```

[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Rules and Regulations]
[Pages 1894-1901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31776]

[[Page 1894]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AS27

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

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

-----------------------------------------------------------------------

SUMMARY: 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 
(PM2.5). 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.

DATES: 
    Effective date: This interim final rule is effective January 10, 
2025.
    Comment date: Comments must be received on or before March 11, 
2025.

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 
www.regulations.gov as soon as possible after they have been received. 
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 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 
www.regulations.gov, under RIN 2900-AS27.

FOR FURTHER INFORMATION CONTACT: 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.)

SUPPLEMENTARY INFORMATION:

I. Background

    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 PM2.5 
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.

II. Scientific Background

a. Exposure to Fine Particulate Matter

    On August 5, 2021, VA promulgated 38 CFR 3.320 to establish 
presumptions of service connection for certain chronic diseases based 
on exposure to PM2.5 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); see 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; \1\ NASEM's 2011 report, Long-Term Health 
Consequences of Exposure to Burn Pits in Iraq and Afghanistan; \2\ and 
NASEM's 2010 report, Review of the Department of Defense (DoD) Enhanced 
Particulate Matter Surveillance Program.\3\ See 86 FR at 42725-42726. 
The 2010 report concluded that Service members deployed to the Middle 
East ``are exposed to high concentrations of PM[2.5].'' \4\ 
See 86 FR at 42725. Toxic compounds present in burn pit fumes include 
PM2.5.\5\ 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.\6\ 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.\7\
---------------------------------------------------------------------------

    \1\ National Academies of Sciences, Engineering, and Medicine 
2020. Respiratory Health Effects of Airborne Hazards Exposures in 
the Southwest Asia Theater of Military Operations. Washington, DC: 
The National Academies Press. https://doi.org/10.17226/25837 
(hereafter ``Respiratory Health Effects of Airborne Hazards'').
    \2\ Institute of Medicine 2011. Long-Term Health Consequences of 
Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC: The 
National Academies Press. https://doi.org/10.17226/13209 
(hereinafter ``NASEM 2011 Report'').
    \3\ National Research Council 2010. Review of the Department of 
Defense Enhanced Particulate Matter Surveillance Program Report. 
Washington, DC: The National Academies Press. https://doi.org/10.17226/12911 (hereinafter ``NRC'').
    \4\ NRC, supra.
    \5\ Wang X, Doherty TA, James C. Military burn pit exposure and 
airway disease: Implications for our Veteran population. Ann Allergy 
Asthma Immunol. 2023 Dec;131(6):720-725. doi: 10.1016/
j.anai.2023.06.012. https://pmc.ncbi.nlm.nih.gov/articles/PMC10728339/.
    \6\ Id.
    \7\ American Cancer Society. Military Burn Pits and Cancer Risk. 
2022. https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html.
---------------------------------------------------------------------------

    When promulgating 38 CFR 3.320 in August 2021, to determine the 
qualifying periods of service, VA primarily considered (1) whether burn

[[Page 1895]]

pits were used in the location, (2) the PM2.5 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.\8\ 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 \9\ and is the only combatant command that 
conducts open burn pit operations.\10\ Egypt, Jordan, Lebanon, and 
Yemen were included as locations with open, active burn pits.\11\ 
Somalia was not included on the list. However, there is evidence of 
burn pit use in Somalia when service members were deployed in support 
of Operation Show Care in 1993.\12\ Additional deployments occurred in 
1992, 1995, 2012, and 2022.\13\
---------------------------------------------------------------------------

    \8\ See Letter from Office of Under Secretary of Defense to the 
U.S. House of Representatives Committee on Appropriations (May 7, 
2021), available on the rulemaking docket at www.regulations.gov 
(hereafter ``Defense Letter'').
    \9\ U.S. Central Command. Area of Responsibility. https://www.centcom.mil/AREA-OF-RESPONSIBILITY/.
    \10\ Department of Defense. Open Burn Pit Report to Congress. 
2019. https://www.acq.osd.mil/eie/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf.
    \11\ See Defense Letter, supra.
    \12\ Center of Military History, United States Army. United 
States Forces, Somalia After Action Report and Historical Overview: 
The United States Army in Somalia, 1992-1994. https://www.history.army.mil/html/documents/somalia/index.html.
    \13\ . CRS Report R42738, Instances of Use of United States 
Armed Forces Abroad, 1798-2022, https://crsreports.congress.gov/product/pdf/R/R42738/38; Stimson Center, US Security Assistance to 
Somalia, https://www.stimson.org/2023/us-security-cooperation-with-somalia/.
---------------------------------------------------------------------------

    Additionally, all the locations listed in 38 U.S.C. 1119(c) have 
similar arid desert climate conditions. DoD's 2008 Enhanced Particulate 
Matter Surveillance Program studied the chemical and physical 
properties of dust at 15 deployment sites in the Middle East, Central 
Asia, and Northeast Africa.\14\ The study found that Military Exposure 
Guideline (MEG) values for PM2.5 were exceeded at all 15 
sites for the entire one-year sampling period.\15\ The study also 
demonstrated how short-term dust events--exacerbated by dirt roads, 
agricultural activities, and disturbance of the desert floor by 
motorized vehicles--all contribute to exceedance of both 
PM10 and PM2.5 mass exposure guidelines and 
standards.\16\ Finally, DoD's report also stated that PM2.5 
levels in the Middle East are as much as ten times greater than the 
levels at both urban and rural southwestern U.S. air monitoring 
sites.\17\
---------------------------------------------------------------------------

    \14\ Department of Defense. Enhanced Particulate Matter 
Surveillance Program Final Report. 2008. https://apps.dtic.mil/sti/pdfs/ADA605600.pdf (hereafter ``EPMSP Report'').
    \15\ Id.
    \16\ Id.
    \17\ Id.
---------------------------------------------------------------------------

    Dust storms and high windblown dust concentrations are one of many 
environmental hazards experienced during deployment to locations within 
U.S. Central Command. Windblown dust in these locations is considered 
an airborne hazard because it combines with elemental carbon and metals 
that arise from transportation and industrial activities.\18\ Although 
dust in these locations can be toxic based on transportation and 
industrial activities alone, open air burn pits increase the 
concentration of toxins in PM2.5.
---------------------------------------------------------------------------

    \18\ NASEM 2011 Report, supra.
---------------------------------------------------------------------------

    As discussed above, in locations that rely on open burning of 
waste, the PM2.5 air pollution in that location will contain 
toxic combustion emissions. Open burning is the ``burning of any matter 
in such a manner that products of combustion resulting from the burning 
are emitted directly into the ambient or surrounding outside air 
without passing through an adequate stack, duct or chimney.'' \19\ The 
Environmental Protection Agency (EPA) defines ``ambient air'' as ``that 
portion of the atmosphere, external to buildings, to which the general 
public has access.'' 40 CFR 50.1(e). Because PM2.5 is a form 
of ambient air pollution that can have many different components from 
many different sources (for example, sand, dust, and smoke) and open 
burning of waste emits toxic combustion emissions into the ambient air; 
VA considers burn pit smoke to be a contributor to PM2.5.
