Proposed Rule2024-21852
VA Adjudication Regulations for Disability or Death Benefit Claims Based on Toxic Exposure
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 1, 2024
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) is proposing to amend its adjudication regulations to implement provisions of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act or Act). The statute amended procedures applicable to claims based on toxic exposure and modified or established presumptions of service connection related to toxic exposure. Pursuant to the Act, VA is proposing to remove the manifestation period requirement and the minimum compensable evaluation requirement from Persian Gulf War claims based on undiagnosed illness and medically unexplained chronic multisymptom illnesses. VA is also proposing to expand the definition of a Persian Gulf veteran; update the list of locations eligible for a presumption of exposure to toxic substances, chemicals, or airborne hazards based on service during the Persian Gulf War; and add presumptions of service connection for 23 diseases associated with exposure to toxins. To implement additional provisions of the Act, VA is also proposing to codify the procedure for determining when medical examinations and nexus opinions are required for claims that cannot be considered on a presumptive basis and the evidence establishes participation in a toxic exposure risk activity (TERA). Additional provisions of the PACT Act will be addressed in separate, future rulemakings.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 190 (Tuesday, October 1, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Proposed Rules]
[Pages 79815-79828]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21852]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AR75
VA Adjudication Regulations for Disability or Death Benefit
Claims Based on Toxic Exposure
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
its adjudication regulations to implement provisions of the Sergeant
First Class Heath Robinson Honoring our Promise to Address
Comprehensive Toxics Act of 2022 (PACT Act or Act). The statute amended
procedures applicable to claims based on toxic exposure and modified or
established presumptions of service connection related to toxic
exposure. Pursuant to the Act, VA is proposing to remove the
manifestation period requirement and the minimum compensable evaluation
requirement from Persian Gulf War claims based on undiagnosed illness
and medically unexplained chronic multisymptom illnesses. VA is also
proposing to expand the definition of a Persian Gulf veteran; update
the list of locations eligible for a presumption of exposure to
[[Page 79816]]
toxic substances, chemicals, or airborne hazards based on service
during the Persian Gulf War; and add presumptions of service connection
for 23 diseases associated with exposure to toxins. To implement
additional provisions of the Act, VA is also proposing to codify the
procedure for determining when medical examinations and nexus opinions
are required for claims that cannot be considered on a presumptive
basis and the evidence establishes participation in a toxic exposure
risk activity (TERA). Additional provisions of the PACT Act will be
addressed in separate, future rulemakings.
DATES: Comments must be received on or before December 2, 2024.
ADDRESSES: Comments must be submitted through <a href="http://www.regulations.gov">www.regulations.gov</a>.
Except as provided below, comments received before the close of the
comment period will be available at <a href="http://www.regulations.gov">www.regulations.gov</a> for public
viewing, inspection, or copying, including any personally identifiable
or confidential business information that is included in a comment. We
post the comments received before the close of the comment period on
<a href="http://www.regulations.gov">www.regulations.gov</a> as soon as possible after they have been received.
VA will not post on <a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats
to individuals or institutions or suggest that the commenter will take
actions to harm the individual. VA encourages individuals not to submit
duplicative comments. We will post comments from multiple unique
commenters even if the content is identical or nearly identical to
other comments. Any public comment received after the comment period's
closing date is considered late and will not be considered in the final
rulemaking. In accordance with the Providing Accountability Through
Transparency Act of 2023, a plain language summary (not more than 100
words in length) of this proposed rule is available at
<a href="http://www.regulations.gov">www.regulations.gov</a>, under RIN 2900-AR75.
FOR FURTHER INFORMATION CONTACT: Sara Cohen, Lead Analyst, Regulations
Staff (211C); Robert Parks, Chief, Regulations Staff (211C),
Compensation Service (21C), Veterans Benefits Administration,
Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC
20420, (202) 461-9700. (This is not a toll-free telephone number.)
