| S 1664 IS
108th CONGRESS
1st Session
S. 1664
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 SENATE OF THE UNITED
STATES
September 25, 2003
Mr. COCHRAN (for himself, Mr.
HARKIN, Mr. ROBERTS, Mr. CRAIG, Mr. CRAPO, Mr. CHAMBLISS, Mr. MILLER, Mr.
COLEMAN, Mr. NELSON of Nebraska, Mr. KOHL, Mr. Talent, Mr. Lugar, Mr. Conrad,
Ms. Landrieu, and Mr. Breaux) introduced the following bill; which was
read twice and referred to the Committee on Agriculture, Nutrition, and
Forestry
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.
END
|