[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Rules and Regulations]
[Pages 60336-60342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18979]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AR25


Presumptive Service Connection for Respiratory Conditions Due to 
Exposure to Fine Particulate Matter

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This rulemaking adopts as final, with changes, an interim 
final rule that amended the Department of Veterans Affairs (VA) 
adjudication regulations governing presumptive service connection based 
on presumed exposures to fine particulate matter. The amendment was 
necessary to provide health care, services, and benefits to Gulf War 
Veterans who were exposed to fine particulate matter associated with 
deployment to the Southwest Asia theater of operations, as well as 
Afghanistan, Syria, Djibouti, and Uzbekistan. The amendment eased the 
evidentiary burden of Gulf War Veterans who file claims with VA for 
asthma, rhinitis, and sinusitis, to include rhinosinusitis.

DATES: 
    Effective date: This rule is effective October 31, 2023.
    Applicability date: The provisions of this final rule shall apply 
to all applications for benefits that are received by VA on or after 
the effective date of this 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 final rule.

FOR FURTHER INFORMATION CONTACT: Jane Allen, Policy Analyst; Robert 
Parks, Chief, Part 3 Regulations Staff (211), Compensation Service 
(21C), Veterans Benefits Administration, Department of Veterans 
Affairs, 810 Vermont Avenue

[[Page 60337]]

NW, Washington, DC 20420, 202-461-9700. (This is not a toll-free 
number.)

SUPPLEMENTARY INFORMATION: On August 5, 2021, VA published an interim 
final rule in the Federal Register (86 FR 42724) to amend its 
adjudication regulations to establish presumptive service connection 
for asthma, rhinitis, and sinusitis, to include rhinosinusitis, in 
association with presumed exposure to fine particulate matter. These 
presumptions apply to veterans who served on active military, naval, 
air, or space 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. VA provided a 60-day comment period which ended on October 4, 
2021. VA received comments from the National Veterans Legal Services 
Program, National Law School Veterans Clinic Consortium, Stronghold 
Freedom Foundation, Disabled American Veterans, Veterans of Foreign 
Wars, Wounded Warrior Project, and nineteen individuals. Nine of the 
comments received expressed general support of the rule. VA has made 
limited changes based on the comments, as discussed below.

I. Asthma, Obstructive Sleep Apnea, and Respiratory Illnesses Under 38 
CFR 3.317

    VA received one comment suggesting that asthma, obstructive sleep 
apnea, and other respiratory illnesses should be considered medically 
unexplained chronic multisystem illnesses under 38 CFR 3.317, 
Compensation for certain disabilities occurring in Persian Gulf 
veterans. This commenter stated that evidence is not required to prove 
that an illness is associated with a veteran's service in Southwest 
Asia for claims under 38 U.S.C. 1117 and 38 CFR 3.317. However, this 
rulemaking and the interim final rule address regulations governing 
presumptive service connection for respiratory conditions based on 
presumed exposures to fine particulate matter. The rulemaking does not 
address 38 CFR 3.317 or whether certain conditions may be considered 
medically unexplained chronic multisymptom illnesses. Further, as 
explained in the interim final rule, the Secretary relied on the broad 
authority under 38 U.S.C. 501(a) when establishing section 3.320. 
Section 3.320 and the presumptions it established are not based on the 
same authority that underlies section 3.317, to include 38 U.S.C. 1117 
and 1118. Therefore, this comment is outside the scope of the 
rulemaking, and VA makes no change based on it.

