[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]]
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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.
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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\
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\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.
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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\
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\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/.
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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\
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\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.
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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.
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\18\ NASEM 2011 Report, supra.
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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.
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\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.
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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.
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\20\ EPMSP Report, supra.
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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\
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\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.
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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\
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\22\ Id.
\23\ Id.
\24\ Id.
\25\ Id.
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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\
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\26\ Secretary's Memorandum, signed November 20, 2024, is
attached to this rulemaking, available at www.regulations.gov.
\27\ Id.
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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\
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\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.
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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\
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\33\ Id.
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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\
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\34\ Id.
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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\
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\35\ Id.
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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\
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\36\ Formal Evaluation Report, supra.
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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\
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\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.
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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.
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\40\ HOME Information Paper, dated December 9, 2024, is attached
to this rulemaking, available at www.regulations.gov.
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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\
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\41\ Secretary's Memorandum, signed December 13, 2024, is
attached to this rulemaking, available at www.regulations.gov.
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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\
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\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).
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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\
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\44\ Id.
\45\ Id.
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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.
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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