---------------------------------------------------------------------------

    \19\ Estrellan, C.R. and Iino, F. (2010) Toxic Emissions from 
Open Burning. Chemosphere, 80, 193-207. https://doi.org/10.1016/j.chemosphere.2010.03.057.
---------------------------------------------------------------------------

    The 38 U.S.C. 1119(c) locations have a history of annual 
PM2.5 levels that exceed military and EPA air quality 
standards. Not only do they exceed air quality standards, average 
PM2.5 concentrations have been increasing in North Africa 
and the Middle East since 1990, while Europe and North America have 
experienced decreasing trends in average PM2.5 
concentrations.\20\ For consistency with the statutory start date for 
service in 38 U.S.C. 1119(c)(1)(B) locations (including Afghanistan, 
Syria, Djibouti, and Uzbekistan) back to September 11, 2001, new 38 CFR 
3.320b will presume exposure to PM2.5 for those countries 
back to September 11, 2001.
---------------------------------------------------------------------------

    \20\ EPMSP Report, supra.
---------------------------------------------------------------------------

b. The PACT Act Process

    The PACT Act presumption determination process consists of four 
phases. The Ongoing Exploratory Surveillance Phase includes 
collaborating with VA partners, to include Veterans Service 
Organizations (VSOs) and other stakeholders, to identify, monitor, and 
investigate potential toxic exposures and adverse health effects. 38 
U.S.C. 1172(a). The Research and Assessment Phase involves collecting 
information, evidence, and data regarding a particular toxic exposure 
and adverse health effect, and potentially conducting a scientific 
study and analysis of the data. 38 U.S.C. 1172(c). Based on the 
findings, VA's Military Environment Exposures Sub-Council (MEESC) may 
recommend that the Secretary initiate a formal evaluation of the issue. 
38 U.S.C. 1172(d).
    If the Secretary adopts that recommendation, the Formal Evaluation 
Phase begins. 38 U.S.C. 1173. In this phase, a technical working group 
is convened to conduct an evaluation of the evidence and research 
collected in the prior phases as well as claims data and potentially 
other factors, to render a conclusion on the strength of the evidence 
and to provide a recommendation to the Secretary with respect to a 
presumption. Id. If the Secretary decides to accept a recommendation to 
establish a presumption, the Rulemaking and Implementation Phase then 
begins. 38 U.S.C. 1174.

c. Ongoing Exploratory Surveillance Phase

    On July 26, 2023, VA published a notice soliciting public comment 
on its plan to assess the scientific literature

[[Page 1896]]

and historical claims data regarding multiple myelomas, acute 
leukemias, and chronic leukemias associated with specific military 
environmental exposures. 88 FR 73094. On November 7, 2023, VA's Health 
Outcomes Military Exposures (HOME) office held a public listening 
session and briefed VSOs and Congressional staffers on the plan to 
study leukemias and multiple myelomas. Most comments were in favor of 
assessing the scientific literature and historic claims data regarding 
multiple myelomas, acute leukemias, and chronic leukemias. 89 FR 33471.

d. Research and Assessment Phase

    In November 2023, Veterans Health Administration (VHA) HOME and 
Veterans Benefits Administration's (VBA) Military Exposure Team (MET) 
(hereafter ``the committee'') began collaboration to evaluate two 
distinct types of information (peer-reviewed scientific literature and 
VBA claims data) to determine the strength of the evidence supporting 
an association between exposure to PM2.5 in the Southwest 
Asia theater of operations or Somalia on or after August 2, 1990, or in 
Afghanistan, Egypt, Jordan, Lebanon, Syria, Yemen, Djibouti, or 
Uzbekistan on or after September 11, 2001 and chronic and acute 
leukemias and multiple myelomas. The committee considered this issue 
because blood and bone marrow cancers were not included as presumptions 
in the PACT Act. The committee followed the Patient, Exposure, 
Comparator, Outcomes, Timing, Setting (PECOTS) framework to guide a 
literature search and identify relevant articles for review--and 
identified 319 peer-reviewed publications that met the search criteria, 
of which 154 were deemed relevant.\21\
---------------------------------------------------------------------------

    \21\ Report to the Secretary of Veterans Affairs on the 
Relationship Between Exposure to Fine Particulate Matter 
(PM2.5) in the Southwest Theatre of Operations or Somalia 
on or After August 2, 1990, or in Afganistan, Egypt, Jordan, 
Lebanon, Syria, Yemen, Djibouti, or Uzbekistan on or After September 
11, 2001 and Chronic and Acute Leukemias and Multiple Myleomas, 
November 2024 (hereafter ``Committee report''), is attached to this 
rulemaking, available at www.regulations.gov.
---------------------------------------------------------------------------

    To assist in reviewing the relevant articles, the committee engaged 
experts including military exposure epidemiologists from VHA and the 
Department of Defense, VA scientists, VA oncologists/hematologists, 
board-certified occupational and environmental medicine (OEM) 
physicians, and a senior medical advisor from the Commissioned Corps of 
the U.S. Public Health Service.\22\ Of the 154 relevant publications, 
42 met the desired grade quality of high or moderate quality based on 
the Grading of Recommendations Assessment, Development, and Evaluation 
(GRADE) guidelines.\23\ Of the moderate and high quality peer-reviewed 
scientific publications, 74% showed a positive association between 
exposure to PM2.5 and development of acute and chronic 
leukemias and multiple myelomas.\24\ The committee concluded with a 
recommendation that the Secretary initiate a formal evaluation of the 
matter.\25\
---------------------------------------------------------------------------

    \22\ Id.
    \23\ Id.
    \24\ Id.
    \25\ Id.
---------------------------------------------------------------------------

e. Formal Evaluation Phase

    On November 20, 2024, the Secretary initiated a formal evaluation 
on chronic and acute leukemias and multiple myelomas and their possible 
association with exposure to PM2.5 pollution in the 
Southwest Asia theater of Operations.\26\ At the same time, the 
Secretary also directed a formal evaluation on other blood cancers.\27\
---------------------------------------------------------------------------

    \26\ Secretary's Memorandum, signed November 20, 2024, is 
attached to this rulemaking, available at www.regulations.gov.
    \27\ Id.
---------------------------------------------------------------------------

    Under 38 U.S.C. 1173(b), a formal evaluation shall be based on the 
review of available scientific literature, including human, 
toxicological, animal, and methodological studies, and other factors, 
and must consider claims data including claim rate, grant rate, and 
service connection prevalence. It can also consider the level of 
disability and mortality caused by the health effects related to the 
case of toxic exposure being evaluated; the quantity and quality of the 
information available and reviewed; the feasibility of and period for 
generating relevant information and evidence; whether such health 
effects are combat- or deployment-related; the ubiquity or rarity of 
the health effects; and any time frame during which a health effect 
must become manifest.
