108th CONGRESS
1st Session
H. R. 3188
To amend the Federal Insecticide, Fungicide, and Rodenticide Act
to provide for the enhanced review of covered pesticide products, to authorize
fees for certain pesticide products, and to extend and improve the collection
of maintenance fees.
IN THE HOUSE OF REPRESENTATIVES
September 25, 2003
Mr. LUCAS of Oklahoma (for himself, Mr. GOODLATTE, Mr. STENHOLM, and Mr.
HOLDEN) introduced the following bill; which was referred to the Committee
on Agriculture
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act
to provide for the enhanced review of covered pesticide products, to authorize
fees for certain pesticide products, and to extend and improve the collection
of maintenance fees.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. PESTICIDE REGISTRATION.
(a) SHORT TITLE- This Act may be cited as the `Pesticide Registration Improvement
Act of 2003'.
(b) REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES- Section 3(h) of
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(h))
is amended--
(1) in paragraph (2)(F), by striking `90 to 180 days' and inserting `120
days'; and
(A) in subparagraph (D)(vi), by striking `240 days' and inserting `120
days'; and
(B) in subparagraph (F), by adding at the end the following:
`(iv) LIMITATION- Notwithstanding clause (ii), the failure of the Administrator
to notify an applicant for an amendment to a registration for an antimicrobial
pesticide shall not be judicially reviewable in a Federal or State court
if the amendment requires scientific review of data within--
`(I) the time period specified in subparagraph (D)(vi), in the absence
of a final regulation under subparagraph (B); or
`(II) the time period specified in paragraph (2)(F), if adopted in
a final regulation under subparagraph (B).'.
(1) AMOUNTS FOR REGISTRANTS- Section 4(i)(5) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(5)) is amended--
(A) in subparagraph (A)--
(i) by striking `(A) Subject' and inserting the following:
`(A) IN GENERAL- Subject'; and
(ii) by striking `of--' and all that follows through `additional registration'
and inserting `for each registration';
(B) in subparagraph (D)--
(i) by striking `(D) The' and inserting the following:
`(D) MAXIMUM AMOUNT OF FEES FOR REGISTRANTS- The';
(ii) in clause (i), by striking `shall be $55,000; and' and inserting
`shall be--
`(I) for fiscal year 2004, $84,000;
`(II) for each of fiscal years 2005 and 2006, $87,000;
`(III) for fiscal year 2007, $68,000; and
`(IV) for fiscal year 2008, $55,000; and'; and
(iii) in clause (ii), by striking `shall be $95,000.' and inserting
`shall be--
`(I) for fiscal year 2004, $145,000;
`(II) for each of fiscal years 2005 and 2006, $151,000;
`(III) for fiscal year 2007, $117,000; and
`(IV) for fiscal year 2008, $95,000.'; and
(C) in subparagraph (E)--
(i) by striking `(E)(i) For' and inserting the following:
`(E) MAXIMUM AMOUNT OF FEES FOR SMALL BUSINESSES-
(ii) by indenting the margins of subclauses (I) and (II) of clause (i)
appropriately; and
(I) subclause (I), by striking `shall be $38,500; and' and inserting
`shall be--
`(aa) for fiscal year 2004, $59,000;
`(bb) for each of fiscal years 2005 and 2006, $61,000;
`(cc) for fiscal year 2007, $48,000; and
`(dd) for fiscal year 2008, $38,500; and'; and
(II) in subclause (II), by striking `shall be $66,500.' and inserting
`shall be--
`(aa) for fiscal year 2004, $102,000;
`(bb) for each of fiscal years 2005 and 2006, $106,000;
`(cc) for fiscal year 2007, $82,000; and
`(dd) for fiscal year 2008, $66,500.'.
(2) TOTAL AMOUNT OF FEES- Section 4(i)(5)(C) of the Federal Insecticide,
Fungicide, and
Rodenticide Act (7 U.S.C. 136(a)-1(i)(5)(C)) is amended--
(A) by striking `(C)(i) The' and inserting the following:
`(C) TOTAL AMOUNT OF FEES- The'; and
(B) by striking `aggregate amount' and all that follows through clause
(ii) and inserting `aggregate amount of--
`(i) for fiscal year 2004, $26,000,000;
`(ii) for fiscal year 2005, $27,000,000;
`(iii) for fiscal year 2006, $27,000,000;
`(iv) for fiscal year 2007, $21,000,000; and
`(v) for fiscal year 2008, $15,000,000.'.
