Presumptive Service Connection for Respiratory Conditions Due to Exposure to Particulate Matter, 42724-42733 [2021-16693]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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
------------------------------------------------------------------------
         PICOTS term              Human studies       Non-Human studies
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

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