Rule2022-08820
Presumptive Service Connection for Rare Respiratory Cancers Due to Exposure to Fine Particulate Matter
Primary source
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Published
April 26, 2022
Effective
April 26, 2022
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) is issuing this interim final rule to amend its adjudication regulations to establish presumptive service connection for nine rare respiratory cancers in association with presumed exposure to fine particulate matter. These presumptions would apply to Veterans with a qualifying period of service, i.e., who served on active military, naval, or air service in the Southwest Asia theater of operations during the Persian Gulf War (hereinafter Gulf War), as well as in Afghanistan, Syria, Djibouti, or Uzbekistan, on or after September 19, 2001, during the Gulf War. This amendment is necessary to implement a decision by the Secretary of Veterans Affairs that determined there is sufficient evidence to support these cancers as presumptive based on exposure to fine particulate matter during service in the Southwest Asia theater of operations, Afghanistan, Syria, Djibouti, or Uzbekistan during certain periods and the subsequent development of the following rare respiratory cancers: Squamous cell carcinoma (SCC) of the larynx, SCC of the trachea, adenocarcinoma of the trachea, salivary gland-type tumors of the trachea, adenosquamous carcinoma of the lung, large cell carcinoma of the lung, salivary gland-type tumors of the lung, sarcomatoid carcinoma of the lung, and typical and atypical carcinoid of the lung. The intended effect of this amendment is to ease the evidentiary burden of this population of Veterans who file claims with VA for these nine rare respiratory cancers.
Full Text
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<title>Federal Register, Volume 87 Issue 80 (Tuesday, April 26, 2022)</title>
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[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Rules and Regulations]
[Pages 24421-24429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08820]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AR44
Presumptive Service Connection for Rare Respiratory Cancers 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 to amend its adjudication regulations to establish
presumptive
[[Page 24422]]
service connection for nine rare respiratory cancers in association
with presumed exposure to fine particulate matter. These presumptions
would apply to Veterans with a qualifying period of service, i.e., who
served on active military, naval, or air service in the Southwest Asia
theater of operations during the Persian Gulf War (hereinafter Gulf
War), as well as in Afghanistan, Syria, Djibouti, or Uzbekistan, on or
after September 19, 2001, during the Gulf War. This amendment is
necessary to implement a decision by the Secretary of Veterans Affairs
that determined there is sufficient evidence to support these cancers
as presumptive based on exposure to fine particulate matter during
service in the Southwest Asia theater of operations, Afghanistan,
Syria, Djibouti, or Uzbekistan during certain periods and the
subsequent development of the following rare respiratory cancers:
Squamous cell carcinoma (SCC) of the larynx, SCC of the trachea,
adenocarcinoma of the trachea, salivary gland-type tumors of the
trachea, adenosquamous carcinoma of the lung, large cell carcinoma of
the lung, salivary gland-type tumors of the lung, sarcomatoid carcinoma
of the lung, and typical and atypical carcinoid of the lung. The
intended effect of this amendment is to ease the evidentiary burden of
this population of Veterans who file claims with VA for these nine rare
respiratory cancers.
DATES:
Effective date: This interim final rule is effective April 26,
2022.
Comment date: Comments must be received on or before June 27, 2022.
Applicability date: The provisions of this interim final rule shall
apply to all applications for service connection for squamous cell
carcinoma (SCC) of the larynx, SCC of the trachea, adenocarcinoma of
the trachea, salivary gland-type tumors of the trachea, adenosquamous
carcinoma of the lung, large cell carcinoma of the lung, salivary
gland-type tumors of the lung, sarcomatoid carcinoma of the lung, and
typical and atypical carcinoid of the lung based on service in the
Southwest Asia theater of operations during the Gulf War, as well as
Afghanistan, Syria, Djibouti, or Uzbekistan, on or after September 19,
2001, during the Gulf War, that are received by VA on or after the
effective date of this interim final rule or that are pending before
VA, the United States Court of Appeals for Veterans Claims, or the
United States Court of Appeals for the Federal Circuit on the effective
date of this interim final rule.
ADDRESSES: Comments may be submitted through <a href="http://www.Regulations.gov">www.Regulations.gov</a>.
Comments received will be available at <a href="http://regulations.gov">regulations.gov</a> for public
viewing, inspection, or copies.
FOR FURTHER INFORMATION CONTACT: Jane Allen, Regulations Analyst;
Robert Parks, Chief, Regulations Staff (211), Compensation Service
(21C), 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700.
(This is not a toll-free telephone number.)
SUPPLEMENTARY INFORMATION:
I. Challenges With Rare Cancers
For the purposes of this rulemaking, VA defines rare cancers as
cancers with an annual U.S. incidence rate of fewer than 6 cases per
100,000 individuals. This standard was adopted by an American Cancer
Society paper \1\ that includes the nine rare respiratory cancers that
are being presumptively service connected. The standard has also been
adapted internationally; a consortium from the European Union,
Surveillance of Rare Cancer in Europe (RARECARE), described the burden
of rare cancers in Europe using a revised definition of rare cancers as
those with fewer than 6 cases per 100,000 people per year.\2\
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\1\ DeSantis CE, Kramer JL, Jemal A. The burden of rare cancers
in the United States. CA Cancer J Clin. 2017 Jul 8;67(4):261-272.
\2\ Gatta G, van der Zwan JM, Casali PG, et al. Rare cancers are
not so rare: The rare cancer burden in Europe. Eur J Cancer.
2011;47: 2493-2511.
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Due to low incidence rates, individuals diagnosed with rare cancers
face challenges not shared by those diagnosed with more common forms of
cancer. Diagnosis often occurs when the cancer has metastasized to
other areas of the body. Rare cancers are also more difficult to treat
based on limited preclinical research and fewer clinical trials.
Prevalence rates are so low that it is unlikely that any epidemiologic
or other study will elucidate a cause as may occur with more common
cancers. Furthermore, once diagnosed, individuals often struggle to
locate information about their cancer, and treatment options are often
less effective than for common cancers. As a result of these
challenges, five-year relative survival is lower for patients with a
rare cancer compared with those diagnosed with a more common cancer
among both males (55% vs 75%) and females (60% vs 74%).\3\
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\3\ Carol E. DeSantis MPH, Joan L. Kramer MD, Ahmedin Jemal DVM,
Ph.D. (2017) ``The Burden of Rare Cancers in America,'' CA: A Cancer
Journal for Clinicians, 67:4, 261-272, available at <a href="https://doi.org/10.3322/caac.21400">https://doi.org/10.3322/caac.21400</a>.