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The PACT Act expanded eligibility for health care and disability
compensation benefits for veterans who were exposed to toxic substances
during military service. The law established a presumption that
veterans were exposed to certain substances, chemicals, and airborne
hazards if they served in various specified locations during certain
time frames. The law created a statutory framework for VA to provide
medical examinations in order to obtain nexus opinions when a veteran
submits a claim for compensation for a non-presumptive condition with
evidence of a disability and evidence of participation in a toxic
exposure risk activity (TERA) in service. The law also expanded the
definition of ``Persian Gulf veteran'' under 38 U.S.C. 1117 to include
six new locations, allowing veterans with service in those locations
during the relevant time period to qualify for presumptions of service
connection based on disability due to undiagnosed illness and medically
unexplained chronic multisymptom illnesses (MUCMI). The PACT Act also
created new 38 U.S.C. 1119, Presumptions of toxic exposure, which
established a presumption of specific toxic exposures for certain
covered veterans. The Act also created new 38 U.S.C. 1120, which
established presumptions of service connection for 23 diseases that are
associated with exposure to burn pits and other toxins. Although that
section originally contained 24 diseases, lymphomatic cancer of any
type was later removed as a technical amendment by Public Law 117-623,
as the term ``lymphomatic cancer'' is not recognized by the medical and
scientific community. However, lymphoma cancer of any type remains a
covered disease presumptive to exposure to burn pits and other toxins
under 38 U.S.C. 1120. The presumption of service connection under 38
U.S.C. 1120 applies to ``covered veterans'' under 38 U.S.C. 1119.
II. Proposed Changes to Sec. 3.1 Definitions
VA is proposing to implement several portions of the PACT Act by
adding new definitions to 38 CFR 3.1. VA is proposing to add the
statutory definition of ``toxic exposure risk activity'' to 38 CFR 3.1,
in new paragraph (bb). Section 303 of the PACT Act established 38
U.S.C. 1168, which governs medical nexus examinations based on TERA. 38
U.S.C. 1168(a) provides that if a veteran submits a claim for service-
connected compensation with evidence of a disability and evidence of
participation in a TERA during active military, naval, air, or space
service, and such evidence is not sufficient to establish service
connection for the disability, VA will provide the veteran with a
medical examination and obtain a medical nexus opinion as to whether it
is at least as likely as not that there is a nexus between the
disability and the TERA. 38 U.S.C. 1168(c) states that ``the term
``toxic exposure risk activity'' has the meaning given that term in
section 1710(e)(4) of this title.'' 38 U.S.C. 1710(e)(4) defines a
``toxic exposure risk activity'' as ``any activity that requires a
corresponding entry in an exposure tracking record system (as defined
in section 1119(c) of this title) for the veteran who carried out the
activity; or that the Secretary determines qualifies for purposes of
this subsection when taking into account what is reasonably prudent to
protect the health of veterans.''
VA has determined that if a veteran's military service qualifies
for a presumption of exposure, VA must concede participation in a TERA.
Locations with a presumption of exposure include any recognized
radiation risk activity locations (38 U.S.C. 1112 and 38 CFR
3.309(d)(3)(ii)); locations associated with herbicide exposure (38
U.S.C. 1116); the Persian Gulf (38 U.S.C. 1117); locations associated
with exposure to burn pits (38 U.S.C. 1119); and at Camp LeJeune (38
CFR 3.307(a)(7)). If a veteran served in a location that qualifies for
a presumption of exposure and submits a claim for a non-presumptive
condition with evidence of a disability, a disability examination and
medical opinion based on TERA must be requested, unless an exception
under 38 U.S.C. 1168(b), as described below in section III, applies.
