Presumptive Service Connection for Bladder, Ureter, and Related Genitourinary Cancers Due to Exposure to Fine Particulate Matter

<RULE> DEPARTMENT OF VETERANS AFFAIRS <CFR>38 CFR Part 3</CFR> <RIN>2900-AS21</RIN> <SUBJECT>Presumptive Service Connection for Bladder, Ureter, and Related Genitourinary Cancers Due to Exposure to Fine Particulate Matter</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Department of Veterans Affairs. <HD SOURCE="HED">ACTION:</HD> Interim final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Veterans Affairs (VA) is issuing this interim final rule (IFR) to amend its adjudication regulations to establish presumptive service connection for urinary bladder, ureter, and related genitourinary (GU) cancers due to exposure to Particulate Matter 2.5 (PM <E T="52">2.5</E> ) and to implement certain provisions of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act). The new presumptions would apply to Veterans who served on active military, naval, air, or space service in Southwest Asia theater of operations or Somalia during the Persian Gulf War (hereafter Gulf War) on or after August 2, 1990, and in Afghanistan, Syria, Djibouti, Uzbekistan, Egypt, Jordan, Lebanon, and Yemen during the Gulf War on or after September 11, 2001. This amendment is necessary to provide expeditious health care, services, and benefits to these veterans. This IFR addresses the needs and concerns of Gulf War veterans and Service members who have served and continue to serve in these locations and have been diagnosed with bladder, ureter, and related GU cancers. Neither Congress nor the President has established an end date for the Gulf War. Therefore, to expedite the provision of health care, services, and benefits to current and future Gulf War veterans who may be affected by PM <E T="52">2.5</E> due to their military service, VA is establishing presumptive service connection for urinary bladder, ureter, and related GU cancers. This IFR will ease the evidentiary burden of Gulf War Veterans who file claims with VA for these conditions. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> This interim final rule is effective January 2, 2025. <E T="03">Comment date:</E> Comments must be received on or before March 3, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Comments must be submitted through <E T="03">www.regulations.gov.</E> Except as provided below, comments received before the close of the comment period will be available at <E T="03">www.regulations.gov</E> 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 <E T="03">www.regulations.gov</E> as soon as possible after they have been received. VA will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. VA encourages individuals not to submit duplicative comments; however, we will post 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 the final rulemaking. In accordance with the Providing Accountability Through Transparency Act of 2023, a plain language summary (not more than 100 words in length) of this interim final rule is available at <E T="03">www.regulations.gov,</E> under RIN 2900-AS21. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Sara Cohen, Lead, Part 3 Regulations Staff, Robert Parks, Chief, Part 3 Regulations Staff (211C), Compensation Service (21C), Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.) </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> On August 10, 2022, Congress enacted Public Law 117-168, the PACT Act. The PACT Act provided a process for VA to establish presumptive service connection based on toxic exposures. 38 U.S.C. 1171 <E T="03">et seq.</E> The PACT Act also added a presumption of service connection for certain diseases associated with exposure to burn pits and other toxins (BPOT) in 38 U.S.C. 1120. This presumption applies to veterans who served in locations listed in 38 U.S.C. 1119(c)(1). The diseases subject to the presumption include kidney cancers and “[r]eproductive cancer of any type.” 38 U.S.C. 1120(b)(2)(E), (G). Kidney and reproductive cancers are part of genitourinary (GU) tract. Although the GU system is composed of kidneys, ureters, urinary bladder, urethra, <SU>1</SU> <FTREF/> reproductive and genital organs, including the ureteric orifice, urachus, and over-lapping sites of the bladder (the urinary organs), the PACT Act did not address all these organs. <FTNT> <SU>1</SU>  VA does not address urethral cancer in this rulemaking, because such cancer is a reproductive cancer, and therefore already subject to presumptive service connection under 38 U.S.C. 1120(b)(2)(E). <E T="03">See</E> 89 FR 79815, 79824 (2024) (proposed rule). </FTNT> Following the 38 U.S.C. 1171 <E T="03">et seq.