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II. Presumptive Service Connection Based on Presumed Exposure to Fine
Particulate Matter (PM2.5)
Particulate matter (PM) (also called particle pollution) is a form
of air pollution consisting of solid particles and liquid droplets. PM
is comprised of particles of various sizes, with fine particles
(PM<INF>2.5</INF>, particles that have a mean aerodynamic diameter
<=2.5 microns) posing the greatest health concern because they can be
inhaled, get deep into the lungs, and potentially enter the bloodstream
where they can affect the heart and other organ systems resulting in
serious health problems.\4\ VA published an interim final rule (86 FR
42724) on August 5, 2021, that established presumptive service
connection for asthma, sinusitis, and rhinitis due to presumed exposure
to PM<INF>2.5</INF> during the Gulf War (38 CFR 3.320). VA defines the
Gulf War as beginning on August 2, 1990 and there is currently no
prescribed end date for the Gulf War (38 CFR 3.2). The interim final
rule included a description of several studies by the National
Academies of Science, Engineering, and Medicine (NASEM) and National
Research Council (NRC) examining the possible contribution of air
pollution to adverse health effects among U.S. military personnel
serving in the Middle East or their descendants.\5\
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\4\ See US EPA, Particulate Matter (PM) Basics, <a href="https://www.epa.gov/pm-pollution/particulate-matter-pm-basics">https://www.epa.gov/pm-pollution/particulate-matter-pm-basics</a>.
\5\ NASEM, Gulf War and Health Series: Volume 3: Fuels and
Products of Combustion (2005), <a href="https://doi.org/10.17226/11180">https://doi.org/10.17226/11180</a> and
Volume 11: Generational Health Effects of Serving in the Gulf War
(2018), <a href="https://doi.org/10.17226/25162">https://doi.org/10.17226/25162</a>. National Research Council,
Review of the Department of Defense Enhanced Particulate Matter
Surveillance Program Report (2010), <a href="https://doi.org/10.17226/12911">https://doi.org/10.17226/12911</a>
(examining Department of Defense Enhanced Particulate Matter
Surveillance Program (EPMSP) Final Report (2008), <a href="https://apps.dtic.mil/sti/pdfs/ADA605600.pdf">https://apps.dtic.mil/sti/pdfs/ADA605600.pdf</a>.) NASEM, Long-Term Health
Consequences of Exposure to Burn Pits in Iraq and Afghanistan
(2011), <a href="https://doi.org/10.17226/13209">https://doi.org/10.17226/13209</a>. NASEM, Respiratory Health
Effects of Airborne Hazards Exposures in the Southwest Asia Theater
of Military Operations (2020), <a href="https://doi.org/10.17226/25837">https://doi.org/10.17226/25837</a>.
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Based on studies that described particulates in Southwest Asia,\6\
VA
[[Page 24423]]
determined that exposures to such particulate matter could present a
health risk to service members. In its prior rulemaking, VA
acknowledged the challenges associated with conducting exposure-
assessment/health surveillance studies in times of conflict and that
that precise or specific information on individual veterans' exposures
that would be needed to support more granular policy is generally not
available.
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\6\ E.g., Summary--Review of the Department of Defense Enhanced
Particulate Matter Surveillance Program Report--NCBI Bookshelf
(<a href="http://nih.gov">nih.gov</a>); Lindsay T. McDonald et. al, Physical and elemental
analysis of Middle East sands from recent combat zones, Am J Ind
Med. 2020;63:980-987. Inhalation Toxicology, 2020, VOL. 32, NO. 5,
189-199. <a href="https://doi.org/10.1080/08958378.2020.1766602">https://doi.org/10.1080/08958378.2020.1766602</a>; Johann P.
Engelbrecht et al., Characterizing Mineral Dusts and Other Aerosols
from the Middle East--Part 1: Ambient Sampling and Part 2: Grab
Samples and Re-Suspensions, Inhalation Toxicology, International
Forum for Respiratory Research 2009:4:297-326 and 327-336, <a href="https://www.tandfonline.com/doi/full/10.1080/08958370802464273">https://www.tandfonline.com/doi/full/10.1080/08958370802464273</a> and <a href="https://www.tandfonline.com/doi/full/10.1080/08958370802464299">https://www.tandfonline.com/doi/full/10.1080/08958370802464299</a>.
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Prior to establishment of 38 CFR 3.320, VA conducted a supplemental
literature review focused on PM<INF>2.5</INF>.\7\ The focus on
PM<INF>2.5</INF> was intentional for the following reasons: (1)
PM<INF>2.5</INF> is generated by a variety of sources including smoke
from open burn pits, (2) the DoD's Enhanced Particulate Matter
Surveillance Program objectively measured in-theater concentrations and
documented concentrations of PM<INF>2.5</INF> that may have exceeded
military and national exposure guidelines at deployment locations, and
(3) its small diameter facilitates greater deposition deep into the
lung with known harmful effects. As discussed further below, VA also
conducted a review of claims data in conjunction with the supplemental
review.
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\7\ See US EPA, Particulate Matter (PM) Basics, <a href="https://www.epa.gov/pm-pollution/particulate-matter-pm-basics">https://www.epa.gov/pm-pollution/particulate-matter-pm-basics</a>.
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a. 2010 NRC Report, Review of the Department of Defense (DoD) Enhanced
Particulate Matter Surveillance Program
In February 2008 the DoD issued the Department of Defense Enhanced
Particulate Matter Surveillance Program (EPMSP) Final Report.\8\ The
purpose of the study was to provide information on the chemical and
physical properties of dust collected at deployment locations. Aerosol
and bulk soil samples were collected during a period of approximately
one year at 15 military sites--including Djibouti, Afghanistan (Bagram,
Khowst), Qatar, United Arab Emirates, Iraq (Balad, Baghdad, Tallil,
Tikrit, Taji, Al Asad), and Kuwait (Northern, Central, Coastal, and
Southern regions). The EPMSP report found that exposures in the region
may have exceeded military/national exposure guidelines, including
EPA's 24-hr NAAQS for PM<INF>2.5</INF> (see p.4 and p. 8, Figure 4-1).
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\8\ Department of Defense Enhanced Particulate Matter
Surveillance Program (EPMSP) Final Report (2008), <a href="https://apps.dtic.mil/sti/pdfs/ADA605600.pdf">https://apps.dtic.mil/sti/pdfs/ADA605600.pdf</a>.
