7 USC 136 - Pesticide registration service fees

View all text of Subchapter II [§ 135 - § 136y]

§ 136w–8. Pesticide registration service fees

(a) Definition of costsIn 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

(2) Covered applications

(A) In general

(B) Existing applications

(i) In general

(ii) Tolerance or exemption fees

(C) DocumentationAn 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

(E) Applications subject to additional feesAn 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) on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening 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

(G) Non-refundable portion of fees

(i) In general

(ii) Limitation

(H) Collection of unpaid fees

(3) Schedule of covered applications and other actions and their registration service fees

(A) Data evaluation recordsAt the decision review time under a fee table specified in subparagraph (B) or as agreed upon under subsection (f)(5), for each covered application under a fee table specified in such subparagraph (B), the Administrator shall—

(i) complete data evaluation records for studies submitted by the applicant in support of the application; and

(ii) release those data evaluation records to the applicant, using appropriate protections for confidential business information.

(B) Schedule, actions, and fees

(4) Pending pesticide registration applications

(A) In general

(B) Voluntary fee

(C) DocumentationAn 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

(6) Fee adjustment

(A) In general

(B) Additional adjustment

(7) Waivers and reductions

(A) In general

(B) Documentation

(i) In general

(ii) Certification

(iii) Inaccurate documentationAn application shall be subject to the applicable registration service fee payable under paragraph (3)(B) 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 requestAs 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

(ii) Supporting documentation

(E) IR–4 exemptionThe 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 and

(ii) the exemption is in the public interest.

(F) Small businesses

(i) In general

(ii) Waiver of feesThe 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

(iv) DocumentationAn 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

(8) Refunds

(A) Early withdrawals

(B) Withdrawals after the first 60 days of decision review time period

(i) In general

(ii) TimingThe 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.

(i) In general

(ii) BasisThe 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

(1) EstablishmentThere 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

(2) Deposits in Fund

(3) Expenditures from Fund

(A) In generalSubject 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) Endangered species review of outdoor use of pesticide products

(i) In general

(ii) Deadlines for guidanceThe Administrator shall issue final guidance required by clause (i) in accordance with the following:(I) With respect to new active ingredients or any registration review decision proposed for 1 or more outdoor uses, not later than 9 months after December 29, 2022.(II) With respect to new outdoor uses of a registered pesticide, not later than 1 year after December 29, 2022.(III) With respect to antimicrobial pesticide products, not later than 3 years after December 29, 2022.

(i) In general

(ii) Workforce assessment(I) In general(II) ReportNot later than 2 years after December 29, 2022—(aa) the contractor selected under subclause (I) shall submit to the Administrator a report describing—(AA) the findings from the assessment under that subclause; and(BB) recommendations for improved methodologies to represent full-time equivalent resources described in that subclause; and(bb) the Administrator shall publish the report submitted under item (aa) on the website of the Environmental Protection Agency.

(iii) Process assessment(I) In general(aa) ContractsWithin 1 year of December 29, 2022, to the extent practicable, the Administrator shall issue a competitive contract to a private, independent consulting firm—(AA) to conduct the assessment described in subclause (II); and(BB) to submit to the Administrator a report describing the findings of the assessment and the processes and performance of the Environmental Protection Agency relating to the implementation of the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.(bb) Eligibility(II) Assessment(aa) In general(bb) Consultation(cc) RequirementsThe assessment under item (aa) shall evaluate and make recommendations regarding—(AA) the initial span screen;(BB) the preliminary technical screen;(CC) performance, processes, and progress toward reducing renegotiation rates and the average length of renegotiations;(DD) performance, processes, and progress toward eliminating the backlog of registrant submissions not covered by subsection (b)(3);(EE) performance, processes, and progress toward ensuring that all registrant submissions not covered by subsection (b)(3) are completed by the applicable deadlines described in the notice of the Administrator entitled “Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments” and dated October 22, 1998 (and any successor amendments to that notice) and described in subsections (c)(3)(B) and (h) of section 136a of this title;(FF) compliance with the provisions of this subchapter relating to renegotiations and registrant submissions not covered by subsection (b)(3);(GG) information technology systems;(HH) recommended improvements to employee training;(II) performance, progress, and processes in completing registration review; and(JJ) other appropriate issues, such as submissions by inert suppliers and fast-track amendments under subsections (c)(3)(B) and (h) of section 136a of this title.(III) Report to CongressNot later than 1 year after the receipt of an assessment required under this section, the Administrator shall submit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives—(aa) a copy of each such assessment; and(bb) the Administrator’s evaluation of the findings and recommendations contained in each such assessment.(IV) RecommendationsThe Administrator shall include with the report submitted under subclause (III) a classification of each recommendation described in the report as—(aa) can be implemented through administrative action of the Administrator; or(bb) requires a statutory change.