    A formal evaluation shall review scientific evidence in a manner 
that conforms to principles of scientific and data integrity; be free 
from suppression or distortion of scientific or technological findings, 
data, information, conclusions, or technical results; evaluate the 
likelihood that a positive association exists between an illness and a 
toxic exposure while serving in the active military, naval, air, or 
space service; and determine whether the evidence supports a finding of 
a positive association between the toxic exposure and the illness. 38 
U.S.C. 1173(c).
    Here, the formal evaluation team (hereinafter ``the team'') 
reviewed the methods and findings of the committee's report from the 
Research and Assessment phase.\28\ The team included the HOME policy 
team, and hematologists/oncologists, epidemiologists, a toxicologist, 
and VBA Compensation Service personnel who were not part of the 
scientific assessment.\29\ The team assessed that the committee's 
report had three major components and was consistent with robust 
scientific methods.\30\ First, the team noted that masters' trained 
biomedical librarians, not part of the scientific assessment committee, 
had followed a PECOTS framework to complete an expansive structured 
literature search. Second, the team noted that the committee had 
critically reviewed the papers of moderate and high-grade quality based 
on the GRADE structure.\31\ Third, the team noted that the committee 
had reviewed VBA claims data on leukemias and multiple myelomas from 
March 2003-March 2023 for both deployed and non-deployed Gulf War Era 
veterans, including 1990-1991 Gulf War veterans, Global War on Terror 
veterans, and Karshi-Khanabad Veterans.\32\
---------------------------------------------------------------------------

    \28\ Formal Evaluation of the Report to The Secretary of 
Veterans Affairs on The Relationship Between Exposure to Fine 
Particulate Matter (PM2.5) in the Southwest Theatre of 
Operations or Somalia on or after August 2, 1990, or In Afghanistan, 
Egypt, Jordan, Lebanon, Syria, Yemen, Djibouti, or Uzbekistan on or 
After September 11, 2001, and Acute Leukemias, Chronic Leukemias, 
and Multiple Myelomas, December 6, 2024 (hereafter ``Formal 
Evaluation Report'') is attached to this rulemaking, available at 
www.regulations.gov.
    \29\ Id.
    \30\ Id.
    \31\ Id.
    \32\ Id.
---------------------------------------------------------------------------

    The team emphasized that the 74% of the moderate and high-quality 
peer-reviewed scientific publications reviewed by the committee, as 
discussed above, consistently showed a positive relationship between 
exposure to PM2.5 and development of leukemias and multiple 
myelomas. The team noted that the VBA claims data provided a 
complementary perspective to the evidence in the scientific literature 
and showed trends among veterans with deployment to countries with 
recognized high levels of PM2.5 and burn pit pollution. 
Notably, veterans deployed to the relevant countries were granted a 
higher proportion of claims (53% vs. 42% for non-deployed), which 
supports the correlation between PM2.5 and higher risk of 
service-related diagnoses of these conditions. The data also showed 
that the deployed cohort filed more claims than non-deployed

[[Page 1897]]

veterans, and also filed claims at a younger age, suggesting earlier 
onset of deployment related conditions. The team highlighted these data 
findings as supporting the link between PM exposure and increased risk 
for hematological cancers.\33\
---------------------------------------------------------------------------

    \33\ Id.
---------------------------------------------------------------------------

    As an additional validation step, the team analyzed a sample of ten 
papers considered by the scientific review to be high-quality studies 
that reported positive associations between exposure to 
PM2.5 and chronic leukemias, acute leukemias, and multiple 
myelomas. The team confirmed that, taken as a body of literature, the 
evidence suggested that environmental exposure to PM2.5 is 
positively associated with acute and chronic leukemias and multiple 
myelomas. In sum, groups of people that had measured, documented 
exposure to PM2.5 had a higher risk of developing leukemias 
and multiple myelomas than those who did not have a measured, 
documented exposure to PM2.5.\34\
---------------------------------------------------------------------------

    \34\ Id.
---------------------------------------------------------------------------

    The team did note certain limitations in the data, including that 
PM is diverse and depends on many factors. PM air pollution can include 
smoke, fumes, soot, and other products of combustion, as well as 
particles from natural sources, including dust and sand. Further, the 
team noted that, of the 42 papers deemed to provide high or moderate 
quality evidence, none were done on military Service members or in the 
environments in which Service members were deployed to the Southwest 
Asia theater of operations or Somalia on or after August 2, 1990, or in 
Afghanistan, Egypt, Jordan, Lebanon, Syria, Yemen, Djibouti, or 
Uzbekistan. The studies relied upon were conducted in other parts of 
the world, studied firefighters, those exposed to ambient air pollution 
or specific pollutants, and individuals exposed to the possibly unique 
PM exposures at the WTC. Nevertheless, the team found that the argument 
that exposure to PMs creates risk for acute and chronic leukemias and 
myelomas is biologically plausible and remains regardless of the 
differences in location or particulates.\35\
---------------------------------------------------------------------------

    \35\ Id.
---------------------------------------------------------------------------

    Despite these limitations, the team concluded that the evidence 
meets the ``sufficient'' category in 38 U.S.C. 1173(c)(2), where the 
evidence is sufficient to conclude a positive association existed. 38 
U.S.C. 1173(c)(2)(A). This is the strongest category of positive 
association under the PACT Act's presumptive decision-making process. 
38 U.S.C. 1173(c)(2)(A). Based on the positive association 
demonstrated, the formal evaluation team recommended--in its December 
6, 2024, formal evaluation report--that the Secretary initiate 
rulemaking to establish acute leukemias, chronic leukemias, and 
multiple myelomas as presumptive service-connected conditions for 
veterans who served in the Southwest Asia theater of Operations or 
Somalia on or after August 2, 1990, or in Afghanistan, Egypt, Jordan, 
Lebanon, Syria, Yemen, Djibouti, or Uzbekistan on or after September 
11, 2001.\36\
---------------------------------------------------------------------------

    \36\ Formal Evaluation Report, supra.
---------------------------------------------------------------------------

    Regarding the formal evaluation for other blood cancers, on 
December 5, 2024, the MEESC recommended that the formal evaluation team 
continue to research these conditions (Polycythemia Vera, MDS, 
Essential (Hemorrhagic) Thrombocythemia, Chronic Myeloproliferative 
Disease, Myelofibrosis, Histiocytosis, and Mastocytosis) and provide a 
formal evaluation report to the Secretary by March 20, 2025, i.e., 
within 120 days of the formal evaluation initiation, in accord with 38 
U.S.C. 1173(d).\37\ The MEESC noted that there were over 60,000 studies 
on polycythemia vera and millions of studies on myeloproliferative 
neoplasms \38\ and, with respect to mechanistic studies that may 
establish biological plausibility, more investigation was needed.\39\
---------------------------------------------------------------------------

    \37\ MEESC Memorandum, dated December 5, 2024, is attached to 
this rulemaking, available at www.regulations.gov.
