2024-22031. Notice of Plans To Assess the Current Scientific Literature and Historical Detailed Claims Data Regarding Exposure to Per- and Polyfluoroalkyl Substances (PFAS) and Kidney Cancer

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Department of Veterans Affairs

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice of public comment and listening session.

SUMMARY:

The Department of Veterans Affairs (VA) announces that it plans to conduct an assessment of the scientific literature and historical claims data to determine whether an association between military environmental exposures and certain medical conditions exists. This scientific assessment will consider the possibility of a relationship between exposure to Per- and polyfluoroalkyl substances (PFAS) and kidney cancer. The population of study will include U.S. service members who may have experienced environmental and/or occupational exposures to PFAS during military service, but additional inclusion criteria will be considered during the scientific assessment. VA is soliciting public comment on the importance of completing this assessment of scientific literature and historical claims data for kidney cancer and other conditions and will also hold a public listening session.

DATES:

Written comments must be received on or before December 20, 2024.

Additionally, VA will hold a public listening session virtually via Webex on Tuesday, November 19, 2024. This session will start at 10:00 a.m. Eastern Standard Time (EST) and end at 11:30 a.m. EST and will focus on plans detailed within this Federal Register notice. Registration is required.

Individuals/organizations can sign up using the information found in the SUPPLEMENTARY INFORMATION section below.

ADDRESSES:

Comments must be submitted through www.regulations.gov. Except as provided below, comments received before the close of the comment period will be available at www.regulations.gov for public viewing, inspection, or copying, including any personally identifiable or confidential business information that is included in a comment. We post the comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. VA will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm the individual. VA encourages individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. Any public comment received after the comment period's closing date is considered late and will not be considered in any potential future rulemaking.

FOR FURTHER INFORMATION CONTACT:

Dr. Erin Dursa, Ph.D., MPH, Director of Surveillance Military Environmental Exposures, Health Outcomes Military Exposures, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, at 202-461-7297.

SUPPLEMENTARY INFORMATION:

In accordance with 38 U.S.C. 1172, as created by section 202 of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (also known as the PACT Act), VA is publishing this notice about its planned scientific assessment of the possibility of a relationship between exposure to PFAS and kidney cancer in Veterans.

PFAS are synthetic chemicals found in many products, including but not limited to clothing, adhesives, paper packaging for food, and heat-resistant/non-stick cookware. They are also a major constituent of fire-fighting foams or aqueous film-forming foams (AFFF) used to extinguish jet fuel fires in military and commercial settings.

A report by the National Academies of Sciences, Engineering, and Medicine (NASEM) reviewed the potential health effects related to PFAS and suggested guidance for clinical follow-up. VA designated a technical working group (TWG) to conduct an assessment pursuant to 38 U.S.C. 1172(c), and the TWG developed recommendations to VA leadership for formal assessment under 38 U.S.C. 1173, pursuant to 38 U.S.C. 1172(d). Members of the TWG were determined based on their subject matter expertise relevant to the NASEM report, Guidance on PFAS Exposure, Testing, and Clinical Follow-Up (2022). The PFAS TWG determined that sufficient evidence exists to justify the evaluation of kidney cancer through the new presumptive decision process for service connection for Veterans exposed to PFAS. This recommendation is based on evidence presented by NASEM and from other scientific authorities, such as International Agency Research on Cancer, Agency for Toxic Substances and Disease Registry, and Environmental Protection Agency.

VA solicits public comment on the importance of completing this assessment of scientific literature and historical claims data for these conditions or others, via written response to this notice or via a virtual listening session for the public to provide feedback. During this listening session, Veterans Health Administration and Veterans Benefits Administration subject matter experts will listen to public feedback and may ask questions but will not be able to share proposals for specific conditions nor address the merits of any comment provided.

Once the conclusions of the assessment have been appropriately reviewed by experts, it may lead to a formal evaluation to inform decisions regarding Veterans' qualifying period of service, such as those who served on active military, naval, or air service in the Southwest Asia theater of operations during the Persian Gulf War, as well as Somalia, Afghanistan, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, or Uzbekistan from September 11, 2001, until the present time.