(4) Collections and appropriations ActsThe 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;

(B) shall be available during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations; and

(5) Unused funds

(A) In generalAmounts 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

(d) Assessment of fees

(1) Definition of covered functions

(2) Minimum amount of appropriations

(3) Use of fees

(4) Subsequent authority

(e) Reforms to reduce decision time review periods and prevent double payment of registration fees

(1) Reduction of decision time review periods

(2) Prevention of double payment of registration service fees

(f) Decision time review periods

(1) In general

(2) Report

(3) Applications subject to decision time review periodsThe 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

(4) Start of decision time review period

(A) In general

(B) Initial span and preliminary technical screenings

(i) Screenings(I) Initial span(II) Preliminary technical screeningAfter conducting the initial span 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).(III) Final fee category

(ii) Rejection(I) In general(II) Written notification

(iii) Requirements of initial span screeningIn conducting an initial span screening of an application, the Administrator shall automate the process, to the maximum extent practicable, and 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 screeningIn conducting a preliminary technical screening of an application, the Administrator shall—(I) determine if the application and the data and information submitted with the application are accurate and complete;(II) determine if 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;(III) determine, if applicable, whether an application qualifies for a reduced risk determination under subsection (c)(10) or (h) of section 136a of this title;(IV) grant or deny any data waiver requests submitted by the applicant with the application;(V) verify and validate the accuracy of the fee category selected by the applicant; and(VI) notify the applicant, in writing, if a new or different fee category is required and calculate the new decision review time based on the original submission date.

(i) In general

(ii) Request granted with no additional fees requiredIf 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

(iv) Request denied

(D) Pending applications

(i) In general

(ii) ApplicationsClause (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) Applications for reduced risk

(i) Fee

(ii) Decision review time period

(5) Extension of decision time review period

(A) NotificationIf the Administrator cannot meet a decision time review period under this subsection, the Administrator shall notify the applicant, in writing, of—

(i) the reasons why additional time is needed; and

(ii) the number of days needed that would allow the Administrator to make a regulatory decision.

(B) Extension by negotiation or mutual agreementThe Administrator, acting solely through the Director of the Office of Pesticide Programs, and the applicant may mutually agree, in writing, to extend a decision time review period under this subsection if—

(i) there is new or additional data or information from the applicant that is necessary for the Administrator to make a decision on the application that cannot be made available within the original decision time review period; or

(ii) a public comment period associated with the application generates significant comments that cannot be addressed within the original decision time review period.

(g) Judicial review

(1) In general

(2) Scope

(A) In general

(B) Other actions

(3) Timing

(A) In general

(B) Meeting with Administrator

(4) Remedies

(h) AccountingThe 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

(2) ComponentsThe 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);

(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 GeneralThe 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

(k) Reports and information technology

(1) Reports

(A) In generalNot later than 120 days after the last day of each of fiscal years 2023 through 2027, the Administrator shall publish an annual report describing—

(i) actions taken under this section;

(ii) registrant submissions not covered by subsection (b)(3)(B);

(iii) the initial span and preliminary technical screenings required in subsection (f)(4)(B); and

(iv) staffing relating to implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.

(B) ContentsEach report published under subparagraph (A) shall include a summary of the following information:

(i) Actions under this sectionTo the extent practicable, data for each action taken under this section that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the Action Code;(II) the application receipt date;(III) the electronic portal tracking number assigned to the application at the time of submission to the electronic submission portal or the Environmental Protection Agency tracking number;(IV) the original decision due date based on the Action Code;(V) the dates of any renegotiations and the renegotiated due dates, if applicable;(VI) the reasons for each renegotiation, if applicable;(VII) if the submission had to be recoded, reassigned codes, if applicable;(VIII) the date that the submission was recoded, if applicable;(IX) the decision completion date, if the action has been completed;(X) the status of the action, which may be—(aa) failed initial span screen;(bb) failed preliminary technical screen;(cc) approved;(dd) withdrawn;(ee) denied;(ff) do not grant; or(gg) pending;(XI) the reason for any denial or do not grant decision, if applicable;(XII) a review of the progress made in carrying out each requirement of subsections (e) and (f), including, 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 the allowance and use of summaries of acute toxicity studies;(XIII) a review of the progress in carrying out section 136a(g) of this title, including—(aa)3

