§ 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)
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—
(D)
Payment
The registration service fee required under this subsection shall be due upon submission of the application.
(F)
Effect of failure to pay fees
The Administrator shall reject any application submitted without the required registration service fee.
(G)
Non-refundable portion of fees
(H)
Collection of unpaid fees
In any case in which the Administrator does not receive payment of a registration service fee (or applicable portion of the registration service fee) by the date that is 30 days after the fee is due, the fee shall be treated as a claim of the United States Government subject to subchapter
II of chapter
37 of title
31.
(3)
Schedule of covered applications and registration service fees
(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).
(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
(A)
In general
Effective for a covered pesticide registration application received during the period beginning on October 1, 2008, and ending on September 30, 2010, the Administrator shall increase by 5 percent the registration service fee payable for the application under paragraph (3).
(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.
(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—
(D)
Minor uses
(i)
In general
The Administrator may exempt from, or waive a portion of, the registration service fee for an application for minor uses for a pesticide.
(ii)
Supporting documentation
An applicant requesting a waiver or exemption 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 exemption
The Administrator shall exempt an application from the registration service fee if the Administrator determines that—
(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 75 percent 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 75 percent of the applicable.[1] registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenues [2] 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.
(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 25 percent.[1] 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.
(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.
(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—
(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—
(B)
Worker protection
(i)
In general
For each of fiscal years 2008 through 2012, the Administrator shall use approximately 1/17 of the amount in the Fund (but not less than $1,000,000) to enhance scientific and regulatory activities relating to worker protection.
(4)
Collections and appropriations Acts
The fees authorized by this section and amounts deposited in the Fund—
(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
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 Renewal Act, 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 S10409 through S10411, dated July 31, 2007.
(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;
(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
(i)
In general
Not later than 21 days after receiving an application and the required registration service fee, the Administrator shall conduct an initial screening of the contents of the application in accordance with clause (iii).
(ii)
Rejection
If the Administrator determines under clause (i) that the application does not pass the initial screening and cannot be corrected within the 21-day period, the Administrator shall reject the application not later than 10 days after making the determination.
(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—
(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.
(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.
(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.
(3)
Timing
(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;
(i)
Auditing
(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, 2014, 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;
(iii)
the amount of money from the Reregistration and Expedited Processing Fund used to carry out inert ingredient review and review of similar applications under section
136a–1
(k)(3) of this title;
(iv)
the number of applications completed for identical or substantially similar applications under section
136a
(c)(3)(B) of this title, including the number of such applications completed within 90 days pursuant to that section;
(v)
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;
(vi)
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—
(II)
providing for accreditation of outside reviewers and the use of outside reviewers to conduct the review of major portions of applications;
(III)
reviewing the scope of use of the notification process to cover broader categories of registration actions;
(B)
a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications;
(C)
a review of the progress in meeting the timeline requirements of section
136a–1
(g) of this title;
(D)
a review of the progress in carrying out section
136a
(g) of this title, including—
(ii)
a description of the staffing and resources relating to the costs associated with the review and decision making relating to reregistration and registration review for compliance with the deadlines specified in this subchapter;
(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)
process improvements in the handling of registration review under section
136a
(g) of this title;
(E)
a review of the progress in meeting the timeline requirements for the review of antimicrobial pesticide products under section
136a
(h) of this title; and
(F)
a review of the progress in carrying out the review of inert ingredients, including the number of applications pending, the number of new applications, the number of applications reviewed, staffing, and resources devoted to the review of inert ingredients and recommendations to improve the timeliness of review of inert ingredients.
(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, 2012.
(2)
Phase out
(A)
Fiscal year 2013
During fiscal year 2013, 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, 2012.
(B)
Fiscal year 2014
During fiscal year 2014, 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, 2012.
(C)
September 30, 2014
Effective September 30, 2014, the requirement to pay and collect registration service fees terminates.
[1] So in original. Period probably should not appear.
[2] So in original. Probably should be “revenue”.