Pub. L. 117-328, div. HH, tit. VI, subtit. A, sec. 705

PESTICIDE REGISTRATION SERVICE FEES.

EnactedYear: 2022Length: 3,465 wordsOfficial source
SEC. 705. PESTICIDE REGISTRATION SERVICE FEES.(a) Extension and Modification of Fee Authority.—(1) In general.—Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—(A) in paragraph (2)(E)(iii), by striking “after review” and inserting “on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening”; (B) by striking “paragraph (3)” each place it appears and inserting “paragraph (3)(B)”; (C) in paragraph (3), by striking “Subject to paragraph (6),” and inserting the following:“(A) Data evaluation records.—At 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.—Subject to paragraph (6),” ; (D) in paragraph (6)—(i) by amending subparagraph (A) to read as follows: “Subject to the following sentence, effective for a covered application received during the period beginning on October 1, 2024, and ending on September 30, 2026, the Administrator may increase by 5 percent the registration service fee payable for the application under paragraph (3). No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement clauses (i) and (ii) of subsection (k)(2)(A).”; and (ii) by amending subparagraph (B) to read as follows: “Subject to the following sentence, effective for a covered application received on or after October 1, 2026, the Administrator may increase by an additional 5 percent the registration service fee in effect as of September 30, 2026. No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement any recommendations for process improvements contained in the report under subsection (c)(4), as appropriate.”; and136 STAT. 6009 (E) in paragraph (7)(A), by striking “(commonly referred to as a Gold Seal letter)” and inserting “(including a Gold Seal letter and a Certificate of Establishment)”. (2) Conforming amendment.—Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8) is amended by striking “subsection (b)(3)” each place it appears and inserting “subsection (b)(3)(B)”. (b) Pesticide Registration Fund.—Section 33(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)) is amended—(1) in paragraph (3), by striking subparagraph (B) and inserting the following:“(B) Endangered species review of outdoor use of pesticide products.—“(i) In general.—The Administrator shall use the amounts made available in the Fund to develop, receive comments with respect to, and finalize, guidance to registrants regarding analysis necessary to support the review of outdoor uses of pesticide products under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.). “(ii) Deadlines for guidance.—The 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 the date of enactment of the Pesticide Registration Improvement Act of 2022. “(II) With respect to new outdoor uses of a registered pesticide, not later than 1 year after the date of enactment of the Pesticide Registration Improvement Act of 2022. “(III) With respect to antimicrobial pesticide products, not later than 3 years after the date of enactment of the Pesticide Registration Improvement Act of 2022. “(C) Independent third party assessments.—“(i) In general.—The Administrator shall use the amounts made available in the Fund to carry out the activities described in clauses (ii) and (iii). “(ii) Workforce assessment.—“(I) In general.—The Administrator shall procure a competitive contract with a qualified, independent contractor with expertise in assessing public sector workforce data analysis and reporting to conduct an assessment of current methodologies and data or metrics available to represent the workforce implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act, including an assessment of filled and vacant positions and full-time equivalent employees relating to that implementation. “(II) Report.—Not later than 2 years after the date of enactment of the Pesticide Registration Improvement Act of 2022—136 STAT. 6010“(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) Contracts.—Within 1 year of the date of enactment of the Pesticide Registration Improvement Act of 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.—The firm described in item (aa) shall be capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the scope of the assessment under subclause (II). “(II) Assessment.—“(aa) In general.—The Administrator, applicants, and registrants shall participate in a targeted assessment of the process for the review of applications submitted under this Act. “(bb) Consultation.—The firm selected under subclause (I) shall consult with the Administrator and applicants at the start of the assessment under item (aa) and prior to submission of the report under subclause (I)(aa)(BB). “(cc) Requirements.—The assessment under item (aa) shall evaluate and make recommendations regarding—“(AA) the initial content screen; “(BB) the preliminary technical screen; “(CC) performance, processes, and progress toward reducing renegotiation 136 STAT. 6011 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 3; “(FF) compliance with the provisions of this Act 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 3. “(III) Report to congress.—Not 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) Recommendations.—The 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.” ; and (2) in paragraph (4)—(A) in subparagraph (A), by striking “and” at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following:136 STAT. 6012 “(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” . (c) Assessment of Fees.—Section 33(d)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)(2)) is amended—(1) by striking “(as in existence in fiscal year 2012)”; and (2) by striking “the amount of appropriations for covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).” and inserting “$166,000,000.”. (d) Reforms to Reduce Decision Time Review Periods and Prevent Double Payment of Registration Fees.—Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amended—(1) by striking the subsection designation and heading and all that follows through “To the maximum” and inserting the following:“(e) Reforms to Reduce Decision Time Review Periods and Prevent Double Payment of Registration Fees.—“(1) Reduction of decision time review periods.—To the maximum” ; and (2) by adding at the end the following:“(2) Prevention of double payment of registration service fees.—The Administrator shall develop and implement a process to determine the appropriate fee category or categories for an application that qualifies for more than one fee category in order to assist applicants and prevent unnecessary payment of fees for multiple categories for a single application.” . (e) Decision Time Review Periods.—Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—(1) in paragraph (1), by striking “Pesticide Registration Improvement Extension Act of 2018” and inserting “Pesticide Registration Improvement Act of 2022”; (2) in paragraph (4)—(A) in subparagraph (B)—(i) in clause (i), by adding at the end the following:“(III) Final fee category.—The fee category of a covered application or other actions may not be changed, without providing the information to the applicant, after completion of the preliminary technical screening described in clause (iv).” ; (ii) in clause (iii), in the matter preceding subclause (I), by inserting “automate the process, to the maximum extent practicable, and” before “determine”; and (iii) in clause (iv)—(I) in the matter preceding subclause (I), by striking “shall determine if—” and inserting “shall—”; (II) in subclause (I)—(aa) by inserting “determine if” before “the application and”; and (bb) by striking “and” at the end; (III) in subclause (II)—136 STAT. 6013(aa) by inserting “determine if” before “the application, data,”; and (bb) by striking the period at the end and inserting a semicolon; and (IV) by adding at the end the following:“(III) determine, if applicable, whether an application qualifies for a reduced risk determination under subsection (c)(10) or (h) of section 3; “(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.” ; and (B) by striking subparagraph (E) and inserting the following:“(E) Applications for reduced risk.—“(i) Fee.—If an application for a reduced risk new active ingredient or a reduced risk new use is determined not to qualify as reduced risk, the applicant shall pay the difference in fee for the corresponding non-reduced risk application. “(ii) Decision review time period.—After receipt by the Administrator of the original covered reduced risk application and fee, the decision time review period for the corresponding non-reduced risk application shall begin within the time periods described in subparagraph (A), based on the submission date of the original covered reduced risk application.” ; and (3) by striking paragraph (5) and inserting the following:“(5) Extension of decision time review period.—“(A) Notification.—If 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 agreement.—The 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. “(C) Priority.—Once a decision time review period for a covered action described in subsection (b)(3)(B) is 136 STAT. 6014 missed or extended, the Administrator shall make any action on the application a priority.” . (f) Reports and Information Technology.—Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8) is amended by striking subsection (k) and inserting the following:“(k) Reports and Information Technology.—“(1) Reports.—“(A) In general.—Not 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 content 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) Contents.—Each report published under subparagraph (A) shall include a summary of the following information:“(i) Actions under this section.—To 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 content 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;136 STAT. 6015 “(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 3(g), including—“(aa) 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 4(k), 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 4(i)(1); “(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 136 STAT. 6016 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 4(i)(1), 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 3(f); and “(XX) a review of progress made in implementing the pesticide surveillance program referred to in paragraph (8) of section 4(k). “(ii) Registrant submissions not covered by section 33(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 process.—Data for the initial content 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.136 STAT. 6017 “(iv) Staffing.—Data 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). “(C) Publication.—The Administrator shall publish each report under subparagraph (A)—“(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) System.—Not later than 1 year after the date of enactment of the Pesticide Registration Improvement Act of 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 real-time, accessible information 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 decisions.—The 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; and136 STAT. 6018 “(iv) drafting and publication of policies communicating Environmental Protection Agency acceptance of novel technologies or approaches.” . (g) Termination of Effectiveness.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—(1) by striking “2023” each place it appears and inserting “2027”; and (2) in paragraph (2)—(A) in subparagraph (A)—(i) in the subparagraph heading, by striking “2024” and inserting “2028” ; and (ii) by striking “2024” and inserting “2028”; and (B) in each of subparagraphs (B) and (C)—(i) in the subparagraph heading, by striking “2025” each place it appears and inserting “2029”; and (ii) by striking “2025” each place it appears and inserting “2029”.
Pub. L. 117-328, div. HH, tit. VI, subtit. A, sec. 705: PESTICIDE REGISTRATION SERVICE FEES. | Justis AI