3 So in original. There is no item (bb).

the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—(AA) the number of cases cancelled;(BB) the number of cases requiring risk mitigation measures;(CC) the number of cases removing risk mitigation measures;(DD) the number of cases with no risk mitigation needed; and(EE) the number of cases in which risk mitigation has been fully implemented;(XIV) a review of the progress made toward implementing enhancements to—(aa) the electronic tracking of conditional registrations; and(bb) the endangered species database;(XV) 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);(XVI) an assessment of the public availability of summary pesticide usage data;(XVII) the number of the active ingredients approved, 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;(XVIII) with respect to funds in the Reregistration and Expedited Processing Fund described under section 136a–1(k) of this title, a review that includes—(aa) a description of the amount and use of such funds—(AA) to carry out activities relating to worker protection under subparagraphs (G) and (H) of section 136a–1(i)(1) of this title;(BB) to award partnership grants under subparagraph (I) of such section; and(CC) to carry out the pesticide safety education program under subparagraph (J) of such section;(bb) an evaluation of the appropriateness and effectiveness of the activities, grants, and program under subparagraphs (G), (H), (I), and (J) of such section;(cc) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program in accordance with the stakeholder input provided under such subparagraphs; and(dd) with respect to activities relating to worker protection carried out under subparagraphs (G) and (H) of section 136a–1(i)(1) of this title, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.(XIX) beginning two years after enactment, report on the progress of meeting the deadlines listed in paragraph (5) of section 136a(f) of this title; and(XX) a review of progress made in implementing the pesticide surveillance program referred to in paragraph (8) of section 136a–1(k) of this title.

(ii) Registrant submissions not covered by subsection (b)(3)(B)Each registrant submission not covered by subsection (b)(3)(B), that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the submission date;(II) the electronic portal tracking number assigned to the application at the time of the submission of the application to the electronic submission portal;(III) the type of regulatory action, as defined by statute or guidance document, and the specific label action;(IV) the status of the action;(V) the due date;(VI) the reason for the outcome; and(VII) the completion date, if applicable.

(iii) Screening processData for the initial span screens and preliminary technical screens that are completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the number of applications successfully passing each type of screen;(II) the number of applications that failed the screening process for each type of screen;(III) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(II);(IV) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(I) and the number of applications resulting in a rejection; and(V) the number of notifications issued under section 152.105 of title 40, Code of Federal Regulations (or successor regulations), and to the extent practicable, the reasons for that issuance.

(iv) StaffingData on the staffing relating to work covered under the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act, organized by registering division, including—(I) the number of new hires and personnel departures;(II) the number of full-time equivalents at the end of each fiscal year;(III) the number of full-time equivalents working on registration review activities; and(IV) the number of full-time equivalents working on registrant submissions not covered by subsection (b)(3)(B).

(i) on the website of the Environmental Protection Agency; and

(ii) by such other methods as the Administrator determines to be the most effective for efficiently disseminating the report.

(2) Information technology

(A) SystemNot later than 1 year after December 29, 2022, the Administrator shall establish an information technology system that—

(i) includes all registering divisions in the Office of Pesticide Programs;

(ii) provides a real-time, accurate, tracking system for all regulatory submissions to the Office of Pesticide Programs;

(iii) provides a 4

4 So in original.

real-time, accessible information 4 that provides each applicant confidential, online access to the status and progress of the regulatory submissions of the applicant; and

(iv) updates the electronic submission portal—(I) to ensure that label reviews are limited to current label changes, to the maximum extent practicable;(II) to automate, to the extent practicable, minor, low risk regulatory actions; and(III) to allow self-certification of certain regulatory actions, as determined by the Administrator.

(B) Access to registration data and decisionsThe Administrator shall implement efforts to expand existing, and develop new, information technology tools and databases to improve access by Environmental Protection Agency employees to data used to fulfill registrations, and public access to information about regulatory decisionmaking tools, including opportunities for—

(i) analysis of the impact of submitted studies on Environmental Protection Agency assessments and decisions;

(ii) facilitation of read-across or computational model development to help fill information gaps;

(iii) tracking and reporting submission and decision metrics relating to the use and acceptance of test methods; and

(iv) drafting and publication of policies communicating Environmental Protection Agency acceptance of novel technologies or approaches.

(l) Savings clause

(m) Termination of effectiveness

(1) In general

(2) Phase out

(A) Fiscal year 2028

(B) Fiscal year 2029

(C)September 30, 2029

(D) Decision review periods

(i) Pending applications

(ii) New applications

(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; Pub. L. 117–328, div. HH, title VI, §§ 705, 706, Dec. 29, 2022, 136 Stat. 6008, 6018.)