[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Rules and Regulations]
[Pages 42724-42733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16693]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AR25
Presumptive Service Connection for Respiratory Conditions Due to
Exposure to 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 service connection for three chronic respiratory health
conditions, i.e., asthma, rhinitis, and sinusitis, to include
rhinosinusitis, in association with presumed exposures 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 (hereafter 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 provide
expeditious health care, services, and benefits to Gulf War Veterans
who were potentially exposed to fine, particulate matter associated
with deployment to the Southwest Asia theater of operations, as well as
Afghanistan, Syria, Djibouti, and Uzbekistan. The intended effect of
this amendment is to address the needs and concerns of Gulf War
Veterans and service members who have served and continue to serve in
these locations as military operations in the Southwest Asia theater of
operations have been ongoing from August 1990 until the present time.
Neither Congress nor the President has established an end date for the
Gulf War. Therefore, to provide immediate health care, services, and
benefits to current and future Gulf War Veterans who may be affected by
particulate matter due to their military service, VA intends to provide
presumptive service connection for the chronic disabilities of asthma,
rhinitis, and sinusitis, to include rhinosinusitis, as well as a
presumption of exposure to fine, particulate matter. This will ease the
evidentiary burden of Gulf War Veterans who file claims with VA for
these three conditions, which are among the most commonly claimed
respiratory conditions.
DATES:
Effective Date: This interim final rule is effective on August 5,
2021.
Applicability Date: The provisions of this interim final rule shall
apply to all applications for service connection for asthma, rhinitis,
and sinusitis based on service in the Southwest Asia theater of
operations, as well as Afghanistan, Syria, Djibouti, or Uzbekistan,
during the Persian Gulf War that are received by VA on or after August
5, 2021, or that were pending before VA, the United States Court of
Appeals for Veterans Claims, or the United States Court of Appeals for
the Federal Circuit on August 5, 2021.
Comment Date: Comments must be received on or before October 4,
2021.
ADDRESSES: Comments may be submitted through www.regulations.gov or
mailed to, Compensation Service, 21C, 1800 G Street NW, Suite 644A,
Washington, DC 20006. Comments should indicate that they are submitted
in response to ``RIN 2900-AR25--Presumptive Service Connection for
Respiratory Conditions Due to Exposure to Particulate Matter''.
Comments received will be available at regulations.gov for public
viewing, inspection or copies.
FOR FURTHER INFORMATION CONTACT: Jane Che, Director, VA Schedule for
Rating Disabilities Program Office (210), Compensation Service,
Veterans Benefits Administration (VBA), Department of Veterans Affairs,
810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is
not a toll-free telephone number.)
SUPPLEMENTARY INFORMATION:
I. National Academies of Science, Engineering, and Medicine (NASEM)
1 and National Research Council (NRC) Reports
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\1\ Originally, the National Academy of Medicine was the
Institute of Medicine (IOM). In 2015, the IOM was reconstituted as
the National Academy of Medicine (NAM), a component of the National
Academies of Sciences, Engineering, and Medicine (NASEM). The term
NASEM is used in this rule to refer to reports published by IOM and
NAM.
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More than 3.7 million United States service members have
participated in operations in Southwest Asia. During and after the
initial Gulf War conflict, veterans began reporting a variety of health
problems, as documented through the NASEM Gulf War and Health, Volumes
1 through 11. In addition, concerns continue to be raised by service
members, veterans, veteran advocates, and Congress about possible
adverse health consequences related to in-theater exposures to
particulate matter, including smoke from open burn pits, and other
airborne hazards. Several studies by NASEM have examined the possible
contribution of air pollution to adverse health effects among U.S.
military personnel serving in the Middle East or their descendants.\2\
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\2\ 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. 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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a. 2010 NRC Report, Review of the Department of Defense (DoD) Enhanced
Particulate Matter Surveillance Program
In February 2008 the Department of Defense issued the Department of
Defense Enhanced Particulate Matter Surveillance Program (EPMSP) Final
Report.\3\ 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
[[Page 42725]]
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 Enhanced Particulate Matter
Surveillance Program 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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\3\ 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 National Research Council (NRC) of NASEM independently reviewed
DOD's final report in Review of the Department of Defense Enhanced
Particulate Matter Surveillance Program Report in 2010.\4\ The NRC
committee highlighted that the EPMSP was one of the first large-scale
efforts to characterize PM 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 PM-related health effects in military personnel
deployed in the Middle East Theater.
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\4\ 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 PM 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. Further complicating this
interpretation are the paucity of exposure data from earlier conflicts,
such as the first Gulf War, that limit understanding of potential
chronic health effects.
Despite these limitations, the NRC committee found that the EPMSP
results clearly documented that deployed Service Members deployed in
the Middle East ``are exposed to high concentrations of PM 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 this service member exposures,
VA requested that NASEMexamine 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.\5\ 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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\5\ 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)
requested NASEM to study the respiratory health effects of airborne
hazards exposures in Southwest Asia. Specifically, VA requested NASEM
to evaluate the extent to which the existing knowledge base informs the
understanding of the potential adverse effects of in-theater military
service on respiratory health; identify gaps in research that could
feasibly be addressed for outstanding questions; Review newly emerging
technologies that could aid in these efforts, and identify
organizations that VA might partner with to accomplish this work.