(3) DEFINITION OF SMALL BUSINESS- Section 4(i)(5)(E)(ii) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(5)(E)(ii))
is amended--
(A) by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively,
and indenting the margins appropriately;
(B) by striking `(ii) For purposes of' and inserting the following:
`(ii) DEFINITION OF SMALL BUSINESS-
(C) in item (aa) (as so redesignated), by striking `150' and inserting
`500';
(D) in item (bb) (as so redesignated), by striking `gross revenue from
chemicals that did not exceed $40,000,000.' and inserting `global gross
revenue from pesticides that did not exceed $60,000,000.'; and
(E) by adding at the end the following:
`(aa) IN GENERAL- In the case of a business entity with 1 or more
affiliates, the gross revenue limit under subclause (I)(bb) shall apply to
the gross revenue for the entity and all of the affiliates of the entity,
including parents and subsidiaries, if applicable.
`(bb) AFFILIATED PERSONS- For the purpose of item (aa), persons are
affiliates of each other if, directly or indirectly, either person controls
or has the power to control the other person, or a third person controls or
has the power to control both persons.
`(cc) INDICIA OF CONTROL- For the purpose of item (aa), indicia of
control include interlocking management or ownership, identity of interests
among family members, shared facilities and equipment, and common use of employees.'.
(4) EXTENSION OF AUTHORITY FOR COLLECTING MAINTENANCE FEES- Section 4(i)(5)(H)
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(5)(H))
is amended by striking `2003' and inserting `2008'.
(5) REREGISTRATION AND OTHER ACTIVITIES- Section 4(g)(2) of the Federal
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136a-1(g)(2)) is amended--
(A) by striking subparagraph (A) and inserting the following:
`(A) IN GENERAL- The Administrator shall make a determination as to eligibility
for reregistration--
`(i) for all active ingredients subject to reregistration under this
section for which tolerances or exemptions from tolerances are required
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
not later than the last date for tolerance reassessment established
under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and
`(ii) for all other active ingredients subject to reregistration under
this section, not later than October 3, 2008.';
(B) in subparagraph (B)--
(i) by striking `(B) Before' and inserting the following:
`(B) PRODUCT-SPECIFIC DATA-
`(i) IN GENERAL- Before';
(ii) by striking `The Administrator' and inserting the following:
`(I) IN GENERAL- Subject to subclause (II), the Administrator'; and
(iii) by adding at the end the following:
`(II) EXTRAORDINARY CIRCUMSTANCES- In the case of extraordinary circumstances,
the Administrator may provide such a longer period, of not more than
2 additional years, for submission of data to the Administrator under
this subparagraph.'; and
(C) in subparagraph (D)--
(i) by striking `(D) If' and inserting the following:
`(D) DETERMINATION TO NOT REREGISTER-
`(i) IN GENERAL- If'; and
(ii) by adding at the end the following:
`(ii) TIMING FOR REGULATORY ACTION- Regulatory action under clause (i)
shall be completed as expeditiously as possible.'.
(1) IN GENERAL- Section 4(i)(6) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a-1(i)(6)) is amended--
(A) by striking `During' and inserting `Except as provided in section
33, during'; and
(B) by striking `2003' and inserting `2010'.
(2) TOLERANCE FEES- Notwithstanding section 408(m)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), the Administrator of the
Environmental Protection Agency shall not collect any tolerance fees under
that section during the period beginning on the effective date of this section
and ending on September 30, 2008.
(e) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS- Section 4(k)(3) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)) is amended--
(1) in the paragraph heading, by striking `EXPEDITED' and inserting `REVIEW
OF INERT INGREDIENTS; EXPEDITED'; and
(2) in subparagraph (A)--
(A) by striking `1997' and all that follows through `of the maintenance
fees' and inserting `2004 through 2006, approximately $3,300,000, and
for each of fiscal years 2007 and 2008, between 1/8 and 1/7 , of the maintenance
fees';
(B) by redesignating clauses (i), (ii), and (iii) as subclauses (I), (II)
and (III), respectively, and indenting appropriately; and
(C) by striking `resources to assure the expedited processing and review
of any application that' and inserting `resources--
`(i) to review and evaluate new inert ingredients; and
`(ii) to ensure the expedited processing and review of any application
(f) PESTICIDE REGISTRATION SERVICE FEES- The Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136a et seq.) is amended--
(1) by redesignating sections 33 and 34 (7 U.S.C. 136x, 136y) as sections
34 and 35, respectively; and
(2) by inserting after section 32 (7 U.S.C. 136w-7) the following:
`SEC. 33. 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) and reporting, auditing, and accounting under this section.
