obligations, or
authorities established by any other section of this subchapter,
including the right to judicial review of duties, obligations, or
authorities established by any other section of this subchapter.
(m) Termination of effectiveness
(1) In general
Except as provided in paragraph (2), the authority provided by
this section terminates on September 30, 2008.
(2) Phase out
(A) Fiscal year 2009
During fiscal year 2009, the requirement to pay and collect
registration service fees applies, except that the level of
registration service fees payable under this section shall be
reduced 40 percent below the level in effect on September 30,
2008.
(B) Fiscal year 2010
During fiscal year 2010, the requirement to pay and collect
registration service fees applies, except that the level of
registration service fees payable under this section shall be
reduced 70 percent below the level in effect on September 30,
2008.
(C) September 30, 2010
Effective September 30, 2010, the requirement to pay and
collect registration service fees terminates.
(D) Decision review periods
(i) Pending applications
In the case of an application received under this section
before September 30, 2008, the application shall be reviewed
in accordance with subsection (f) of this section.
(ii) New applications
In the case of an application received under this section
on or after September 30, 2008, subsection (f) of this
section shall not apply to the application.
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