    \38\ A myeloproliferative neoplasm is ``A type of disease in 
which the bone marrow makes too many red blood cells, platelets, or 
certain white blood cells.'' National Cancer Institute Dictionaries, 
myeloproliferative neoplasm, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/myeloproliferative-neoplasm.
    \39\ Id.
---------------------------------------------------------------------------

    To aid an evaluation of the MEESC's recommendation on these ``other 
blood cancers,'' the Office of the Secretary of Veterans Affairs 
requested additional information concerning the survivability of those 
seven diseases. On December 9, 2024, HOME provided the Secretary an 
information paper on the issue.\40\ In summary, two of the seven other 
blood cancers (MDS and myelofibrosis) may progress to acute myeloid 
leukemia (AML), and veterans whose disease so progresses often have a 
very poor prognosis.
---------------------------------------------------------------------------

    \40\ HOME Information Paper, dated December 9, 2024, is attached 
to this rulemaking, available at www.regulations.gov.
---------------------------------------------------------------------------

    The Secretary considered the formal evaluation report on acute 
leukemias, chronic leukemias, and multiple myelomas; the MEESC's 
recommendation to continue the formal evaluation on other blood 
cancers; and the additional information on survivability provided by 
HOME. On December 13, 2024, the Secretary directed VA to initiate 
rulemaking to establish acute leukemias, chronic leukemias, and 
multiple myelomas, and precursors MDS and myelofibrosis, as presumptive 
service-connected conditions related to exposure to PM2.5 in 
the Southwest Asia theater of operations or Somalia on or after August 
2, 1990, or in Afghanistan, Egypt, Jordan, Lebanon, Syria, Yemen, 
Djibouti, or Uzbekistan on or after September 11, 2001.\41\
---------------------------------------------------------------------------

    \41\ Secretary's Memorandum, signed December 13, 2024, is 
attached to this rulemaking, available at www.regulations.gov.
---------------------------------------------------------------------------

    Though much of the evidence supporting the Secretary's decision has 
already been chronicled above, we also provide additional information 
on each of the conditions below:
1. Leukemias
    As noted above, the formal evaluation team reviewed the report 
generated by the scientific assessment committee, evaluated the 
methods, findings, and conclusions, and validated the conclusions.\42\ 
Among the pertinent findings, the team cited the EPA's determination 
that there is suggestive evidence of a relationship between long-term 
exposure to PM2.5 and cancers.\43\
---------------------------------------------------------------------------

    \42\ Formal Evaluation Report, supra.
    \43\ Id; see also Environmental Protection Agency Integrated 
Science Assessment (ISA) for Particulate Matter (2019), https://www.epa.gov/isa/integrated-science-assessment-isa-particulate-matter 
(finding the relationship ``likely to be causal''); World Health 
Organization, International Agency for Research on Cancer, 
Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 
109, 2015. https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Outdoor-Air-Pollution-2015 (finding that PM was carcinogenic to 
humans and detailing the mechanistic process by which PM initiates 
mutations).
---------------------------------------------------------------------------

    Of the PM components detected in air samples taken at Joint Base 
Balad Iraq in 2007 and 2009, some volatile organic compounds with 
documented associations with leukemias and other hematopoietic cancers, 
such as benzene and 1,3-butadiene, were measured at levels that exceed 
safety thresholds.\44\ The team also highlighted several high-quality 
papers that reported positive associations between exposure to 
PM2.5 and chronic leukemias and acute leukemias, which 
supported the findings that PM2.5 exposure placed 
individuals at increased risk for leukemias.\45\
---------------------------------------------------------------------------

    \44\ Id.
    \45\ Id.
---------------------------------------------------------------------------

    The team concluded there is sufficient evidence supporting the 
conclusion that veterans deployed in the relevant areas

[[Page 1898]]

develop leukemia earlier in their lives than those who did not 
deploy.\46\ Among other findings, the studies cited show 
PM2.5 exposure plays a major role in the process of 
activating or maintaining gene expression, leading to the development 
of leukemia.\47\ Exposure to benzene, which may be absorbed by 
particulates as a result of burn pits, significantly increases the risk 
of developing leukemia.\48\ Additional associative environmental causes 
are soot \49\ and toxic metals,\50\ which are known airborne 
hazards.\51\ Further, excessive exposure to carcinogens due to 
inhalation of PM, such as fire, smoke, dust, and burning debris, leads 
to increased rates of leukemia.\52\ Moreover, pollutants at the World 
Trade Center (WTC) recovery site were similar to PM2.5, and 
the workers who engaged in onsite recovery efforts developed 
hematological cancers, including myeloma, leukemia, and lymphoma at a 
higher rate than those who did not.\53\ The studies cited also show 
that the higher the exposure to PM2.5 in the year prior to 
diagnosis, the more likely a leukemia diagnosis would occur.\54\
---------------------------------------------------------------------------

    \46\ Id.
    \47\ G. Visani et al., ``Environmental nanoparticles are 
significantly over-expressed in acute myeloid leukemia,'' Leukemia 
Research, Volume 50, 2016-11-01, https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0145212616301916?returnurl=https:%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0145212616301916%3Fshowall%3Dtrue&referrer=https:%2F%2Fpubmed.ncbi.nlm.nih.gov%.
    \48\ Demers PA, Heyer NJ, Rosenstock L. Mortality among 
firefighters from three northwestern United States cities. Br J Ind 
Med. 1992 Sep;49(9):664-70. doi: 10.1136/oem.49.9.664. PMID: 
1390274; PMCID: PMC1039313. https://pmc.ncbi.nlm.nih.gov/articles/PMC1039313 (hereinafter ``Demers Mortality among firefighters''); 
Andrea Micheli et.al, Risk of death for hematological malignancies 
for residents close to an Italian petrochemical refinery: a 
population-based case-control study, https://link.springer.com/article/10.1007/s10552-014-0468-1.
    \49\ Jenny N. Poynter et al., ``Chemical exposures and risk of 
acute myeloid leukemia and myelodysplastic syndromes in a 
population-based study,'' International Journal of Cancer, 140-1, 
2017, https://pmc.ncbi.nlm.nih.gov/articles/PMC5245124.
    \50\ Maro Ohanian et al., ``A heavy metal baseline score 
predicts outcome in acute myeloid leukemia,'' American Journal of 
Hematology, Volume 95, Issue 4, 2020, https://onlinelibrary.wiley.com/doi/10.1002/ajh.25731.
    \51\ Formal Evaluation Report, supra.
    \52\ Jiehui Li et al., ``Association between World Trade Center 
exposure and excess cancer risk,'' JAMA, Volume 308, 2012, https://jamanetwork.com/journals/jama/fullarticle/1486831 (hereinafter ``Li 
World Trade Center Exposure''); Demers Mortality among firefighters, 
supra.
