2022-14937. PB&ACSS JV, LLC.; Transfer of Data (June 2022)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be transferred to PB&ACSS JV, LLC. and its subcontractors and consultants, CDM Smith, Summitec LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, in accordance with the CBI regulations. PB&ACSS JV, LLC. and its subcontractors and consultants have been awarded a contract to perform work for OPP, and access to this information will enable PB&ACSS JV, LLC. and its subcontractors and consultants to fulfill the obligations of the contract.

DATES:

Data transfer and access to information will occur by July 18, 2022.

FOR FURTHER INFORMATION CONTACT:

William Northern, Information Technology and Resources Management Division (7601T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action.

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification (ID) number EPA- EPA-HQ-OPP-2022-0164, is available at http://www.regulations.gov. Additional information about the docket, along with instructions for visiting the docket in-person, is available at https://www.epa.gov/​dockets.

II. Contractor Requirements

Under Contract No. 68HERC22D0017, PB&ACSS JV, LLC. and its subcontractors and consultants, CDM Smith, Summitec, LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, will perform critical reviews of EPA designated studies submitted by the registrants and/or from the open literature, and these reviews will be provided to the task order Contract Officer's Representative (COR) in DER or other similar study evaluation report form or system, as applicable. A template of the DER format provided to the contractor shall be followed in the preparation of Data Evaluation Records (DER)s. See DER Templates for Test Guidelines https://www.epa.gov/​pesticide-registration/​study-profile-templates. Specific guidance for completing each section is provided in the DER templates. Each review will encompass all items in the study that contribute to the overall knowledge of the pesticide, and will include the following:

1. An evaluation of the accuracy, credibility and scientific validity of that study;

2. Its suitability for meeting specific data requirements.

3. Any necessary graphic displays of data, and/or summary tables illustrating results of the study.

4. Sound scientific rationale for the conclusions reached on specific studies.

5. Clarity in data presentation and adherence to the template and overall guidance.

An evaluation for each study will include the following:

• Study identifying information.
• An in-depth examination of the materials and methods employed.
• An in-depth examination of the reported results.
• An in-depth discussion of the reviewer's scientific assessment of the study.
• A description of the reviewer's assessment which summarizes the overall conclusions and significance of the study.
• Establishment of a no observable adverse effects levels (NOAEL) and lowest observable adverse effects levels (LOAEL) based on significant toxicological effects, if applicable.
• Characterize Good Laboratory Practice (GLP) compliance in study protocols, reviews, and for data evaluations.
• Discussion of data's relevancy for supporting public health claims in review of efficacy data.

OPP has determined that access by PB&ACSS JV, LLC. and its subcontractors and consultants, CDM Smith, Summitec, LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, to information on all pesticide chemicals is necessary for the performance of this contract.

Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under FIFRA sections 3, 4, 6, and 7 and under FFDCA sections 408 and 409.

In accordance with the requirements of 40 CFR 2.307(h)(2), the contract with PB&ACSS JV, LLC. and its subcontractors and consultants, CDM Smith, Summitec, LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, prohibits use of the information for any purpose not specified in the contract; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, to the contractor and its subcontractors and consultants are required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to the contractor and its subcontractors and consultants until the requirements in this document have been fully satisfied. Records of information provided to the contractor and its subcontractors and consultants will be maintained by EPA Project Officers for this contract. All information supplied to to the contractor and its subcontractors and consultants by EPA for use in connection with this contract will be returned to EPA when to the contractor and its subcontractors and consultants have completed their work.

Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

Dated: July 5, 2022.

Delores Barber,

Director, Information Technology and Resources Management Division, Office of Program Support.