[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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