[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 [www.gpo.gov]
[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 www.Regulations.gov. 
Comments received will be available at regulations.gov 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 https://doi.org/10.3322/caac.21400.
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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 
(PM2.5, 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 PM2.5 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, https://www.epa.gov/pm-pollution/particulate-matter-pm-basics.
    \5\ 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. National Research Council, 
Review of the Department of Defense Enhanced Particulate Matter 
Surveillance Program Report (2010), https://doi.org/10.17226/12911 
(examining Department of Defense Enhanced Particulate Matter 
Surveillance Program (EPMSP) Final Report (2008), https://apps.dtic.mil/sti/pdfs/ADA605600.pdf.) NASEM, Long-Term Health 
Consequences of Exposure to Burn Pits in Iraq and Afghanistan 
(2011), https://doi.org/10.17226/13209. NASEM, Respiratory Health 
Effects of Airborne Hazards Exposures in the Southwest Asia Theater 
of Military Operations (2020), https://doi.org/10.17226/25837.
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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 
(nih.gov); 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. https://doi.org/10.1080/08958378.2020.1766602; 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, https://www.tandfonline.com/doi/full/10.1080/08958370802464273 and https://www.tandfonline.com/doi/full/10.1080/08958370802464299.
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    Prior to establishment of 38 CFR 3.320, VA conducted a supplemental 
literature review focused on PM2.5.\7\ The focus on 
PM2.5 was intentional for the following reasons: (1) 
PM2.5 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 PM2.5 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, https://www.epa.gov/pm-pollution/particulate-matter-pm-basics.
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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 PM2.5 (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), https://apps.dtic.mil/sti/pdfs/ADA605600.pdf.
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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), https://doi.org/10.17226/12911.
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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), https://doi.org/10.17226/13209.
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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), https://doi.org/10.17226/25837.
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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 PM2.5 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, http://rarecarenet.istitutotumori.mi.it/rarecarenet/.
    \13\ GARD, Genetic and Rare Disease Information Center, https://rarediseases.info.nih.gov/.
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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 
PM2.5, and multiple health outcomes, including cancer. 
Within the discussion of long-term PM2.5 exposure and 
cancer, the 2019 p.m. ISA evaluates and characterizes the scientific 
evidence that supports a biologically plausible mechanism by which 
long-term PM2.5 exposure could lead to the development of 
cancer, such as lung cancer. As noted in Section 10.2 of the 2019 p.m. 
ISA: ``PM2.5 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, PM2.5 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 
PM2.5 exhibits multiple characteristics of a carcinogen 
provides biological plausibility for the generally consistent, positive 
associations between long-term PM2.5 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 PM2.5 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 http://www.epa.gov/isa.
    \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 PM2.5 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 PM2.5, 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 PM2.5 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 
PM2.5, 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 
PM2.5. 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 PM2.5 
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 
PM2.5 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 PM2.5 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: 
https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Outdoor-Air-Pollution-2015.
    \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 http://www.epa.gov/isa.
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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 PM2.5 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 PM2.5 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 PM2.5 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.
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    \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).
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    Based on presumed PM2.5 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 PM2.5 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 PM2.5 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 
PM2.5 varies in different regions. Therefore, VA included 
Afghanistan, Syria, and Djibouti as qualifying locations for 
presumption of service connection based on presumed exposure to 
PM2.5.
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    \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 https://doi.org/10.1080/08958378.2020.1766602. See UNEP, WMO, UNCCD (2016) ``Global 
Assessment of Sand and Dust Storms,'' United Nations Environment 
Programme, Nairobi, 1-15, 21-24, available at https://uneplive.unep.org/redesign/media/docs/assessments/global_assessment_of_sand_and_dust_storms.pdf.
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    As the literature and studies overwhelmingly demonstrate the 
prevalence of PM2.5 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 PM2.5 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, 
https://phc.amedd.army.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf. 
(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 
PM2.5 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 PM2.5 during the Gulf War. Based on presumed 
exposure to PM2.5, 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 
PM2.5, 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., PM2.5, 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.regulations.gov.

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