Federal Register / Vol. 87, No. 80 / Tuesday, April 26, 2022 / Rules and Regulations 24421 

§ 30.65 Failure to disclose lead-based 

paint hazards. 

* * * * * 

(b) Amount of penalty. The maximum 

penalty is $19,507 for each violation. 

■ 13. In § 30.68, revise paragraph (c) to 

read as follows: 

§ 30.68 Section 8 owners. 

* * * * * 

(c) Maximum penalty. The maximum 

penalty for each violation under this 

section is $42,788. 

* * * * * 

PART 87—NEW RESTRICTIONS ON 

LOBBYING 

■ 14. The authority citation for part 87 

continues to read as follows: 

Authority: 28 U.S.C. 1 note; 31 U.S.C. 

1352; 42 U.S.C. 3535(d). 

■ 15. In § 87.400, revise paragraphs (a), 

(b), and (e) to read as follows: 

§ 87.400 Penalties. 

(a) Any person who makes an 

expenditure prohibited herein shall be 

subject to a civil penalty of not less than 

$22,021 and not more than $220,213 for 

each such expenditure. 

(b) Any person who fails to file or 

amend the disclosure form (see 

appendix B of this part) to be filed or 

amended if required herein, shall be 

subject to a civil penalty of not less than 

$22,021 and not more than $220,213 for 

each such failure. 

* * * * * 

(e) First offenders under paragraph (a) 

or (b) of this section shall be subject to 

a civil penalty of $22,021, absent 

aggravating circumstances. Second and 

subsequent offenses by persons shall be 

subject to an appropriate civil penalty 

between $22,021 and $220,213 as 

determined by the agency head or his or 

her designee. 

* * * * * 

PART 180—CONSOLIDATED HUD 

HEARING PROCEDURES FOR CIVIL 

RIGHTS MATTERS 

■ 16. The authority citation for part 180 

continues to read as follows: 

Authority: 28 U.S.C. 1 note; 29 U.S.C. 794; 

42 U.S.C. 2000d–1, 3535(d), 3601–3619, 

5301–5320, and 6103. 

■ 17. In § 180.671, revise paragraphs 

(a)(1) through (3) to read as follows: 

§ 180.671 Assessing civil penalties for Fair 

Housing Act cases. 

(a) * * * 

(1) $23,011, if the respondent has not 

been adjudged in any administrative 

hearing or civil action permitted under 

the Fair Housing Act or any State or 

local fair housing law, or in any 

licensing or regulatory proceeding 

conducted by a Federal, State, or local 

governmental agency, to have 

committed any prior discriminatory 

housing practice. 

(2) $57,527, if the respondent has 

been adjudged in any administrative 

hearing or civil action permitted under 

the Fair Housing Act, or under any State 

or local fair housing law, or in any 

licensing or regulatory proceeding 

conducted by a Federal, State, or local 

government agency, to have committed 

one other discriminatory housing 

practice and the adjudication was made 

during the 5-year period preceding the 

date of filing of the charge. 

(3) $115,054, if the respondent has 

been adjudged in any administrative 

hearings or civil actions permitted 

under the Fair Housing Act, or under 

any State or local fair housing law, or in 

any licensing or regulatory proceeding 

conducted by a Federal, State, or local 

government agency, to have committed 

two or more discriminatory housing 

practices and the adjudications were 

made during the 7-year period 

preceding the date of filing of the 

charge. 

* * * * * 

PART 3282—MANUFACTURED HOME 

PROCEDURAL AND ENFORCEMENT 

REGULATIONS 

■ 18. The authority citation for part 

3282 continues to read as follows: 

Authority: 15 U.S.C. 2967; 42 U.S.C. 

3535(d), 5403, and 5424. 

■ 19. Revise § 3282.10 to read as 

follows: 

§ 3282.10 Civil and criminal penalties. 

Failure to comply with these 

regulations may subject the party in 

question to the civil and criminal 

penalties provided for in section 611 of 

the Act, 42 U.S.C. 5410. The maximum 

amount of penalties imposed under 

section 611 of the Act shall be $3,198 

for each violation, up to a maximum of 

$3,997,550 for any related series of 

violations occurring within one year 

from the date of the first violation. 

Damon Y. Smith, 

General Counsel. 

[FR Doc. 2022–08768 Filed 4–25–22; 8:45 am] 

BILLING CODE 4210–67–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2022–0272] 

Safety Zones; Annual Events in the 

Captain of the Port Buffalo Zone— 

Cleveland National Air Show; 

Correction 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation; correction. 

SUMMARY: The Coast Guard is correcting 

a notification of enforcement of 

regulation that appeared in the Federal 

Register on April 20, 2022. That 

notification is entitled ‘‘Safety Zones; 

Annual Events in the Captain of the Port 

Buffalo Zone—Cleveland National Air 

Show.’’ This correction applies to the 

docket number. 

DATES: This correction is effective April 

26, 2022. 

FOR FURTHER INFORMATION CONTACT: For 

information about this document call or 

email Spencer Phillips, Coast Guard; 

telephone 202–372–3854, email 

spencer.phillips@uscg.mil. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2022–08432, appearing on page 23444 

in the Federal Register of Wednesday, 

April 20, 2022, the following correction 

is made: 

1. On page 23444, in the third 

column, in the headings, ‘‘[Docket No. 

USCG–0270]’’ is corrected to read 

‘‘[Docket No. USCG–2022–0272]’’. 

Dated: April 21, 2022. 

James E. McLeod, 

Deputy Chief, Office of Regulations and 

Administrative Law. 

[FR Doc. 2022–08886 Filed 4–25–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AR44 

Presumptive Service Connection for 

Rare Respiratory Cancers Due to 

Exposure to Fine Particulate Matter 

AGENCY: Department of Veterans Affairs. 

ACTION: Interim final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) is issuing this interim final 

rule to amend its adjudication 

regulations to establish presumptive 


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24422 Federal Register / Vol. 87, No. 80 / Tuesday, April 26, 2022 / Rules and Regulations 

1 DeSantis CE, Kramer JL, Jemal A. The burden of 

rare cancers in the United States. CA Cancer J Clin. 

2017 Jul 8;67(4):261–272. 

2 Gatta G, van der Zwan JM, Casali PG, et al. Rare 

cancers are not so rare: The rare cancer burden in 

Europe. Eur J Cancer. 2011;47: 2493–2511. 

3Carol E. DeSantis MPH, Joan L. Kramer MD, 

Ahmedin Jemal DVM, Ph.D. (2017) ‘‘The Burden of 

Rare Cancers in America,’’ CA: A Cancer Journal for 

Clinicians, 67:4, 261–272, available at https://

doi.org/10.3322/caac.21400. 

4See US EPA, Particulate Matter (PM) Basics, 

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

5NASEM, Gulf War and Health Series: Volume 3: 

Fuels and Products of Combustion (2005), https:// 

doi.org/10.17226/11180 and Volume 11: 

Generational Health Effects of Serving in the Gulf 

War (2018), https://doi.org/10.17226/25162. 

National Research Council, Review of the 

Department of Defense Enhanced Particulate Matter 

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

10.17226/12911 (examining Department of Defense 

Enhanced Particulate Matter Surveillance Program 

(EPMSP) Final Report (2008), https://apps.dtic.mil/ 

sti/pdfs/ADA605600.pdf.) NASEM, Long-Term 

Health Consequences of Exposure to Burn Pits in 

Iraq and Afghanistan (2011), https://doi.org/ 

10.17226/13209. NASEM, Respiratory Health 

Effects of Airborne Hazards Exposures in the 

Southwest Asia Theater of Military Operations 

(2020), https://doi.org/10.17226/25837. 