II. Service in Afghanistan Under 38 CFR 3.317(a) and (b)

    One commenter expressed concern that VA considers veterans who 
served in Afghanistan to be exposed to infectious diseases and fine 
particulate matter in the same manner as other veterans in Southwest 
Asia, however, excludes their service from the exposures and illnesses 
under paragraph (a) and (b) of 38 CFR 3.317. However, as explained 
above, this rulemaking and the interim final rule address regulations 
governing presumptive service connection for respiratory conditions 
based on presumed exposures to fine particulate matter and do not 
address 38 CFR 3.317.
    Paragraphs (a) and (b) of 38 CFR 3.317 regulate claims for 
compensation due to undiagnosed illnesses and medically unexplained 
chronic multisymptom illnesses. The rule establishing 38 CFR 3.317 (a) 
and (b) (75 FR 59968) was based on a National Academies of Sciences, 
Engineering, and Medicine (NASEM) review focused primarily upon health 
effects of exposure to hazards associated with service in the Southwest 
Asia theater of operations, as that area was defined for purposes of 
the 1991 Gulf War. See Executive Order 12744 (Jan. 12, 1991). 
Afghanistan is not located in Southwest Asia and therefore was not 
included as a qualifying location under 38 CFR 3.317(a) and (b). 
However, section 405 of the Sergeant First Class Heath Robinson 
Honoring our Promise to Address Comprehensive Toxics Act of 2022, 
Public Law 117-168, (PACT Act) expanded the definition of a Persian 
Gulf veteran by adding Afghanistan, Israel, Egypt, Turkey, Syria, and 
Jordan as eligible locations under 38 U.S.C. 1117. Thus, individuals 
with service in Afghanistan are no longer excluded from the exposures 
and illnesses under paragraph (a) and (b) of 38 CFR 3.317 due to the 
PACT Act. But implementing that provision of the PACT Act is beyond the 
scope of this rule, and VA plans to address that statutory change in a 
separate rulemaking. Therefore, VA makes no changes based on this 
comment.

III. Effective Dates

    Three commenters inquired about effective dates and stated that 
claims for the three new presumptive conditions should be granted 
retroactive effective dates in the same manner as claims under Nehmer 
v. United States Department of Veterans Affairs. Nehmer was a class-
action lawsuit against VA by Vietnam veterans and their survivors, who 
alleged that VA had improperly denied their claims for service-
connected compensation for disabilities allegedly caused by exposure to 
the herbicide Agent Orange in service. See Nehmer v. U.S. Department of 
Veterans Affairs, No. CV-86-6161 TEH (N.D. Cal.). 38 CFR 3.816 
regulates effective date rules required by Nehmer and defines a Nehmer 
class member as ``a Vietnam veteran who has a covered herbicide 
disease; or a surviving spouse, child, or parent of a deceased Vietnam 
veteran who died from a covered herbicide disease.'' 38 CFR 3.816(b). 
VA notes that the effective date provisions of the Nehmer court order 
and section 3.816 apply only to claims based on exposure to herbicides 
in the Republic of Vietnam during the Vietnam era and are therefore 
inapplicable to this final rule.
    Further, as stated in the interim final rule, this rule applies to 
claims received by VA on or after the effective date of the rule and to 
claims pending before VA on that date. This will ensure that VA adheres 
to the provisions of its change-of-law regulation, 38 CFR 3.114, which 
states, ``[w]here 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 
shall be fixed in accordance with the facts found, but shall not be 
earlier than the effective date of the act or administrative issue.'' 
Section 3.114 reflects ordinary statutory effective date principles 
that VA is bound to apply in cases outside the scope of Nehmer. See 38 
U.S.C. 5110. Specifically, the law requires that the effective date for 
an award of benefits pursuant to an Act or administrative issue ``shall 
not be earlier than the effective date of the Act or administrative 
issue.'' 38 U.S.C. 5110(g).
    Therefore, VA makes no changes based on these comments.