    \53\ Samara Solan et al., ``Cancer incidence in World Trade 
Center Rescue and Recovery Workers, 2001-2008,'' Environmental 
Health Perspectives, Volume 121,6, 2013, https://pmc.ncbi.nlm.nih.gov/articles/PMC3672914.
    \54\ Robin C. Puett et al., ``Relationship of leukaemias with 
long-term ambient air pollution exposures in the adult Danish 
population,'' British Journal of Cancer, Volume 123, 12, 2020, 
https://pmc.ncbi.nlm.nih.gov/articles/PMC7722932/.
---------------------------------------------------------------------------

    PM2.5 exposure is of concern for those deployed to the 
Southwest Asia theater of operations and other known BPOT locations. VA 
has already examined studies by NASEM on the contribution of air 
pollution to adverse health effects among U.S. Service Members serving 
in the Middle East.\55\ 86 FR at 42725-42726. Thus, VA has determined 
that it will consider chronic and acute leukemias for this population 
to be associated with exposure to PM2.5. Accordingly, VA 
concludes it is appropriate to add chronic leukemias and acute 
leukemias to 38 CFR 3.320b.
---------------------------------------------------------------------------

    \55\ NASEM, Gulf War and Health Series: Volume 3: Fuels and 
Products of Combustion (2005), https://doi.org/10.17226/11180 and 
Volume 11: Generational Health Effects of Serving in the Gulf War 
(2018), https://doi.org/10.17226/25162; Respiratory Health Effects 
of Airborne Hazards, supra.
---------------------------------------------------------------------------

2. Multiple Myelomas
    Similar to leukemia, the scientific committee and formal evaluation 
team found strong scientific evidence linking exposure to 
PM2.5 to the development of multiple myelomas.\56\ The 
studies cited show that exposure to coal dust, coke dust, crude 
petroleum, iron, lubricants, and solvents found in PM2.5 was 
a probable carcinogen causing multiple myelomas.\57\ Another study 
noted higher than normal diagnoses of multiple myelomas occurred in WTC 
responders. These responders were exposed to a complex mix of 
pollutants, including benzene and polycyclic aromatic hydrocarbons, 
asbestos, paint and solvent vapors, aromatic hydrocarbons, 
polychlorinated biphenyls, pesticides, microscopic shards of glass, 
polychlorinated biphenyls, other organochlorines, dioxins, furans, 
engine exhaust, and metals, which previous studies had associated with 
higher rates of multiple myelomas.\58\ The dust carrying 
PM2.5 at the WTC recovery site was potent in inducing change 
in multiple myeloma cells, increasing risk for the disease.\59\ First 
responders were diagnosed with multiple myelomas at a higher rate than 
the general population.\60\ An excess number of cases of multiple 
myeloma were observed among first responders, in particular among those 
younger than 45 years of age.\61\ The environmental etiology at the WTC 
may be similar to exposure to pollutants, including 
PM2.5.\62\ Another study showed that both men and women who 
lived near a waste incineration plant had increased rates of multiple 
myelomas compared to those who did not.\63\
---------------------------------------------------------------------------

    \56\ Committee Report, supra; Formal Evaluation Report, supra.
    \57\ Sunita Ghosh et al., Multiple myeloma and occupational 
exposures: a population-based case-control study https://pubmed.ncbi.nlm.nih.gov/21654434/; B. Charbotel et al., 
``Occupational exposures in rare cancers: A critical review of the 
literature,'' Critical Reviews in Oncology and Hematology, Volume 
90, Issue 2, https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S104084281300259X (hereafter ``Occupational exposures in rare 
cancers'').
    \58\ Jacqueline Moline, et.al. Multiple Myeloma in World Trade 
Center Responders: A Case Series, https://journals.lww.com/joem/fulltext/2009/08000/multiple_myeloma_in_world_trade_center_responders_.7.aspx (hereafter 
``Moline, Multiple Myeloma'').
    \59\ Kai Wu, et al. Proteomic Characterization of the World 
Trade Center dust-activated mdig and c-myc signaling circuit linked 
to multiple myeloma, https://pmc.ncbi.nlm.nih.gov/articles/PMC5105131/(hereinafter ``Wu'').
    \60\ Id.
    \61\ Moline, Multiple Myeloma, supra.
    \62\ Wu, supra.
    \63\ Eugenia Marine Barjoan et al., ``Cancer incidence in the 
vicinity of a waste incineration plant in the Nice area between 2005 
and 2014,'' Environmental Research, Volume 188, 2020, 109681, 
https://www.sciencedirect.com/science/article/pii/S0013935120305740?via%3Dihub.
---------------------------------------------------------------------------

    For these reasons, VA concludes that the evidence is sufficient to 
warrant a presumption of multiple myelomas due to PM2.5 for 
the affected population. As stated above, VA recognizes the adverse 
health effects of PM2.5 exposure on U.S. Service Members 
serving in the Middle East. VA concludes it is appropriate to add 
multiple myelomas to 38 CFR 3.320b.
3. Myelodysplastic Syndromes (MDS) and Myelofibrosis
    MDS and myelofibrosis are rare blood cancers that can progress to 
AML, a condition which will be presumptive under this rule. In addition 
to the presumptions above, VA has examined MDS and myelofibrosis and 
concluded that these diseases warrant presumptive service connection 
because they can progress to AML, and veterans whose disease so 
progresses often have a very poor prognosis.\64\
---------------------------------------------------------------------------

    \64\ HOME Information Paper, supra; Secretary's December 13, 
2024 Memorandum, supra.
---------------------------------------------------------------------------

    Approximately 30% to 40% of individuals with MDS will eventually 
progress to AML \65\ and ``often have a very poor prognosis.'' \66\ The 
majority of

[[Page 1899]]

patients with both MDS and AML fail to respond to available therapies 
\67\ and often die from complications and/or disease progression.\68\ 
Even among those with MDS who do not progress to AML, the five-year 
survival rate is only 37%\69\, meaning that 2 of 3 individuals with MDS 
will not survive 5 years. Like MDS, patients diagnosed with 
myelofibrosis can progress to AML based on their risk.\70\ For low-risk 
patients, the five-year AML transformation rate is 6%, but it is 21% 
for high-risk patients (and 37% of patients diagnosed with 
myelofibrosis are high risk).\71\ Even for those individuals who do not 
progress to AML, the five-year mortality is nonetheless relatively high 
at 51%.\72\ Accordingly, VA has determined that expanding the 
presumptions to include these two conditions is necessary to ensure 
veterans diagnosed with MDS and myelofibrosis are given the benefit of 
a presumption before these diseases progress.
