Presumptive Service Connection for Leukemias, Multiple Myelomas, Myelodysplastic Syndromes, and Myelofibrosis Due to Exposure to Fine Particulate Matter

<RULE> DEPARTMENT OF VETERANS AFFAIRS <CFR>38 CFR Part 3</CFR> <RIN>RIN 2900-AS27</RIN> <SUBJECT>Presumptive Service Connection for Leukemias, Multiple Myelomas, Myelodysplastic Syndromes, and Myelofibrosis 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 acute leukemias, chronic leukemias, multiple myelomas, myelodysplastic syndromes (MDS), and myelofibrosis due to exposure to Particulate Matter 2.5 (PM <E T="52">2.5</E> ). The new presumptions would apply to veterans who served on active military, naval, air, or space service in the 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> This interim final rule is effective January 10, 2025. <E T="03">Comment date:</E> Comments must be received on or before March 11, 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-AS27. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Amy Davis, Regulations Analyst, and 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, the President signed into law the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act). Public Law 117-168. The PACT Act provided a process for VA to establish presumptive service connection based on toxic exposures. 38 U.S.C. 1171-1174. 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). One of VA's priorities is to address the long overdue needs of the Gulf War cohort and to address the need for these veterans to receive timely care, services, and benefits. VA has reviewed both medical and scientific literature and has found sufficient evidence to conclude that a positive association exists between exposure to PM <E T="52">2.5</E> and acute and chronic leukemias and multiple myelomas. Accordingly, VA has determined that presumptions of service connection for these diseases and two precursors to acute myeloid leukemia (AML), MDS and myelofibrosis, are warranted for certain Gulf War veterans. In this IFR, VA adds 38 CFR 3.320b to its adjudicatory regulations to presume service connection for acute leukemias, chronic leukemias, multiple myelomas, MDS, and myelofibrosis for certain Gulf War veterans. VA adds these as presumptive conditions in 38 CFR 3.320b by IFR so that any veteran with these diseases 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>1</SU> <FTREF/> NASEM's 2011 report, Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan;  <SU>2</SU> <FTREF/> and NASEM's 2010 report, Review of the Department of Defense (DoD) Enhanced Particulate Matter Surveillance Program. <SU>3</SU> <FTREF/> <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> ].”  <SU>4</SU> <FTREF/> <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>5</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>6</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>7</SU> <FTREF/> <FTNT> <SU>1</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> (hereafter “Respiratory Health Effects of Airborne Hazards”). </FTNT> <FTNT> <SU>2</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>3</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>4</SU>  NRC, <E T="03">supra.</E> </FTNT> <FTNT> <SU>5</SU>  Wang X, Doherty TA, James C. <E T="03">Military burn pit exposure and airway disease: Implications for our Veteran population.</E> Ann Allergy Asthma Immunol. 2023 Dec;131(6):720-725. doi: 10.1016/j.anai.2023.06.012. <E T="03">https://pmc.ncbi.nlm.nih.gov/articles/PMC10728339/.</E> </FTNT> <FTNT> <SU>6</SU>   <E T="03">Id.</E> </FTNT> <FTNT> <SU>7</SU>  American Cancer Society. Military Burn Pits and Cancer Risk. 2022. <E T="03">https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html.</E> </FTNT> When promulgating 38 CFR 3.320 in August 2021, to determine the qualifying periods of service, VA primarily considered (1) whether burn pits were used in the location, (2) the PM <E T="52">2.5</E> levels, and (3) desert climates according to 86 FR at 42725-42729. However, in August 2022, the PACT Act created new 38 U.S.C. 1119, “Presumptions of toxic exposure,” with different qualifying periods of service. Section 1119(c) defines a “covered veteran” as a veteran who served in the following eligible locations: Bahrain, Iraq, Kuwait, Oman, Qatar, Saudi Arabia, Somalia, and the United Arab Emirates, on or after August 2, 1990, and Afghanistan, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, and Uzbekistan on or after September 11, 2001. VA's new presumptions in 38 CFR 3.320b will include the locations in current 38 CFR 3.320(a)(5), and the locations listed in 38 U.S.C. 1119(c) (including Egypt, Jordan, Lebanon, Somalia, and Yemen). This approach conforms with the information available regarding documented burn pit use. In 2021, DoD provided Congress with a list of locations within U.S. Central Command where open burn pits have been used since 2001. <SU>8</SU> <FTREF/> The U.S. Central Command's Area of Responsibility consists of 21 nations that stretch from Northeast Africa across the Middle East to Central and South Asia  <SU>9</SU> <FTREF/> and is the only combatant command that conducts open burn pit operations. <SU>10</SU> <FTREF/> Egypt, Jordan, Lebanon, and Yemen were included as locations with open, active burn pits. <SU>11</SU> ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 70k characters. 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