IV. Exposures in Other Locations

    One commenter inquired whether the interim final rule included 
exposure to fine particulate matter in other locations, specifically in 
Germany. 38 CFR 3.320 was based on scientific and medical studies that 
focused on the respiratory effects of fine particulate matter for 
Veterans who served in the Southwest Asia theater of operations, 
Afghanistan, Syria, Djibouti, and Uzbekistan during the Gulf War. As 
stated in the interim final rule, veterans began reporting a variety of 
respiratory health issues during and after the initial

[[Page 60338]]

Gulf War conflict. As a result, Congress mandated that VA study the 
health outcomes of veterans deployed to the Southwest Asia theater of 
operations. VA then requested NASEM to study the evidence regarding 
respiratory health outcomes in veterans of the Southwest Asia 
conflicts. The results of that study form the basis for this 
rulemaking. As Germany was not a location considered in the study, it 
cannot be included as a qualifying location under 38 CFR 3.320. VA 
makes no changes based on this comment.

V. Eligible Locations in Southwest Asia

    One commenter questioned whether eligible locations in Southwest 
Asia, Afghanistan, Syria, Djibouti, or Uzbekistan will be limited to 
specific bases or combat outposts. The simple answer is no. A 
qualifying period of service for presumptive service connection based 
on exposure to fine particulate matter is defined as service in the 
Southwest Asia theater of operations during the Gulf War, or in 
Afghanistan, Syria, Djibouti or Uzbekistan on or after September 19, 
2001, during the Gulf War. The Southwest Asia theater of operations 
refers to 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, the Red 
Sea, and the airspace above these locations. 38 CFR 3.317(e)(2). The 
eligible locations listed under 38 CFR 3.320 are more expansive than 
specific bases or combat outposts. VA makes no changes based on this 
comment.

VI. Combat Presumption

    One commenter stated that VA failed to consider that for ``veterans 
who claim that their condition is a result of their combat service in 
Southwest Asia, their [sic] becomes an evidentiary burden shift that 
requires the VA to show affirmative evidence proving that the claimed 
presumptive condition did not manifest during service in Southwest 
Asia, the VA must confirm if an event after service caused the 
veteran's condition, or the VA must confirm if the claimed condition 
was directly caused as a result of the veteran's own willful misconduct 
or while under the influence of drugs or alcohol.'' The commenter 
suggested that claims based on combat service for asthma, rhinitis, and 
sinusitis, to include rhinosinusitis, already have a presumption in 
place that is equally advantageous to veterans as the new 38 CFR 3.320. 
VA disagrees with this suggestion.
    There are three basic elements required to establish service 
connection: (1) a current disability, (2) an injury or disease that was 
incurred or aggravated during service, and (3) a causal relationship 
between the injury or disease and the veteran's current disability. 
Several presumptions have been created to ease the burden of providing 
evidence of these three elements.
    Consideration of combat service is directed by 38 CFR 3.304(d), 
which provides a reduced evidentiary burden for combat veterans in 
proving an in-service illness or injury (Element #2). See Collette v. 
Brown, 82 F.3d 389, 392-93 (Fed. Cir. 1996). However, the reduced 
evidentiary burden provided by 38 CFR 3.304(d) should not be confused 
with the presumption provided by 38 CFR 3.320. 38 CFR 3.320 eases the 
evidentiary burden of proving exposure to fine particulate matter in 
service (Element #2) and additionally addresses the requirement to 
demonstrate causation (Element #3). Claims for service connection based 
on combat must still show ``a causal relationship between the present 
disability and the injury, disease, or aggravation of a preexisting 
injury or disease incurred during active duty.'' See Shedden v. 
Principi, 381 F.3d 1163, 1167 (Fed. Cir. 2004). We also note that while 
the presumptions in section 3.320 should, in the vast majority of 
cases, obviate the question of whether a given disease or injury was 
incurred in combat, to the extent rare cases genuinely implicate both 
regulations, VA sees no reason why they cannot operate to benefit the 
same veteran. As the presumption under the new 38 CFR 3.320 addresses 
different and additional aspects of establishing entitlement to service 
connection than 38 CFR 3.304(d), VA makes no changes based on this 
comment.

