42724 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Rules and Regulations 

1Originally, 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. 

2NASEM, 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. 

3 Department of Defense Enhanced Particulate 

Matter Surveillance Program (EPMSP) Final Report 

(2008), https://apps.dtic.mil/sti/pdfs/ 

ADA605600.pdf. 

Accessible Format: On request to the 

program contact person listed under FOR

FURTHER INFORMATION CONTACT, 

individuals with disabilities can obtain 

this document in an accessible format. 

The Department will provide the 

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text format (txt), a thumb drive, an MP3 

file, braille, large print, audiotape, or 

compact disc, or other accessible format. 

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the document published in the Federal 

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Specifically, through the advanced 

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the Department. 

Katherine Neas, 

Acting Assistant Secretary for the Office of 

Special Education and Rehabilitative 

Services. 

[FR Doc. 2021–16853 Filed 8–3–21; 4:15 pm] 

BILLING CODE 4000–01–P 

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. 

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 

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

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 


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4National Research Council, Review of the 

Department of Defense Enhanced Particulate Matter 

Surveillance Program Report (2010), https://doi.org/ 

10.17226/12911. 

5NASEM, Long-Term Health Consequences of 

Exposure to Burn Pits in Iraq and Afghanistan 

(2011), https://doi.org/10.17226/13209. 

6NASEM, Respiratory Health Effects of Airborne 

Hazards Exposures in the Southwest Asia Theater 

of Military Operations (2020), https://doi.org/ 

10.17226/25837. 

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). 

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. 

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, LongTerm 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. 

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.’’ 

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 AlMishraq sulfur plant fire, fuels, oil-well 

fires, nerve agents, and depleted 


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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 serviceconnection 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

GW 1 

deployed 

GW 1-era nondeployed GWOT 

deployed 

GWOT-era 

non-deployed 

K2 cohort 

(subset) 

Totals across 

cohorts 

Population Size ........................................ 750,205 2,615,287 2,450,344 2,599,446 15,670 8.4 M 


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7See, 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. 

TABLE 1—AGGREGATE DISABILITY CLAIMS DATA BY COHORT—Continued 

GW 1 

deployed 

GW 1-era nondeployed GWOT 

deployed 

GWOT-era 

non-deployed 

K2 cohort 

(subset) 

Totals across 

cohorts 

Rhinitis 

# 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% 

Sinusitis 

# 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% 

Asthma 

# 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% 

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 policyrelevant 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. 

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 nondeployment 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. 


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8Particulate matter size of 2.5 microns (PM2.5) 

9World 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. 

10See US EPA, Particulate Matter (PM) Basics, 

https://www.epa.gov/pm-pollution/particulatematter-pm-basics. 

11E.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. 

12See, 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 

‘‘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 nonhuman categories. 

Additional SMEs were recruited to 

critically evaluate the strengths and 

weakness of evidence using a semiquantitative 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 Problem.Adults (18–50 years) ....................................................... Relevant model systems (e.g., in-vitro, in-vivo). 

Intervention OR Exposure ... Chronic exposure to particulate matter (PM2.5) air pollution.Acute/chronic exposure to PM2.5.8

Comparator .......................... No exposure (or fine PM levels < federal guidelines) .... No exposure. 

Outcomes ............................. ICD–9/10 codes 9 for respiratory conditions and/or biomarkers consistent with these conditions.Respiratory condition phenotypes and/or observed behaviors. 

Timing .................................. Months to years .............................................................. Days to months. 

Setting .................................. All countries ..................................................................... Not applicable. 

The 2020 NASEM report reviewed 

different types of exposures such as 

open burn pits, emissions from the 2003 

Al-Mishraq sulfur plant fire, fuels, oilwell 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. 

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. 

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 


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discretionary authority to grant a presumption of 

service connection). 

13See 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. 

14Army 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/Environmental

ConditionsatK-2AirBaseUzbekistan_FS_64-038- 

0617.pdf. (accessed July 30, 2021). 

15E.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-inuzbekistan. 

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. 

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. 

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.public

health.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. 

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 veterancentric 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

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 


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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 veterancentric 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 noncompensable 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 § 3.159, the 

regulation regarding VA’s duty to assist 

claimants in developing their claims, 

specifically by adding new § 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 

§§ 3.309, 3.313, 3.316, and 3.317. 

VA is adding new § 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. 


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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 § 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 

§§ 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 § 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 § 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 


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42732 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Rules and Regulations 

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-ServiceConnected 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 

■ 1. The authority citation for part 3, 

subpart A continues to read as follows: 

Authority: 38 U.S.C. 501(a). 

