2023-28211. Pesticide Registration Notice 2023-2; Establishment of the Vector Expedited Review Voucher (VERV) Program; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) is announcing the availability of Pesticide Registration Notice (PR Notice) 2023–2, entitled “Establishment of the Vector Expedited Review Voucher (VERV) Program.” PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important program policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This PR Notice establishes and describes the new VERV Program. The implementation of the VERV Program will incentivize the development of new insecticides to control and prevent the spread of vector-borne disease.

DATES:

PR Notice 2023–2 is effective upon signature. Since the revised form is already approved and in use, all older versions of the form will not be accepted.

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2023–0476, is available online at https://www.regulations.gov. Additional instructions for visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Susan Jennings, Office of Pesticide Programs (7501M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (706) 355–8574; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

This action is directed to the public in general, although this PR Notice may be of particular interest to those persons who may seek a pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Since other entities may also be interested or affected based on future activities, the Agency has not attempted to describe all the specific entities that this PR Notice may apply to.

II. What is the Agency's authority for taking this action?

FIFRA section 4(k)(7), 7 U.S.C. 136a–1(k)(7), as established in an amendment to FIFRA contained in the Pesticide Registration Improvement Act of 2022 (PRIA 5).

III. What guidance does this PR Notice provide?

As outlined in FIFRA section 4(k)(7), the Agency must establish the VERV Program by December 29, 2023, to incentivize development of new insecticides to control the spread of vector-borne disease to protect public health from mosquito born illnesses by granting vouchers for successfully registered products. If granted, the voucher may be redeemed to shorten the decision review time for a future pesticide application falling under certain specified PRIA categories. To achieve this, EPA is issuing PR Notice 2023–2 to establish the new VERV Program by providing guidance on applicable requirements and procedures for registrants to apply for, track, and redeem vouchers under the VERV Program.

Specifically, the Agency has amended the current form used for pesticide registration applications by adding optional fields to allow pesticide registrants to apply for the voucher program and to redeem previously granted vouchers for expediated review. An optional check box was added to the registration form for both the initial voucher application and the application for which expedited review is sought. Registration applicants may also attach an explanation for their voucher request, that includes a description of the insecticide and public health impacts with other required information, electronically or by paper with the registration form. The Agency will review the voucher application and award the voucher if the application meets the requirements of FIFRA section 4(k)(7). If a voucher is granted, an applicant may redeem the voucher by choosing the expedited review option on the amended registration form.

In addition, as specified in EPA regulations at 40 CFR 152.119(c), applicant-submitted information, including that provided on EPA Form No. 8570–1, entitled “Application for Pesticide Registration/Amendment,” will, on request, be made available to the public for inspection after a pesticide product is registered. EPA has previously determined that none of the information that applicants provide on EPA Form No. 8570–1 is confidential business information (CBI) or otherwise protected under FIFRA. As such, the Agency is able to release the form in response to a request under the Freedom of Information Act (FOIA), 5 U.S.C. 552 and EPA implementing regulations at 40 CFR 2.100.

IV. Do PR Notices impose binding requirements?

The PR Notice discussed in this document is intended to provide guidance to EPA personnel and decisionmakers and to pesticide registrants. While requirements in statutes and Agency regulations are binding on EPA and pesticide registrants, the PR Notice does not impose new binding requirements on either EPA or pesticide registrants, and EPA may depart from the guidance presented in the PR Notice where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

V. Is the revised form approved under the Paperwork Reduction Act (PRA)?

According to the PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires approval under the PRA, unless it has been approved by the Office of Management and Budget (OMB) and displays a currently valid OMB control number. This PR Notice does not create any paperwork burdens that require additional approval by OMB under the PRA because the information collection activities associated with EPA Form No. 8570–1 and the activities described in this PR Notice are already approved by OMB under OMB Control No. 2070–0226. The approved activities and related instruments are contained in the Information Collection Requests (ICR), entitled “Consolidated Pesticide Registration Submission Portal”, identified as EPA ICR No. 2624.02 and approved under OMB Control No. 2070–0226.

Authority:7 U.S.C. 136 et seq.

Dated: December 18, 2023.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.