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The NRC independently reviewed DoD's final report in Review of the
Department of Defense Enhanced Particulate Matter Surveillance Program
Report in 2010.\9\ The NRC committee highlighted that the EPMSP was one
of the first large-scale efforts to characterize particulate matter
exposure in deployed military personnel. Despite the practical
challenges of conducting this effort in an austere deployment
environment, the NRC report found the results of the EMPSP can be
viewed as providing sufficient evidence that deployed military
personnel endured occupational exposure to a potential hazard to
justify implementation of a comprehensive medical-surveillance program
to assess particulate matter-related health effects in military
personnel deployed to the Southwest Asia theater of operations.
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\9\ National Research Council, Review of the Department of
Defense Enhanced Particulate Matter Surveillance Program Report
(2010), <a href="https://doi.org/10.17226/12911">https://doi.org/10.17226/12911</a>.
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The NRC committee noted the EPMSP's approach and methodological
techniques preclude comparison to existing literature on air sampling
and limit a full understanding of particulate matter chemical
composition. The study also describes the challenges associated with
conducting exposure-assessment/health surveillance studies, including
related to: The need to have co-deployed medical/public health experts
to conduct sampling; limitations in monitoring technologies in harsh
environments for which they have not been validated and where they may
overestimate concentrations due to bounce-off problems, limitations in
DoD's health effects studies, difficulties in characterization of
exposure of troops to multiple sources (dust storms, vehicle emissions,
and emissions from burn pits), and potential confounding factors (such
as smoking). This along with the infrequency of sampling as well as the
lack of consideration of other ambient pollutants in the deployment
environment make it challenging to fully ascertain the relationship
between exposure data and health effects.
Despite these limitations, the NRC committee found that the EPMSP
results clearly documented that service members deployed to the
Southwest Asia theater of operations ``are exposed to high
concentrations of particulate matter and that the particle composition
varies considerably over time and space.'' Further, the NRC Report
committee concluded that ``it is indeed plausible that exposure to
ambient pollution in the Middle East theater is associated with adverse
health outcomes.'' The health outcomes noted may occur both during
service (acute) as well as manifest years after exposure (chronic).
b. 2011 NASEM Report, Long-Term Consequences of Exposure to Burn Pits
in Iraq and Afghanistan
To further address and investigate service member exposures, VA
requested that NASEM examine the long-term health consequences of
service members' exposure to open burn pits while serving in Iraq and
Afghanistan. In NASEM's report, Long-Term Consequences of Exposure to
Burn Pits in Iraq and Afghanistan, published in 2011, NASEM concluded
that particulate matter from regional sources was of potential
importance.\10\ The report also recommended that VA expand its research
studies beyond burn pits to explore the role of a broader range of
possible airborne hazards.
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\10\ NASEM, Long-Term Health Consequences of Exposure to Burn
Pits in Iraq and Afghanistan (2011), <a href="https://doi.org/10.17226/13209">https://doi.org/10.17226/13209</a>.
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c. 2020 NASEM Report: Respiratory Health Effects of Airborne Hazards
Exposures in the Southwest Asia Theater of Military Operations
In September 2018, the VA Post Deployment Health Services (PDHS),
now called Health Outcomes Military Exposures (HOME), asked NASEM to
study the respiratory health effects of airborne hazards exposures in
Southwest Asia. On September 11, 2020, NASEM published its findings and
recommendations in the report, Respiratory Health Effects of Airborne
Hazards Exposures in the Southwest Asia Theater of Military
Operations.\11\ According to the report, ``[b]ased on the epidemiologic
studies of military personnel and veterans reviewed in this and
previous National Academies reports, the committee concludes that there
is inadequate or insufficient evidence of an association between
airborne hazards exposures in the Southwest Asia theater and the
subsequent development of respiratory cancers. While data exist on
1990-1991 Gulf War veterans, the committee notes that no studies have
been published concerning those who participated in the post-9/11
conflicts and that--even if such studies were available--the amount of
time since exposure may only now be long enough to justify new
incidence studies of respiratory cancers in this cohort.''
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\11\ NASEM, Respiratory Health Effects of Airborne Hazards
Exposures in the Southwest Asia Theater of Military Operations
(2020), <a href="https://doi.org/10.17226/25837">https://doi.org/10.17226/25837</a>.
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More generally, the 2020 NASEM report identified that existing
studies were limited in the available data for
[[Page 24424]]
exposure estimation; the availability of pertinent health, physiologic,
behavioral, and biomarker data, especially data collected both pre- and
post-deployment; the amount of time that passed since exposure; and use
of additional or alternate sources of data that might enrich analyses.
The NASEM committee, noting that the limitations in data quality
prevented scientific determinations regarding health outcomes,
recommended that a new approach was needed to allow researchers to
better examine and respond to whether specific respiratory outcomes are
associated with deployment.
III. VA's Identification of Nine Rare Respiratory Cancers Through a
Review of Data From NIH/Office of Rare Disease Research
Following publication of the interim final rule (86 FR 42724)
mentioned above, VA began a focused review of the scientific and
medical evidence related to exposure to PM<INF>2.5</INF> and the
subsequent development of rare respiratory cancers. VA initiated this
review to address the needs of veterans diagnosed with rare cancers.
VA's HOME office obtained publicly available data on rare cancers
from the Office of Rare Disease Research, National Center for Advancing
Translational Sciences (NCATS), in the National Institute of Health
(NIH). The data was then cross-referenced with data from the 2017
publication, The Burden of Rare Cancers in America. This 2017 study
analyzed rare cancers in the United States using invasive cancers found
on the RARECARE list. The RARECARE list is a rare cancer surveillance
list based in Europe that is often used by US researchers.\12\ The HOME
office found 181 rare cancers with less than 6/100,000 incidence and 13
very rare cancers with less than 25 cases in 5 years. The incidence
data came from the North American Association of Central Cancer
Registries and the Surveillance, Epidemiology, and End Results (SEER)
program, both resources from the National Cancer Institute within NIH.
A secondary source were data from the Office of Rare Disease Research,
NCATS; NIH. These data listed 275 rare diseases and includes mainly
cancers with available genetic data. This information matches closely
with a public list of rare diseases on the NIH's The Genetic and Rare
Diseases Information Center (GARD) website.\13\ Rare cancers present in
pediatric populations, or that are developmental, genetic, syndromic,
or congenital were excluded. This reduced the list to 153 rare cancers
after duplicates were removed.
