United States Code

USC most recently checked for updates: Aug 15, 2020

§ 136w–8.
Pesticide registration service fees
(a)
Definition of costs
In this section, the term “costs”, when used with respect to review and decisionmaking pertaining to an application for which registration service fees are paid under this section, means—
(1)
costs to the extent that—
(A)
officers and employees provide direct support for the review and decisionmaking for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses;
(B)
persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and
(C)
advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications;
(2)
costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and
(3)
costs of collecting registration service fees under subsections (b) and (c) and reporting, auditing, and accounting under this section.
(b)
Fees
(1)
In general

Effective beginning on the effective date of the Pesticide Registration Improvement Act of 2003, the Administrator shall assess and collect covered pesticide registration service fees in accordance with this section.

(2)
Covered 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 or for any other action covered by a table specified in paragraph (3) shall be subject to a registration service fee under this section.

(B)
Existing applications
(i)
In general

Subject to clause (ii), an application for the registration of a pesticide that was submitted to the Administrator before the effective date of the Pesticide Registration Improvement Act of 2003 and is pending on that effective date shall be subject to a service fee under this section if the application is for the registration of a new active ingredient that is not listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.

(ii)
Tolerance or exemption fees

The amount of any fee otherwise payable for an application described in clause (i) under this section shall be reduced by the amount of any fees paid to support the related petition for a pesticide tolerance or exemption under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(C)
Documentation
An application subject to a registration service fee under this section shall be submitted with documentation certifying—
(i)
payment of the registration service fee; or
(ii)
payment of at least 25 percent of the registration service fee and a request for a waiver from or reduction of the remaining amount of the registration service fee.
(D)
Payment

The registration service fee required under this subsection shall be due upon submission of the application.

(E)
Applications subject to additional fees
An application may be subject to additional fees if—
(i)
the applicant identified the incorrect registration service fee and decision review period;
(ii)
after review of a waiver request, the Administrator denies the waiver request; or
(iii)
after review of the application, the Administrator determines that a different registration service fee and decision review period apply to 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
(i)
In general

The Administrator shall retain 25 percent of the applicable registration service fee.

(ii)
Limitation

Any waiver, refund, credit or other reduction in the registration service fee shall not exceed 75 percent of the registration service fee.

(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 other actions and their registration service fees

Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:

TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE INGREDIENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

R010

1

New Active Ingredient, Food use. (2)(3)

24

753,082

R020

2

New Active Ingredient, Food use; reduced risk. (2)(3)

18

627,568

R040

3

New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)

18

462,502

R060

4

New Active Ingredient, Non-food use; outdoor. (2)(3)

21

523,205

R070

5

New Active Ingredient, Non-food use; outdoor; reduced risk. (2)(3)

16

436,004

R090

6

New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)

16

323,690

R110

7

New Active Ingredient, Non-food use; indoor. (2)(3)

20

290,994

R120

8

New Active Ingredient, Non-food use; indoor; reduced risk. (2)(3)

14

242,495

R121

9

New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)

18

182,327

R122

10

Enriched isomer(s) of registered mixed-isomer active ingredient. (2)(3)

18

317,128

R123

11

New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities. (2)(3)

18

471,861

R125

12

New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)

16

323,690

TABLE 2. — REGISTRATION DIVISION — NEW USES

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

(4)
Pending pesticide registration applications
(A)
In general

An applicant that submitted a registration application to the Administrator before the effective date of the Pesticide Registration Improvement Act of 2003, but that is not required to pay a registration service fee under paragraph (2)(B), may, on a voluntary basis, pay a registration service fee in accordance with paragraph (2)(B).

(B)
Voluntary fee

The Administrator may not compel payment of a registration service fee for an application described in subparagraph (A).

(C)
Documentation
An application for which a voluntary registration service fee is paid under this paragraph shall be submitted with documentation certifying—
(i)
payment of the registration service fee; or
(ii)
a request for a waiver from or reduction of the registration service fee.
(5)
Resubmission of covered applications

If a covered 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 covered 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 application received during the period beginning on October 1, 2019, and ending on September 30, 2021, the Administrator shall increase by 5 percent the registration service fee payable for the application under paragraph (3).