VII. Presumptive Service Connection for Vietnam Veterans Exposed to 
Asbestos

    One commenter proposed that VA establish presumptive service 
connection for Vietnam Veterans who served aboard World War II era 
ships and were exposed to asbestos. As previously explained, this 
rulemaking is based on current medical and scientific evidence related 
to the respiratory health effects of fine particulate matter for 
veterans who served in the Southwest Asia theater of operations during 
the Gulf War, or in Afghanistan, Syria, Djibouti or Uzbekistan on or 
after September 19, 2001, during the Gulf War. As this comment is 
beyond the scope of our rulemaking, VA makes no changes based on this 
comment.

VIII. Allergic Rhinitis

    One commenter asked whether veterans who are currently service 
connected for allergic rhinitis with a 0 percent evaluation can file an 
appeal based on this amendment and what the criteria would be. Veterans 
who are already service connected and seek an increased evaluation 
because their condition has worsened should submit a claim for 
increased evaluation on VA Form 21-526EZ, Application for Disability 
Compensation and Related Compensation Benefits. VA makes no changes 
based on this comment.
    Another commenter inquired whether claims for allergic rhinitis 
would warrant a VA examination to determine if this condition was in 
fact ``chronic rhinitis'' and therefore eligible for presumptive 
service connection. Generally, pursuant to 38 CFR 3.159(c)(4), VA will 
assist a claimant in obtaining an examination if it is necessary to 
decide the claim. An examination may serve the purpose of obtaining 
medical evidence relevant to establishing entitlement to benefits, such 
as information about diagnosis, onset, and etiology, or may be 
necessary to develop adequate information for rating purposes. Applying 
the criteria from 38 CFR 3.159(c)(4) to the substantive criteria of the 
version of section 3.320 implemented by the interim final rule, an 
examination is warranted in claims under 38 CFR 3.320(a)(2) when three 
criteria are met: (1) the veteran claims a qualifying condition listed 
at 38 CFR 3.320(a)(2)(i)-(iii) (or signs or symptoms of a qualifying 
condition under 38 CFR 3.320(a)(2)), (2) the veteran's military records 
show a qualifying period of service under 38 CFR 3.320(a)(5), and (3) 
evidence shows that the veteran's qualifying condition manifested 
within 10 years from the date of last discharge. However, as explained 
below, VA is removing the 10-year manifestation period, and so that 
criterion is no longer necessary for an examination to be warranted. 
Allergic rhinitis is a covered condition under 38 CFR 3.320 as long as 
the condition is chronic in nature and not an acute manifestation. VA 
makes no changes based on this comment.

IX. Chronicity Should Be Presumed

    One commenter recommended that VA explicitly state that chronicity 
is presumed to be innate to asthma, rhinitis, and sinusitis, to include 
rhinosinusitis. The paragraph heading at 38 CFR 3.320(a)(2) is 
``Chronic diseases associated with exposure to fine particulate 
matter.'' 38 CFR 3.320 makes clear that the diseases associated with

[[Page 60339]]

exposure to fine particulate matter are chronic in nature. However, as 
explained in the interim final rule notice, diseases that are seasonal 
or acute allergic manifestations in nature are not covered diseases as, 
pursuant to 38 CFR 3.380, ``[s]easonal and other acute allergic 
manifestations subsiding in the absence of or removal of the allergen 
are generally to be regarded as acute diseases, healing without 
residuals.'' Therefore, VA makes no changes based on this comment.