---------------------------------------------------------------------------

    \65\ Menssen AJ, Walter MJ. Genetics of progression from MDS to 
secondary leukemia. Blood. 2020 Jul; https://pubmed.ncbi.nlm.nih.gov/32430504/ (hereinafter ``Menssen''); Akriti 
Jain et al. Patterns of lower risk myelodysplastic syndrome 
progression: factors predicting progression to high-risk 
myelodysplastic syndrome and acute myeloid leukemia, https://pmc.ncbi.nlm.nih.gov/articles/PMC11215361/ (hereinafter ``Jain'').
    \66\ Jennifer L. Dotson et al. Myelodysplastic Syndrome, https://www.ncbi.nlm.nih.gov/books/NBK534126/ (hereafter ``Dotson'').
    \67\ Elias Jabbour et al. Acute Myeloid Leukemia Following 
Myelodysplastic Syndrome and Failure of Therapy with Hypomethylating 
Agents: An Emerging Entity With a Poor Prognosis, https://pmc.ncbi.nlm.nih.gov/articles/PMC4098769/ (``hereinafter 
``Jabbour'').
    \68\ Jain, supra.
    \69\ Mikkael Sekeres et al. Diagnosis and Treatment of 
Myelodysplastic Syndromes, https://jamanetwork.com/journals/jama/fullarticle/2795886 (hereafter ``Sekeres'').
    \70\ Barbara Mora et al. Prognostic and Predictive Models in 
Myelofibrosis, https://pubmed.ncbi.nlm.nih.gov/39179882/ (hereafter 
``Mora'').
    \71\ Ayalew Tefferi et al., One Thousand Patients With Primary 
Myelofibrosis: The Mayo Clinic Experience, https://pmc.ncbi.nlm.nih.gov/articles/PMC3538387/ (hereafter ``Tefferi'').
    \72\ Srdan Verstovsek et al. Changes in the incidence and 
overall survival of patients with myeloproliferative neoplasms 
between 2002 and 2016 in the United States, https://pubmed.ncbi.nlm.nih.gov/34689695/ (hereafter ``Verstovsek'').
---------------------------------------------------------------------------

    MDS are a group of rare cancers that occur when the blood-forming 
cells in the bone marrow become abnormal.\73\ The blood cells produced 
by the abnormal bone marrow cells are damaged and accumulate in the 
bone marrow engulfing the normal blood cells.\74\ As a result, 
individuals with MDS do not produce enough normal, healthy blood 
cells.\75\ Most cases arise after age 65.\76\ In the U.S. population, 
annually, 4.9 out of every 100,000 persons will develop MDS (i.e., 
20,451 annually).\77\ The five-year prevalence (FY18-FY23) among post-
9/11 veterans enrolled in VHA for health care is 10.78 out of 100,000. 
Given that data, it is estimated that approximately 102 to 136 post-9/
11 deployed veterans with MDS could eventually have their disease 
progress to AML.\78\
---------------------------------------------------------------------------

    \73\ Dotson, supra.
    \74\ Id.
    \75\ Id.
    \76\ Id.
    \77\ Id.
    \78\ HOME Information Paper, supra.
---------------------------------------------------------------------------

    MDS are categorized into subtypes of those individuals who have a 
lower or higher risk for progressing to AML.\79\ For those with lower 
risk for AML, median survival is three to 10 years, whereas patients 
with higher-risk disease have a median survival of less than three 
years.\80\
---------------------------------------------------------------------------

    \79\ Sekeres, supra.
    \80\ Id.
---------------------------------------------------------------------------

    Myelofibrosis is also a rare blood cancer that occurs when scar 
tissue forms in the bone marrow, disrupting the production of heathy 
blood cells.\81\ The prevalence for developing myelofibrosis is one to 
nine out of every 100,000 in the U.S.\82\ The five-year (FY18-FY23) 
prevalence rate of myelofibrosis among post 9-11 veterans enrolled in 
VA health care was 4.26/100,000.\83\ The overall life expectancy 
depends on the severity of the disease, with an overall median survival 
estimated at six years.\84\ The overall 10-year survival rate from one 
study showed that intermediate risk patients had a 30% survival rate 
and high risk patients had a 0% to 13% survival rate.\85\ Based on the 
five-year veteran prevalence data cited above, it is estimated that 
approximately 14 to 27 post-9/11 deployed veterans with myelofibrosis 
could eventually have their disease progress to AML.\86\
---------------------------------------------------------------------------

    \81\ National Cancer Institute, ``Myelofibrosis,'' https://www.cancer.gov/search/results?swKeyword=Myelofibrosis; Orpha.net, 
Knowledge on rare diseases and orphan drugs, ``Myelofibrosis,'' 
https://www.orpha.net/en/disease/detail/824?name=myelofibrosis&mode=name.
    \82\ Id.
    \83\ HOME Information Paper, supra.
    \84\ Domenico Penna et al., 20+ Years and alive with primary 
myelofibrosis: Phenotypic signature of very long-lived patients, 
https://onlinelibrary.wiley.com/doi/full/10.1002/
ajh.25351#xd_co_f=ZDY0YjJhMDEtN2RlYS00MWM0LWJkZDUtZjNlNTcyN2IxNmE4~ 
(hereafter ``Penna'').
    \85\ Tefferi, supra.
    \86\ HOME Information Paper, supra.
---------------------------------------------------------------------------

    As discussed above, PM2.5 exposure has been shown to be 
associated with the development of leukemias and multiple myelomas. 
Because a significant number of cases of MDS and myelofibrosis progress 
to leukemia, and because these diseases have a severe outcome and 
significant mortality rates on their own, VA has determined a 
presumption of service connection is warranted for MDS and 
myelofibrosis as precursors to AML.

IV. Addition of Leukemias, Multiple Myelomas, MDS, and Myelofibrosis to 
38 CFR 3.320b

    In the PACT Act, Congress authorized VA to enact additional 
presumptions based on a positive association with a substance, 
chemical, or airborne hazard. 38 U.S.C.1120(b)(15). Because the 
evidence shows a positive association between exposure to 
PM2.5 and acute leukemias, chronic leukemias, and multiple 
myelomas, VA concludes that these conditions and MDS and myelofibrosis, 
as precursors to AML, should be extended a presumption of service 
connection in new 38 CFR 3.320b. VA includes monoclonal gammopathy of 
undetermined significance (MGUS) \87\ as part of multiple myelomas 
because the VA Schedule of Rating Disabilities places MGUS as part of 
the same diagnostic code as multiple myeloma. 38 CFR 4.117, Diagnostic 
Code 7712.
---------------------------------------------------------------------------

    \87\ The PACT Act added MGUS as a condition presumptive to 
herbicide exposure. 38 U.S.C. 1116(a)(2)(L).
---------------------------------------------------------------------------

    VA will use the heading of ``[p]resumptive service connection for 
leukemias, multiple myelomas, myelodysplastic syndromes and 
myelofibrosis'' for 38 CFR 3.320b. VA will describe the presumption of 
exposure in paragraph (a), describe the presumptions of service 
connection in paragraph (b), and provide the standard exceptions for 
presumptions in paragraph (c).
