Notice2024-22031

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

Primary source

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Published
September 26, 2024

Issuing agencies

Veterans Affairs Department

Abstract

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.

Full Text

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<title>Federal Register, Volume 89 Issue 187 (Thursday, September 26, 2024)</title>
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[Federal Register Volume 89, Number 187 (Thursday, September 26, 2024)]
[Notices]
[Pages 78986-78987]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22031]


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DEPARTMENT OF VETERANS AFFAIRS


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

AGENCY: Department of Veterans Affairs.

ACTION: Notice of public comment and listening session.

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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 <a href="http://www.regulations.gov">www.regulations.gov</a>. 
Except as provided below, comments received before the close of the 
comment period will be available at <a href="http://www.regulations.gov">www.regulations.gov</a> 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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. VA will not post on 
<a href="http://Regulations.gov">Regulations.gov</a> 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.

[[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.
    <bullet> 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: <a href="https://www.research.net/r/PFGH8YL">https://www.research.net/r/PFGH8YL</a>.

    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.
[FR Doc. 2024-22031 Filed 9-25-24; 8:45 am]
BILLING CODE 8320-01-P


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Indexed from Federal Register on September 26, 2024.

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