X. Additional Respiratory Conditions Should Be Included Under 38 CFR 
3.320

    One commenter stated that VA failed to provide a reasonable 
explanation as to why asthma, rhinitis, and sinusitis, to include 
rhinosinusitis, were approved for presumptive service connection and 
not all 27 health outcomes listed in NASEM's 2020 report, Respiratory 
Health Effects of Airborne Hazards Exposures in the Southwest Asia 
Theater of Military Operations. As explained in the interim final rule, 
NASEM's report identified 27 of the most prevalent respiratory health 
outcomes experienced by Gulf War veterans. Of the 27 respiratory health 
outcomes, only three respiratory symptoms met the criteria for limited 
or suggestive evidence of an association with service in Southwest 
Asia: chronic persistent cough, shortness of breath (dyspnea), and 
wheezing. The remaining 24 conditions, including asthma, rhinitis, and 
sinusitis, had inadequate or insufficient evidence to determine an 
association.
    To respond to the findings in NASEM's 2020 report, VA convened a 
workgroup of VA subject matter experts in disability compensation, 
health care, infectious diseases, occupational and environmental 
medicine, public health, epidemiology, toxicology, and research. The VA 
workgroup reviewed the most claimed chronic conditions related to 
airborne hazards for disability compensation benefits and found that 
asthma, sinusitis, and rhinitis were the most claimed and granted (on 
the basis of direct service connection) respiratory conditions, and 
these conditions also most closely represented the symptomatology of 
chronic persistent cough, shortness of breath (dyspnea), and wheeze. 
The VA workgroup then analyzed respiratory claims data comparing 
veterans who were deployed to Southwest Asia with veterans who had 
never been deployed. The VA workgroup found that the claim rates and 
service connection prevalence rates for asthma, rhinitis, and sinusitis 
were higher than for non-deployed veterans.
    VA recognizes that there are limitations in evidence specific to 
deployed service members and a range in the strength of association 
between fine particulate matter exposure and the 27 respiratory health 
outcomes. However, section 501(a)(1) of title 38, United States Code, 
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.'' This broad authority 
includes the establishment of a presumption of service connection and 
exposure under specified circumstances, provided there is a rational 
basis for the presumptions. For the reasons noted above and in the 
interim final rule, including the review of NASEM's 2020 report, review 
of internal claims data, and a comprehensive supplemental literature 
review, the Secretary has determined that there was a rational basis to 
support a presumption of service connection when there is proof of 
qualifying service (38 CFR 3.320(a)(5)) and the subsequent development 
of asthma, rhinitis, or sinusitis, to include rhinosinusitis. However, 
the Secretary also determined that there was not a rational basis at 
this time to support creating a presumption of service connection for 
the remaining 24 health outcomes listed in NASEM's 2020 report. VA 
makes no changes based on this comment.
    Multiple commenters also suggested that VA should create 
presumptions for additional conditions. For example, one commenter 
suggested that secondary health concerns for individuals diagnosed with 
asthma or severe sinusitis should be reviewed and added to 38 CFR 
3.320. VA recognizes that chronic respiratory conditions can lead to 
numerous secondary health effects. However, for the reasons explained 
above and in the interim final rule, the Secretary determined that at 
this time there was a reasonable basis to support creating presumptions 
of service connection for only the three listed conditions. VA makes no 
changes based on this comment.
    Another commenter specifically requested that VA create a 
presumption of service connection for chronic obstructive pulmonary 
disorder (COPD), chronic bronchitis, obstructive sleep apnea, and 
emphysema. The commenter stated that COPD, chronic bronchitis, 
obstructive sleep apnea, and emphysema involve symptoms of chronic 
persistent cough, shortness of breath, and wheezing and have increased 
claim rates that are comparable to or exceed those for asthma, 
rhinitis, and sinusitis. Another commenter questioned why obstructive 
sleep apnea was not added as a presumptive condition. For the reasons 
provided below, VA makes no changes based on these comments.
    The complexity of the etiologic factors associated with obstructive 
sleep apnea were considered when establishing new presumptions under 38 
CFR 3.320. Unlike asthma, sinusitis, and rhinitis, obstructive sleep 
apnea can be related to anatomic risk factors, such as craniofacial 
profile, structural abnormalities (e.g., pharyngeal wall instability) 
and neck circumference. Furthermore, obesity and high body mass index 
are the strongest risk factors for obstructive sleep apnea.\1\
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    \1\ Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, 
Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep 
apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935/1984-
0063.20200056. PMID: 34381578; PMCID: PMC8340897.
    Sutherland K, Keenan BT, Bittencourt L, Chen NH, Gislason T, 
Leinwand S, Magalang UJ, Maislin G, Mazzotti DR, McArdle N, Mindel 
J, Pack AI, Penzel T, Singh B, Tufik S, Schwab RJ, Cistulli PA; 
SAGIC Investigators. A Global Comparison of Anatomic Risk Factors 
and Their Relationship to Obstructive Sleep Apnea Severity in 
Clinical Samples. J Clin Sleep Med. 2019 Apr 15;15(4):629-639. doi: 
10.5664/jcsm.7730. PMID: 30952214; PMCID: PMC6457518.
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    Additionally, provisions of the PACT Act added presumptions related 
to Gulf War service for additional respiratory conditions, including 
COPD, chronic bronchitis, and emphysema. Incorporation of provisions of 
this Act relevant to this regulation will be the subject of separate 
and future rulemakings.
    Further, we note that section 202 of the PACT Act created a new 
process for establishing presumptions of service connection based on 
toxic exposure. Under the new process, VA is required to publish notice 
in the Federal Register, no less than once per year, to notify the 
public of the formal evaluations of environmental exposures and adverse 
health outcomes that the Secretary plans to conduct. With each notice 
published in the Federal Register, VA will seek public comment and hold 
an open meeting for members of the public to ensure that the public 
participates in the decision-making process (38 U.S.C. 1171-1174). VA 
welcomes comments and contributions from the public on future notices.