6E.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:// 

service connection for nine rare 

respiratory cancers in association with 

presumed exposure to fine particulate 

matter. These presumptions would 

apply to Veterans with a qualifying 

period of service, i.e., who served on 

active military, naval, or air service in 

the Southwest Asia theater of operations 

during the Persian Gulf War (hereinafter 

Gulf War), as well as in Afghanistan, 

Syria, Djibouti, or Uzbekistan, on or 

after September 19, 2001, during the 

Gulf War. This amendment is necessary 

to implement a decision by the 

Secretary of Veterans Affairs that 

determined there is sufficient evidence 

to support these cancers as presumptive 

based on exposure to fine particulate 

matter during service in the Southwest 

Asia theater of operations, Afghanistan, 

Syria, Djibouti, or Uzbekistan during 

certain periods and the subsequent 

development of the following rare 

respiratory cancers: Squamous cell 

carcinoma (SCC) of the larynx, SCC of 

the trachea, adenocarcinoma of the 

trachea, salivary gland-type tumors of 

the trachea, adenosquamous carcinoma 

of the lung, large cell carcinoma of the 

lung, salivary gland-type tumors of the 

lung, sarcomatoid carcinoma of the 

lung, and typical and atypical carcinoid 

of the lung. The intended effect of this 

amendment is to ease the evidentiary 

burden of this population of Veterans 

who file claims with VA for these nine 

rare respiratory cancers. 

DATES:

Effective date: This interim final rule 

is effective April 26, 2022. 

Comment date: Comments must be 

received on or before June 27, 2022. 

Applicability date: The provisions of 

this interim final rule shall apply to all 

applications for service connection for 

squamous cell carcinoma (SCC) of the 

larynx, SCC of the trachea, 

adenocarcinoma of the trachea, salivary 

gland-type tumors of the trachea, 

adenosquamous carcinoma of the lung, 

large cell carcinoma of the lung, salivary 

gland-type tumors of the lung, 

sarcomatoid carcinoma of the lung, and 

typical and atypical carcinoid of the 

lung based on service in the Southwest 

Asia theater of operations during the 

Gulf War, as well as Afghanistan, Syria, 

Djibouti, or Uzbekistan, on or after 

September 19, 2001, during the Gulf 

War, that are received by VA on or after 

the effective date of this interim final 

rule or that are pending before VA, the 

United States Court of Appeals for 

Veterans Claims, or the United States 

Court of Appeals for the Federal Circuit 

on the effective date of this interim final 

rule. 

ADDRESSES: Comments may be 

submitted through 

www.Regulations.gov. Comments 

received will be available at 

regulations.gov for public viewing, 

inspection, or copies. 

FOR FURTHER INFORMATION CONTACT: Jane 

Allen, Regulations Analyst; Robert 

Parks, Chief, Regulations Staff (211), 

Compensation Service (21C), 810 

Vermont Avenue NW, Washington, DC 

20420, (202) 461–9700. (This is not a 

toll-free telephone number.) 

SUPPLEMENTARY INFORMATION: 

I. Challenges With Rare Cancers 

For the purposes of this rulemaking, 

VA defines rare cancers as cancers with 

an annual U.S. incidence rate of fewer 

than 6 cases per 100,000 individuals. 

This standard was adopted by an 

American Cancer Society paper 1 that 

includes the nine rare respiratory 

cancers that are being presumptively 

service connected. The standard has 

also been adapted internationally; a 

consortium from the European Union, 

Surveillance of Rare Cancer in Europe 

(RARECARE), described the burden of 

rare cancers in Europe using a revised 

definition of rare cancers as those with 

fewer than 6 cases per 100,000 people 

per year.2

Due to low incidence rates, 

individuals diagnosed with rare cancers 

face challenges not shared by those 

diagnosed with more common forms of 

cancer. Diagnosis often occurs when the 

cancer has metastasized to other areas of 

the body. Rare cancers are also more 

difficult to treat based on limited 

preclinical research and fewer clinical 

trials. Prevalence rates are so low that it 

is unlikely that any epidemiologic or 

other study will elucidate a cause as 

may occur with more common cancers. 

Furthermore, once diagnosed, 

individuals often struggle to locate 

information about their cancer, and 

treatment options are often less effective 

than for common cancers. As a result of 

these challenges, five-year relative 

survival is lower for patients with a rare 

cancer compared with those diagnosed 

with a more common cancer among 

both males (55% vs 75%) and females 

(60% vs 74%).3

II. Presumptive Service Connection 

Based on Presumed Exposure to Fine 

Particulate Matter (PM2.5) 

Particulate matter (PM) (also called 

particle pollution) is a form of air 

pollution consisting of solid particles 

and liquid droplets. PM is comprised of 

particles of various sizes, with fine 

particles (PM2.5, particles that have a 

mean aerodynamic diameter ≤2.5 

microns) posing the greatest health 

concern because they can be inhaled, 

get deep into the lungs, and potentially 

enter the bloodstream where they can 

affect the heart and other organ systems 

resulting in serious health problems.4

VA published an interim final rule (86 

FR 42724) on August 5, 2021, that 

established presumptive service 

connection for asthma, sinusitis, and 

rhinitis due to presumed exposure to 

PM2.5 during the Gulf War (38 CFR 

3.320). VA defines the Gulf War as 

beginning on August 2, 1990 and there 

is currently no prescribed end date for 

the Gulf War (38 CFR 3.2). The interim 

final rule included a description of 

several studies by the National 

Academies of Science, Engineering, and 

Medicine (NASEM) and National 

Research Council (NRC) examining the 

possible contribution of air pollution to 

adverse health effects among U.S. 

military personnel serving in the Middle 

East or their descendants.5

Based on studies that described 

particulates in Southwest Asia,6 VA 


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www.tandfonline.com/doi/full/10.1080/ 

08958370802464299. 

7See US EPA, Particulate Matter (PM) Basics, 

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

8 Department of Defense Enhanced Particulate 

Matter Surveillance Program (EPMSP) Final Report 

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

ADA605600.pdf. 

9National Research Council, Review of the 

Department of Defense Enhanced Particulate Matter 

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

10.17226/12911. 

10NASEM, Long-Term Health Consequences of 

Exposure to Burn Pits in Iraq and Afghanistan 

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

11NASEM, Respiratory Health Effects of Airborne 

Hazards Exposures in the Southwest Asia Theater 

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

10.17226/25837. 

determined that exposures to such 

particulate matter could present a health 

risk to service members. In its prior 

rulemaking, VA acknowledged the 

challenges associated with conducting 

exposure-assessment/health 

surveillance studies in times of conflict 

and that that precise or specific 

information on individual veterans’ 

exposures that would be needed to 

support more granular policy is 

generally not available. 