As required by the PACT Act, if an entry in an exposure tracking
record system reflects an activity carried out by the veteran while on
active duty, then the veteran will be considered to have participated
in a TERA (38 U.S.C. 1710(e)(4)(C)). VA generally proposes to recognize
participation in a TERA based on any entry in an exposure tracking
record system (e.g., the Individual Longitudinal Exposure Record
(ILER)). However, there are circumstances where an ILER entry may show
only a claimant's name and contain no deployment information nor show
any potential toxic exposure. For an entry in an exposure tracking
record system to constitute participation in a TERA, based on the
statutory definition of such term (38 U.S.C. 1710(e)(4)(C)), the entry
must correspond to an activity performed by the veteran. Because name-
only entries do not contain any evidence of an activity performed by
the veteran, VA proposes that these entries will not constitute
participation in a
[[Page 79817]]
TERA, as name-only entries do not fall under the statutory definition
of TERA.
VA also proposes that records in an exposure tracking record system
from contractor or civilian service periods should not be accepted as
participation in a TERA. For example, ILER records contain different
component categories. These components include mixed deployment
histories to include periods of Active Duty, Reserves, National Guard,
civilian time, and contractor work. An examination and TERA medical
opinion are required under 38 U.S.C. 1168(a) when there is evidence of
a disability and evidence of participation in a TERA during active
military, naval, air, or space service. Because contractor or civilian
service periods are not considered active military service, deployments
as a civilian or contractor listed in an exposure tracking record
system should not be used to concede participation in a TERA for the
purpose of triggering the examination requirements under 38 U.S.C.
1168(a).
VA also proposes to amend 38 CFR 3.1 by adding new paragraph (cc)
defining the term ``exposure tracking record system.'' The term would
be defined as in section 302 of the PACT Act, to mean any system,
program, or pilot program used by the Secretary of Veterans Affairs or
the Secretary of Defense to track how veterans or members of the Armed
Forces have been exposed to various occupational or environmental
hazards, including ILER, or successor system.
ILER is a joint Department of Defense (DoD) and VA web-based
application that provides the ability to link a veteran to military
exposures and/or deployments to improve the efficiency, effectiveness,
and quality of health care, epidemiology, health effects research, and
adjudication of benefits associated with exposures. The exposure data
in ILER currently integrates information from multiple sources,
including, but not limited to, the Defense Occupational and
Environmental Health Readiness System--Industrial Hygiene (DOEHRS-IH),
Armed Forces Health Surveillance Branch (AFHSB), Defense Manpower Data
Center (DMDC), and Military Health System (MHS) Data Repository. ILER
currently provides access to over six million unique veteran records
and acts as a single access point to deployment history; including
time, location, military and non-military deployment data, military
occupational specialty (MOS), occupational hazard data, environmental
hazards known or later found, monitoring performance in the area(s),
diagnosis, treatment, and laboratory data. ILER has the capability of
enabling a search by individual, location, exposure type, and health
effect.
DOEHRS is the biggest source of information for ILER. DOEHRS
contains information resulting from routine investigations for
occupational and other health standards (similar to investigations for
compliance with the Occupational Safety and Health Act, the Safe
Drinking Water Act, or other investigations that may be conducted by
the Environmental Protection Agency). Data stored in DOEHRS contains
area sampling information and analysis for potentially hazardous
conditions; specifically, this information includes analysis of
recorded data. The surveillance data is linked by ILER through the DMDC
to the names of individuals present at the time of the area sampling so
that if an unsafe environment is identified, the correct service
members can be identified for monitoring or treatment. Records
identifying entries or exposures that exceeded permissible limits or
are of concern, which may either be generally applicable occupational
exposure limits or DoD-specific limits, are displayed in red. While
TERA does not require exposures over any specific thresholds, evidence
of exposures over permissible limits or are of concern are provided to
the VA medical examiner to inform their medical opinion. All exposure
information is recorded in DOEHRS (and available through ILER) and
includes routine surveillance with normal environmental exposure as
well as exposures that may have exceeded permissible limits. Sampling
data is collected both from domestic sources as well as from forward
operating bases.
Finally, VA also proposes to amend 38 CFR 3.1 by adding a
definition of ``physical trauma'' in new paragraph (dd). This amendment
is necessary to implement proposed changes to 38 CFR 3.159 and is
discussed below in section III.