XI. 10-Year Manifestation Period

    VA received nine comments that either objected to or requested 
revision

[[Page 60340]]

of the 10-year manifestation period requirement. VA found that several 
comments identified factors that were not considered in our initial 
analysis. Based on the substantive comments received, summarized below, 
VA will amend 38 CFR 3.320(a)(2) to remove the requirement that asthma, 
sinusitis, and rhinitis manifest within 10 years from the date of the 
most recent separation from military service.
    VA received one comment that questioned whether the 10-year 
manifestation period starts following the most recent period of 
service, even if qualifying service in the defined locations did not 
occur during that period of service, or whether the manifestation 
period begins at the end of the period of service during which actual 
qualifying service took place, even if there is a later, separate 
period of active service during which no qualifying service took place. 
Another commenter stated that the 10-year manifestation period was 
poorly defined.
    Several commenters recommended that the 10-year manifestation 
period be extended beyond 10 years. One commenter noted they had 
suffered symptoms of respiratory illness since their discharge in 2006 
but did not receive a formal diagnosis until 2020, more than 10 years 
since discharge. The commenter felt that they would not be eligible for 
presumptive service connection based on the 10-year manifestation 
period.
    Several commenters objected to the 10-year manifestation period 
stating that many veterans do not seek treatment and self-treat with 
over-the-counter medications, making it difficult to produce medical 
records in support of their claim. One commenter noted that symptoms of 
asthma, rhinitis, and sinusitis that would warrant a non-compensable 
rating may not require treatment from a medical provider, and veterans 
may not seek medical treatment until their symptoms increase in 
severity and self-treatment of the disability is no longer sufficient. 
Several commenters also stated that veterans who served during the Gulf 
War were not aware that there was a possible connection between their 
symptoms and their service, as the scientific studies on the effects of 
fine particulate matter did not exist at the time; therefore, they may 
not have collected and maintained medical records in support of their 
claims.
    Two commenters stated that the 10-year manifestation period for 
asthma, rhinitis, and sinusitis, to include rhinosinusitis, was not 
based on evidence establishing their development and should therefore 
be removed.
    One commenter recommended elimination of the 10-year manifestation 
period and stated that for the majority of the diseases for which VA 
has recognized a presumption due to exposure to toxic substances, VA 
has not required that the disease manifest itself within any specific 
period of time after exposure.
    One commenter stated that VA should not impose a manifestation 
period unless and until it provides the public with adequate notice and 
an opportunity to comment on a proposed manifestation period after 
publicly disclosing and providing all the scientific evidence it 
reviewed and considered. The commenter further stated that VA not 
citing every study used in its decision-making is a failure in 
Administrative Procedure Act required notice.
    One commenter disagreed with the 10-year manifestation period 
starting after the veteran's most recent discharge, even if that 
discharge did not include a qualifying period of service, as long as 
there was a previous deployment to a qualifying location. The commenter 
recommended that the 10-year manifestation period begin at the date of 
discharge that included deployment to a qualifying location.
    VA appreciates the substantive comments received on the interim 
final rule. Upon further evaluation, and weighing the evidence and 
claims data available against the substantive comments received, VA 
will amend 38 CFR 3.320(a)(2) to remove the 10-year manifestation 
requirement under 38 CFR 3.320(a)(2). While claims data was given 
significant weight in VA's initial determination, VA acknowledges that 
sufficient consideration was not given to the difficulties veterans may 
face in documenting the onset of their disease. In addition, section 
405 of the PACT Act removed the manifestation period requirement under 
38 U.S.C. 1117 (codified at 38 CFR 3.317). As stated above, 
incorporation of provisions Public Law 117-168 will be the subject of 
separate and future rulemaking.