`(1) IN GENERAL- Effective beginning in fiscal year 2004, 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 Act that is received by the Administrator on or after October
1, 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 October
1, 2003, and is pending on the date of enactment of the Pesticide Registration
Improvement Act of 2003, 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 October 1, 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).
`(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.
`(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 2 of Public Law 89-106 (7 U.S.C. 450i(e)); and
`(ii) the waiver is in the public interest.
`(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 4(i)(5)(E)(ii)) 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 4(i)(5)(E)(ii)) at
the time of application; and
`(II) has average annual global gross revenues described in section
4(i)(5)(E)(ii)(I)(bb) 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 4(i)(5)(E)(ii)) 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 4(i)(5)(E)(ii)(I)(bb) 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.
`(A) EARLY WITHDRAWALS- If, during the first 60 days after the beginning
of the applicable decision time review period under subsection (f)(3),
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.
`(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- 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) during any portion of a fiscal year as
the result of paragraph (2) and is subsequently permitted to assess the
fees under subsection (b) 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)
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 Act 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 Act.
`(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);
`(B) covered pesticide registration applications for which an applicant
has voluntarily
paid registration service fees under subsection (b)(4); 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) and (D), 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) 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), 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); 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).
`(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 November 1, 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.
`(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.
`(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) 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.
`(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); and
`(3) provide an annual accounting describing collections and expenditures
authorized under subsection (d).
`(1) FINANCIAL STATEMENTS OF AGENCIES- For the purpose of section 3515(c)
of title 31, United States Code, 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) and disbursed;
`(B) compliance with subsection (f);
`(C) the amount appropriated to meet the requirements of subsection (d)(1);
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.
`(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), including--
`(i) the number of applications reviewed, including the decision times
for each application specified in subsection (f);
`(ii) the number of actions pending in each category of actions described
in subsection (f)(3), 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 Act 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 4(g).
`(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 Act, including the
right to judicial review of duties, obligations, or authorities established
by any other section of this Act.
`(m) TERMINATION OF EFFECTIVENESS-
`(1) IN GENERAL- Except as provided in paragraph (2), the authority provided
by this section terminates on September 30, 2008.
`(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).
`(ii) NEW APPLICATIONS- In the case of an application received under
this section on or after September 30, 2008, subsection (f) shall not
apply to the application.'.
(g) CONFORMING AMENDMENTS- The table of contents in section 1(b) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 136) is amended--
(1) by striking the item relating to section 4(k)(3) and inserting the following:
`(3) Review of inert ingredients; expedited processing of similar applications.';
(2) by striking the items relating to sections 30 and 31 and inserting the
following:
`Sec. 30. Minimum requirements for training of maintenance applicators and
service technicians.
`Sec. 31. Environmental Protection Agency minor use program.
`Sec. 32. Department of Agriculture minor use program.
`(b)(1) Minor use pesticide data.
`(2) Minor Use Pesticide Data Revolving Fund.
`Sec. 33. Pesticide registration service fees.
`(a) Definition of costs.
`(2) Covered pesticide registration applications.
`(3) Schedule of covered applications and registration service fees.
`(4) Pending pesticide registration applications.
`(5) Resubmission of pesticide registration applications.
`(7) Waivers and reductions.
`(c) Pesticide Registration Fund.
`(3) Expenditures from Fund.
`(4) Collections and appropriations Acts.
`(1) Definition of covered functions.
`(2) Minimum amount of appropriations.
`(5) Subsequent authority.
`(e) Reforms to reduce decision time review periods.
`(f) Decision time review periods.
`(3) Applications subject to decision time review periods.
`(4) Start of decision time review period.
`(5) Extension of decision time review period.
`(1) Financial statements of agencies.
`(m) Termination of effectiveness.
`Sec. 35. Authorization for appropriations.'.
(h) EFFECTIVE DATE- This section and the amendments made by this section take
effect on October 1, 2003.
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