S. 483 — what changed

added “(4) Expedited rulemaking and guidance development for certain product performance data requirements

added “(A) Set-aside—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

added “(B) Products claiming efficacy against invertebrate pests of significant public health or economic importance—The Administrator shall use amounts made available under subparagraph (A) to develop, receive comments with respect to, finalize, and implement the necessary rulemaking and guidance for product performance data requirements to evaluate products claiming efficacy against the following invertebrate pests of significant public health or economic importance (in order of importance):

added “(i) Bed bugs.

added “(ii) Premise (including crawling insects, flying insects, and baits).

added “(iii) Pests of pets (including pet pests controlled by spot-ons, collars, shampoos, powders, or dips).

added “(iv) Fire ants.

added “(C) Deadlines for guidance—The Administrator shall develop, and publish guidance required by subparagraph (B), with respect to claims of efficacy against pests described in such subparagraph as follows:

added “(i) With respect to bed bugs, issue final guidance not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2018.

added “(ii) With respect to pests specified in clause (ii) of such subparagraph—

added “(I) submit draft guidance to the Scientific Advisory Panel and for public comment not later than June 30, 2018; and

added “(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than September 30, 2019.

added “(iii) With respect to pests specified in clauses (iii) and (iv) of such subparagraph—

added “(I) submit draft guidance to the Scientific Advisory Panel and for public comment not later than June 30, 2019; and

added “(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than March 31, 2021.

added “(D) Revision—The Administrator shall revise the guidance required by subparagraph (B) from time to time, but shall permit applicants and registrants sufficient time to obtain data that meet the requirements specified in such revised guidance.

added “(E) Deadline for product performance data requirements—The Administrator shall, not later than September 30, 2021, issue regulations prescribing product performance data requirements for any pesticide intended for preventing, destroying, repelling, or mitigating any invertebrate pest of significant public health or economic importance specified in clauses (i) through (iv) of subparagraph (B).”

added “(5) Good laboratory practices inspections

added “(A) Set-aside—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

added “(B) Activities—The Administrator shall use amounts made available under subparagraph (A) for 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), with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under this Act. As part of such monitoring program, the Administrator shall make available to each laboratory inspected under such program in support of such registrations a preliminary summary of inspection observations not later than 60 days after the date on which such an inspection is completed.”

added Section 5(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136c(a)) is amended—

added “(C) applications for any other action covered by a table specified in subsection (b)(3).”

added “(i) the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—

added “(I) the number of cases cancelled;

added “(II) the number of cases requiring risk mitigation measures;

added “(III) the number of cases removing risk mitigation measures;

added “(IV) the number of cases with no risk mitigation needed; and

added “(V) the number of cases in which risk mitigation has been fully implemented;”

added “(ii) implementing enhancements to—

added “(I) the electronic tracking of covered applications;

added “(II) the electronic tracking of conditional registrations;

added “(III) the endangered species database;

added “(IV) the electronic review of labels submitted with covered applications; and

added “(V) the electronic review and assessment of confidential statements of formula submitted with covered applications; and”

added “(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 3;

added “(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;

added “(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);

added “(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

added “(O) with respect to funds in the Pesticide Registration Fund reserved under subsection (c)(3), a review that includes—

added “(i) a description of the amount and use of such funds—

added “(I) to carry out activities relating to worker protection under clause (i) of subsection (c)(3)(B);

added “(II) to award partnership grants under clause (ii) of such subsection; and

added “(III) to carry out the pesticide safety education program under clause (iii) of such subsection;

added “(ii) an evaluation of the appropriateness and effectiveness of the activities, grants, and program described in clause (i);

added “(iii) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program; and

added “(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.”

added Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended to read as follows:

added “(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:”