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\12\ RARECARENet, <a href="http://rarecarenet.istitutotumori.mi.it/rarecarenet/">http://rarecarenet.istitutotumori.mi.it/rarecarenet/</a>.
\13\ GARD, Genetic and Rare Disease Information Center, <a href="https://rarediseases.info.nih.gov/">https://rarediseases.info.nih.gov/</a>.
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VA noted then that there were nine rare cancers of the respiratory
tract: Squamous cell carcinoma (SCC) of the larynx, SCC of the trachea,
adenocarcinoma of the trachea, salivary gland-type tumors of the
trachea, adenosquamous carcinoma of the lung, large cell carcinoma of
the lung, salivary gland-type tumors of the lung, sarcomatoid carcinoma
of the lung, and typical and atypical carcinoid of the lung. These nine
respiratory cancers are exceptionally rare and therefore definitive
literature demonstrating an etiology, or lack thereof, is not available
and it is not anticipated that it will become available. The HOME
office then performed a supplemental literature review of the nine
identified rare cancers. Scientific literature on these cancers is
extremely limited. The HOME office located and reviewed at least one
peer-reviewed source on each rare respiratory cancer (available for
download under the ``Supporting/Related Materials'' section). This
literature search demonstrated the paucity of other supporting
epidemiological or etiologic information from which to derive
conclusions on the associations between exposures and the development
of these rare respiratory cancers. This does not indicate that there is
no connection, it indicates there is not data or published literature
to definitively establish a connection.
IV. The Environmental Protection Agency's (EPA) 2019 Integrated Science
Assessment (ISA) for Particulate Matter
The EPA is responsible for establishing and periodically reviewing
National Air Ambient Quality Standards (NAAQS) for six principal
criteria pollutants, which include particulate matter, carbon monoxide,
nitrogen dioxide, lead, ozone, and sulfur dioxide to protect public
health and welfare. To support this mission, the EPA develops
Integrated Science Assessments (ISAs) as part of the periodic review of
the NAAQS for each criteria pollutant. The ISAs provide comprehensive
reviews of the policy-relevant scientific literature related to the
health and welfare effects of a criteria pollutant and form the
scientific foundation for each NAAQS review.
The EPA's 2019 ISA for Particulate Matter (2019 p.m. ISA) provides
a thorough evaluation of the scientific evidence pertaining to the
relationship between PM exposure, including exposure to
PM<INF>2.5,</INF> and multiple health outcomes, including cancer.
Within the discussion of long-term PM<INF>2.5</INF> exposure and
cancer, the 2019 p.m. ISA evaluates and characterizes the scientific
evidence that supports a biologically plausible mechanism by which
long-term PM<INF>2.5</INF> exposure could lead to the development of
cancer, such as lung cancer. As noted in Section 10.2 of the 2019 p.m.
ISA: ``PM<INF>2.5</INF> exhibits several key characteristics of
carcinogens (Smith et al., 2016), as shown in toxicological studies
demonstrating genotoxic effects, oxidative stress, electrophilicity,
and epigenetic alterations, with supportive evidence provided by
epidemiologic studies. Furthermore, PM<INF>2.5</INF> has been shown to
act as a tumor promoter in a rodent model of urethane-initiated
carcinogenesis.'' \14\ The body of scientific evidence indicating that
PM<INF>2.5</INF> exhibits multiple characteristics of a carcinogen
provides biological plausibility for the generally consistent, positive
associations between long-term PM<INF>2.5</INF> exposure and lung
cancer mortality and incidence reported in epidemiologic studies,\15\
resulting in the 2019 p.m. ISA concluding that there is a ``likely to
be causal'' relationship between long-term PM<INF>2.5</INF> exposure
and cancer.
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\14\ U.S. EPA. Integrated Science Assessment (ISA) for
Particulate Matter (Final Report, Dec 2019). U.S. Environmental
Protection Agency, Washington, DC, EPA/600/R-19/188, 2019, available
at <a href="http://www.epa.gov/isa">http://www.epa.gov/isa</a>.
\15\ Id. at Figure 10-3 and 10-60.
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V. Biological Plausibility of Rare Respiratory Cancers
Drawing on conclusions from EPA's 2019 p.m. ISA for cancer and
their evaluation of the evidence for lung cancer incidence and
mortality, VA has determined that it is biologically plausible that the
mechanisms by which PM<INF>2.5</INF> may lead to the development of
lung cancer can be applied to the development of rare cancers in the
lung and can also be applied to development of rare cancers of the
respiratory tract. Scientific evidence provides a biologically
plausible link by which exposure to PM<INF>2.5</INF>, which often
includes some known human carcinogens (e.g., hexavalent chromium,
nickel, arsenic, and PAHs), can lead to respiratory tract inflammation
as well as genotoxicity (i.e., DNA damage) and epigenetic effects that
can result in dysregulated cell growth and ultimately cancer.\16\
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\16\ Id.
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VA acknowledges that the epidemiological studies evaluated in the
[[Page 24425]]
2019 p.m. ISA that report generally consistent and positive
associations between long-term PM<INF>2.5</INF> exposures and lung
cancer mortality and incidence are not appropriate to extend to the
rare cancers under consideration here. As discussed further below,
epidemiological data for rare cancers is extremely limited.
Additionally, VA's HOME office and Compensation Service analyzed
rare respiratory cancer related claims data for Veterans who were
deployed to the Southwest Asia theater of operations, as well as
Afghanistan, Syria, Djibouti, and Uzbekistan. VA's HOME office and
Compensation Service also compared the VBA claims data to data for a
similar cohort of Veterans who served during the same period but who
had never deployed. Comparison of cohorts showed no meaningful
difference between the number of claims received and also no meaningful
difference between grant and denial rates. As of September 30, 2021,
the VA had received a total of 151 claims for the nine rare respiratory
cancers identified by the HOME office from Veterans with Gulf War
service.
Although claims data did not demonstrate a significant difference
between cohorts, which could be informative with respect to considering
a presumption of service connection, VA notes the potential for
biological plausibility between airborne hazards, specifically
PM<INF>2.5</INF>, and carcinogenesis of the respiratory tract. VA
utilized the Bradford Hill criteria to conclude that there were
possible relationships with these nine rare cancers and exposure to
PM<INF>2.5</INF>. The Bradford Hill criteria are used widely in public
health research to establish epidemiologic evidence of a causal
relationship between a presumed cause and an observed effect.\17\ While
there are limited claims data available to suggest otherwise, the nine
rare respiratory system cancers were identified as meeting the minimum
standard for the Bradford Hill principle of biological plausibility.