A NASEM committee was formed to undertake this review, which
completed its work in early summer 2020. 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.\6\ The NASEM committee focused on
``hazards associated with burn pit exposures; Excess mortality, cancer,
bronchial asthma, chronic bronchitis, sinusitis, constrictive
bronchiolitis, and other respiratory health outcomes that are of great
concern to veterans; and emerging evidence on respiratory health
outcomes in service members from research such as the Millennium Cohort
Study, Study of Active Duty Military for Pulmonary Disease Related to
Environmental Deployment Exposures (STAMPEDE), National Health Study
for a New Generation of U.S. Veterans, Comparative Health Assessment
Interview (CHAI) Study, Pulmonary Health and Deployment to Iraq and
Afghanistan Objective Study, Effects of Deployment Exposures on
Cardiopulmonary and Autonomic Function Study, and research being
conducted by the Department of Veterans Affairs (VA) War Related
Illness and Injury Study Center (WRIISC) Airborne Hazards Center of
Excellence (AHCE) in New Jersey.''
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\6\ 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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The NASEM committee formulated a list of 27 respiratory health
outcomes it deemed to be of concern to veterans in its review:
Rhinitis, sinusitis, sleep apnea, vocal cord dysfunction, asthma,
chronic bronchitis, chronic obstructive pulmonary disease, constrictive
bronchiolitis, emphysema, acute eosinophilic pneumonia,
hypersensitivity pneumonitis, idiopathic interstitial pneumonia,
idiopathic pulmonary fibrosis, pulmonary alveolar proteinosis,
sarcoidosis, acute bronchitis, pneumonia, tuberculosis, chronic
persistent cough, shortness of breath (dyspnea), wheeze, esophageal
cancer, laryngeal cancer, lung cancer, oral/nasal/pharyngeal cancers,
as well as changes in pulmonary function and mortality due to diseases
of the respiratory system.
The NASEM committee also considered different types and sources of
exposure in its review: Exposures associated with military operations
in the Southwest Asia theater such as open burn pits, emissions from
the 2003 Al-Mishraq sulfur plant fire, fuels, oil-well fires, nerve
agents, and depleted
[[Page 42726]]
uranium; regional environmental exposures such as air pollution,
particulate matter, biologic agents and allergens, the toxicity of sand
and dust; and occupational exposures such as vapors, gases, dust, and
fumes.
The summarized findings of the 2020 NASEM report found that: (1) Of
the 27 different respiratory systems and diseases, three respiratory
symptoms, i.e., chronic persistent cough, shortness of breath
(dyspnea), and wheezing, met the criteria for limited or suggestive
evidence of an association with service in Southwest Asia whereas the
remaining 24 conditions had inadequate or insufficient evidence to
determine an association; (2) deployment to the 1990-1991 Gulf War and
changes in lung function were determined to have limited or suggestive
evidence of no association; and (3) many of the studies that report on
these conditions were weakened by bias due to self-selection of the
participants and self-reported outcomes and exposures and/or lack of
control for confounders such as cigarette smoking.
The 2020 NASEM report stated that, while there was inadequate or
insufficient evidence to determine an association between respiratory
health outcomes and deployment to Southwest Asia, the existing studies
included were limited in the available data in 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 recommended that a new approach was needed to allow
researchers to better examine and respond to whether specific
respiratory outcomes are associated with deployment.
d. VA's Review and Analysis of the 2020 NASEM Report: Respiratory
Health Effects of Airborne Hazards Exposures in the Southwest Asia
Theater of Military Operations
VA adheres to established internal procedure requiring it to review
and respond to the recommendations in NASEM reports as outlined in VA
Directive 0215, Management of Reports Issued by the National Academies
of Sciences, Engineering, and Medicine. This VA Directive establishes
the process for developing responses to all NASEM studies, whether
legally mandated or not. VA is not obligated by statute to provide
Congress with VA's response to the 2020 NASEM report.
Pursuant to the VA Directive process, VA convened a workgroup of VA
subject matter experts (SMEs) in disability compensation, health care,
infectious diseases, occupational and environmental medicine, public
health, epidemiology, toxicology, and research. The workgroup convened
in early spring of 2021 and was composed of subject matter experts from
the Veterans Health Administration and the Veterans Benefits
Administration. This workgroup was charged with analyzing the
information presented by NASEM and informing the VA Secretary of its
findings. The VA workgroup used the same management, coordination, and
collaboration process in responding to NASEM reports that are
undertaken and submitted because of legal mandates.
Upon review of the findings and recommendations of the 2020 NASEM
report, the VA workgroup noted that NASEM focused its review on
``airborne hazards encountered during service in Southwest Asia Theater
of Military Operations and Afghanistan'' but did not opine on the
relevance of the literature regarding the potential impact of long-term
general population or occupational exposure to ambient levels of
particulate matter pollution in nor the mechanistic, animal and
toxicologic studies. Other Federal agencies (i.e., the Environmental
Protection Agency, Occupational Safety and Health Administration, and
the National Institutes for Health) have explored those relationships
in detail. In addition, VA conducted its own review of epidemiological
studies of population exposures related to cough, wheeze, and shortness
of breath (dyspnea). The practice per VA Directive 0215 is that the VA
workgroup on NASEM reports reviews pertinent literature that has been
published during the time following the NASEM literature review and
writing/publication of the report. VA identified the narrowed focus of
the NASEM literature that omitted areas of inquiry that were felt to be
relevant to a complete understanding of the hazards associated with
respiratory outcomes.