Prior to establishment of 38 CFR 

3.320, VA conducted a supplemental 

literature review focused on PM2.5.7 The 

focus on PM2.5 was intentional for the 

following reasons: (1) PM2.5 is generated 

by a variety of sources including smoke 

from open burn pits, (2) the DoD’s 

Enhanced Particulate Matter 

Surveillance Program objectively 

measured in-theater concentrations and 

documented concentrations of PM2.5

that may have exceeded military and 

national exposure guidelines at 

deployment locations, and (3) its small 

diameter facilitates greater deposition 

deep into the lung with known harmful 

effects. As discussed further below, VA 

also conducted a review of claims data 

in conjunction with the supplemental 

review. 

a. 2010 NRC Report, Review of the 

Department of Defense (DoD) Enhanced 

Particulate Matter Surveillance Program 

In February 2008 the DoD issued the 

Department of Defense Enhanced 

Particulate Matter Surveillance Program 

(EPMSP) Final Report.8 The purpose of 

the study was to provide information on 

the chemical and physical properties of 

dust collected at deployment locations. 

Aerosol and bulk soil samples were 

collected during a period of 

approximately one year at 15 military 

sites—including Djibouti, Afghanistan 

(Bagram, Khowst), Qatar, United Arab 

Emirates, Iraq (Balad, Baghdad, Tallil, 

Tikrit, Taji, Al Asad), and Kuwait 

(Northern, Central, Coastal, and 

Southern regions). The EPMSP report 

found that exposures in the region may 

have exceeded military/national 

exposure guidelines, including EPA’s 

24-hr NAAQS for PM2.5 (see p.4 and p. 

8, Figure 4–1). 

The NRC independently reviewed 

DoD’s final report in Review of the 

Department of Defense Enhanced 

Particulate Matter Surveillance Program 

Report in 2010.9 The NRC committee 

highlighted that the EPMSP was one of 

the first large-scale efforts to 

characterize particulate matter exposure 

in deployed military personnel. Despite 

the practical challenges of conducting 

this effort in an austere deployment 

environment, the NRC report found the 

results of the EMPSP can be viewed as 

providing sufficient evidence that 

deployed military personnel endured 

occupational exposure to a potential 

hazard to justify implementation of a 

comprehensive medical-surveillance 

program to assess particulate matterrelated health effects in military 

personnel deployed to the Southwest 

Asia theater of operations. 

The NRC committee noted the 

EPMSP’s approach and methodological 

techniques preclude comparison to 

existing literature on air sampling and 

limit a full understanding of particulate 

matter chemical composition. The study 

also describes the challenges associated 

with conducting exposure-assessment/ 

health surveillance studies, including 

related to: The need to have codeployed medical/public health experts 

to conduct sampling; limitations in 

monitoring technologies in harsh 

environments for which they have not 

been validated and where they may 

overestimate concentrations due to 

bounce-off problems, limitations in 

DoD’s health effects studies, difficulties 

in characterization of exposure of troops 

to multiple sources (dust storms, vehicle 

emissions, and emissions from burn 

pits), and potential confounding factors 

(such as smoking). This along with the 

infrequency of sampling as well as the 

lack of consideration of other ambient 

pollutants in the deployment 

environment make it challenging to 

fully ascertain the relationship between 

exposure data and health effects. 

Despite these limitations, the NRC 

committee found that the EPMSP results 

clearly documented that service 

members deployed to the Southwest 

Asia theater of operations ‘‘are exposed 

to high concentrations of particulate 

matter and that the particle composition 

varies considerably over time and 

space.’’ Further, the NRC Report 

committee concluded that ‘‘it is indeed 

plausible that exposure to ambient 

pollution in the Middle East theater is 

associated with adverse health 

outcomes.’’ The health outcomes noted 

may occur both during service (acute) as 

well as manifest years after exposure 

(chronic). 

b. 2011 NASEM Report, Long-Term 

Consequences of Exposure to Burn Pits 

in Iraq and Afghanistan 

To further address and investigate 

service member exposures, VA 

requested that NASEM examine the 

long-term health consequences of 

service members’ exposure to open burn 

pits while serving in Iraq and 

Afghanistan. In NASEM’s report, 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.10 The 

report also recommended that VA 

expand its research studies beyond burn 

pits to explore the role of a broader 

range of possible airborne hazards. 

c. 2020 NASEM Report: Respiratory 

Health Effects of Airborne Hazards 

Exposures in the Southwest Asia 

Theater of Military Operations 

In September 2018, the VA Post 

Deployment Health Services (PDHS), 

now called Health Outcomes Military 

Exposures (HOME), asked NASEM to 

study the respiratory health effects of 

airborne hazards exposures in 

Southwest Asia. On September 11, 

2020, NASEM published its findings 

and recommendations in the report, 

Respiratory Health Effects of Airborne 

Hazards Exposures in the Southwest 

Asia Theater of Military Operations.11

According to the report, ‘‘[b]ased on the 

epidemiologic studies of military 

personnel and veterans reviewed in this 

and previous National Academies 

reports, the committee concludes that 

there is inadequate or insufficient 

evidence of an association between 

airborne hazards exposures in the 

Southwest Asia theater and the 

subsequent development of respiratory 

cancers. While data exist on 1990–1991 

Gulf War veterans, the committee notes 

that no studies have been published 

concerning those who participated in 

the post-9/11 conflicts and that—even if 

such studies were available—the 

amount of time since exposure may only 

now be long enough to justify new 

incidence studies of respiratory cancers 

in this cohort.’’ 

More generally, the 2020 NASEM 

report identified that existing studies 

were limited in the available data for 


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12RARECARENet, http://

rarecarenet.istitutotumori.mi.it/rarecarenet/. 

13 GARD, Genetic and Rare Disease Information 

Center, https://rarediseases.info.nih.gov/. 

14U.S. EPA. Integrated Science Assessment (ISA) 

for Particulate Matter (Final Report, Dec 2019). U.S. 

Environmental Protection Agency, Washington, DC, 

EPA/600/R–19/188, 2019, available at http://

www.epa.gov/isa. 

15 Id. at Figure 10–3 and 10–60. 

16 Id. 

exposure estimation; the availability of 

pertinent health, physiologic, 

behavioral, and biomarker data, 

especially data collected both pre- and 

post-deployment; the amount of time 

that passed since exposure; and use of 

additional or alternate sources of data 

that might enrich analyses. The NASEM 

committee, noting that the limitations in 

data quality prevented scientific 

determinations regarding health 

outcomes, recommended that a new 

approach was needed to allow 

researchers to better examine and 

respond to whether specific respiratory 

outcomes are associated with 

deployment. 

III. VA’s Identification of Nine Rare 

Respiratory Cancers Through a Review 

of Data From NIH/Office of Rare 

Disease Research 

Following publication of the interim 

final rule (86 FR 42724) mentioned 

above, VA began a focused review of the 

scientific and medical evidence related 

to exposure to PM2.5 and the subsequent 

development of rare respiratory cancers. 

VA initiated this review to address the 

needs of veterans diagnosed with rare 

cancers. 

VA’s HOME office obtained publicly 

available data on rare cancers from the 

Office of Rare Disease Research, 

National Center for Advancing 

Translational Sciences (NCATS), in the 

National Institute of Health (NIH). The 

data was then cross-referenced with 

data from the 2017 publication, The 

Burden of Rare Cancers in America. 

This 2017 study analyzed rare cancers 

in the United States using invasive 

cancers found on the RARECARE list. 

