REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES. Section 3 (7 U.S.C. 136a), as amended by section 106(b), is further amended by adding at the end the following: “(h) Registration Requirements for Antimicrobial Pesticides.— “(1) Evaluation of process.— To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of the date of enactment of this subsection for antimicrobial pesticide product registration applications and applications for amended registration of antimicrobial pesticide products, including— “(A) new antimicrobial active ingredients; “(B) new antimicrobial end-use products; “(C) substantially similar or identical antimicrobial pesticides; and “(D) amendments to antimicrobial pesticide registrations. “(2) Review time period reduction goal.— Each reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period following submission of a complete application, consistent with the degree of risk, to a period of not more than— “(A) 540 days for a new antimicrobial active ingredient pesticide registration; “(B) 270 days for a new antimicrobial use of a registered active ingredient; “(C) 120 days for any other new antimicrobial product; 110 STAT. 1505 “(D) 90 days for a substantially similar or identical antimicrobial product; “(E) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and “(F) 90 to 180 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this paragraph. “(3) Implementation.— “(A) Proposed rulemaking.— “(i) Issuance.— Not later than 270 days after the date of enactment of this subsection, the Administrator publication, shall publish in the Federal Register proposed regulations to accelerate and improve the review of antimicrobial pesticide products designed to implement, to the extent practicable, the goals set forth in paragraph (2). “(ii) Requirements.— Proposed regulations issued under clause (i) shall— “(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and other such products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms, or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; “(II) differentiate the types of review undertaken for antimicrobial pesticides; “(III) conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the function of review under this Act, considering the use patterns of the product, toxicity, expected exposure, and product type; “(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial pesticide products continue to meet product performance standards and effectiveness levels for each type of label claim made; and “(V) implement effective and reliable deadlines for process management. “(iii) Comments.— In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affected parties to maximize the effectiveness of the rule development process. “(B) Final regulations.— “(i) Issuance.— The Administrator shall issue final regulations not later than 240 days after the close of the comment period for the proposed regulations. 110 STAT. 1506 “(ii) Failure to meet goal.— If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explain why the goal was not attained, describe the element of the regulations included instead, and identify future steps to attain the goal. “(iii) Requirements.— In issuing final regulations, the Administrator shall— “(I) consider the establishment of a certification process for regulatory actions involving risks that can be responsibly managed, consistent with the degree of risk, in the most cost-efficient manner; “(II) consider the establishment of a certification process by approved laboratories as an adjunct to the review process; “(III) use all appropriate and cost-effective review mechanisms, including— “(aa) expanded use of notification and nonnotification procedures; “(bb) revised procedures for application review; and “(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations; and “(IV) clarify criteria for determination of the completeness of an application. “(C) Expedited review.— This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)(3). “(D) Alternative review periods.— If the final regulations to carry out this paragraph are not effective 630 days after the date of enactment of this subsection, until the final regulations become effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be— “(i) 2 years for a new antimicrobial active ingredient pesticide registration; “(ii) 1 year for a new antimicrobial use of a registered active ingredient; “(iii) 180 days for any other new antimicrobial product; “(iv) 90 days for a substantially similar or identical antimicrobial product; “(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and “(vi) 240 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this subparagraph. “(E) Wood preservatives.— An application for the registration, or for an amendment to the registration, of a wood preservative product for which a claim of pesticidal activity listed in section 2(mm) is made (regardless of any other pesticidal claim that is made with respect to the product) shall be reviewed by the Administrator within 110 STAT. 1507the same period as that established under this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of the wood preservative product, if the application requires the applicant to satisfy the same data requirements as are required to support an application for a wood preservative product that is an antimicrobial pesticide. “(F) Notification.— “(i) In general.— Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied not later than the final day of the appropriate review period under this paragraph, unless the applicant and the Administrator agree to a later date. “(ii) Final decision.— If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall be considered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter 7 of title 5, United States Code. “(iii) Exemption.— This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days after the date of enactment of this subsection. “(4) Annual report.— “(A) Submission.— Beginning on the date of enactment of this subsection and ending on the date that the goals under paragraph (2) are achieved, the Administrator shall, not later than March 1 of each year, prepare and submit an annual report to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate. “(B) Requirements.— A report submitted under subparagraph (A) shall include a description of— “(i) measures taken to reduce the backlog of pending registration applications; “(ii) progress toward achieving reforms under this subsection; and “(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.”.