While the 2020 NASEM report concluded there was inadequate or
insufficient evidence of an association between airborne hazards
exposures in the Southwest Asia theater and subsequent development of
rhinitis, sinusitis, and asthma, the report did conclude that certain
respiratory symptoms such as chronic persistent cough, shortness of
breath (dyspnea), and wheeze did have limited or suggestive evidence of
an association. Understanding the immediate needs and concerns of the
Gulf War cohort and airborne exposures in service, VA reviewed the most
commonly claimed chronic conditions related to airborne hazards for
disability compensation benefits (as described further below) and found
that asthma, sinusitis, and rhinitis were the most commonly claimed and
granted respiratory conditions, and these conditions also most closely
represented the symptomatology of chronic persistent cough, shortness
of breath (dyspnea), and wheeze. Sleep apnea was noted as the top
claimed and granted respiratory condition. However, VA has not
identified literature to support inclusion of sleep apnea as a
presumption at this time. VA is currently reviewing the other
disabilities reviewed by NASEM in the 2020 report for consideration for
potential presumptive service connection. VA will utilize a phased
approach in reviewing these disabilities to explore additional studies
and data.
e. VA's Review of Internal Claims Data
In response to the 2020 NASEM report, VA analyzed respiratory
claims data for veterans who were deployed to Southwest Asia theater of
operations and other locations and compared this data to a similar
cohort of veterans who served during the same period but who had never
deployed. Based on a review of aggregate claims data (see table below),
VA observed that the claims rates for rhinitis, sinusitis, and asthma
in the combined Gulf War I and GWOT deployed cohorts were higher than
the claims rates of similar non-deployed cohorts. In addition, the
service-connection prevalence rates, (i.e., percentage of cohort
population for which VA finds service connection) were higher for the
deployed cohorts than the non-deployed cohorts.
Table 1--Aggregate Disability Claims Data by Cohort
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GW 1-era non- GWOT-era non- K2 cohort Totals across
GW 1 deployed deployed GWOT deployed deployed (subset) cohorts
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Population Size......................................... 750,205 2,615,287 2,450,344 2,599,446 15,670 8.4 M
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[[Page 42727]]
Rhinitis
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# Claims................................................ 16,684 26,094 276,609 91,063 1,564 410,810
Claims Rate \1\......................................... 2.2% 1% 11.3% 3.5% 10% 4.9%
# Grants................................................ 8,405 14,131 206,348 64,522 1,198 293,406
Grant Rate \2\.......................................... 49.3% 54.2% 74.6% 70.9% 76.6% 71%
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Sinusitis
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# Claims................................................ 22,787 37,740 195,747 65,863 1,206 322,137
Claims Rate \1\......................................... 2.2% 1.4% 8% 2.5% 7.7% 3.8%
# Grants................................................ 9,869 18,235 87,151 29,849 571 145,104
Grant Rate \2\.......................................... 43.3% 48.3% 44.5% 45.3% 47.3% 45%
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Asthma
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# Claims................................................ 18,126 25,052 123,739 46,180 435 212,805
Claims Rate \1\......................................... 2.4% 1% 5% 1.8% 2.8% 2.5%
# Grants............................................... 7,453 12,910 62,971 25,209 210 108,543
Grant Rate \2\.......................................... 41.8% 51.5% 50.9% 54.6% 48.3% 51%
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VBA Corporate Data, as of April 2021.
\1\ ``Claims Rate'' is the percentage of cohort who filed a claim for service connection.
\2\ ``Grant Rate'' is percentage of claims granted service connection.
This increased volume of claims and the sheer number of grants
within the deployed cohorts for these conditions was critical in
determining that more scientific review was necessary.
f. EPA's 2019 Integrated Science Assessment for Particulate Matter
The Environmental Protection Agency's (EPA's) Integrated Science
Assessment (ISA) ``is a comprehensive evaluation and synthesis of
policy-relevant science aimed at characterizing exposures to ambient
particulate matter (PM), and health and welfare effects associated with
these exposures.'' The evaluation of the science and the overarching
conclusions of the ISA serves as the scientific foundation for the
review of the primary (health-based) and secondary (welfare-based)
National Ambient Air Quality Standards for Particulate Matter in the
United States. EPA's ISA is prepared through a structured and
transparent process that includes review by a formal independent panel
of scientific experts (specifically, the Clean Air Scientific Advisory
Committee) and by the public.\7\ The ISA uses a formal causal framework
to classify the weight of the evidence for health effects.
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\7\ See, e.g., Clean Air Science Advisory Committee (CASAC),
CASAC Review of the EPA's Integrated Science Assessment for
Particulate Matter (External Review Draft--October 2018) (Apr.
2019), available at https://yosemite.epa.gov/sab/sabproduct.nsf/
6CBCBBC3025E13B4852583D90047B352/$File/EPA-CASAC-19-002+.pdf.
