2024-09164. Response To Comments for The Department of Veterans Affairs To Assess the Scientific Literature and Claims Data Regarding Certain Medical Conditions Associated With Military Environmental Exposures

AGENCY:

Department of Veterans Affairs.

ACTION:

Response to comments.

SUMMARY:

On July 26, 2023, the Department of Veterans Affairs (VA) published a notice soliciting public comment on its plan to assess the scientific literature and historical claims data regarding certain medical conditions (multiple myeloma, acute leukemias, and chronic leukemias) associated with military environmental exposures. On October 24, 2023, VA published a second notice announcing its intent to host a virtual public listening session on this topic on November 7, 2023. This third notice provides responses to the public comments received during the open comment period and public listening session.

FOR FURTHER INFORMATION CONTACT:

Peter Rumm, MD, Director of Policy, Health Outcomes Military Exposures, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, 202-461-7297. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

VA provided a 30-day comment period, which ended on August 25, 2023. Individuals or organizations submitted 26 comments to this first Federal Register Notice (FRN). Participation in the public listening session included 12 comments presented by speakers and 13 comments submitted using the chat feature during the meeting. The Veterans Health Administration's (VHA's) HOME Program Office received and responded to 357 emails from Veterans and made 8 telephone calls to address individual Veterans' potential military environmental exposure concerns for those who were unable to speak during the listening session due to time constraints.

Overall, comments supported VA's plan to assess the scientific literature and historical claims data regarding multiple myeloma, acute leukemias, and chronic leukemia associated with military environmental exposures although some discussed additional concerns. The 26 formal comments received during the 30-day comment period on the first FRN were grouped into 3 main categories, with some comments falling into more than one category:

• Category 1 —Comments directly related to multiple myeloma, acute leukemias, and chronic leukemia: 18 out of 26 (69%). Notably, of the 18, 17 out of 18 (94%) of these comments expressed support for VA's plan to assess the scientific literature and historical claims data regarding certain medical conditions (multiple myeloma, acute leukemias, and chronic leukemias) associated with military environmental exposures.

○ More comments were received specifically supportive of multiple myeloma versus the leukemias.

○ There was only 1 non-supportive comment out of 18 (under 6%).

• Category 2 —Comments pertaining to additional locations: 8 out of 26 (31%) comments suggested VA consider presumptions for locations outside Gulf War and southwest Asia locations that are covered by the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act.

• Category 3 —Comments pertaining to additional conditions: 7 out of 26 (27%) comments suggested various conditions for future review.

VA thanks the commenters and attendees for their support and comments. To expand upon the comments in more detail, participants suggested that VA include additional conditions ( e.g., neurologic conditions, sleep apnea, hypertension, chronic multi-symptom illness, and immune disorders) to be considered for association with exposure from burn pits and other toxic substances ( e.g., benzene, formaldehyde, dioxin, and heavy metals) present on post-9/11 deployments in addition to the PACT Act established categories of presumptive conditions. Other deployments, including burn pits or other toxins in Vietnam (see also below) were mentioned. Commenters also noted a preference for additional locations ( e.g., Naval Air Facility Atsugi, Japan, Vietnam, Haiti, Honduras, Panama, and Bosnia) to be considered for toxic exposure, as well as various military bases or garrisons. Finally, some participants expressed a desire for more public input into the VA decision-making process.

Senior VA leadership attended the November 7, 2023, WEBEX virtual public listening session. After Mr. Josh Jacobs, Under Secretary for Benefits (USB), provided opening remarks, Dr. Patricia Hastings, Chief Consultant HOME, delivered a presentation on the revised presumptive decision process. Twelve representatives from Veterans Service Organizations, academia, and the Veteran community expressed their views and comments during the session. In addition to the 12 speakers, the chat feature within WEBEX recorded an additional 13 comments. Dr. Shereef Elnahal, Under Secretary for Health (USH), provided closing remarks and emphasized VA and Congress' interest in responding to the public's instructive and important comments. USB Jacobs and USH Elnahal expressed appreciation for the public's participation in this process.

The listening session allowed VA to be proactive in its approach to improve care, treatment, and benefits for toxic-exposed Veterans, and consider areas of public interest regarding current or planned research of potential presumptive conditions. During the listening session, most comments fell into the additional location and conditions categories. Several comments supported future study and potential recognition of sleep apnea as a presumptive condition. Listeners were assured that additional locations and conditions are continuously monitored and may be presented for a formal review in the future. HOME and Veterans Benefits Administration (VBA) Military Exposures Team staff members communicated with participants who raised specific questions during the session.

VBA's compensation disability evaluation and rating system is complex, as is the arena of military environmental exposures. Some comments indicated misunderstandings of the VA's benefits system and decision-making process. Additional evidence of misunderstandings regarding VHA in areas such as the impact of vaccines and chemical exposures were also expressed. To limit misunderstanding, VBA and VHA are expanding outreach efforts each year to enhance understanding of Veteran health and benefits systems.

Moving Forward

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 cohorts. Additionally, active epidemiological surveillance and ongoing monitoring of military exposures in collaboration with the Department of Defense is ongoing. VA's involvement in surveillance, monitoring, and research covers a wide variety of areas. When a scientific review concludes that there is a statistically significant signal or possible association between military environment exposure and health outcomes, this may trigger an investigation that may lead to additional research or may be subject to an FRN and comment process required under section 202 of the PACT Act. Additional notices of this type will be published as VA reviews conditions and their possible association with military environmental exposures to provide health care, services, and benefits to Veterans entitled to them. VA has considered the issues presented by commenters and decided to conduct a scientific review of multiple myeloma and chronic and acute leukemias, taking into account the latest scientific classification schemes for blood cancers and scientific evidence regarding shared etiologies. VA will follow the procedures in 38 U.S.C. 1172-1174 for initiating and conducting assessments and formal evaluations. VA has designated a Technical Working Group (TWG) to assess cases of the toxic exposure of Veterans and their dependents pursuant to 38 U.S.C. 1172(c). The TWG may develop a recommendation for formal evaluation under 38 U.S.C. 1173, pursuant to 38 U.S.C. 1172(d). Once a formal evaluation begins, a recommendation to establish or modify a presumption of service connection must be submitted to the Secretary within 120 days per 38 U.S.C. 1173(d). Within 160 days of receiving the recommendation to establish or modify a presumption of service connection, the Secretary must determine whether a presumption is warranted per 38 U.S.C. 1174(a). This may include commencing rulemaking to establish or modify presumptions for some or all of the conditions formally evaluated and/or publishing notice in the FRN of any determination that establishment or modification of a presumption or presumptions are unwarranted for some or all of the conditions that were subject to the formal evaluation.

Signing Authority

Denis McDonough, Secretary of Veterans Affairs, approved and signed this document on April 17, 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.

Jeffrey M. Martin,

Assistant Director, Office of Regulation Policy & Management, Office of General Counsel, Department of Veterans Affairs.