</E> process, VA determined it was necessary and clinically appropriate to consider expanding presumptive status consideration to cancers of these additional organs. One of VA's priorities is to address the long overdue needs of the Gulf War cohort and to address the imminent need for these veterans to receive care, services, and benefits. VA has reviewed both medical and scientific literature, and concludes that (1) urinary bladder cancer is sufficiently linked to PM <E T="52">2.5</E> and that (2) cancers of the ureter, ureteric orifice, urachus, and over-lapping sites of the bladder are closely related to urinary bladder cancer with a common embryologic, anatomical, structural, and functional relationship. Moreover, the cancers of the ureter, ureteric orifice, urachus, and over-lapping sites of the bladder are exposed to toxic waste from the kidneys and the bladder as part of the GU system's function. Because, as discussed below, there is a medical nexus between the composition and duration of PM <E T="52">2.5</E> and airborne hazard exposures to the development of GU cancers, VA has determined that presumptions of service connection for these cancers are warranted. <E T="03">See</E> 38 U.S.C. 1174(a)(1). In this IFR, VA adds 38 CFR 3.320a to its adjudicatory regulations to presume service connection for these cancers for certain Gulf War Veterans. VA adds these cancers as presumptive in 38 CFR 3.320a by IFR so that any Veteran with these cancers and who served in a prescribed location need not wait for benefits. <HD SOURCE="HD1">II. Scientific Background</HD> <HD SOURCE="HD2">a. Exposure to Fine Particulate Matter</HD> On August 5, 2021, VA promulgated 38 CFR 3.320 to establish presumptions of service connection for certain chronic diseases based on exposure to PM <E T="52">2.5</E> during service in the Southwest Asia theater of operations during the Persian Gulf War, or service in Afghanistan, Syria, Djibouti, or Uzbekistan, on or after September 19, 2001, during the Persian Gulf War. 86 FR 42724, 42733 (2021) (interim final rule); <E T="03">see</E> 88 FR 60341 (2023) (adopting the interim final rule with changes). VA based these presumptions on review and analysis of airborne hazards in the Southwest Asia theater of operations during the Persian Gulf War, by examining the National Academies of Science, Engineering, and Medicine's (NASEM) 2020 report, Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations;  <SU>2</SU> <FTREF/> NASEM's 2011 report, Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan;  <SU>3</SU> <FTREF/> and NASEM's 2010 report, Review of the Department of Defense (DoD) Enhanced Particulate Matter Surveillance Program. <FTREF/> <SU>4</SU> <E T="03">See</E> 86 FR at 42725-42726. The 2010 report concluded that Service members deployed to the Middle East “are exposed to high concentrations of PM[ <E T="52">2.5</E> ]. <FTREF/> ”  <SU>5</SU> <E T="03">See</E> 86 FR at 42725. Toxic compounds present in burn pit fumes include PM <E T="52">2.5.</E> <SU>6</SU> <FTREF/> This airborne pollution includes smoke from oil well fires, sand, dust, mechanical fumes from aircraft, vehicle, and ship engines, wood, plastic, rubber, metals, munitions, chemicals, and food and human waste. <SU>7</SU> <FTREF/> Incomplete combustion of organic and inorganic material in burn pits results in high volumes of toxic PM in the air that includes metals, benzene, and other toxic compounds. <SU>8</SU> <FTREF/> <FTNT> <SU>2</SU>  National Academies of Sciences, Engineering, and Medicine 2020. <E T="03">Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations.</E> Washington, DC: The National Academies Press. <E T="03">https://doi.org/10.17226/25837.</E> </FTNT> <FTNT> <SU>3</SU>  Institute of Medicine 2011. <E T="03">Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan.</E> Washington, DC: The National Academies Press. <E T="03">https://doi.org/10.17226/13209</E> (hereinafter “NASEM 2011 Report”). </FTNT> <FTNT> <SU>4</SU>  National Research Council 2010. <E T="03">Review of the Department of Defense Enhanced Particulate Matter Surveillance Program Report.</E> Washington, DC: The National Academies Press. <E T="03">https://doi.org/10.17226/12911</E> (hereinafter “NRC”). </FTNT> <FTNT> <SU>5</SU>  NRC, <E T="03">supra.</E> </FTNT> <FTNT> <SU>6</SU>  Wang ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 55k characters. 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