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The EPA's causal framework and approach to evaluating the
scientific evidence that informs the corresponding causality
determinations is outlined in the ``Preamble To The Integrated Science
Assessments (ISA)'' available at https://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=310244. Within the ISAs, the EPA evaluates and
integrates evidence across scientific disciplines to assess the causal
nature of relationships between PM and health or welfare effects.
Specifically, during the evaluation of the health effects evidence the
focus is on assessing consistency of effects within a discipline,
coherence of effects across disciplines, and whether there is evidence
of biologically plausibility, while also taking into consideration the
exposures of studies. The 2019 PM ISAs, EPA concluded that there is a
``likely to be causal relationship'' between both short- (i.e., hours
up to a month) and long-term (i.e., month to years) exposure to fine
particulate matter and respiratory health effects. Their definition of
a `likely to be causal relationship' is as follows, ``Evidence is
sufficient to conclude that a causal relationship is likely to exist
with relevant pollutant exposures. That is, the pollutant has been
shown to result in health effects in studies where results are not
explained by chance, confounding, and other biases, but uncertainties
remain in the evidence overall.'' (c.f., Table P-2). For long-term
PM2.5 exposure, the strongest evidence is for changes in
lung function and lung function growth and asthma development in
children. For adults there is evidence of acceleration of lung function
decline, but inconsistent evidence for asthma development.
Additionally, there is very limited, and inconsistent evidence of
respiratory effects in healthy populations for both short- and long-
term PM2.5 exposure. The strongest evidence is from animal
toxicological studies, but this is not consistent with epidemiologic
and controlled human exposure studies.
g. VA's Comprehensive Supplemental Literature Review
VA's Health Outcomes Military Exposures (HOME) and the Airborne
Hazards and Burn Pits Center of Excellence (AHBPCE) completed a
literature review of asthma, sinusitis, and rhinitis that specifically
considered literature on general population exposures to particulate
matter in non-deployment settings. Additional relevant literature
published after the 2020 NASEM report was identified, and the VA
workgroup met to define search parameters and inclusion/exclusion
criteria for literature review.
The VA workgroup utilized the PICOTS (Patient, Intervention/
Exposure, Comparator, Outcomes, Timing, Setting) Framework (see below,
Table 2--PICOTS Framework) to strengthen the evidence gathered, which
was refined in consultation with the Director of the Veterans Affairs
Central Office Library, who conducted the primary search. VA SMEs also
performed a supplemental search to ensure completeness. To incorporate
the full range of evidence, human and non-human studies were
considered. ``Human studies'' refers to observational, case-control,
cohort, and meta-analytic studies involving people.
[[Page 42728]]
``Non-human studies'' refers to experimental research not performed on
people but includes in-vivo and in-vitro studies in animal models, cell
lines, and donated human tissue. Such research is particularly useful
for determining if specific air pollutants or a mixture thereof is
related to respiratory symptoms that might reasonably be seen as
precursors to or analogous with the symptoms documented in humans
(i.e., biological plausibility). Initial literature screening was
performed by VA SMEs to ensure appropriateness for review as well as
assignment to human and non-human categories.
Additional SMEs were recruited to critically evaluate the strengths
and weakness of evidence using a semi-quantitative transparent approach
that was based on the Grading of Recommendations Assessment,
Development and Evaluation (GRADE) structure. Each reviewing SME was
provided with instructions on the overall goals of the review, the
PICOTS framework (below) as well as instructions on the scoring matrix
with the GRADE structure. Each article was evaluated by at least two
subject matter experts, and the aggregate results were reviewed by a
panel of subject matter experts to derive consensus opinion.
Table 2--PICOTS Framework
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PICOTS term Human studies Non-Human studies
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Patient Population OR Adults (18-50 years) Relevant model
Problem. systems (e.g., in-
vitro, in-vivo).
Intervention OR Exposure.... Chronic exposure to Acute/chronic
particulate matter exposure to
(PM2.5) air PM2.5.\8\
pollution.
Comparator.................. No exposure (or fine No exposure.
PM levels < federal
guidelines).
Outcomes.................... ICD-9/10 codes \9\ Respiratory
for respiratory condition
conditions and/or phenotypes and/or
biomarkers observed behaviors.
consistent with
these conditions.
Timing...................... Months to years..... Days to months.
Setting..................... All countries....... Not applicable.
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The 2020 NASEM report reviewed different types of exposures such as
open burn pits, emissions from the 2003 Al-Mishraq sulfur plant fire,
fuels, oil-well fires, nerve agents, and depleted uranium; regional
environmental exposures such as air pollution, particulate matter,
biologic agents, and allergens, toxicity of sand and dusts; and
occupational exposures such as vapors, gases, dusts, and fumes. The
supplemental review focused on fine particulate matter
(PM2.5), which is a mixture of solid particles and liquid
droplets that have a mean aerodynamic diameter <=2.5 microns.\10\ 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 into the lung and
potential for harmful effects. It is recognized that the source of fine
particles and their resultant chemical composition are important
considerations beyond particle size that should be considered yet there
is a paucity of these data.
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\8\ Particulate matter size of 2.5 microns (PM2.5)
\9\ World Health Organization (WHO) authorized the publication
of the International Classification of Diseases 10th Revision (ICD-
10), which was implemented for mortality coding and classification
from death certificates. The U.S. developed a Clinical Modification
(CM) (ICD-10-CM) for medical diagnoses based on WHO's ICD-10. ICD-
10-CM replaces ICD-9-CM, volumes 1 and 2.