The RARECARE list is a rare cancer 

surveillance list based in Europe that is 

often used by US researchers.12 The 

HOME office found 181 rare cancers 

with less than 6/100,000 incidence and 

13 very rare cancers with less than 25 

cases in 5 years. The incidence data 

came from the North American 

Association of Central Cancer Registries 

and the Surveillance, Epidemiology, 

and End Results (SEER) program, both 

resources from the National Cancer 

Institute within NIH. A secondary 

source were data from the Office of Rare 

Disease Research, NCATS; NIH. These 

data listed 275 rare diseases and 

includes mainly cancers with available 

genetic data. This information matches 

closely with a public list of rare diseases 

on the NIH’s The Genetic and Rare 

Diseases Information Center (GARD) 

website.13 Rare cancers present in 

pediatric populations, or that are 

developmental, genetic, syndromic, or 

congenital were excluded. This reduced 

the list to 153 rare cancers after 

duplicates were removed. 

VA noted then that there were nine 

rare cancers of the respiratory tract: 

Squamous cell carcinoma (SCC) of the 

larynx, SCC of the trachea, 

adenocarcinoma of the trachea, salivary 

gland-type tumors of the trachea, 

adenosquamous carcinoma of the lung, 

large cell carcinoma of the lung, salivary 

gland-type tumors of the lung, 

sarcomatoid carcinoma of the lung, and 

typical and atypical carcinoid of the 

lung. These nine respiratory cancers are 

exceptionally rare and therefore 

definitive literature demonstrating an 

etiology, or lack thereof, is not available 

and it is not anticipated that it will 

become available. The HOME office 

then performed a supplemental 

literature review of the nine identified 

rare cancers. Scientific literature on 

these cancers is extremely limited. The 

HOME office located and reviewed at 

least one peer-reviewed source on each 

rare respiratory cancer (available for 

download under the ‘‘Supporting/ 

Related Materials’’ section). This 

literature search demonstrated the 

paucity of other supporting 

epidemiological or etiologic information 

from which to derive conclusions on the 

associations between exposures and the 

development of these rare respiratory 

cancers. This does not indicate that 

there is no connection, it indicates there 

is not data or published literature to 

definitively establish a connection. 

IV. The Environmental Protection 

Agency’s (EPA) 2019 Integrated Science 

Assessment (ISA) for Particulate Matter 

The EPA is responsible for 

establishing and periodically reviewing 

National Air Ambient Quality Standards 

(NAAQS) for six principal criteria 

pollutants, which include particulate 

matter, carbon monoxide, nitrogen 

dioxide, lead, ozone, and sulfur dioxide 

to protect public health and welfare. To 

support this mission, the EPA develops 

Integrated Science Assessments (ISAs) 

as part of the periodic review of the 

NAAQS for each criteria pollutant. The 

ISAs provide comprehensive reviews of 

the policy-relevant scientific literature 

related to the health and welfare effects 

of a criteria pollutant and form the 

scientific foundation for each NAAQS 

review. 

The EPA’s 2019 ISA for Particulate 

Matter (2019 p.m. ISA) provides a 

thorough evaluation of the scientific 

evidence pertaining to the relationship 

between PM exposure, including 

exposure to PM2.5, and multiple health 

outcomes, including cancer. Within the 

discussion of long-term PM2.5 exposure 

and cancer, the 2019 p.m. ISA evaluates 

and characterizes the scientific evidence 

that supports a biologically plausible 

mechanism by which long-term PM2.5

exposure could lead to the development 

of cancer, such as lung cancer. As noted 

in Section 10.2 of the 2019 p.m. ISA: 

‘‘PM2.5 exhibits several key 

characteristics of carcinogens (Smith et 

al., 2016), as shown in toxicological 

studies demonstrating genotoxic effects, 

oxidative stress, electrophilicity, and 

epigenetic alterations, with supportive 

evidence provided by epidemiologic 

studies. Furthermore, PM2.5 has been 

shown to act as a tumor promoter in a 

rodent model of urethane-initiated 

carcinogenesis.’’ 14 The body of 

scientific evidence indicating that PM2.5

exhibits multiple characteristics of a 

carcinogen provides biological 

plausibility for the generally consistent, 

positive associations between long-term 

PM2.5 exposure and lung cancer 

mortality and incidence reported in 

epidemiologic studies,15 resulting in the 

2019 p.m. ISA concluding that there is 

a ‘‘likely to be causal’’ relationship 

between long-term PM2.5 exposure and 

cancer. 

V. Biological Plausibility of Rare 

Respiratory Cancers 

Drawing on conclusions from EPA’s 

2019 p.m. ISA for cancer and their 

evaluation of the evidence for lung 

cancer incidence and mortality, VA has 

determined that it is biologically 

plausible that the mechanisms by which 

PM2.5 may lead to the development of 

lung cancer can be applied to the 

development of rare cancers in the lung 

and can also be applied to development 

of rare cancers of the respiratory tract. 

Scientific evidence provides a 

biologically plausible link by which 

exposure to PM2.5, which often includes 

some known human carcinogens (e.g., 

hexavalent chromium, nickel, arsenic, 

and PAHs), can lead to respiratory tract 

inflammation as well as genotoxicity 

(i.e., DNA damage) and epigenetic 

effects that can result in dysregulated 

cell growth and ultimately cancer.16

VA acknowledges that the 

epidemiological studies evaluated in the 


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17 Kristen M. Fedak, Autumn Bernal, Zachary A. 

Capshaw, Sherilyn Gross, ‘‘Applying the Bradford 

Hill criteria in the 21st century: How data 

integration has changed causal inference in 

molecular epidemiology,’’ Emerging Themes in 

Epidemiology, 12, 14 (2015): doi:10.1186/s12982- 

015-0037-4. 

18 International Agency for Research on Cancer. 

IARC monographs on the evaluation of 

carcinogenic risks to humans, volume 109. Outdoor 

Air Pollution. Lyon, France: IARC; 2013 Available 

from: https://publications.iarc.fr/Book-And-ReportSeries/Iarc-Monographs-On-The-Identification-OfCarcinogenic-Hazards-To-Humans/Outdoor-AirPollution-2015. 

19U.S. EPA. Integrated Science Assessment (ISA) 

for Particulate Matter (Final Report, Dec 2019). U.S. 

Environmental Protection Agency, Washington, DC, 

EPA/600/R–19/188, 2019, available at http://

www.epa.gov/isa. 

20See VA, Presumptive Service Connection for 

Respiratory Conditions Due to Exposure to 

Particulate Matter, 86 FR 42724. 

21See, 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). 

22See id. 

23See 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, 

Continued 

2019 p.m. ISA that report generally 

consistent and positive associations 

between long-term PM2.5 exposures and 

lung cancer mortality and incidence are 

not appropriate to extend to the rare 

cancers under consideration here. As 

discussed further below, 

epidemiological data for rare cancers is 

extremely limited. 

Additionally, VA’s HOME office and 

Compensation Service analyzed rare 

respiratory cancer related claims data 

for Veterans who were deployed to the 

Southwest Asia theater of operations, as 

well as Afghanistan, Syria, Djibouti, and 

Uzbekistan. VA’s HOME office and 

Compensation Service also compared 

the VBA claims data to data for a similar 

cohort of Veterans who served during 

the same period but who had never 

deployed. Comparison of cohorts 

showed no meaningful difference 

between the number of claims received 

and also no meaningful difference 

between grant and denial rates. As of 

September 30, 2021, the VA had 

received a total of 151 claims for the 

nine rare respiratory cancers identified 

by the HOME office from Veterans with 

Gulf War service. 

