2024-12626. Pesticides; Draft Pesticide Registration Notice; Revised Procedures for Citing Data To Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35); Notice of Availability and Request for Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA or “Agency”) is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) entitled “Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35).” PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This draft PR Notice, will supersede PR Notice 98-5, entitled “New forms for the Certification with Respect to Citation of Data” dated June 12, 1998. The Agency is eliminating the instructions provided in PR Notice 98-5 that required registrants to submit two versions of EPA Form No. 8570-35 (“Data Matrix”), and the use of paper submissions. The changes in procedure are necessary updates to reflect current operations established to help reduce the burden associated with completing, submitting, and processing these forms for both applicants and the Agency, as well as to provide improved efficiencies for providing public access to the information without the extra burden associated with the use of formal procedures to request additional information.

DATES:

Comments must be received on or before July 10, 2024.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2023-0398, through the https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Earl Ingram, Office of Chemical Safety and Pollution Prevention (7603M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

This action is directed to the general public, although this action may be of particular interest to those persons who are required to submit data in support of pesticide registrations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

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

Pesticide registration activities are governed by FIFRA, 7 U.S.C. 136 et seq.

III. What guidance does this PR Notice provide?

This draft PR Notice provides updated guidance to registrants and applicants (hereinafter “registrants”) concerning their submission of the forms used for citing data to support pesticide registrations. The forms themselves that are currently in use are not being changed. This PR Notice will supersede PR Notice 98-5, entitled “New forms for the Certification with Respect to Citation of Data” dated June 12, 1998, that announced the availability of these forms to use for citation of data to support pesticide registrations, which were newly established in 1998 to streamline the forms previously used. With this PR Notice, OPP is revising the procedures established in 1998. Specifically, OPP is eliminating the instruction in PR Notice 98-5 that registrants submit two versions of EPA Form 8570-35 (“Data Matrix”), i.e., one the “Internal Agency Use Copy” and the other the “Public File Copy”. Consistent with federal mandates that direct agencies to adopt electronic submissions, OPP is also eliminating the instruction to use paper submissions as described in PR Notice 98-5 because these forms can be completed and submitted electronically.

In addition, EPA has determined that none of the information provided on EPA Form No. 8570-35 is confidential. EPA regulations at 40 CFR 152.119(c) require that, when requested, the Agency provides the form to the public for inspection after a product is registered. The information in the data matrix form is specified by EPA regulations at 40 CFR 152.119(b):

Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable.

CBI claims for information submitted under EPA's data requirements in 40 CFR part 158 is strictly limited in 40 CFR 158.33 to manufacturing or quality control processes, the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, and the identity or percentage quantity of any deliberately added inert ingredient of a pesticide, pursuant to FIFRA section 10(d)(1) (A) through (C). None of this information is reported in the data matrix form. Because none of the information on EPA Form No. 8570-35 is CBI, the Agency is able to release the form in response to a Freedom of Information Act (FOIA) request.

In addition, OPP is eliminating the instruction to use paper submissions as described in PR Notice 98-5 because these forms can be completed and submitted electronically. This PR Notice provides updated instructions for completing and submitting these forms electronically through the Pesticide Submission Portal (PSP) that OPP established to allow registrants to create and submit packages electronically in lieu of submitting multiple paper copies. The PSP is accessed through the EPA's Central Data Exchange (CDX) Network ( https://cdx.epa.gov/​), which is a web-based system used for various electronic environmental data submissions to EPA.

The changes in procedure presented in this draft PR Notice are necessary updates to reflect current operations established to help reduce the burden associated with completing, submitting and processing these forms for both applicants and the Agency, as well as to provide improved efficiencies for providing public access to the information without the extra burden associated with the use of formal requests for the additional information contained in the “Internal Agency Use Copy” of EPA Form 8570-35 (“Data Matrix”).

IV. Do PR Notices contain binding requirements?

The draft PR Notice discussed in this document is intended to provide guidance to EPA personnel and decision makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR Notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance 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. Are these forms 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. The information collection activities associated with EPA Forms 8570-34 and 8570-35 and the activities described in this PR Notice are already approved by OMB under the PRA and are contained in the Information Collection Requests (ICRs) entitled “Consolidated Pesticide Registration Submission Portal” identified as EPA ICR No. 2624.01 and approved under OMB Control No. 2070-0226; and the “Pesticide Data Call-in Program” identified as EPA ICR No. 2288 and approved under OMB Control No. 2070-0174. For additional information about these ICRs, use the link https://www.reginfo.gov/​public/​ and search on the applicable OMB control number.

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

Dated: June 4, 2024.

Edward Messina,

Director, Office of Pesticide Programs.