III. Proposed Changes to Sec. 3.159 Department of Veterans Affairs
Assistance in Developing Claims
VA proposes to amend 38 CFR 3.159 to implement the new medical
nexus examination and exception authority created in 38 U.S.C. 1168 by
section 303 of the PACT Act. Based on 38 U.S.C. 1168, if a veteran
submits a claim for a disability that cannot be considered on a
presumptive basis and evidence establishes that the veteran
participated in a TERA, and the evidence of record is not sufficient to
establish service connection for the disability, VA will obtain a
medical examination and medical nexus opinion to determine if the
veteran's claimed disability is at least as likely as not due to the
veteran's TERA. Likewise, if a veteran submits a claim for a disability
that is subject to a presumption of service connection, but the veteran
did not have qualifying service in a location where VA has conceded
toxic exposure, and evidence establishes that the veteran participated
in a TERA, a medical examination and medical nexus opinion would be
required if service connection could not otherwise be established.
Additionally, VA would not obtain a medical examination and medical
nexus opinion if the evidence did not establish that the veteran
participated in a TERA because doing so would require the examiners to
provide opinions based on speculation.
To implement the new medical nexus examination and exception
authority created in 38 U.S.C. 1168 by section 303 of the PACT Act, VA
is proposing to amend Sec. 3.159(c)(4) by renumbering current
paragraphs (c)(4)(iii) and (iv) as (c)(4)(v) and (vi), respectively.
Additionally, VA proposes to amend the language in paragraph (c)(4)(i)
by clarifying that the requirements apply except as provided in
paragraph (c)(4)(iv). VA also proposes to include new paragraph
(c)(4)(iii), which would outline when a medical examination and medical
opinion must be provided for claims where the evidence establishes
participation in a TERA.
Section 1168(b) of title 38 of the U.S.C. provides an exception to
when medical examinations and nexus opinions are required for claims
where there is evidence of participation in a TERA and the claim cannot
be considered on a presumptive basis. The exception states that an
examination is not required if the Secretary determines that there is
no indication of an association between the claimed disability and the
TERA. This exception provides VA with the authority to define when a
medical examination and nexus opinion must be provided for claims where
the evidence establishes participation in a TERA and will be utilized
to minimize meritless examination requests. However, in all cases where
the veteran submits competent medical or scientific evidence that
indicates a possible association between their claimed disability and
TERA, VA will provide an examination and medical nexus opinion.
The determination that there is no indication of an association
between a disability and a TERA on a categorical basis will necessarily
involve factors specific and unique to the disabilities and TERAs
involved. And so, in interpreting the language of 38 U.S.C.
[[Page 79818]]
1168(b), VA is not proposing a single standard that would govern all
such determinations going forward. However, at this time VA has
determined that there is no indication of an association between the
following disabilities and TERAs and is proposing to apply the
exception at 38 U.S.C. 1168(b) in the following circumstances. As noted
below, VA has also requested comment on whether there are any
additional examination exceptions pursuant to section 1168(b), beyond
those proposed below, that the agency should consider implementing.
First, VA proposes to apply the exception when a veteran submits a
claim for service connection for a disability that resulted from
physical trauma. VA would not automatically order a medical examination
or medical nexus opinion if the veteran claims service connection for a
disability that resulted from physical trauma unless the veteran
submits competent medical or scientific evidence that indicates that
the claimed disability may be associated with the in-service TERA. VA
has determined that there is no indication of an association between
disabilities due to physical trauma and TERAs because the etiology of
these conditions is the physical trauma itself.
VA proposes to define physical trauma as ``a serious injury to the
body.'' \1\ VA notes that in this definition, VA intends the body to
include the head and all members of the person. See Black's Law
Dictionary 6th Ed. (1991) (defining body). The definition of physical
trauma will include three main types: blunt force trauma, trauma due to
repetitive use, and penetrating trauma.