    Although this rulemaking is based on current medical and scientific 
evidence related to the health effects of PM2.5 on veterans 
who served during the Gulf War, VA will continue to review new 
scientific evidence as it develops regarding all health effects 
resulting from exposure to BPOT, including PM2.5. This 
rulemaking does not limit the future establishment of additional 
presumptions of service connection.

V. Authority

    As discussed above, VA is enacting these presumptions pursuant to 
the 38 U.S.C. 1171 et seq. process or alternatively under 38 U.S.C. 
501(a)(1), which permits VA to issue necessary or appropriate 
regulations with respect to the nature and extent of proof and evidence 
to establish rights to benefits, such as presumptions of service 
connection.

VI. Severability

    The purpose of this section is to clarify the agency's intent with 
respect to the severability of provisions of this rule. Each provision 
the agency of this rule can operate independently. If any

[[Page 1900]]

provision of this rule is determined by judicial review or operation of 
law to be invalid, that partial invalidation will not render the 
remainder of this rule invalid. Likewise, if the application of any 
portion of this rule to a particular circumstance is determined to be 
invalid, the agency intends that the rule remain applicable to all 
other circumstances.
    Moreover, we clarify here that VA benefits standards are distinct 
from the applicable standards for civil litigation, such that this 
final rule should have no effect on civil actions, to include Camp 
Lejeune Justice Act litigation.

Administrative Procedure Act

    Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), VA has concluded that 
there is good cause to publish the IFR without prior opportunity for 
comment and to publish the rule with an immediate effective date. There 
is good cause to immediately address the needs of Service members and 
veterans who have been exposed to airborne hazards, i.e. 
PM2.5, due to their service in the Southwest Asia theater of 
operations, Afghanistan, Syria, Djibouti, Uzbekistan, Somalia, Egypt, 
Jordan, Lebanon, and Yemen.
    Given the nature of the diseases at issue, VA concludes that the 
ordinary notice-and-comment procedures here would be impracticable, in 
that they would cause veterans serious harm by delaying and in certain 
situations entirely denying veterans the benefits of these 
presumptions. In particular, good cause exists because this veteran 
population is aging and leukemias, multiple myelomas, MDS, and 
myelofibrosis are diseases of significant morbidity and mortality.\88\
---------------------------------------------------------------------------

    \88\ National Cancer Institute, Cancer Stat Facts: Leukemia, 
https://seer.cancer.gov/statfacts/html/leuks.html; National Cancer 
Institute, Cancer Stat Facts: Myeloma, https://seer.cancer.gov/statfacts/html/mulmy.html (hereafter ``NCI, supra''); Sekeres, 
supra; Tefferi, supra; Penna, supra.
---------------------------------------------------------------------------

    For the population who served from August 1990 to present, which 
are the veterans affected by this rulemaking, there are 551,000 
veterans aged 65 and older.\89\ Per the most recent data available from 
the U.S. Centers for Disease Control and Prevention, which was from 
2020 to 2021, the life expectancy for the overall United States 
population has dropped from 77 years to 76.1 years. The life expectancy 
of men dropped from 74.2 years to 73.2 years and women from 79.9 years 
to 79.1 years.\90\ According to a 2017 VA National Center for Veterans 
Analysis and Statistics report, life expectancy is 0.8 and 1.2 life 
years shorter for male and female veterans, respectively, than the 
general U.S. population.\91\
---------------------------------------------------------------------------

    \89\ Jonathan Vespa, ``Aging Veterans: America's Veteran 
Population in Later Life,'' American Community Survey Reports, July 
2023, https://www.census.gov/content/dam/Census/library/publications/2023/acs/acs-54.pdf.
    \90\ CDC National Center for Health Statistics, ``Life 
expectancy in the U.S. dropped for the second year in a row in 
2021,'' CDC National Center for Health Statistics, August 31, 2022, 
https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220831.htm.
    \91\ Department of Veterans Affairs, National Center for 
Veterans Analysis and Statistics, ``Mortality rates and life 
expectancy of Veterans from 1980 to 2014, and by education and 
income'' April 2017, https://www.va.gov/vetdata/docs/SpecialReports/Mortality_study_USVETS_2015_1980_2014.pdf.
---------------------------------------------------------------------------

    Leukemias account for 3.1% of all new cancer cases each year and 
account for 3.9% of all cancer deaths each year.\92\ The age adjusted 
rate of new cases of leukemias is about 14.1 per 100,000 per year, and 
the age-adjusted death rate is about 5.9 per 100,000 per year.\93\ The 
five-year overall survival rate is about 67%, such that one out of 
every three veterans with leukemia will not live five more years. The 
survival rate varies across different types of leukemias because some 
types of leukemia are more aggressive and fatal than others. The median 
age at diagnosis of leukemias is 67, and the median age at death is 76, 
with the highest proportion of deaths among those between the ages of 
75 and 84.\94\ As highlighted above, there are 551,000 Veterans who 
served after 1990 in this 65+ age range.
---------------------------------------------------------------------------

    \92\ NCI, supra.
    \93\ Id.
    \94\ Id.
---------------------------------------------------------------------------

    Myelomas are rarer than leukemias, with a lifetime risk of 
0.8%.\95\ The age-adjusted rate of new cases of myelomas is 7.2 per 
100,000 and the age-adjusted death rate is 3.0 per 100,000; myelomas 
account for 1.8% of all new cancer cases, and 2.0% of all cancer 
deaths.\96\ The five-year survival rate for those with myelomas is 
61.1%, such that more than one out of every three veterans with 
myelomas will not live five more years, though the rate varies by stage 
at diagnosis.\97\ The median age at diagnosis for myelomas is 69 and 
the median age at death is 76, with the highest proportion of deaths 
among those between 75 and 84.\98\
---------------------------------------------------------------------------

    \95\ Id.
    \96\ Id.
    \97\ Id.
    \98\ Id.
---------------------------------------------------------------------------

    MDS are uncommon and are typically diagnosed in individuals after 
age 65.\99\ Approximately 30% to 40% of MDS patients eventually 
progress to AML.\100\ Once the disease has progressed to AML, patients 
have a very poor prognosis.\101\ Those with higher-risk disease have a 
median survival of less than three years.\102\ For those with MDS who 
do not progress to leukemia, the overall five-year survival rate in the 
U.S. is approximately 37%.\103\
---------------------------------------------------------------------------

    \99\ American Cancer Society, Key Statistics for Myelodysplastic 
Syndromes (MDS), https://www.cancer.org/cancer/types/myelodysplastic-syndrome/about/key-statistics.html; Dotson, supra.
    \100\ Menssen supra; Dotson, supra,
    \101\ Sekeres, supra,
    \102\ Id.
    \103\ Id.