The remaining Bradford Hill criteria were applied and the nine rare
respiratory cancers additionally met the criteria of analogy. VA is
employing the analogy of the demonstrable effects of PM<INF>2.5</INF>
on the development of lung cancers to these nine respiratory cancers.
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\17\ Kristen M. Fedak, Autumn Bernal, Zachary A. Capshaw,
Sherilyn Gross, ``Applying the Bradford Hill criteria in the 21st
century: How data integration has changed causal inference in
molecular epidemiology,'' Emerging Themes in Epidemiology, 12, 14
(2015): doi:10.1186/s12982-015-0037-4.
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To inform application of these criteria for the nine rare
respiratory cancers, VA references analogy between the link between
PM<INF>2.5</INF> and lung cancer. In 2013, the International Agency for
Research on Cancer (IARC) classified outdoor air pollution and one of
its major components, PM, as carcinogenic. In its evaluation, the IARC
identified sufficient evidence showing that exposure to outdoor air
pollution and PM causes lung cancer.\18\ EPA's 2019 PM ISA also
supports the link between particulate matter and lung cancer \19\ The
VA experts maintain that the Veterans deployed to the Southwest Asia
theater of operations, Afghanistan, Syria, Djibouti, and Uzbekistan can
reasonably infer exposure to PM<INF>2.5</INF> can be an etiology for
respiratory cancers.
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\18\ International Agency for Research on Cancer. IARC
monographs on the evaluation of carcinogenic risks to humans, volume
109. Outdoor Air Pollution. Lyon, France: IARC; 2013 Available from:
<a href="https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Outdoor-Air-Pollution-2015">https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Outdoor-Air-Pollution-2015</a>.
\19\ U.S. EPA. Integrated Science Assessment (ISA) for
Particulate Matter (Final Report, Dec 2019). U.S. Environmental
Protection Agency, Washington, DC, EPA/600/R-19/188, 2019, available
at <a href="http://www.epa.gov/isa">http://www.epa.gov/isa</a>.
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Although VA's HOME office reviewed a number of resources related to
rare respiratory cancers (available for download under the
``Supporting/Related Materials'' section), the literature supporting a
link between PM<INF>2.5</INF> and malignant transformation of cells in
other organ systems is as limited as the link to these nine rare
respiratory cancers. Thus, based on the scientific evidence providing
biological plausibility for lung cancer, VA concluded that it is only
biologically plausible that PM<INF>2.5</INF> exposure could lead to the
nine rare respiratory cancers. However, VA is continuing its scientific
review of other malignancies, both rare and more common. VA remains
committed to cancer surveillance, research and review of peer reviewed
science, and plans to review the more robust body of research that
exists for more common types of cancers to evaluate the relationship
between these cancers and military environmental exposures.
VI. Gulf War Service
In its recent rulemaking, VA established a presumption of exposure
to PM<INF>2.5</INF> for Veterans deployed in the Southwest Asia theater
of operations, as defined in 38 CFR 3.317(e)(2), including Iraq,
Kuwait, Saudi Arabia, the neutral zone between Iraq and Saudi Arabia,
Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the
Gulf of Oman, the Persian Gulf, the Arabian Sea, and the Red Sea during
the Gulf War.\20\ VA acknowledges that there are important differences
between potential exposures experienced by deployed service members and
the populations in the studies relied upon by the 2019 PM ISA, and that
there are limitations in evidence specific to deployed service members,
as discussed above, as well as in the body of evidence surrounding rare
respiratory cancers. In the context of regulating potential service
connection related to presumed exposure and benefits there is a strong
role for policy decisions.\21\ The Secretary's broad discretion weighs
more strongly here than it would if the science related to the
composition and duration of actual particulate matter and airborne
hazard exposures of service members were more robust. As discussed
further below, an important consideration in establishing these new
presumptions for nine rare respiratory cancers is that additional
investment in studying these rare cancers is unlikely to fully resolve
scientific uncertainty related to service connection due to the small
size of the impacted population.
---------------------------------------------------------------------------
\20\ See VA, Presumptive Service Connection for Respiratory
Conditions Due to Exposure to Particulate Matter, 86 FR 42724.
\21\ See, e.g., VA, Diseases Associated With Exposure to Certain
Herbicide Agents (Hairy Cell Leukemia and Other Chronic B-Cell
Leukemias, Parkinson's Disease and Ischemic Heart Disease), 75 FR
53202 (where there was only limited/suggestive evidence of an
association between Ischemic Heart Disease and service and the
Secretary exercised his discretionary authority to grant a
presumption of service connection).
---------------------------------------------------------------------------
Based on presumed PM<INF>2.5</INF> exposures and its findings
above, VA is establishing a presumption of service connection for the
nine rare respiratory cancers, for the service periods and
manifestation timelines that follow.
VII. Service in Afghanistan, Syria, and Djibouti on or After September
19, 2001
The presumption of exposure to PM<INF>2.5</INF> also applies to
Afghanistan, Syria, and Djibouti for those deployed there on or after
September 19, 2001, the earliest date when service members were
deployed in these locations.\22\ As discussed in the preamble to the
interim final rule that established section 3.320, the literature and
studies overwhelmingly show the prevalence of PM<INF>2.5</INF> due to
the nature of the arid climate in these locations as well.\23\ VA
[[Page 24426]]
determined that the Southwest Asia theater of operations, Afghanistan,
Syria, and Djibouti had similar arid or semi-arid climates with periods
of high winds to suspend geologic dusts and regional pollutants,
adhered to or a part of these dusts, though the composition of
PM<INF>2.5</INF> varies in different regions. Therefore, VA included
Afghanistan, Syria, and Djibouti as qualifying locations for
presumption of service connection based on presumed exposure to
PM<INF>2.5</INF>.
---------------------------------------------------------------------------
\22\ See id.
\23\ See Lindsay T. McDonald, Steven J. Christopher, Steve L.