XII. Cause-and-Effect Standard

    One commenter urged VA to reject a cause-and-effect standard in 
deciding whether to adopt a presumption of service connection and 
recommended a statistical association test as the most appropriate 
standard to use. In addition, the commenter urged VA to apply a 
statistical association test consistently when creating new 
presumptions. VA notes that it did not employ a cause-and-effect 
standard in determining to establish the presumptions of service 
connection for asthma, rhinitis, and sinusitis, to include 
rhinosinusitis. We note that the PACT Act created a new process for 
establishing presumptions of service connection based on toxic 
exposure. As stated above, implementation of provisions in Public Law 
117-168 will be the subject of separate and future rulemaking. 
Therefore, VA makes no changes based on this comment.

XIII. Definition of Qualifying Period of Service

    One commenter suggested that VA revise the language describing 
qualifying periods of service because the current wording may be 
misinterpreted as excluding Gulf War Veterans who served prior to 
September 19, 2001. The commenter noted that including the definition 
of the Southwest Asia theater of operations and the definition of the 
Gulf War within 38 CFR 3.320 would improve clarity. VA agrees with this 
recommendation and will amend 38 CFR 3.320 to include new paragraph 
(a)(6). 38 CFR 3.320(a)(6) will provide the definition of the Southwest 
Asia theater of operations, also found at 38 CFR 3.317(e)(2), and the 
definition of the Gulf War, also found at 38 CFR 3.2(i). This addition 
will clarify the intent of the regulation.
    Additionally, VA is amending the definition of the qualifying 
periods of service in paragraph (a)(5) by adding space service to the 
list of types of service as it was inadvertently omitted from the 
interim final rule.

XIV. Clarifications/Future Reviews

    One commenter asked that VA clarify that this rule in no way 
precludes future rules providing presumptive service connection for 
health conditions resulting from Gulf War service that are not 
respiratory in nature. While this rulemaking is based on current 
medical and scientific evidence related to the respiratory health 
effects of fine particulate matter on veterans who served during the 
Gulf War, VA will continue to review new scientific evidence as it 
develops relating to all health effects resulting from exposure to fine 
particulate matter. This rulemaking does not limit the future 
establishment of presumptive service connection for conditions related 
to respiratory or other body systems.
    One commenter requested that VA notify stakeholders promptly 
regarding the progress of its ongoing review of health outcomes related 
to exposure to fine particulate matter, its expected timetable, the 
steps it is taking and will take as part of the review, and the

[[Page 60341]]

opportunities for additional public comment that will be provided. VA 
appreciates the comments and valuable feedback it receives from its 
stakeholders and will continue to participate in notice-and-comment 
rulemaking (as appropriate) on future presumptive conditions.
    VA appreciates all comments submitted in response to the interim 
final rule. Based on the rationale stated in the interim final rule and 
in this document, the final rule is adopted with changes as noted.

