[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41713-41714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14937]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0164; FRL-9998-01-OCSPP]


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: (703) 305-6478; 
email address: [email protected].

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

[[Page 41714]]

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.
[FR Doc. 2022-14937 Filed 7-12-22; 8:45 am]
BILLING CODE 6560-50-P