(B)
Additional adjustment

Effective for a covered application received on or after October 1, 2021, the Administrator shall increase by an additional 5 percent the registration service fee in effect as of September 30, 2021.

(C)
Publication

The Administrator shall publish in the Federal Register the service fee schedules revised pursuant to this paragraph.

(7)
Waivers and reductions
(A)
In general

An applicant for a covered application 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), except that no waiver or fee reduction shall be provided in connection with a request for a letter of certification (commonly referred to as a Gold Seal letter).

(B)
Documentation
(i)
In general

A request for a waiver from or reduction of the registration service fee shall be accompanied by appropriate documentation demonstrating the basis for the waiver or reduction.

(ii)
Certification

The applicant shall provide to the Administrator a written certification, signed by a responsible officer, that the documentation submitted to support the waiver or reduction request is accurate.

(iii)
Inaccurate documentation
An application shall be subject to the applicable registration service fee payable under paragraph (3) if, at any time, the Administrator determines that—
(I)
the documentation supporting the waiver or reduction request is not accurate; or
(II)
based on the documentation or any other information, the waiver or reduction should not have been granted or should not be granted.
(C)
Determination to grant or deny request
As soon as practicable, but not later than 60 days, after the date on which the Administrator receives a request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall—
(i)
determine whether to grant or deny the request; and
(ii)
notify the applicant of the determination.
(D)
Minor uses
(i)
In general

The Administrator may 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—
(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)); 1
1
 See References in Text note below.
and
(ii)
the exemption is in the public interest.
(F)
Small businesses
(i)
In general

The Administrator shall waive 50 percent of the registration service fees payable by an entity for a covered application under this section if the entity is a small business (as defined in section 136a–1(i)(1)(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)(1)(E)(ii) of this title) at the time of application; and
(II)
has average annual global gross revenues described in section 136a–1(i)(1)(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)(1)(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 registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenue described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.
(G)
Federal and State agency exemptions

An agency of the Federal Government or a State government shall be exempt from covered registration service fees under this section.

(8)
Refunds
(A)
Early withdrawals

If, during the first 60 days after the beginning of the applicable decision time review period under subsection (f)(3), a covered application is withdrawn by the applicant, the Administrator shall refund all but 25 percent.2

2
 So in original. The period probably should not appear.
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 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 covered 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 covered application;
(II)
on the basis that the Administrator completed portions of the review of the application before the effective date of this section; or
(III)
on the basis that the Administrator rejected the application under subsection (f)(4)(B).
(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 (5); 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, partnership grants, and pesticide safety education
(i)
In general

For each of fiscal years 2013 through 2023, the Administrator shall use approximately 117 of the amount in the Fund (but not less than $1,000,000) to enhance scientific and regulatory activities relating to worker protection, with an emphasis on field-worker populations in the United States.

(ii)
Partnership grants

Of the amounts in the Fund, the Administrator shall use for partnership grants, for each of fiscal years 2013 through 2023, $500,000.

(iii)
Pesticide safety education program

Of the amounts in the Fund, the Administrator shall use $500,000 for each of fiscal years 2013 through 2023 to carry out the pesticide safety education program.

(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
(A)
In general
Amounts in the Fund not currently needed to carry out this section shall be—
(i)
maintained readily available or on deposit;
(ii)
invested in obligations of the United States or guaranteed by the United States; or
(iii)
invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.
(B)
Use of investment income

After consultation with the Secretary of the Treasury, the Administrator may use income from investments described in clauses (ii) and (iii) of subparagraph (A) to carry out this section.

(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 2012) 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 2012 (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)
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 subchapter with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Extension Act of 2018 for pesticide registration actions for covered pesticide registration applications (including reduced risk applications). Such reforms shall include identifying opportunities for streamlining review processes for applications for a new active ingredient or a new use and providing prompt feedback to applicants during such review process.