\10\ See US EPA, Particulate Matter (PM) Basics, https://www.epa.gov/pm-pollution/particulate-matter-pm-basics.
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Based on the observations from many veterans and studies that
described particulates in Southwest Asia,\11\ VA determined that the
levels of particulate matter were high in Southwest Asia and could
present a health risk to service members.
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\11\ 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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II. VA's Findings Post-2020 NASEM Report Review
As previously noted, the VA Technical Working Group identified
knowledge gaps from the 2020 NASEM report and felt additional review of
the literature, of relevance to service members and veterans, was
warranted. In first reviewing the EPA's 2019 ISA on PM2.5,
it was noted that the literature reviewed included those articles
published through 2017. In addition, the ISA included both children and
adults and had a much broader scope. The VA's supplemental review was
targeted to address these knowledge gaps. Ultimately, VA's conclusions
on respiratory health effects were similar to those of the EPA's 2009
and 2019 ISAs. The VA committee acknowledges that: (1) There exists a
range in the strength of association between PM2.5 exposure
and the respiratory conditions of interest, and (2) most of the
population epidemiological studies are based upon the assumption that
chronic respiratory symptoms are a function of long-term exposure and
reductions in ambient concentration lead to resolution of short-term
responses, and thus are difficult to apply to the exposure scenario
experienced by service members in SW Asia. Therefore, VA's own
literature review is not a sufficient basis for concluding that such
exposure scenarios would be expected to cause incident (or new-onset)
asthma, sinusitis, and/or rhinitis secondary to exposure.
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 ISA, and that there are
limitations in evidence specific to deployed service members, as
discussed above. In the context of regulating potential service
connection related to presumed exposure and benefits there is a strong
role for policy decisions.\12\ The Secretary's broad
[[Page 42729]]
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.
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\12\ 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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a. Gulf War Service
Based on the weight of the evidence considered as described above,
VA presumes exposure to PM2.5 for Gulf War 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 Persian Gulf War. Based on
presumed PM2.5 exposures, VA is granting a presumption of
service connection for the chronic respiratory conditions of asthma,
sinusitis, and rhinitis, to include rhinosinusitis, for the service
periods and manifestation timelines that follow.
b. Service in Afghanistan, Syria, and Djibouti on or After September
19, 2001
The presumption of PM2.5 exposure will also include
those deployed to Afghanistan, Syria, and Djibouti on or after
September 19, 2001, the earliest date when service members were
deployed in these locations. The literature and studies overwhelmingly
show the prevalence of particulate matter due to the nature of the arid
climate in these locations as well.\13\ VA 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 the PM varies in different
regions. Therefore, VA is including Afghanistan, Syria, and Djibouti as
qualifying locations for presumption of service connection based on
presumed exposure to PM2.5.
---------------------------------------------------------------------------
\13\ 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.
---------------------------------------------------------------------------
VA's Airborne Hazards and Open Burn Pit Registry, which encourages
veteran participation to help VA gather data and better understand the
potential health effects of exposure to airborne hazards during
military service, currently covers the Southwest Asia theater of
operations, including Afghanistan, and will also expand the locations
to include Syria and Uzbekistan. Expansion will be encouraged through
periodic communications through the MyPay pay notifications with both
active duty service members and veterans, and through press releases as
well as through VA's Health Outcomes Military Exposures website
(https://www.publichealth.va.gov/exposures/burnpits/index.asp).
As the literature and studies overwhelmingly demonstrate the
prevalence of particulate matter in these locations, VA is including
Afghanistan, Syria and Djibouti in addition to the Southwest Asia
theater of operations, as qualifying locations for the presumption of
service connection and exposure to fine, particulate matter.
c. Service in Uzbekistan on or After September 19, 2001
Furthermore, the VA workgroup recommended that the presumption of
PM2.5 exposure include those service members who were
deployed to Uzbekistan in support of Operation Enduring Freedom. 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.\14\ 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 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.
---------------------------------------------------------------------------
\14\ 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 will presume PM2.5 exposure for those
service members who were deployed to Uzbekistan on or after September
19, 2001. VA acknowledges that this will cover 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 will
enhance its operational efficiencies by simplifying the work necessary
for claims adjudication.
VA will continue to collaborate with DoD as directed by E.O. 13982,
``Care of Veterans with Service in Uzbekistan,'' executed on January
19, 2021, and published on January 25, 2021. This Executive Order
requires that DoD conduct a study to assess the conditions at the K-2
Air Base, to identify any toxic substances that may have contaminated
the Air Base, and to conduct an epidemiological study on potential
health consequences for those deployed to K-2 Air Base. Once the
studies have been completed, VA will consider the results and findings
from these studies in making determinations regarding diseases subject
to presumptive service connection.\15\
---------------------------------------------------------------------------
\15\ E.O. 13982, ``Care of Veterans With Service in
Uzbekistan,'' (January 19, 2021), https://www.federalregister.gov/documents/2021/01/25/2021-01712/care-of-veterans-with-service-in-uzbekistan.