Morton & Amanda C. LaRue (2020) ``Physical and elemental analysis of
Middle East sands from recent combat zones,'' Inhalational
Toxicology, 32:5, 189-199, available at <a href="https://doi.org/10.1080/08958378.2020.1766602">https://doi.org/10.1080/08958378.2020.1766602</a>. See UNEP, WMO, UNCCD (2016) ``Global
Assessment of Sand and Dust Storms,'' United Nations Environment
Programme, Nairobi, 1-15, 21-24, available at <a href="https://uneplive.unep.org/redesign/media/docs/assessments/global_assessment_of_sand_and_dust_storms.pdf">https://uneplive.unep.org/redesign/media/docs/assessments/global_assessment_of_sand_and_dust_storms.pdf</a>.
---------------------------------------------------------------------------
As the literature and studies overwhelmingly demonstrate the
prevalence of PM<INF>2.5</INF> in these locations, VA included
Afghanistan, Syria, and Djibouti in addition to the Southwest Asia
theater of operations, as qualifying locations for the presumption of
exposure to PM<INF>2.5</INF> for purposes of service connection for the
nine rare respiratory cancers.
VIII. Service in Uzbekistan on or After September 19, 2001
As discussed in the preamble to the interim final rule that
established section 3.320, in March 2020, the Army Public Health Center
issued, Environmental Conditions at Karshi Khanabad (K-2) Air Base,
Uzbekistan, to provide information to service members and Veterans on
environmental exposures at the K-2 Air Base and the risk of potential
long-term adverse health effects related to such deployment.\24\ It
noted that service members, mostly Army, Air Force, and some Marines,
were stationed at the air base Camp Stronghold Freedom from October
2001 to November 2005. This fact sheet referenced the results of three
declassified assessments conducted by the DoD, namely the Environmental
Site Characterization and an Operational Health Risk Assessment
completed in 2001 and follow-up Post-Deployment Occupational and
Environmental Health Site Assessments completed in 2002 and 2004. The
collective findings of these assessments found the K-2 Air Base often
had high levels of dust and other particulate matter in the air,
depending upon the season and weather conditions, but also noted
significantly high levels of dust during dust storms. The fact sheet
concluded that there was inconclusive evidence that there is an
increased risk of chronic respiratory conditions associated with
military deployment to K-2 Air Base. It was noted that DoD was
collaborating with VA and independent researchers to further evaluate
the potential long-term health risks related to deployment exposures.
---------------------------------------------------------------------------
\24\ Army Public Health Center, Environmental Conditions at
Karshi Khanabad (K-2) Air Base, Uzbekistan, Fact Sheet 64-038-0617,
<a href="https://phc.amedd.army.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf">https://phc.amedd.army.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf</a>.
(accessed July 30, 2021).
---------------------------------------------------------------------------
Based on these findings regarding particulate matter exposure at
the K-2 Air Base, VA established a presumption of exposure to
PM<INF>2.5</INF> for those service members who were deployed to
Uzbekistan on or after September 19, 2001. VA acknowledged that this
presumption covers a greater geographic area and time frame than the
other studies annotated in this document. However, VA believes this is
a Veteran-centric approach that enhances its operational efficiencies
by simplifying the decision making necessary for claims adjudication.
IX. Manifestation Period
When VA established presumptions of service connection for asthma,
rhinitis, and sinusitis, to include rhinosinusitis, it imposed a
requirement that for such diseases to be presumptively service
connected, they must have become manifest to any degree, including non-
compensable, within 10 years from the date of separation from military
service that includes a qualifying period of service. As explained in
the preamble to that rule, that requirement was based on a review of
the available scientific and medical evidence, including human and
epidemiological studies that showed the manifestation of those
conditions did not exceed 10 years.
However, VA is not imposing a manifestation period requirement with
respect to the nine rare respiratory cancers. Unlike asthma, rhinitis,
and sinusitis, cancers may have varying latency periods and also have
longer latency periods, even up to decades. Given the uncertain and
potential long latency period between exposure and malignant
transformation of these rare cancers, there is no time limit between
the Veteran's service and the development of disease for the purpose of
this presumption. Thus, VA will presume that the nine rare respiratory
cancers are service connected if manifested to any degree (including
non-compensable) at any time following separation from a qualifying
period of military service.
X. Statutory Provisions
The Persian Gulf War Veterans Act of 1998, Public Law 105-277,
(codified at 38 U.S.C. 1118), and the Veterans Programs Enhancement Act
of 1998, Public Law 105-368, directed the Secretary of Veterans Affairs
to enter into an agreement with NASEM to review and evaluate available
scientific evidence regarding associations between illnesses and
agents, hazards, or medicine or vaccine to which service members may
have been exposed during the Gulf War. NASEM provided biennial reports
to VA assessing whether a statistical association exists between
exposure to an agent, hazard, or medicine or vaccine and the onset of
diseases. Based on the NASEM reports and all other sound medical and
scientific information and analysis available, VA would then determine
whether a positive association exists between certain exposures and the
occurrence of any disease. 38 U.S.C. 1118 defines ``positive
association'' to mean that the credible evidence for an association is
equal to or outweighs the credible evidence against an association. If
a positive association existed, VA would publish regulations
establishing presumptive service connection for that illness.
The statutory provision at 38 U.S.C. 1118 that outlined the
procedure for establishing presumptions based on Gulf War service
expired on October 1, 2018. However, 38 U.S.C. 501(a)(1) provides that
``[t]he Secretary has authority to prescribe all rules and regulations
which are necessary or appropriate to carry out the laws administered
by [VA] and are consistent with those laws, including . . . regulations
with respect to the nature and extent of proof and evidence and the
method of taking and furnishing them in order to establish the right to
benefits under such laws.'' The Secretary may create presumptions for
conditions based on exposure to particulate matter under Congress'
broad delegation of general regulatory authority in 38 U.S.C.
501(a)(1), provided there is a rational basis for the presumptions.
NOVA v. Sec'y of Veterans Affairs, 669 F.3d 1340, 1348 (Fed. Cir. 2012)
(``A regulation is not arbitrary or capricious if there is a `rational
connection between the facts found and the choice made.' '' (quoting
Motor Vehicle Mfrs. Ass'n. of the U.S. v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 43 (1983)).''
XI. Effective Dates
This rule applies to claims received by VA on or after the
effective date of the rule and to claims pending before VA, the United
States Court of Appeals for Veterans Claims, and the United States
Court of Appeals for the Federal Circuit on that date. This rule will
not apply retroactively to claims previously adjudicated. This will
ensure that VA
[[Page 24427]]
adheres to the provisions of its change of law regulation, 38 CFR
3.114, provides that when pension, compensation, dependency and
indemnity compensation is awarded or increased pursuant to a
liberalizing law, or a liberalizing VA issue approved by the Secretary
or by the Secretary's direction, the effective date of such award or
increase will be fixed in accordance with the facts found, and will not
be earlier than the effective date of the act or administrative issue.