Although claims data did not 

demonstrate a significant difference 

between cohorts, which could be 

informative with respect to considering 

a presumption of service connection, 

VA notes the potential for biological 

plausibility between airborne hazards, 

specifically PM2.5, and carcinogenesis of 

the respiratory tract. VA utilized the 

Bradford Hill criteria to conclude that 

there were possible relationships with 

these nine rare cancers and exposure to 

PM2.5. The Bradford Hill criteria are 

used widely in public health research to 

establish epidemiologic evidence of a 

causal relationship between a presumed 

cause and an observed effect.17 While 

there are limited claims data available to 

suggest otherwise, the nine rare 

respiratory system cancers were 

identified as meeting the minimum 

standard for the Bradford Hill principle 

of biological plausibility. The remaining 

Bradford Hill criteria were applied and 

the nine rare respiratory cancers 

additionally met the criteria of analogy. 

VA is employing the analogy of the 

demonstrable effects of PM2.5 on the 

development of lung cancers to these 

nine respiratory cancers. 

To inform application of these criteria 

for the nine rare respiratory cancers, VA 

references analogy between the link 

between PM2.5 and lung cancer. In 2013, 

the International Agency for Research 

on Cancer (IARC) classified outdoor air 

pollution and one of its major 

components, PM, as carcinogenic. In its 

evaluation, the IARC identified 

sufficient evidence showing that 

exposure to outdoor air pollution and 

PM causes lung cancer.18 EPA’s 2019 

PM ISA also supports the link between 

particulate matter and lung cancer 19

The VA experts maintain that the 

Veterans deployed to the Southwest 

Asia theater of operations, Afghanistan, 

Syria, Djibouti, and Uzbekistan can 

reasonably infer exposure to PM2.5 can 

be an etiology for respiratory cancers. 

Although VA’s HOME office reviewed 

a number of resources related to rare 

respiratory cancers (available for 

download under the ‘‘Supporting/ 

Related Materials’’ section), the 

literature supporting a link between 

PM2.5 and malignant transformation of 

cells in other organ systems is as limited 

as the link to these nine rare respiratory 

cancers. Thus, based on the scientific 

evidence providing biological 

plausibility for lung cancer, VA 

concluded that it is only biologically 

plausible that PM2.5 exposure could lead 

to the nine rare respiratory cancers. 

However, VA is continuing its scientific 

review of other malignancies, both rare 

and more common. VA remains 

committed to cancer surveillance, 

research and review of peer reviewed 

science, and plans to review the more 

robust body of research that exists for 

more common types of cancers to 

evaluate the relationship between these 

cancers and military environmental 

exposures. 

VI. Gulf War Service 

In its recent rulemaking, VA 

established a presumption of exposure 

to PM2.5 for Veterans deployed in the 

Southwest Asia theater of operations, as 

defined in 38 CFR 3.317(e)(2), including 

Iraq, Kuwait, Saudi Arabia, the neutral 

zone between Iraq and Saudi Arabia, 

Bahrain, Qatar, the United Arab 

Emirates, Oman, the Gulf of Aden, the 

Gulf of Oman, the Persian Gulf, the 

Arabian Sea, and the Red Sea during the 

Gulf War.20 VA acknowledges that there 

are important differences between 

potential exposures experienced by 

deployed service members and the 

populations in the studies relied upon 

by the 2019 PM ISA, and that there are 

limitations in evidence specific to 

deployed service members, as discussed 

above, as well as in the body of 

evidence surrounding rare respiratory 

cancers. In the context of regulating 

potential service connection related to 

presumed exposure and benefits there is 

a strong role for policy decisions.21 The 

Secretary’s broad discretion weighs 

more strongly here than it would if the 

science related to the composition and 

duration of actual particulate matter and 

airborne hazard exposures of service 

members were more robust. As 

discussed further below, an important 

consideration in establishing these new 

presumptions for nine rare respiratory 

cancers is that additional investment in 

studying these rare cancers is unlikely 

to fully resolve scientific uncertainty 

related to service connection due to the 

small size of the impacted population. 

Based on presumed PM2.5 exposures 

and its findings above, VA is 

establishing a presumption of service 

connection for the nine rare respiratory 

cancers, for the service periods and 

manifestation timelines that follow. 

VII. Service in Afghanistan, Syria, and 

Djibouti on or After September 19, 2001 

The presumption of exposure to PM2.5

also applies to Afghanistan, Syria, and 

Djibouti for those deployed there on or 

after September 19, 2001, the earliest 

date when service members were 

deployed in these locations.22 As 

discussed in the preamble to the interim 

final rule that established section 3.320, 

the literature and studies 

overwhelmingly show the prevalence of 

PM2.5 due to the nature of the arid 

climate in these locations as well.23 VA 


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available at https://uneplive.unep.org/redesign/ 

media/docs/assessments/global_assessment_of_

sand_and_dust_storms.pdf. 24 Army Public Health Center, Environmental 

Conditions at Karshi Khanabad (K–2) Air Base, 

Uzbekistan, Fact Sheet 64–038–0617, https://

phc.amedd.army.mil/ 

PHC%20Resource%20Library/ 

EnvironmentalConditionsatK-2AirBaseUzbekistan_

FS_64-038-0617.pdf. (accessed July 30, 2021). 

determined that the Southwest Asia 

theater of operations, Afghanistan, 

Syria, and Djibouti had similar arid or 

semi-arid climates with periods of high 

winds to suspend geologic dusts and 

regional pollutants, adhered to or a part 

of these dusts, though the composition 

of PM2.5 varies in different regions. 

Therefore, VA included Afghanistan, 

Syria, and Djibouti as qualifying 

locations for presumption of service 

connection based on presumed 

exposure to PM2.5. 

As the literature and studies 

overwhelmingly demonstrate the 

prevalence of PM2.5 in these locations, 

VA included Afghanistan, Syria, and 

Djibouti in addition to the Southwest 

Asia theater of operations, as qualifying 

locations for the presumption of 

exposure to PM2.5 for purposes of 

service connection for the nine rare 

respiratory cancers. 

VIII. Service in Uzbekistan on or After 

September 19, 2001 

As discussed in the preamble to the 

interim final rule that established 

section 3.320, in March 2020, the Army 

Public Health Center issued, 

Environmental Conditions at Karshi 

Khanabad (K–2) Air Base, Uzbekistan, 

to provide information to service 

members and Veterans on 

environmental exposures at the K–2 Air 

Base and the risk of potential long-term 

adverse health effects related to such 

deployment.24 It noted that service 

members, mostly Army, Air Force, and 

some Marines, were stationed at the air 

base Camp Stronghold Freedom from 

October 2001 to November 2005. This 

fact sheet referenced the results of three 

declassified assessments conducted by 

the DoD, namely the Environmental Site 

Characterization and an Operational 

Health Risk Assessment completed in 

2001 and follow-up Post-Deployment 

Occupational and Environmental Health 

Site Assessments completed in 2002 

and 2004. The collective findings of 

these assessments found the K–2 Air 

Base often had high levels of dust and 

other particulate matter in the air, 

depending upon the season and weather 

conditions, but also noted significantly 

high levels of dust during dust storms. 

The fact sheet concluded that there was 

inconclusive evidence that there is an 

increased risk of chronic respiratory 

conditions associated with military 

deployment to K–2 Air Base. It was 

noted that DoD was collaborating with 

VA and independent researchers to 

further evaluate the potential long-term 

health risks related to deployment 

exposures. 