VA is also soliciting public comment, via writing within this notice or via the public listening session, about other conditions that would benefit from review of the possible association, the conditions, and health outcomes related to them. ( print page 78987)

VA continues to review and assess information about military environmental exposure incidents, emerging scientific evidence regarding toxic substances, and health outcomes in deployed and non-deployed veteran cohorts. Additionally, active epidemiological surveillance and ongoing monitoring of military exposures in collaboration with the Department of Defense are underway. If the assessment of these conditions concludes a possible association between military environmental exposure and an adverse health outcome is present, this may lead to additional research or be subject to a Federal Register notice and comment process, as required by section 1172. VA will publish other notices of this type as it reviews other potential adverse health conditions and their possible association with military environmental exposures to provide health care, services, and benefits to Veterans.

As noted, while VA will accept written comments on this notice, the accompanying listening session aims to allow individuals to share their research, input, and comments on certain adverse health conditions associated with military environmental exposure. Participants can also share their recommendations on other conditions that would benefit from review.

• November 19, 2024—Notice of Plans for the Department of Veterans Affairs to Assess the Current Scientific Literature and Historical Claims Data Regarding Exposure to Per- and Polyfluoroalkyl Substances and Cancer. Registration link:https://www.research.net/​r/​PFGH8YL.

Note:

This listening session will have closed captioning available via the WebEx platform. The webinar will be recorded and transcribed.

Registration: Individuals interested in attending must register with Webex for the listening session. We will ask attendees if they want to provide verbal or written feedback during registration so we can coordinate enough time for verbal comments. However, verbal participation is not required to complete registration. If you wish to provide verbal or written feedback during the listening session, please register by November 15, 2024. Individuals who indicate interest in commenting will receive a confirmation message 2 business days before the session. Individuals who wish to submit materials to VA must do so by November 15, 2024.

VA will work to accommodate all individuals who wish to comment verbally. However, VA will prioritize those who registered in advance. The time allotted for individuals to comment verbally will depend on the number of registrations. We will turn off cameras and mute microphones until the presenter's scheduled time to accommodate as many comments as possible. VA will request written submissions if there is not enough time to hear all comments.

Note:

During the listening session, VA will not share proposals or address feedback. VA will use suggestions made during this listening session and public comments on VA's plan to improve future evaluations. VA will continue to comply with the requirements of section 1172(a) and ensure appropriate public notice and opportunity for participation.

Special Accommodations: Attendees requiring special accommodations should make their requests to VA no later than November 5, 2024 (2 weeks before the listening session on November 19, 2024) by contacting the point of contact identified in this notice.

After reviewing comments received in response to this notice and the public listening session, VA will conduct the assessment of the specified conditions. VA will then follow the procedures in 38 U.S.C. 1172-1174 for initiating and conducting assessments and formal evaluations. If appropriate, VA will designate a TWG to conduct a scientific assessment pursuant to 38 U.S.C. 1172(c), and the TWG may develop a recommendation for formal evaluations under 38 U.S.C. 1173, pursuant to 38 U.S.C. 1172(d). Once a formal evaluation is commenced, a recommendation with respect to establishing a presumption of service connection must be submitted to the Secretary within 120 days, in accordance with 38 U.S.C. 1173(d). And within 160 days of receiving the recommendation with respect to establishing a presumption of service connection, the Secretary must determine whether a presumption is warranted in accordance with 38 U.S.C. 1174(a). This may include initiating rulemaking to establish new presumptions for some or all the conditions formally evaluated and/or publishing notice in the Federal Register of any determination that a presumption or presumptions are unwarranted for some or all of the conditions that were the subject of the scientific assessment.

Signing Authority

Denis McDonough, Secretary of Veterans Affairs, approved and signed this document on September 16, 2024, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

Luvenia Potts,

Regulation Development Coordinator, Office of Regulation Policy & Management, Office of General Counsel, Department of Veterans Affairs.