(f)
Decision time review periods
(1)
In general

Not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2018, the Administrator shall make publicly available a schedule of decision review periods for covered pesticide registration actions or for any other action covered by a table specified in subsection (b)(3) and corresponding registration service fees under this subchapter.

(2)
Report

The schedule shall be the same as the applicable schedule provided under subsection (b)(3).

(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)
applications for any other action covered by a table specified in subsection (b)(3).
(4)
Start of decision time review period
(A)
In general

Except as provided in subparagraphs (C), (D), and (E), in the case of a covered 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 application and fee.

(B)
Initial content and preliminary technical screenings
(i)
Screenings
(I)
Initial content

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)
Preliminary technical screening
After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening—
(aa)
not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and
(bb)
not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).
(ii)
Rejection
(I)
In general

If the Administrator determines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant does not correct the failure before the date that is 10 business days after the applicant receives a notification of the failure, the Administrator shall reject the application.

(II)
Written notification

The Administrator shall make every effort to provide a written notification of a rejection under subclause (I) during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.

(iii)
Requirements of initial content screening
In conducting an initial content screening of an application, the Administrator shall determine whether—
(I)
(aa)
the applicable registration service fee has been paid; or
(bb)
at least 25 percent of the applicable registration service fee has been paid and the application contains a waiver or refund request for the outstanding amount and documentation establishing the basis for the waiver request; and
(II)
the application appears to contain all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.
(iv)
Requirements of preliminary technical screening
In conducting a preliminary technical screening of an application, the Administrator shall determine if—
(I)
the application and the data and information submitted with the application are accurate and complete; and
(II)
the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this subchapter, could result in the granting of the application.
(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 on the date that is 30 days after the effective date of the Pesticide Registration Improvement Act of 2003.

(5)
Extension of decision time review period

The Administrator and the applicant may mutually agree in writing to extend a decision time review period under this subsection.

(g)
Judicial review
(1)
In general

Any applicant adversely affected by the failure of the Administrator to make a determination on the application of the applicant for registration of a new active ingredient or new use for which a registration service fee is paid under this section may obtain judicial review of the failure solely under this section.

(2)
Scope
(A)
In general

In an action brought under this subsection, the only issue on review is whether the Administrator failed to make a determination on the application specified in paragraph (1) by the end of the applicable decision time review period required under subsection (f) for the application.

(B)
Other actions

No other action authorized or required under this section shall be judicially reviewable by a Federal or State court.

(3)
Timing
(A)
In general

A person may not obtain judicial review of the failure of the Administrator to make a determination on the application specified in paragraph (1) before the expiration of the 2-year period that begins on the date on which the decision time review period for the application ends.

(B)
Meeting with Administrator

To be eligible to seek judicial review under this subsection, a person seeking the review shall first request in writing, at least 120 days before filing the complaint for judicial review, a decision review meeting with the Administrator.

(4)
Remedies

The Administrator may not be required or permitted to refund any portion of a registration service fee paid in response to a complaint that the Administrator has failed to make a determination on the covered pesticide registration application specified in paragraph (1) by the end of the applicable decision review period.

(h)
Accounting
The Administrator shall—
(1)
provide an annual accounting of the registration service fees paid to the Administrator and disbursed from the Fund, by providing financial statements in accordance with—
(A)
the Chief Financial Officers Act of 1990 (Public Law 101–576; 104 Stat. 2838) and amendments made by that Act; and
(B)
the Government Management Reform Act of 1994 (Public Law 103–356; 108 Stat. 3410) and amendments made by that Act;
(2)
provide an accounting describing expenditures from the Fund authorized under subsection (c); and
(3)
provide an annual accounting describing collections and expenditures authorized under subsection (d).
(i)
Auditing
(1)
Financial statements of agencies

For the purpose of section 3515(c) of title 31, the Fund shall be considered a component of an executive agency.

(2)
Components
The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this section shall include an analysis of—
(A)
the fees collected under subsection (b) 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.