Based on these findings regarding 

particulate matter exposure at the K–2 

Air Base, VA established a presumption 

of exposure to PM2.5 for those service 

members who were deployed to 

Uzbekistan on or after September 19, 

2001. VA acknowledged that this 

presumption covers a greater geographic 

area and time frame than the other 

studies annotated in this document. 

However, VA believes this is a Veterancentric approach that enhances its 

operational efficiencies by simplifying 

the decision making necessary for 

claims adjudication. 

IX. Manifestation Period 

When VA established presumptions 

of service connection for asthma, 

rhinitis, and sinusitis, to include 

rhinosinusitis, it imposed a requirement 

that for such diseases to be 

presumptively service connected, they 

must have become manifest to any 

degree, including non-compensable, 

within 10 years from the date of 

separation from military service that 

includes a qualifying period of service. 

As explained in the preamble to that 

rule, that requirement was based on a 

review of the available scientific and 

medical evidence, including human and 

epidemiological studies that showed the 

manifestation of those conditions did 

not exceed 10 years. 

However, VA is not imposing a 

manifestation period requirement with 

respect to the nine rare respiratory 

cancers. Unlike asthma, rhinitis, and 

sinusitis, cancers may have varying 

latency periods and also have longer 

latency periods, even up to decades. 

Given the uncertain and potential long 

latency period between exposure and 

malignant transformation of these rare 

cancers, there is no time limit between 

the Veteran’s service and the 

development of disease for the purpose 

of this presumption. Thus, VA will 

presume that the nine rare respiratory 

cancers are service connected if 

manifested to any degree (including 

non-compensable) at any time following 

separation from a qualifying period of 

military service. 

X. Statutory Provisions 

The Persian Gulf War Veterans Act of 

1998, Public Law 105–277, (codified at 

38 U.S.C. 1118), and the Veterans 

Programs Enhancement Act of 1998, 

Public Law 105–368, directed the 

Secretary of Veterans Affairs to enter 

into an agreement with NASEM to 

review and evaluate available scientific 

evidence regarding associations between 

illnesses and agents, hazards, or 

medicine or vaccine to which service 

members may have been exposed during 

the Gulf War. NASEM provided biennial 

reports to VA assessing whether a 

statistical association exists between 

exposure to an agent, hazard, or 

medicine or vaccine and the onset of 

diseases. Based on the NASEM reports 

and all other sound medical and 

scientific information and analysis 

available, VA would then determine 

whether a positive association exists 

between certain exposures and the 

occurrence of any disease. 38 U.S.C. 

1118 defines ‘‘positive association’’ to 

mean that the credible evidence for an 

association is equal to or outweighs the 

credible evidence against an association. 

If a positive association existed, VA 

would publish regulations establishing 

presumptive service connection for that 

illness. 

The statutory provision at 38 U.S.C. 

1118 that outlined the procedure for 

establishing presumptions based on 

Gulf War service expired on October 1, 

2018. However, 38 U.S.C. 501(a)(1) 

provides that ‘‘[t]he Secretary has 

authority to prescribe all rules and 

regulations which are necessary or 

appropriate to carry out the laws 

administered by [VA] and are consistent 

with those laws, including . . . 

regulations with respect to the nature 

and extent of proof and evidence and 

the method of taking and furnishing 

them in order to establish the right to 

benefits under such laws.’’ The 

Secretary may create presumptions for 

conditions based on exposure to 

particulate matter under Congress’ 

broad delegation of general regulatory 

authority in 38 U.S.C. 501(a)(1), 

provided there is a rational basis for the 

presumptions. NOVA v. Sec’y of 

Veterans Affairs, 669 F.3d 1340, 1348 

(Fed. Cir. 2012) (‘‘A regulation is not 

arbitrary or capricious if there is a 

‘rational connection between the facts 

found and the choice made.’ ’’ (quoting 

Motor Vehicle Mfrs. Ass’n. of the U.S. v. 

State Farm Mut. Auto. Ins. Co., 463 U.S. 

29, 43 (1983)).’’ 

XI. Effective Dates 

This rule applies to claims received 

by VA on or after the effective date of 

the rule and to claims pending before 

VA, the United States Court of Appeals 

for Veterans Claims, and the United 

States Court of Appeals for the Federal 

Circuit on that date. This rule will not 

apply retroactively to claims previously 

adjudicated. This will ensure that VA 


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adheres to the provisions of its change 

of law regulation, 38 CFR 3.114, 

provides that when pension, 

compensation, dependency and 

indemnity compensation is awarded or 

increased pursuant to a liberalizing law, 

or a liberalizing VA issue approved by 

the Secretary or by the Secretary’s 

direction, the effective date of such 

award or increase will be fixed in 

accordance with the facts found, and 

will not be earlier than the effective date 

of the act or administrative issue. See 

also 38 U.S.C. 5110(g). 

Additionally, VA will maintain its 

consistent historical practice of making 

new presumptions effective on a 

prospective basis, both to avoid tension 

with the legal principles discussed 

above and for the sake of fairness to 

other veteran cohorts. 

XII. Regulatory Amendment 

The Secretary of Veterans Affairs has 

determined that the available scientific 

and medical evidence is sufficient to 

warrant a presumption of service 

connection for nine rare respiratory 

cancers due to presumed exposure to 

PM2.5 during the Gulf War. Based on 

presumed exposure to PM2.5, VA is 

recognizing a presumption of service 

connection for squamous cell carcinoma 

(SCC) of the larynx, SCC of the trachea, 

adenocarcinoma of the trachea, salivary 

gland-type tumors of the trachea, 

adenosquamous carcinoma of the lung, 

large cell carcinoma of the lung, salivary 

gland-type tumors of the lung, 

sarcomatoid carcinoma of the lung, and 

typical and atypical carcinoid of the 

lung. 

The principles guiding the Secretary’s 

determination include the rarity of the 

conditions, catastrophic nature of the 

diseases, biological plausibility, analogy 

to lung cancer, and the reality that these 

conditions present a situation where it 

may not be possible to develop 

additional evidence one way or another. 

With respect to the nine rare cancers, 

the Secretary’s determination is 

supported by the biological plausibility 

between airborne hazards, specifically 

PM2.5, and carcinogenesis of the 

respiratory tract. This determination 

also took into consideration the 

debilitating nature of these rare cancers, 

and the unique challenges faced by 

Veterans with a rare respiratory cancer 

diagnosis. 

Additionally, the Secretary found that 

further research is unlikely to provide 

more conclusive evidence due to 

disease rarity. Due to the extremely low 

incidence rates, rare cancers defy both 

epidemiologic study and the study of 

pathophysiologic and potential 

environmental mechanisms. Published 

exposure studies are typically case 

reports. Faced with the challenges 

posed by conditions that are rare, 

devastating, and for which there is an 

argument for biological plausibility, but 

due to that same rarity may defy the 

timely development of clearer evidence, 

the Secretary of Veterans Affairs has 

opted to resolve the issue in favor of 

making sure VA does all it can for 

vulnerable veterans. 

Therefore, under the general 

rulemaking authority at 38 U.S.C. 

501(a), the Secretary of Veterans Affairs 

is establishing presumptive service 

connection for Veterans who were 

deployed to the Southwest Asia theater 

of operations as well as Afghanistan, 

Syria, Djibouti, or Uzbekistan during 

certain periods and who subsequently 

develop any of the following rare 

respiratory cancers at any time after 

discharge from military service: 

Squamous cell carcinoma (SCC) of the 

larynx, SCC of trachea, adenocarcinoma 

of the trachea, salivary gland-type 

tumors of the trachea, adenosquamous 

carcinoma of the lung, large cell 

carcinoma of the lung, salivary glandtype tumors of the lung, sarcomatoid 

carcinoma of the lung, and typical and 

atypical carcinoid of the lung. 