Administrative Procedure Act

    VA has considered all comments submitted in response to the interim 
final rule and does not consider any to be objecting to the rule. 
Rather, the comments received have suggested ways in which the rule 
could be refined or liberalized. And for the reasons set forth in the 
foregoing responses to those comments, VA has made changes. 
Accordingly, based upon the authorities and reasons set forth in the 
interim final rule, VA is adopting the provisions of the interim final 
rule as a final rule with the changes as described above.

Executive Orders 12866, 13563 and 14094

    Executive Order 12866 (Regulatory Planning and Review) directs 
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. Executive Order 14094 (Executive Order on 
Modernizing Regulatory Review) supplements and reaffirms the 
principles, structures, and definitions governing contemporary 
regulatory review established in Executive Order 12866 and Executive 
Order 13563. The Office of Information and Regulatory Affairs has 
determined that this rulemaking is a significant regulatory action 
under Executive Order 12866, section 3(f)(1), as amended by Executive 
Order 14094. The Regulatory Impact Analysis (RIA) associated with this 
rulemaking can be found as a supporting document at 
www.regulations.gov.

Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable 
to this rulemaking because notice of proposed rulemaking is not 
required. 5 U.S.C. 601(2), 603(a), 604(a). On August 5, 2021, VA 
published an interim final rule in the Federal Register (86 FR 42724). 
This Final rule adopts the Interim Final rule without changes.

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 final rule will have no such effect on 
State, local, and Tribal governments, or on the private sector.

Paperwork Reduction Act

    This 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 program numbers and titles for this rule are 
64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation 
for Service-Connected Deaths for Veterans' Dependents; 64.104, Pension 
for Non-Service-Connected Disability for Veterans; 64.105, Pension to 
Veterans, Surviving Spouses, and Children; 64.109, Veterans 
Compensation for Service-Connected Disability; and 64.110, Veterans 
Dependency and Indemnity Compensation for Service-Connected Death.

Congressional Review Act

    Under the Congressional Review Act, this regulatory action may 
result in an annual effect on the economy of $100 million or more, 5 
U.S.C. 804(2), and so is subject to the 60-day delay in effective date 
under 5 U.S.C. 801(a)(3). 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 (RIA) associated with the 
Regulation.

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, 
Health care, Pensions, and Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved and signed 
this document on August 25, 2023, 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 
General Counsel, Department of Veterans Affairs.

    For the reasons stated in the preamble, the interim final rule 
amending 38 CFR part 3, which was published at 86 FR 42724, is adopted 
as final with the following changes:

PART 3--ADJUDICATION

0
1. The authority citation for part 3 continues to read as follows:

    Authority:  38 U.S.C. 501(a), unless otherwise noted.

Subpart A--Pension Compensation and Dependency and Indemnity 
Compensation

0
2. Revise Sec.  3.320 to read as follows:


Sec.  3.320  Claims based on exposure to fine particulate matter.

    (a) Service connection based on presumed exposure to fine 
particulate matter--(1) General. Except as provided in paragraph (b) of 
this section, a disease listed in paragraphs (a)(2) and (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) at any time 
following 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.

[[Page 60342]]

    (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, air, or space 
service in:
    (i) The Southwest Asia theater of operations during the Persian 
Gulf War.
    (ii) Afghanistan, Syria, Djibouti, or Uzbekistan on or after 
September 19, 2001, during the Persian Gulf War.
    (6) Definitions. (i) The term Southwest Asia theater of operations 
means 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, the Red 
Sea, and the airspace above these locations, as defined in Sec.  
3.317(e)(2).
    (ii) The term Persian Gulf War means August 2, 1990, through date 
to be prescribed by Presidential proclamation or law, as defined in 
Sec.  3.2(i).
    (b) Exceptions. A disease listed in paragraphs (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.

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

[FR Doc. 2023-18979 Filed 8-31-23; 8:45 am]
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