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d. Manifestation Period for Chronic Respiratory Conditions of Asthma,
Rhinitis, and Sinusitis
The VA workgroup also considered the onset of asthma, rhinitis, and
sinusitis after service members separated from military service in the
Southwest Asia theater of operations as well as Afghanistan, Syria,
Djibouti, and Uzbekistan. The consensus of the VA workgroup was that
the manifestation period for these three chronic respiratory conditions
was generally five to 10 years after separation from service, supported
by a review of claims data, and the human and epidemiological studies
showed that manifestation of these respiratory conditions did not
exceed 10 years. The VA Secretary will apply the liberal
[[Page 42730]]
manifestation period of 10 years from separation from the last period
of military service that includes a qualifying period of service. VA
believes that a 10-year manifestation period for eligibility for
presumptive service connection for the chronic respiratory conditions
of asthma, rhinitis, and sinusitis, to include rhinosinusitis, would
not only allow veterans time to seek healthcare treatment and/or
diagnosis for such respiratory conditions after they leave military
service but would expand eligibility to more Gulf War veterans if a
longer manifestation period of 10 years was designated as opposed to a
shorter manifestation period, e.g., five years, which would preclude
certain veterans who develop and/or are diagnosed with a chronic
respiratory condition outside of this timeframe. In consideration of
the length of the military operations in the Gulf War and a large
number of affected service members and veterans, the 10-year
manifestation period more liberally provides these veterans with the
healthcare, benefits, and services they have earned.
In addition, there is no minimum time limit required for the length
of military deployment. There is no set guidance on deployment and this
varies widely by service: some smaller units may deploy for two weeks
or less for specialized missions (special operations, construction
units), while larger units may deploy for three to six months in the
case of the U.S. Air Force, while some Army units have deployed in
extreme cases for up to 15 months. There is no average deployment time
because of these extremes.
Current VA regulations governing presumptive service connection for
certain diseases such as chronic diseases, diseases associated with
exposure to certain herbicide agents, and others, generally require
that the presumptive disease manifest to a compensable degree (i.e.,
10-percent or more) within the applicable time limits. However, in
other contexts, some adjudication regulations governing presumptive
service connection, for example presumptions for certain diseases due
to exposure to ionizing radiation in 38 CFR 3.311 and mustard gas in 38
CFR 3.316, as well as for amyotrophic lateral sclerosis in 38 CFR
3.318, do not require the associated disability to have manifested to a
compensable degree or more. VA is opting against requiring a specific
level or dose of exposure to particulate matter and is instead taking
the more veteran-centric approach of presuming sufficient exposure
based on service in these identified regions. This approach accounts
for the fact that precise or specific information on individual
veterans' exposures that is needed to support more granular policy is
generally not available. In addition, this approach is also consistent
with some other presumptions of service connection. For example, VA
does not require exposure dosage for Vietnam veterans who were presumed
to have been exposed to a herbicide agent such as Agent Orange.
Thus, VA will not require that the chronic respiratory conditions
of asthma, rhinitis, and sinusitis, to include rhinosinusitis, manifest
to a compensable degree or more so that more Gulf War Veterans can meet
the lower eligibility criteria for presumptive service connection for
exposure to fine, particulate matter even at a non-compensable level,
which could also make veterans eligible to receive VA health care
services for that condition at no cost to themselves.
One of the VA Secretary's priorities is to address the needs of the
Gulf War cohort and to address the imminent need for care, services,
and benefits to these veterans that is long overdue. The VA Secretary
has determined that, for the three most commonly claimed respiratory
health conditions, waiting for the results of additional studies for
more conclusive scientific evidence would unnecessarily delay the
delivery of services and benefits to veterans who served in the Gulf
War. Based on the critical need to provide immediate benefits such as
disability compensation and healthcare services to veterans as well as
the supplemental analysis conducted by VA on the 2020 NASEM report, the
VA Secretary is establishing presumptive service connection and a
presumption of exposure to fine, particulate matter for those veterans
who were deployed to the Southwest Asia theater of operations as well
as Afghanistan, Syria, Djibouti, or Uzbekistan and who are diagnosed
with the chronic respiratory conditions of asthma, rhinitis, sinusitis,
to include rhinosinusitis, as long as such conditions manifested within
10 years after separation from the last period of military service that
includes a qualifying period of service.
This regulation is based on the Secretary's broad authority under
38 U.S.C. 501(a) to ``prescribe all rules and regulations which are
necessary or appropriate to carry out the laws administered by the
Department and are consistent with those laws, including--. . .
regulations with respect to the nature and extent of proof and evidence
. . . 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's 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)).
For the reasons explained above, the Secretary has determined that such
a rational basis exists for the chronic respiratory conditions of
asthma, rhinitis, and sinusitis, to include rhinosinusitis.
III. Part 3 Adjudication Regulations Update
VA is amending Sec. 3.159, the regulation regarding VA's duty to
assist claimants in developing their claims, specifically by adding new
Sec. 3.320 to the current subparagraph that addresses VA's duty to
provide medical examinations or obtain medical opinions when it has
been established that a veteran has a disease or symptoms of a disease
listed in the regulations governing presumptive conditions in
Sec. Sec. 3.309, 3.313, 3.316, and 3.317.