See also 38 U.S.C. 5110(g).
Additionally, VA will maintain its consistent historical practice
of making new presumptions effective on a prospective basis, both to
avoid tension with the legal principles discussed above and for the
sake of fairness to other veteran cohorts.
XII. Regulatory Amendment
The Secretary of Veterans Affairs has determined that the available
scientific and medical evidence is sufficient to warrant a presumption
of service connection for nine rare respiratory cancers due to presumed
exposure to PM<INF>2.5</INF> during the Gulf War. Based on presumed
exposure to PM<INF>2.5</INF>, VA is recognizing a presumption of
service connection for squamous cell carcinoma (SCC) of the larynx, SCC
of the trachea, adenocarcinoma of the trachea, salivary gland-type
tumors of the trachea, adenosquamous carcinoma of the lung, large cell
carcinoma of the lung, salivary gland-type tumors of the lung,
sarcomatoid carcinoma of the lung, and typical and atypical carcinoid
of the lung.
The principles guiding the Secretary's determination include the
rarity of the conditions, catastrophic nature of the diseases,
biological plausibility, analogy to lung cancer, and the reality that
these conditions present a situation where it may not be possible to
develop additional evidence one way or another. With respect to the
nine rare cancers, the Secretary's determination is supported by the
biological plausibility between airborne hazards, specifically
PM<INF>2.5</INF>, and carcinogenesis of the respiratory tract. This
determination also took into consideration the debilitating nature of
these rare cancers, and the unique challenges faced by Veterans with a
rare respiratory cancer diagnosis.
Additionally, the Secretary found that further research is unlikely
to provide more conclusive evidence due to disease rarity. Due to the
extremely low incidence rates, rare cancers defy both epidemiologic
study and the study of pathophysiologic and potential environmental
mechanisms. Published exposure studies are typically case reports.
Faced with the challenges posed by conditions that are rare,
devastating, and for which there is an argument for biological
plausibility, but due to that same rarity may defy the timely
development of clearer evidence, the Secretary of Veterans Affairs has
opted to resolve the issue in favor of making sure VA does all it can
for vulnerable veterans.
Therefore, under the general rulemaking authority at 38 U.S.C.
501(a), the Secretary of Veterans Affairs is establishing presumptive
service connection for Veterans who were deployed to the Southwest Asia
theater of operations as well as Afghanistan, Syria, Djibouti, or
Uzbekistan during certain periods and who subsequently develop any of
the following rare respiratory cancers at any time after discharge from
military service: Squamous cell carcinoma (SCC) of the larynx, SCC of
trachea, adenocarcinoma of the trachea, salivary gland-type tumors of
the trachea, adenosquamous carcinoma of the lung, large cell carcinoma
of the lung, salivary gland-type tumors of the lung, sarcomatoid
carcinoma of the lung, and typical and atypical carcinoid of the lung.
To accomplish these changes, VA is renumbering existing paragraphs
(a)(3) and (a)(4) as (a)(4) and (a)(5) respectively. VA is inserting a
new paragraph (a)(3), which addresses the rare cancers associated with
exposure to fine particulate matter as explained in the preamble. New
paragraph (a)(3) states that the listed rare cancers will be service
connected if manifested to any degree (including non-compensable) at
any time following separation from a qualifying period of military
service and lists the nine noted rare cancers. Additionally, because
the rare cancers are not subject to a manifestation period, but the
chronic diseases listed in paragraph (a)(2) are still subject to the
10-year manifestation period as described in current paragraph (a)(1),
VA is moving that 10-year manifestation period requirement from
paragraph (a)(1) to paragraph (a)(2). Finally, VA is correcting a
clerical error in the introductory text of paragraph (b). The text
refers incorrectly refers to diseases listed in paragraph (a)(1), but
is being corrected to refer to diseases listed in paragraphs (a)(2) and
(3).
VA is committed to improving the delivery of health care and
benefits to Veterans affected by exposure to airborne hazards during
military service and will continue all cancer surveillance and
literature review regarding possible associations of other cancers and
respiratory hazards in the Southwest Asia theater of operations,
Afghanistan, Syria, Djibouti, and Uzbekistan.
Administrative Procedure Act
Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), VA finds that there is
good cause to publish this rule without prior opportunity for public
comment and good cause to publish this rule with an immediate effective
date. Section 553(b)(B) provides that a regulation may be issued
without prior opportunity for public comment when an agency for good
cause finds ``that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.'' It is
necessary to immediately implement this interim final rule to carry out
the Secretary of Veterans Affairs' decision to address the needs of
soon-to-be discharged service members and Veterans who have been
exposed to airborne hazards, i.e., PM<INF>2.5</INF>, due to their
service in the Southwest Asia theater of operations, Afghanistan,
Syria, Djibouti, or Uzbekistan, and who subsequently develop squamous
cell carcinoma (SCC) of the larynx, SCC of the trachea, adenocarcinoma
of the trachea, salivary gland-type tumors of the trachea,
adenosquamous carcinoma of the lung, large cell carcinoma of the lung,
salivary gland-type tumors of the lung, sarcomatoid carcinoma of the
lung, or typical and atypical carcinoid of the lung. Delay in the
implementation of this rule would be impracticable, unnecessary, and
contrary to public interest, particularly to Veterans.
It would be impracticable to provide opportunity for prior notice
and comment for this rulemaking because a delay in implementation would
require VA to delay disability compensation benefits for Gulf War
Veterans claiming these nine respiratory cancers that could be granted
under these presumptions. It would be contrary to the public interest
because a delay in creation of a presumption of service connection for
these nine new diseases (which lowers the evidentiary burden for
Veterans who are claiming benefits) would delay access to health care,
services, and benefits. Furthermore, Veterans diagnosed with rare
respiratory cancers have lower survival rates than those diagnosed with
more common cancers and may not be receiving adequate health care due
to their lack of service-connected status for their disability.