---------------------------------------------------------------------------
\1\ National Institute of General Medical Sciences. Physical
Trauma. Accessed at <a href="https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx">https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx</a> on November 18, 2022.
---------------------------------------------------------------------------
VA proposes to define blunt force trauma to mean ``when an object
or force strikes the body, often causing concussions, deep cuts, or
broken bones.'' \2\ Trauma due to repetitive use will be defined as
occurring ``when repeated stress to the body's soft tissue structures,
including muscles, tendons, and nerves, results in repetitive strain
injuries.'' \3\ Penetrating trauma will be defined to mean ``when an
object pierces the skin or body, usually creating an open wound.'' \4\
Penetrating trauma with embedded fragments will not fall under this
exception. An embedded fragment is a piece of metal or other material
(also referred to as shrapnel) that stays in the body after injury and
can potentially lead to toxic exposure.\5\ Therefore, if a veteran
submits a claim for service connection for a disability due to embedded
fragments and there is evidence of participation in a TERA, a medical
examination and medical nexus opinion will be required.
---------------------------------------------------------------------------
\2\ Ibid.
\3\ O'Neil BA, Forsythe ME, Stanish WD. Chronic occupational
repetitive strain injury. Can Fam Physician. 2001 Feb;47:311-6.
PMID: 11228032; PMCID: PMC2016244.
\4\ National Institute of General Medical Sciences. Physical
Trauma. Accessed at <a href="https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx">https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx</a> on November 18, 2022.
\5\ Department of Veterans Affairs. Toxic Embedded Fragment
Surveillance Center Information For Veterans. 2014. Accessed at
<a href="https://www.publichealth.va.gov/docs/exposures/TEFSC-veterans-fact-sheet.pdf">https://www.publichealth.va.gov/docs/exposures/TEFSC-veterans-fact-sheet.pdf</a> on October 11, 2022.
---------------------------------------------------------------------------
To aid claims processors in identifying claims for conditions that
fall under the physical trauma exception, VA proposes to publish and
maintain a non-exhaustive list of conditions that may fall under the
exception on the VA PACT Act website. However, VA notes that the list
would not be binding on claims processors, who would still be required
to make case-by-case determinations of whether a disability resulted
from physical trauma based on the facts of the case. The VA ``The PACT
Act and your VA benefits'' website is the primary site for all
healthcare and benefits-related information on the PACT Act and
provides the public with detailed information regarding these topics.
Publishing the list on VA's PACT Act website provides VA the
flexibility to update the list by the most efficient means based on the
continually evolving science on health outcomes due to toxic exposure.
This approach allows VA to provide updates to veterans and stakeholders
in a timely manner. Although the specific website has not been created
yet and so a link cannot be provided at this time, VA proposes to
include a link to the VA PACT Act website in 38 CFR 3.159(c)(4)(iv) and
would do so in the final rule. The VA PACT Act website can be found at:
<a href="https://www.va.gov/resources/the-pact-act-and-your-va-benefits/">https://www.va.gov/resources/the-pact-act-and-your-va-benefits/</a>. In
addition, VA will provide notice in the Federal Register whenever
updates are made to the non-exhaustive list of physical trauma
exceptions.
VA is also proposing to apply the exception at 38 U.S.C. 1168(b) to
any claim for service connection of a mental disorder under 38 CFR
4.130, Schedule of Ratings--Mental Disorders. VA would not
automatically order a medical examination or medical nexus opinion if
the veteran claims service connection for a mental disorder unless the
veteran submits competent medical or scientific evidence that indicates
there may be an association between their disability and the in-service
TERA. VA has determined that there is no indication of an association
between mental disorders and toxic exposures because currently
available medical and scientific literature has not identified an
association between mental disorders and toxic exposure.