VA is adding new Sec. 3.320 to address presumptive service
connection based on exposure to particulate matter for Gulf War
veterans. Specifically, in new paragraph (a)(1), this provision
outlines that service connection will be granted for the listed
diseases for a veteran with a qualifying period of service as long as
such disease manifested to any degree (i.e., non-compensable would
qualify) within 10 years from separation from the last period of
military service that includes a qualifying period of service. This is
based on the presumption that a veteran with a qualifying period of
service was exposed to fine, particulate matter during that service.
New subparagraph (a)(2) lists the three new chronic diseases for
presumptive service connection as asthma, rhinitis, and sinusitis, to
include rhinosinusitis. Chronic rhinosinusitis will be considered for
presumptive service connection if claimed or diagnosed as related to
particulate matter exposure. Since chronic rhinosinusitis is also a
disease that affects the nasal cavity and paranasal sinuses similar to
chronic sinusitis and rhinitis, VA will adjudicate claims for chronic
rhinosinusitis under the Diagnostic Code (DC) for sinusitis in 38 CFR
4.97, Schedule of ratings-respiratory system under DCs 6510-6514 as
appropriate.
[[Page 42731]]
Moreover, these three diseases must not be seasonal or an acute
allergic manifestation in nature, as pursuant to 38 CFR 3.380,
``[s]easonal and other acute allergic manifestations subsiding on the
absence of or removal of the allergen are generally to be regarded as
acute diseases, healing without residuals.''
In the event a claimant does not specifically claim one of the
three presumptive diseases by name but references symptoms of a general
medical condition such as ``shortness of breath'' or ``respiratory
issues'' on claims forms or applications, VA will continue to process
and adjudicate such claims to include on the basis of presumptive
service connection due to exposure to particulate matter. VA will
review and verify the claimant's records, including records of
deployment to a qualifying period of service and area. If confirmed, VA
will schedule an examination (or medical opinion if/when necessary) to
determine if the veteran has a diagnosis for any of the new presumptive
diseases and will adjudicate the claim under new Sec. 3.320
accordingly.
In addition, new paragraph (a)(3) provides the presumption that a
veteran with a qualifying period of service was exposed to fine,
particulate matter in service. And new paragraph (a)(4) establishes the
qualifying period of service in Southwest Asia theater of operations as
during the Persian Gulf War, as well as Afghanistan, Syria, Djibouti,
or Uzbekistan on or after September 19, 2001 during the Persian Gulf
War.
Lastly, new paragraph (b) provides the three circumstances under
which presumptive service connection will not be granted. VA will not
consider a disease to be service connected on a presumptive basis if
there is affirmative evidence that shows: (1) The disease was not
incurred or aggravated during a qualifying period of service; (2) the
disease was caused by a supervening condition or event that happened
between the most recent separation from a qualifying period of service
and the onset of the disease; or (3) the disease was due to the
veteran's own willful misconduct. This new paragraph (b) is consistent
with current regulations governing other conditions based on
presumptive service connection such as exposure to ionizing radiation,
exposure to mustard gas, or based on Gulf War service and disabilities
due to undiagnosed illness and medically unexplained chronic multi-
symptom illnesses. See 38 CFR 3.311(g), 3.316(b), and 3.317(a)(ii)(7)
and (c)(4).
IV. Review of Other Part 3 Adjudication Regulations
On July 30, 2008, Congress passed Public Law 110-289, the Housing
and Economic Recovery Act of 2008, of which section 2603 expanded
eligibility of specially adapted housing benefits to veterans who are
permanently and totally disabled due to severe burn injuries ``as
determined pursuant to regulations prescribed by the Secretary.'' On
December 18, 2009, VA published in the Federal Register (74 FR 67145) a
proposed rule to amend Sec. Sec. 3.809 and 3.809a, the provisions
governing specially adapted housing and special home adaptation grants,
respectively, to conform with Public Law 110-289. (RIN 2900-AN21)
Particularly, VA proposed to add eligibility criteria of severe burn
injuries to Sec. 3.809a to be defined as (1) deep partial thickness
burns that have resulted in contractures with limitation of motion of
two or more extremities or of at least one extremity and the trunk, or
(2) subdermal burns that have resulted in contracture(s) with
limitation of motion of one or more extremities or the trunk. Although
Public Law 110-289 did not specifically address non-dermatological
severe burn injuries, VA proposed to add a third eligibility criteria
of severe burn injury, defined as residuals of an inhalation injury. VA
noted that ``inhalation injuries can result from the same incidents
that cause severe burns'' and attributed the breathing of steam or
``toxic inhalants such as fumes, gases, and mists present in a fire
environment. Toxic inhalants comprise a variety of noxious gases and
particulate matter that are capable of producing local irritation,
asphyxiation, and systemic toxicity.'' See 74 FR at 67147. It was also
noted that a significant number of individuals with burns to the skin
also have inhalational injury, and the presence of inhalational injury
is a determinant of mortality. VA concluded that this third eligibility
criteria for inhalational injury was a logical outgrowth of section
2306 of Public Law 110-289 that added severe burn injury as a
qualifying disability for special home adaptation grants as the law
made no mention of inhalation injury.
Taken together, the fact that inhalation injury arose from
legislation that only established severe burn injury as a qualifying
injury for specially adapted housing and special home adaptation grants
and that VA's explanation for adding inhalation injury consistently
describes such injury as attributable to combustion or fire
environments and events that could cause severe burn injuries, VA
concluded that the inhalation injury provision of Sec. 3.809a would
only apply to cases where veterans could also be exposed to possible
severe burn injury (e.g., firefighting, escaping a burning building,
etc.)