To accomplish these changes, VA is 

renumbering existing paragraphs (a)(3) 

and (a)(4) as (a)(4) and (a)(5) 

respectively. VA is inserting a new 

paragraph (a)(3), which addresses the 

rare cancers associated with exposure to 

fine particulate matter as explained in 

the preamble. New paragraph (a)(3) 

states that the listed rare cancers will be 

service connected if manifested to any 

degree (including non-compensable) at 

any time following separation from a 

qualifying period of military service and 

lists the nine noted rare cancers. 

Additionally, because the rare cancers 

are not subject to a manifestation 

period, but the chronic diseases listed in 

paragraph (a)(2) are still subject to the 

10-year manifestation period as 

described in current paragraph (a)(1), 

VA is moving that 10-year manifestation 

period requirement from paragraph 

(a)(1) to paragraph (a)(2). Finally, VA is 

correcting a clerical error in the 

introductory text of paragraph (b). The 

text refers incorrectly refers to diseases 

listed in paragraph (a)(1), but is being 

corrected to refer to diseases listed in 

paragraphs (a)(2) and (3). 

VA is committed to improving the 

delivery of health care and benefits to 

Veterans affected by exposure to 

airborne hazards during military service 

and will continue all cancer 

surveillance and literature review 

regarding possible associations of other 

cancers and respiratory hazards in the 

Southwest Asia theater of operations, 

Afghanistan, Syria, Djibouti, and 

Uzbekistan. 

Administrative Procedure Act 

Pursuant to 5 U.S.C. 553(b)(B) and 

(d)(3), VA finds that there is good cause 

to publish this rule without prior 

opportunity for public comment and 

good cause to publish this rule with an 

immediate effective date. Section 

553(b)(B) provides that a regulation may 

be issued without prior opportunity for 

public comment when an agency for 

good cause finds ‘‘that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest.’’ It is necessary to immediately 

implement this interim final rule to 

carry out the Secretary of Veterans 

Affairs’ decision to address the needs of 

soon-to-be discharged service members 

and Veterans who have been exposed to 

airborne hazards, i.e., PM2.5, due to their 

service in the Southwest Asia theater of 

operations, Afghanistan, Syria, Djibouti, 

or Uzbekistan, and who subsequently 

develop squamous cell carcinoma (SCC) 

of the larynx, SCC of the trachea, 

adenocarcinoma of the trachea, salivary 

gland-type tumors of the trachea, 

adenosquamous carcinoma of the lung, 

large cell carcinoma of the lung, salivary 

gland-type tumors of the lung, 

sarcomatoid carcinoma of the lung, or 

typical and atypical carcinoid of the 

lung. Delay in the implementation of 

this rule would be impracticable, 

unnecessary, and contrary to public 

interest, particularly to Veterans. 

It would be impracticable to provide 

opportunity for prior notice and 

comment for this rulemaking because a 

delay in implementation would require 

VA to delay disability compensation 

benefits for Gulf War Veterans claiming 

these nine respiratory cancers that could 

be granted under these presumptions. It 

would be contrary to the public interest 

because a delay in creation of a 

presumption of service connection for 

these nine new diseases (which lowers 

the evidentiary burden for Veterans who 

are claiming benefits) would delay 

access to health care, services, and 

benefits. Furthermore, Veterans 

diagnosed with rare respiratory cancers 

have lower survival rates than those 

diagnosed with more common cancers 

and may not be receiving adequate 

health care due to their lack of serviceconnected status for their disability. 

Additionally, with the exception of 

typical and atypical carcinoid of the 

lung, which have a better prognosis than 

other pulmonary malignancy and may 

have a survival rate of 10 years if 

diagnosed without delay, all these rare 

respiratory cancers have a median 


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25 Del Ciello, Annemilia et al. ‘‘Missed lung 

cancer: when, where, and why?.’’ Diagnostic and 

interventional radiology (Ankara, Turkey) vol. 23,2 

(2017): 118–126. doi:10.5152/dir.2016.16187 

survival timeframe of well under 5 

years. Delays in the diagnosis of these 

rare cancers may occur due to the fact 

that these cancers have a wide array of 

symptoms and due to challenges of 

diagnostic tests and screening for these 

cancers, which may affect up to 90% of 

diagnostic errors for these cancers.25

Even if diagnosed as early as possible 

the survival timeframes are grim and the 

quality of life is universally poor. Due 

to the catastrophic nature of these rare 

cancers and the associated short 

survival periods for people suffering 

from them, preventing the presumption 

from going into effect while the public 

comment process is completed would 

be extremely detrimental to veterans 

who are currently afflicted with these 

rare cancers. 

In addition, the new presumptions are 

entirely pro-claimant in nature. And 

because VA has a sufficient scientific 

basis to support the new presumptions, 

continuing to delay claims that could be 

granted under the presumption while 

rulemaking is ongoing would 

unnecessarily deprive veterans and 

beneficiaries of benefits to which they 

would otherwise be entitled and 

prolong their inability to receive 

benefits. Additionally, this could create 

risks to beneficiaries’ welfare and health 

that would be exacerbated by any 

additional delay in implementation. 

Due to the complexity and the historical 

scientific uncertainty surrounding both 

these issues of airborne hazard 

exposures and rare respiratory cancers, 

many veterans who will be affected by 

this rule have long borne the burden 

and expense of their disabilities while 

awaiting the results of research and 

investigation. Under these 

circumstances, imposing further delay 

on their receipt of benefits, potentially 

at the risk of their welfare and health, 

is contrary to the public interest. 

Finally, the Secretary’s decision to 

pursue presumptions of service 

connection to ease access to VA benefits 

for veterans who have been exposed to 

airborne hazards, i.e., particulate matter, 

requires immediate effect in light of the 

COVID–19 pandemic. The economic 

consequences of the pandemic may 

have strained the personal resources of 

many who may benefit from these 

presumptions. For veterans that are not 

otherwise eligible for health care, these 

presumptions could result in needed 

health care eligibility based on service 

connection. For this reason, delay in 

implementation of this rule would be 

contrary to the public interest. 

5 U.S.C. 553(d) also requires a 30-day 

delayed effective date following 

publication of a rule, except for ‘‘(1) a 

substantive rule which grants or 

recognizes an exemption or relieves a 

restriction; (2) interpretative rules and 

statements of policy; or (3) as otherwise 

provided by the agency for good cause 

found and published with the rule.’’ 

Pursuant to section 553(d)(3), the 

Secretary of Veterans Affairs finds for 

the reasons noted above that there is 

good cause to make the rule effective 

upon publication in order to provide 

benefits and health care to Veterans 

suffering from these nine rare 

respiratory cancers without delay. 

For the foregoing reasons, and as 

explained in further detail above, the 

Secretary of Veterans Affairs is issuing 

this rule as an interim final rule with an 

immediate effective date. However, the 

Secretary of Veterans Affairs will 

consider and address comments that are 

received within 60 days of the date this 

interim final rule is published in the 

Federal Register. 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. The Office of 

Information and Regulatory Affairs has 

determined that this rule is a significant 

regulatory action under Executive Order 

12866. The Regulatory Impact Analysis 

associated with this rulemaking can be 

found as a supporting document at 

www.regulations.gov. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this interim final rule will not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act (5 U.S.C. 601–612). The 

certification is based on the fact that no 

small entities or businesses determine 

service connection, the rating criteria, or 

assign evaluations for disability claims. 