The National Academies of Science, Engineering, and Medicine
(NASEM) has been studying the health effects of serving in the Gulf War
since 1993 and has published 13 reports in their Gulf War and Health
series.\6\ Over the last 25 years, NASEM has not found an association
between toxic exposures during the Gulf War and mental disorders. In
Gulf War and Health, Volume 10 (2016), NASEM was tasked with reviewing
and evaluating the literature on health outcomes with higher incidence
rates in Gulf War deployed veterans, including post-deployment mental
disorders. NASEM determined that there was sufficient evidence of
association between deployment to the Gulf War and several mental
disorders, including posttraumatic stress disorder, generalized anxiety
disorders, depression, and substance use disorder. However, this
association was found to be due to combat exposure, and not associated
with exposure to toxins.\7\
---------------------------------------------------------------------------
\6\ VA Public Health. Gulf War Health and Medicine Division
Reports. Accessed at <a href="https://www.publichealth.va.gov/exposures/gulfwar/reports/health-and-medicine-division.asp">https://www.publichealth.va.gov/exposures/gulfwar/reports/health-and-medicine-division.asp</a> on October 25,
2022.
\7\ National Academies of Sciences, Engineering, and Medicine.
2016. Gulf War and Health: Volume 10: Update of Health Effects of
Serving in the Gulf War, 2016. Washington, DC: The National
Academies Press. <a href="https://doi.org/10.17226/21840">https://doi.org/10.17226/21840</a>.
---------------------------------------------------------------------------
Although this decision is predicated on the currently available
scientific evidence, section 507 of the PACT Act requires VA to partner
with NASEM ``to assess possible relationships between toxic exposures
experienced during service in the Armed Forces and mental health
conditions, including chronic multisymptom illness, traumatic brain
injury, posttraumatic stress disorder, depression, episodes of
psychosis, schizophrenia, bipolar disorder, suicide attempts, and
suicide deaths.'' The Act requires VA to submit a report detailing
NASEM's findings not later than three years from the date of enactment
of the Act. Depending on the results of this study, VA may revise its
exceptions under 38 U.S.C. 1168(b).
VA is also proposing to apply the exception under 38 U.S.C. 1168(b)
to claims for certain conditions that the VA Secretary has determined
have no association with herbicide exposure when the only participation
in a TERA
[[Page 79819]]
that is established relates to herbicide exposure. The Agent Orange Act
of 1991, Public Law 102-4, provided that whenever the Secretary
determined, based on sound medical and scientific evidence, that a
positive association exists between exposure to an herbicide agent and
a disease, the Secretary would publish regulations establishing
presumptive service connection for that disease. If the Secretary
determined that a presumption of service connection was not warranted,
VA was required to publish a notice of that determination, including an
explanation of the scientific basis for that determination.
Since 1994, NASEM has published 11 biennial reports in their
Veterans and Agent Orange series, as required by the Agent Orange
Act.\8\ VA has published nine notices \9\ explaining that presumptions
of service connection are not warranted for a number of diseases
addressed in NASEM's reports, due to the Secretary's determination that
there is not a positive association between herbicide exposure and the
diseases evaluated. VA has determined that there is no indication of an
association between these certain conditions and herbicide exposure.
Thus, VA is proposing to exclude these conditions from warranting a
medical examination and medical opinion under 38 U.S.C. 1168(b) when
the only relevant TERA is herbicide exposure. And therefore, VA would
not automatically order a medical examination or medical nexus opinion
if a veteran claims service connection for an excluded condition when
the only participation in a TERA that is established relates to
herbicide exposure, unless the veteran submits with, or during the
course of the claim, competent medical or scientific evidence \10\ that
indicates there may be an association between their disability and
herbicide exposure. This exception would not apply to claims for the
excluded conditions if participation in a TERA other than herbicide
exposure was established.
---------------------------------------------------------------------------
\8\ VA Public Health. Health and Medicine Division Reports on
Agent Orange. Accessed at <a href="https://www.publichealth.va.gov/exposures/agentorange/publications/health-and-medicine-division.asp">https://www.publichealth.va.gov/exposures/agentorange/publications/health-and-medicine-division.asp</a> on October
25, 2022.