Additionally, with the exception of typical and atypical carcinoid of
the lung, which have a better prognosis than other pulmonary malignancy
and may have a survival rate of 10 years if diagnosed without delay,
all these rare respiratory cancers have a median
[[Page 24428]]
survival timeframe of well under 5 years. Delays in the diagnosis of
these rare cancers may occur due to the fact that these cancers have a
wide array of symptoms and due to challenges of diagnostic tests and
screening for these cancers, which may affect up to 90% of diagnostic
errors for these cancers.\25\ Even if diagnosed as early as possible
the survival timeframes are grim and the quality of life is universally
poor. Due to the catastrophic nature of these rare cancers and the
associated short survival periods for people suffering from them,
preventing the presumption from going into effect while the public
comment process is completed would be extremely detrimental to veterans
who are currently afflicted with these rare cancers.
---------------------------------------------------------------------------
\25\ Del Ciello, Annemilia et al. ``Missed lung cancer: when,
where, and why?.'' Diagnostic and interventional radiology (Ankara,
Turkey) vol. 23,2 (2017): 118-126. doi:10.5152/dir.2016.16187
---------------------------------------------------------------------------
In addition, the new presumptions are entirely pro-claimant in
nature. And because VA has a sufficient scientific basis to support the
new presumptions, continuing to delay claims that could be granted
under the presumption while rulemaking is ongoing would unnecessarily
deprive veterans and beneficiaries of benefits to which they would
otherwise be entitled and prolong their inability to 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 both these issues of airborne hazard exposures
and rare respiratory cancers, 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, imposing further delay on their receipt of benefits,
potentially at the risk of their welfare and health, is contrary to the
public interest.
Finally, the Secretary's decision to pursue presumptions of service
connection to ease access to VA benefits for veterans who have been
exposed to airborne hazards, i.e., particulate matter, requires
immediate effect in light of the COVID-19 pandemic. The economic
consequences of the pandemic may have strained the personal resources
of many who may benefit from these presumptions. For veterans that are
not otherwise eligible for health care, these presumptions could result
in needed health care eligibility based on service connection. For this
reason, delay in implementation of this rule would be contrary to the
public interest.
5 U.S.C. 553(d) 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 of Veterans
Affairs finds for the reasons noted above that there is good cause to
make the rule effective upon publication in order to provide benefits
and health care to Veterans suffering from these nine rare respiratory
cancers without delay.
For the foregoing reasons, and as explained in further detail
above, the Secretary of Veterans Affairs is issuing this rule as an
interim final rule with an immediate effective date. However, the
Secretary of Veterans Affairs will consider and address comments that
are received within 60 days of the date this interim final rule is
published in the Federal Register.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct 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.
The Office of Information and Regulatory Affairs has determined that
this rule is a significant regulatory action under Executive Order
12866. The Regulatory Impact Analysis associated with this rulemaking
can be found as a supporting document at www.<a href="http://regulations.gov">regulations.gov</a>.
Regulatory Flexibility Act
The Secretary hereby certifies that this interim final rule will
not have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act (5
U.S.C. 601-612). The certification is based on the fact that no small
entities or businesses determine service connection, the rating
criteria, or assign evaluations for disability claims. Therefore,
pursuant to 5 U.S.C. 605(b), the initial and final regulatory
flexibility analysis requirements of sections 603 and 604 do not apply.
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)
This interim final rule contains no provisions constituting a
collection of information under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521).
Assistance Listing
The Assistance Listing numbers and titles for this rule are 64.101,
Burial Expenses Allowance for Veterans; 64.102, Compensation for
Service-Connected Deaths for Veterans' Dependents; 64.105, Pension to
Veterans, Surviving Spouses, and Children; 64.109, Veterans
Compensation for Service-Connected Disability; and 64.110, Veterans
Dependency and Indemnity Compensation for Service-Connected Death.
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 not a major rule, as defined by 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 this
document on February 28, 2022, and authorized the undersigned to sign
and submit the document to the Office of the Federal Register for
publication
[[Page 24429]]
electronically as an official document of the Department of Veterans
Affairs.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of
General Counsel, Department of Veterans Affairs.
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).
0
2. Revise Sec. 3.320 to read as follows:
Sec. 3.320 Claims based on exposure to fine particulate matter.
(a) Service connection based on presumed exposure to fine
particulate matter--(1) General. Except as provided in paragraph (b) of
this section, a disease listed in paragraphs (a)(2) and (a)(3) of this
section shall be service connected even though there is no evidence of
such disease during the period of military service.
(2) Chronic diseases associated with exposure to fine particulate
matter. The following chronic diseases will be service connected if
manifested to any degree (including non-compensable) within 10 years
from the date of separation from a qualifying period of military
service as defined in paragraph (a)(5) of this section.
(i) Asthma.
(ii) Rhinitis.
(iii) Sinusitis, to include rhinosinusitis.
(3) Rare cancers associated with exposure to fine particulate
matter. The following rare cancers will be service connected if
manifested to any degree (including non-compensable) at any time
following separation from a qualifying period of military service as
defined in paragraph (a)(5) of this section.
(i) Squamous cell carcinoma of the larynx.
(ii) Squamous cell carcinoma of the trachea.
(iii) Adenocarcinoma of the trachea.
(iv) Salivary gland-type tumors of the trachea.
(v) Adenosquamous carcinoma of the lung.
(vi) Large cell carcinoma of the lung.
(vii) Salivary gland-type tumors of the lung.
(viii) Sarcomatoid carcinoma of the lung.
(ix) Typical and atypical carcinoid of the lung.
(4) Presumption of exposure. A Veteran who has a qualifying period
of service as defined in paragraph (a)(5) of this section shall be
presumed to have been exposed to fine, particulate matter during such
service, unless there is affirmative evidence to establish that the
veteran was not exposed to fine, particulate matter during that
service.
(5) Qualifying period of service. The term qualifying period of
service means any period of active military, naval, or air service in:
(i) The Southwest Asia theater of operations, as defined in Sec.
3.317(e)(2), during the Persian Gulf War as defined in Sec. 3.2(i).
(ii) Afghanistan, Syria, Djibouti, or Uzbekistan on or after
September 19, 2001 during the Persian Gulf War as defined in Sec.
3.2(i).
(b) Exceptions. A disease listed in paragraph (a)(2) and (3) of
this section shall not be presumed service connected if there is
affirmative evidence that:
(1) The disease was not incurred during or aggravated by a
qualifying period of service; or
(2) The disease was caused by a supervening condition or event that
occurred between the Veteran's most recent departure from a qualifying
period of service and the onset of the disease; or
(3) The disease is the result of the Veteran's own willful
misconduct.
[FR Doc. 2022-08820 Filed 4-25-22; 8:45 am]
BILLING CODE 8320-01-P
</pre></body>
</html>Indexed from Federal Register on April 26, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.