---------------------------------------------------------------------------

    The median age of diagnosis for myelofibrosis is 65.\104\ 
Approximately 37% of the patients will be high risk.\105\ The overall 
five-year mortality rate for myelofibrosis is 51%, and the overall life 
expectancy depends on the severity of the disease, with a median 
survival estimated at six years.\106\ The overall 10-year survival rate 
from one study was 30% for the intermediate risk population and 0% to 
13% for high risk population.\107\
---------------------------------------------------------------------------

    \104\ National Organization for Rare Diseases, ``Primary 
Myelofibrosis,'' https://rarediseases.org/rare-diseases/primary-myelofibrosis/.
    \105\ Id.
    \106\ Verstovesek, supra; Penna 20+ Years, supra.
    \107\ Primary myelofibrosis, supra.
---------------------------------------------------------------------------

    Those with myelofibrosis also may develop AML,\108\ with the same 
poor prognosis. For high-risk patients, the five-year transformation 
rate is 21 \109\
---------------------------------------------------------------------------

    \108\ Mora, supra.
    \109\ Primary myelofibrosis, supra.
---------------------------------------------------------------------------

    Given this population's life expectancy, it is not served by 
waiting for a notice and comment period before obtaining the benefits 
of this presumption. Indeed, delaying this rulemaking for notice and 
comment runs the real risk of harming the very population this 
rulemaking intends to help. The new presumptions are entirely pro-
claimant in nature. They do not adversely affect any person. And 
because VA has a sufficient scientific basis to support the new 
presumptions, withholding the presumptions during the notice and 
comment process could unnecessarily deprive veterans and beneficiaries 
of benefits to which they would otherwise be entitled and prolong their 
inability to timely receive benefits. Additionally, this could create 
risks to beneficiaries' welfare and health that would be exacerbated by 
any additional delay in implementation. Due to the complexity and the 
historical scientific uncertainty surrounding these issues of airborne 
hazard exposures and disease, many veterans who will be affected by 
this rule have long borne the burden and expense of their disabilities 
while awaiting the results of research and investigation. Under these 
circumstances, there is good cause to

[[Page 1901]]

prevent imposing further delay on their receipt of benefits, 
potentially at the risk of their welfare and health.
    Overall, the Secretary's decision to extend new presumptions to 
veterans who have been exposed to PM2.5 due to their service 
in the Southwest Asia theater of operations, and Somalia, Afghanistan, 
Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, and Uzbekistan requires 
immediate effect to help them access these benefits without undue 
delay. For veterans that are not otherwise eligible for health care, 
these presumptions could result in needed health care eligibility based 
on service connection.
    Section 553(d) of 5 U.S.C. also requires a 30-day delayed effective 
date following publication of a rule, except for ``(1) a substantive 
rule which grants or recognizes an exemption or relieves a restriction; 
(2) interpretative rules and statements of policy; or (3) as otherwise 
provided by the agency for good cause found and published with the 
rule.'' Pursuant to section 553(d)(3), the Secretary finds that there 
is good cause to make the rule effective upon publication, for the 
reasons discussed above. However, VA will consider and address comments 
that are received within 60 days of the date this IFR is published in 
the Federal Register.

Executive Orders 12866, 13563 and 14094

    Executive Order 12866 (Regulatory Planning and Review) directs 
agencies to assess the costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, and other advantages; 
distributive impacts; and equity). Executive Order 13563 (Improving 
Regulation and Regulatory Review) emphasizes the importance of 
quantifying both costs and benefits, reducing costs, harmonizing rules, 
and promoting flexibility. Executive Order 14094 (Executive Order on 
Modernizing Regulatory Review) supplements and reaffirms the 
principles, structures, and definitions governing contemporary 
regulatory review established in Executive Order 12866 of September 30, 
1993 (Regulatory Planning and Review), and Executive Order 13563 of 
January 18, 2011 (Improving Regulation and Regulatory Review). The 
Office of Information and Regulatory Affairs has determined that this 
rulemaking is a significant regulatory action under Executive Order 
12866, Section 3(f)(1) as amended by Executive Order 14094. The 
Regulatory Impact Analysis associated with this rulemaking can be found 
as a supporting document at www.regulations.gov.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This interim final rule will have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Paperwork Reduction Act (PRA)

    Although this interim final rule contains provisions constituting 
collection of information under the provisions of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3521), there are no provisions 
associated with this rulemaking constituting any new collection of 
information or any revisions to the existing collection of information. 
The collection of information for 38 CFR 3.320b is currently approved 
by the Office of Management and Budget (OMB) and has been assigned OMB 
control numbers 2900-0747, 2900-0886, and 2900-0004.

Congressional Review Act

    Pursuant to Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 
801 et seq.), the Office of Information and Regulatory Affairs 
designated this rule as satisfying the criteria under 5 U.S.C. 804(2).

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, 
Health care, Pensions, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved and signed 
this document on December 31, 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.

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

    For the reasons stated in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 3 as set forth below:

PART 3--Adjudication

Subpart A--Pension, Compensation, and Dependency and Indemnity 
Compensation

0
1. The authority citation for subpart A continues to read as follows:

    Authority: 38 U.S.C. 501(a), unless otherwise noted.

0
2. Add Sec.  3.320b to read as follows:

Sec.  3.320b  Presumptive service connection for leukemias, multiple 
myelomas, myelodysplastic syndromes, and myelofibrosis.

    (a) Presumption of exposure. A covered veteran as defined in Sec.  
3.320a(c) shall be presumed to have been exposed to certain toxic 
substances, chemicals, and airborne hazards, including fine particulate 
matter, during such service, unless there is affirmative evidence to 
establish that the veteran was not exposed to any such toxic 
substances, chemicals, and airborne hazards during that service.
    (b) Presumption of service connection. Except as provided in 
paragraph (c) of this section, the following diseases becoming manifest 
in a covered veteran, as defined in Sec.  3.320a(c), shall be 
considered to have been incurred in or aggravated during active 
military, naval, air, or space service, notwithstanding that there is 
no record of evidence of such disease during the period of such 
service:
    (1) Acute leukemias.
    (2) Chronic leukemias.
    (3) Multiple myelomas, including monoclonal gammopathy of 
undetermined significance (MGUS).
    (4) Myelodysplastic Syndromes (MDS).
    (5) Myelofibrosis.
    (c) Exceptions. A disease listed in paragraph (b) of this section 
shall not be presumed service connected if there is affirmative 
evidence that:
    (1) The disease was not incurred or aggravated during active 
military, naval, air, or space service; or
    (2) The disease was caused by a supervening condition or event that 
occurred between the veteran's most recent departure from active 
military, naval, air, or space service and the onset of the disease; or
    (3) The disease is the result of the veteran's own willful 
misconduct.

(Authority: 38 U.S.C. 501, 1119, 1171, 1172, 1173, 1174)

[FR Doc. 2024-31776 Filed 1-8-25; 8:45 am]
BILLING CODE 8320-01-P
```