■ 2. Amend § 3.159 by revising 

paragraph (c)(4)(i)(B) to read as follows: 

§ 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 §§ 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 

* * * * * 

■ 3. Add § 3.320 to read as follows: 

§ 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 


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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Rules and Regulations 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 § 3.317(e)(2), 

during the Persian Gulf War as defined 

in § 3.2(i). 

(ii) Afghanistan, Syria, Djibouti, or 

Uzbekistan on or after September 19, 

2001 during the Persian Gulf War as 

defined in § 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2020–0489; FRL–8691–02– 

R3] 

Approval and Promulgation of Air 

Quality Implementation Plans; District 

of Columbia; Nonattainment New 

Source Review Requirements for 2015 

8-Hour Ozone Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a state 

implementation plan (SIP) revision 

submitted by the Department of Energy 

and Environment (DOEE) of the District 

of Columbia (the District). The revision 

will fulfill the District’s Nonattainment 

New Source Review (NNSR) SIP 

element requirement for the 2015 8-hour 

ozone National Ambient Air Quality 

Standard (NAAQS). EPA is approving 

the revision to the District of Columbia 

SIP in accordance with the requirements 

of the Clean Air Act (CAA). 

DATES: This final rule is effective on 

September 7, 2021. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R03–OAR–2020–0489. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Although listed in the index, 

some information is not publicly 

available, e.g., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through https://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Willson, Permits Branch 

(3AD10), Air & Radiation Division, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. The 

telephone number is (215) 814–5795. 

Mr. Willson can also be reached via 

electronic mail at Willson.Matthew@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 11, 2021 (86 FR 8734), EPA 

published a notice of proposed 

rulemaking (NPRM) for the District of 

Columbia. In the NPRM, EPA proposed 

approval of the District’s NNSR 

Certification for the 2015 8-hour ozone 

NAAQS. The formal SIP revision was 

submitted by the District on May 5, 

2020. Specifically, the District certified 

that its existing NNSR program, 

covering the District portion of the 

Washington, DC–MD–VA 

Nonattainment Area (Washington Area) 

for the 2015 8-hour ozone NAAQS, is at 

least as stringent as the requirements at 

40 CFR 51.165, as amended by the final 

rule titled ‘‘Implementation of the 2015 

National Ambient Air Quality Standards 

for Ozone: Nonattainment Area State 

Implementation Plan Requirements’’ 

(SIP Requirements Rule), for ozone and 

its precursors. See 83 FR 62998 

(December 6, 2018). 

On October 1, 2015, EPA promulgated 

a revised 8-hour ozone NAAQS of 0.070 

parts per million (ppm). 80 FR 65292 

(October 26, 2015). Under EPA’s 

regulations at 40 CFR 50.19, the 2015 8- 

hour ozone NAAQS is attained when 

the three-year average of the annual 

fourth-highest daily maximum 8-hour 

average ambient air quality ozone 

concentration is less than or equal to 

0.070 ppm. 

Upon promulgation of a new or 

revised NAAQS, the CAA requires EPA 

to designate as nonattainment any area 

that is violating the NAAQS based on 

the three most recent years of ambient 

air quality data at the conclusion of the 

designation process. The Washington 

Area was classified as marginal 

nonattainment for the 2015 8-hour 

ozone NAAQS on June 4, 2018 (effective 

August 3, 2018) using 2014–2016 

ambient air quality data. 83 FR 25776. 

On December 6, 2018, EPA issued the 

final SIP Requirements Rule, which 

establishes the requirements that state, 

tribal, and local air quality management 

agencies must meet as they develop 

implementation plans for areas where 

air quality exceeds the 2015 8-hour 

ozone NAAQS. 80 FR 65291, October 

26, 2015. Areas that were designated as 

marginal ozone nonattainment areas are 

required to attain the 2015 8-hour ozone 

NAAQS no later than August 3, 2021. 40 

CFR 51.1303 and 83 FR 10376, March 9, 

2018. 

Based on initial nonattainment 

designations for the 2015 8-hour ozone 

NAAQS, as well as the December 6, 

2018 final SIP Requirements Rule, the 

District was required to develop a SIP 

revision addressing certain CAA 

requirements for the Washington Area, 

and submit to EPA a NNSR Certification 

SIP or SIP revision no later than 36 

months after the effective date of area 

designations for the 2015 8-hour ozone 


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