\9\ 59 FR 341, published January 4, 1994, Disease Not Associated
With Exposure to Certain Herbicide Agents; 61 FR 41442, published
August 8, 1996, Disease Not Associated With Exposure to Certain
Herbicide Agents. August 8, 1996; 64 FR 59232, published November 2,
1999, Diseases Not Associated With Exposure to Certain Herbicide
Agents; 67 FR 45600, published June 24, 2002, Diseases Not
Associated With Exposure to Certain Herbicide Agents; 68 FR 27630,
published May 20, 2003, Diseases Not Associated With Exposure to
Certain Herbicide Agents; 75 FR 32540 published June 8, 2010, Health
Effects Not Associated With Exposure to Certain Herbicide Agents; 75
FR 81332, published December 27, 2010, Determinations Concerning
Illnesses Discussed in National Academy of Sciences Report: Veterans
and Agent Orange: Update 2010;77 FR 47924, published August 10,
2012, Determinations Concerning Illnesses Discussed in National
Academy of Sciences Report: Veterans and Agent Orange: Update 2010;
79 FR 20308, published April 11, 2014, Determinations Concerning
Illnesses Discussed in National Academy of Sciences Report: Veterans
and Agent Orange: Update 2012.
\10\ Competent medical or scientific evidence is typically
provided by one who is qualified to provide such evidence, due to
training, education, or experience in that particular field. See
Parks v. Shinseki, 716 F.3d 581,585 (2013).
---------------------------------------------------------------------------
VA has reviewed the list of conditions that the Secretary
determined did not warrant establishment of presumptive service
connection, published in the most recent Federal Register notice (79 FR
20308), but has made several changes for purposes of the exception
under 38 U.S.C. 1168(b). Conditions that are not considered
disabilities for VA rating purposes, such as laboratory findings, have
been removed. Conditions that have been determined to be presumptive to
herbicide exposure and added to 38 U.S.C. 1112(c) since publication of
the Federal Register notice have been removed. In addition, VA reviewed
currently available scientific evidence regarding any associations with
the conditions on the list and herbicide exposure. VA finds there is
sufficient scientific evidence warranting removal of renal cancer from
the previously published TERA exceptions list.\11\ VA's review of
currently available scientific evidence did not identify sufficient
evidence of an association between the remaining conditions on the list
and herbicide exposure. Several conditions were listed using vague and
non-specific medical terminology, such as ``eye problems'' and ``bone
conditions.'' ``Eye problems'' has been changed to ``diseases of the
eye.'' ``Bone conditions'' has been changed to ``osteoporosis'' because
osteoporosis was the only bone condition considered in the most recent
Veterans and Agent Orange report.
---------------------------------------------------------------------------
\11\ Andreotti, G., Beane Freeman, L.E., Shearer, J.J., Lerro,
C.C., Koutros, S., Parks, C.G., Blair, A., Lynch, C.F., Lubin, J.H.,
Sandler, D.P., & Hofmann, J.N. (2020). Occupational Pesticide Use
and Risk of Renal Cell Carcinoma in the Agricultural Health Study.
Environmental health perspectives, 128(6), 67011. <a href="https://doi.org/10.1289/EHP6334">https://doi.org/10.1289/EHP6334</a>.
---------------------------------------------------------------------------
The list of conditions published in the Federal Register and
recognized as not warranting a presumption of service connection based
on herbicide exposure also included ``cancers at other unspecified
sites (other than those as to which the Secretary has already
established a presumption.)'' VA determined that excluding all other
cancers for which there is not an established presumption was too broad
and may result in a veteran being denied a VA examination in error.
This determination is based on the fact that toxic exposure research
has advanced dramatically since the initial list was published in the
Federal Register, and VA cannot conclusively say that there is no
indication of an association between herbicide exposure and all other
cancers not already established by presumption.