(k)
Reports
(1)
In general

Not later than March 1, 2005, and each March 1 thereafter through March 1, 2023, 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 label amendments that have been reviewed using electronic means;
(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), 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—
(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;
(III)
reviewing the scope of use of the notification process to cover broader categories of registration actions;
(IV)
providing for electronic submission and review of labels, including process improvements to further enhance the procedures used in electronic label review; and
(V)
the allowance and use of summaries of acute toxicity studies;
(vii)
the use of performance-based contracts, other contracts, and procurement to ensure that—
(I)
the goals of this subchapter for the timely review of applications for registration are met; and
(II)
the registration program is administered in the most productive and cost effective manner practicable; and
(viii)
the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;
(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—
(i)
the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—
(I)
the number of cases cancelled;
(II)
the number of cases requiring risk mitigation measures;
(III)
the number of cases removing risk mitigation measures;
(IV)
the number of cases with no risk mitigation needed; and
(V)
the number of cases in which risk mitigation has been fully implemented;
(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;
(II)
providing for accreditation of outside reviewers and the use of outside reviewers in the registration review process; and
(III)
streamlining the registration review process, consistent with 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;
(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;
(G)
a review of the progress made toward—
(i)
carrying out paragraphs (4) and (5) of section 136a–1(k) of this title and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in such paragraphs;
(ii)
implementing enhancements to—
(I)
the electronic tracking of covered applications;
(II)
the electronic tracking of conditional registrations;
(III)
the endangered species database;
(IV)
the electronic review of labels submitted with covered applications; and
(V)
the electronic review and assessment of confidential statements of formula submitted with covered applications; and
(iii)
facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket;
(H)
the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4);
(I)
a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate);
(J)
an assessment of the public availability of summary pesticide usage data;
(K)
a review of the progress made in developing, updating, and implementing product performance test guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and, by regulation, prescribing product performance data requirements for such pesticide products registered under section 136a of this title;
(L)
a review of the progress made in the priority review and approval of new pesticides to control invertebrate public health pests that may transmit vector-borne disease for use in the United States, including each territory or possession of the United States, and United States military installations globally;
(M)
a review of the progress made in implementing enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations);
(N)
the number of approvals for active ingredients, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency; and
(O)
with respect to funds in the Pesticide Registration Fund reserved under subsection (c)(3), a review that includes—
(i)
a description of the amount and use of such funds—
(I)
to carry out activities relating to worker protection under clause (i) of subsection (c)(3)(B);
(II)
to award partnership grants under clause (ii) of such subsection; and
(III)
to carry out the pesticide safety education program under clause (iii) of such subsection;
(ii)
an evaluation of the appropriateness and effectiveness of the activities, grants, and program described in clause (i);
(iii)
a description of how stakeholders are engaged in the decision to fund such activities, grants, and program; and
(iv)
with respect to activities relating to worker protection carried out under subparagraph (B)(i) of such subsection, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.
(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.

(4)
Other report
(A)
Scope
In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have—
(i)
10 or fewer employees; and
(ii)
annual global gross revenue that does not exceed $2,000,000.
(B)
Information required
In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on—
(i)
the number of small businesses described in subparagraph (A) that are paying maintenance fees; and
(ii)
the number of registrations each company holds.
(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, 2023.

(2)
Phase out
(A)
Fiscal year 2024

During fiscal year 2024, 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, 2023.

(B)
Fiscal year 2025

During fiscal year 2025, 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, 2023.

(C)
September 30, 2025

Effective September 30, 2025, 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, 2023, 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, 2023, subsection (f) shall not apply to the application.

(June 25, 1947, ch. 125, § 33, as added Pub. L. 108–199, div. G, title V, § 501(f)(2), Jan. 23, 2004, 118 Stat. 422; amended Pub. L. 110–94, § 5, Oct. 9, 2007, 121 Stat. 1002; Pub. L. 110–193, § 1(a), Mar. 6, 2008, 122 Stat. 649; Pub. L. 112–177, § 2(a)(2)(B), (b), Sept. 28, 2012, 126 Stat. 1328, 1330; Pub. L. 116–8, §§ 5, 6, Mar. 8, 2019, 133 Stat. 487, 491.)
cite as: 7 USC 136w-8