With regard to inhalation injuries for special home adaptation
grants and PM exposure, VA concludes that the majority of these sources
of particulate matter would not immediately put veterans in danger of
suffering severe burn injury as particulate matter is ubiquitous in the
environment. Therefore, VA will not automatically presume that anyone
who is permanently and totally disabled due to a respiratory illness as
a result of exposure to particulate matter will automatically qualify
for special home adaptation grant (per 38 CFR 3.809a) based on the
eligibility criteria of inhalation injury. Instead, the evidentiary
record must show that the respiratory illness (or residuals) were due
to an event where the possibility of severe burn injury may have
occurred.
Administrative Procedure Act
Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), VA has found that there
is good cause to publish this rule without prior opportunity for
comment and to publish this rule with an immediate effective date. It
is necessary to immediately implement this interim final rule in order
to carry out the VA Secretary's decision to address the needs of
service members and veterans who have been exposed to airborne hazards,
i.e., particulate matter, due to their service in the Southwest Asia
theater of operations, Afghanistan, Syria, Djibouti, or Uzbekistan.
Delay in the implementation of this rule would be contrary to the
public interest.
The new presumptions are entirely pro-claimant in nature. And
because VA has a sufficient scientific basis to support the new
presumptions, continuing to deny 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 timely receive benefits.
Additionally, this could create risks to beneficiaries' welfare and
health that would be exacerbated by any additional delay in
implementation. Due to the complexity and the historical scientific
uncertainty surrounding these issues of airborne hazard exposures and
disease, many veterans who will be affected by this rule have long
borne the burden and expense of their disabilities while awaiting the
results of research
[[Page 42732]]
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.
Further, the Secretary's decision to extend certain VA-administered
benefits to service members and veterans who have been exposed to
airborne hazards, i.e., particulate matter, due to their service in the
Southwest Asia theater of operations, Afghanistan, Syria, Djibouti, or
Uzbekistan requires immediate effect to help them access these benefits
without undue delay, particularly given that the COVID-19 pandemic,
with its sustained adverse economic consequences, may have reduced or
limited their personal resources. 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 finds that there
is good cause to make the rule effective upon publication, for the
reasons discussed above.
For the foregoing reasons, and as explained in further detail in
the interim final rule, the Secretary of Veterans Affairs is issuing
this rule as an interim final rule with an immediate effective date.
However, VA 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 an economically 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 only
individuals, not small entities or businesses, will be affected.
Therefore, pursuant to 5 U.S.C. 605(b), the initial and final
regulatory flexibility analysis requirements of 5 U.S.C. 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
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).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance program numbers and
titles for this rule are 64.101, Burial Expenses Allowance for
Veterans; 64.102, Compensation for Service-Connected Deaths for
Veterans' Dependents; 64.104, Pension for Non-Service-Connected
Disability for Veterans; 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
This regulatory action is a major rule under the Congressional
Review Act, 5 U.S.C. 801-808, because it may result in an annual effect
on the economy of $100 million or more. In accordance with 5 U.S.C.
801(a)(1), VA will submit to the Comptroller General and to Congress a
copy of this regulation and the Regulatory Impact Analysis associated
with the regulation. However, for the reasons explained above, VA has
found that there is good cause to publish this rule with an immediate
effective date, pursuant to 5 U.S.C. 808(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 July 12, 2021 and authorized the undersigned to sign and
submit the document to the Office of the Federal Register for
publication electronically as an official document of the Department of
Veterans Affairs.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of
the Secretary, 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 part 3, subpart A continues to read as
follows:
Authority: 38 U.S.C. 501(a).
0
2. Amend Sec. 3.159 by revising paragraph (c)(4)(i)(B) to read as
follows:
Sec. 3.159 Department of Veterans Affairs assistance in developing
claims.
* * * * *
(c) * * *
(4) * * *
(i) * * *
(B) Establishes that the veteran suffered an event, injury or
disease in service, or has a disease or symptoms of a disease listed in
Sec. Sec. 3.309, 3.313, 3.316, 3.317, and 3.320 manifesting during an
applicable presumptive period provided the claimant has the required
service or triggering event to qualify for that presumption; and
* * * * *
0
3. Add Sec. 3.320 to read as follows:
Sec. 3.320 Claims based on exposure to particulate matter
(a) Service connection based on presumed exposure to particulate
matter--(1) General. Except as provided in paragraph (b) of this
section, a
[[Page 42733]]
disease listed in paragraph (a)(2) of this section shall be service
connected even though there is no evidence of such disease during the
period of service if it becomes 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 defined in
paragraph (a)(4) of this section.
(2) Chronic diseases associated with exposure to particulate
matter. The chronic diseases referred to in paragraph (a)(1) of this
section are the following:
(i) Asthma.
(ii) Rhinitis.
(iii) Sinusitis, to include rhinosinusitis.
(3) Presumption of exposure. A veteran who has a qualifying period
of service as defined in paragraph (a)(4) 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.
(4) 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)(1) 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. 2021-16693 Filed 8-4-21; 8:45 am]
BILLING CODE 8320-01-P