Therefore, pursuant to 5 U.S.C. 605(b), 

the initial and final regulatory flexibility 

analysis requirements of sections 603 

and 604 do not apply. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

one year. This interim final rule will 

have no such effect on State, local, and 

tribal governments, or on the private 

sector. 

Paperwork Reduction Act (PRA) 

This interim final rule contains no 

provisions constituting a collection of 

information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). 

Assistance Listing 

The Assistance Listing numbers and 

titles for this rule are 64.101, Burial 

Expenses Allowance for Veterans; 

64.102, Compensation for ServiceConnected Deaths for Veterans’ 

Dependents; 64.105, Pension to 

Veterans, Surviving Spouses, and 

Children; 64.109, Veterans 

Compensation for Service-Connected 

Disability; and 64.110, Veterans 

Dependency and Indemnity 

Compensation for Service-Connected 

Death. 

Congressional Review Act 

Pursuant to Subtitle E of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (known as the 

Congressional Review Act) (5 U.S.C. 801 

et seq.), the Office of Information and 

Regulatory Affairs designated this rule 

as not a major rule, as defined by 5 

U.S.C. 804(2). 

List of Subjects in 38 CFR Part 3 

Administrative practice and 

procedure, Claims, Disability benefits, 

Health care, Pensions, Veterans. 

Signing Authority 

Denis McDonough, Secretary of 

Veterans Affairs, approved this 

document on February 28, 2022, and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 


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Federal Register / Vol. 87, No. 80 / Tuesday, April 26, 2022 / Rules and Regulations 24429 

electronically as an official document of 

the Department of Veterans Affairs. 

Jeffrey M. Martin, 

Assistant Director, Office of Regulation Policy 

& Management, Office of General Counsel, 

Department of Veterans Affairs. 

For the reasons stated in the 

preamble, the Department of Veterans 

Affairs amends 38 CFR part 3 as set 

forth below: 

PART 3—ADJUDICATION 

Subpart A—Pension Compensation 

and Dependency and Indemnity 

Compensation 

■ 1. The authority citation for subpart A 

continues to read as follows: 

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

■ 2. Revise § 3.320 to read as follows: 

§ 3.320 Claims based on exposure to fine 

particulate matter. 

(a) Service connection based on 

presumed exposure to fine particulate 

matter—(1) General. Except as provided 

in paragraph (b) of this section, a 

disease listed in paragraphs (a)(2) and 

(a)(3) of this section shall be service 

connected even though there is no 

evidence of such disease during the 

period of military service. 

(2) Chronic diseases associated with 

exposure to fine particulate matter. The 

following chronic diseases will be 

service connected if manifested to any 

degree (including non-compensable) 

within 10 years from the date of 

separation from a qualifying period of 

military service as defined in paragraph 

(a)(5) of this section. 

(i) Asthma. 

(ii) Rhinitis. 

(iii) Sinusitis, to include 

rhinosinusitis. 

(3) Rare cancers associated with 

exposure to fine particulate matter. The 

following rare cancers will be service 

connected if manifested to any degree 

(including non-compensable) at any 

time following separation from a 

qualifying period of military service as 

defined in paragraph (a)(5) of this 

section. 

(i) Squamous cell carcinoma of the 

larynx. 

(ii) Squamous cell carcinoma of the 

trachea. 

(iii) Adenocarcinoma of the trachea. 

(iv) Salivary gland-type tumors of the 

trachea. 

(v) Adenosquamous carcinoma of the 

lung. 

(vi) Large cell carcinoma of the lung. 

(vii) Salivary gland-type tumors of the 

lung. 

(viii) Sarcomatoid carcinoma of the 

lung. 

(ix) Typical and atypical carcinoid of 

the lung. 

(4) Presumption of exposure. A 

Veteran who has a qualifying period of 

service as defined in paragraph (a)(5) of 

this section shall be presumed to have 

been exposed to fine, particulate matter 

during such service, unless there is 

affirmative evidence to establish that the 

veteran was not exposed to fine, 

particulate matter during that service. 

(5) Qualifying period of service. The 

term qualifying period of service means 

any period of active military, naval, or 

air service in: 

(i) The Southwest Asia theater of 

operations, as defined in § 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)(2) and (3) of this section 

shall not be presumed service connected 

if there is affirmative evidence that: 

(1) The disease was not incurred 

during or aggravated by a qualifying 

period of service; or 

(2) The disease was caused by a 

supervening condition or event that 

occurred between the Veteran’s most 

recent departure from a qualifying 

period of service and the onset of the 

disease; or 

(3) The disease is the result of the 

Veteran’s own willful misconduct. 

[FR Doc. 2022–08820 Filed 4–25–22; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2021–0395; FRL–9563–02– 

R4] 

Air Plan Approval; Kentucky; 

Emissions Statement Requirements for 

the 2015 8-Hour Ozone Standard 

Nonattainment Area 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a revision to 

the Kentucky State Implementation Plan 

(SIP) submitted to EPA by the 

Commonwealth of Kentucky through 

the Kentucky Division for Air Quality 

(KDAQ) on October 15, 2020. The SIP 

revision was submitted by KDAQ to 

address the emissions statement 

requirements for the 2015 8-hour ozone 

national ambient air quality standards 

(NAAQS) for Kentucky counties in the 

Cincinnati, Ohio-Kentucky 2015 8-hour 

ozone NAAQS nonattainment area 

(Cincinnati, OH-KY Area), and for some 

of the Kentucky counties in the 

Louisville, Kentucky-Indiana 2015 8- 

hour ozone NAAQS nonattainment area 

(Louisville, KY-IN Area). Specifically, 

EPA is approving the emissions 

statement requirements for portions of 

Boone, Campbell, and Kenton Counties 

in the Cincinnati, OH-KY Area, and 

Bullitt and Oldham Counties in the 

Louisville, KY-IN Area. EPA will 

consider and take action, or has 

considered and taken action, on 

submissions addressing the emissions 

statement requirements for the 

remaining counties in these two 

nonattainment areas, including the 

Jefferson County, Kentucky portion of 

the Louisville, KY-IN Area, in a separate 

rulemaking. This action is being taken 

pursuant to the Clean Air Act (CAA or 

Act). 

DATES: This rule is effective May 26, 

2022. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2021–0395. All documents in the docket 

are listed on the www.regulations.gov 

website. Although listed in the index, 

some information may not be publicly 

available, i.e., Confidential Business 

Information 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 either electronically through 

www.regulations.gov or in hard copy at 

the Air Regulatory Management Section, 

Air Planning and Implementation 

Branch, Air and Radiation Division, 

U.S. Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW, Atlanta, 

Georgia 30303–8960. EPA requests that, 

if at all possible, you contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT section to schedule your 

inspection. The Regional Office’s 

official hours of business are Monday 

through Friday 8:30 a.m. to 4:30 p.m., 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Tiereny Bell, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air and 

Radiation Division, Region 4, U.S. 

Environmental Protection Agency, 61 

Forsyth Street SW, Atlanta, Georgia 

30303–8960. The telephone number is 

(404) 562–9088. Ms. Bell can also be 

reached via electronic mail at 

bell.tiereny@epa.gov. 


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