Pursuant to the exception at 38 U.S.C. 1168(b), VA proposes to
exclude the following conditions when the only participation in a TERA
that is established relates to herbicide exposure: (1) Cancers of the
oral cavity (including lips and tongue), pharynx (including tonsils),
and nasal cavity (including ears and sinuses); (2) cancers of the
pleura, mediastinum, and other unspecified sites within the respiratory
system and intrathoracic organs; (3) cancers of the digestive organs
(esophageal cancer; stomach cancer; colorectal cancer (including small
intestine and anus), hepatobiliary cancers (liver, gallbladder, and
bile ducts), and pancreatic cancer); (4) bone and connective tissue
cancer; (5) melanoma; (6) nonmelanoma skin cancer (basal cell and
squamous cell); (7) cancers of the reproductive organs (cervix, uterus,
ovary, breast, testes, and penis; not including prostate); (8) cancers
of the brain and nervous system (including eye); (9) endocrine cancers
(including thyroid and thymus); (10) leukemia (other than all chronic
B-cell leukemias including chronic lymphocytic leukemia and hairy cell
leukemia); (11) neurobehavioral disorders (cognitive and
neuropsychiatric); (12) neurodegenerative diseases (including
amyotrophic lateral sclerosis (ALS) but not including Parkinson's
disease and Parkinsonism); (13) chronic peripheral nervous system
disorders (other than early-onset peripheral neuropathy); (14) asthma;
(15) chronic obstructive pulmonary disease; (16) farmer's lung; (17)
gastrointestinal, metabolic, and digestive disorders; (18) immune
system disorders (immune suppression, allergy, and autoimmunity); (19)
circulatory disorders (other than hypertension, ischemic heart disease,
and stroke); (20) endometriosis; (21) hearing loss; (22) diseases of
the eye; and (23) osteoporosis.
VA proposes to apply the exception under 38 U.S.C. 1168(b) to
claims for disabilities that manifested during military service or with
an etiology not associated with toxic exposure. This exception will
apply to conditions that manifested during service for which a medical
nexus opinion would not be needed to decide service connection on
[[Page 79820]]
a direct basis (evidence of chronicity or continuity is of record) and
to claims where the evidence of record indicates that the claimed
condition has an etiology that is not associated with toxic exposure
(to include post-service event).
VA also proposes to apply the exception under 38 U.S.C. 1168(b) to
claims where the only established participation in a TERA is based on
an entry in an exposure tracking record system that does not correspond
to an activity performed by the veteran that could result in potential
in-service exposure to toxic substances, chemicals, or airborne
hazards. Claims processors should apply a liberal standard to determine
participation in a TERA. VA generally proposes to recognize
participation in a TERA based on any entry in ILER, except for
contractor and civilian service records and where only the veteran's
name appears. However, there are circumstances where an entry in the
ILER database may show, for example, only a post-military service
health record or physical injuries. Such entries do not show the
veteran was in proximity to, or in the environment of, toxic
substances, chemicals, and/or airborne hazards, and so such entries
cannot corroborate potential exposure to toxic substances, chemicals,
or airborne hazards. Such entries would be sufficient to establish
participation in a TERA, but where the relevant entry provides no
indication of a potential toxic exposure during military service, VA
has determined that there would be no indication of an association
between the claimed disability and such entry. In such scenarios, VA
proposes that it will not provide an examination and opinion, pursuant
to the exception in section 1168(b).
VA further proposes that in order to corroborate a potential
exposure to toxic substances, chemicals, and/or airborne hazards, the
entries in an exposure tracking record system that establish the
veteran's participation in a TERA must show that the veteran was in
proximity to, or in an environment which contained, toxic substances,
chemicals, and/or airborne hazards. The proximity should not be
considered in terms of actual distance, but whether the conditions,
circumstances, and hardships of service placed the claimant in a
potentially toxic environment. Examples of service in proximity to, or
in an environment which contained, a toxic substance, chemical, or
airborne hazard include, but are not limited to, service in the
following locations: Congressionally recognized radiation risk
locations (38 U.S.C. 1112, 1154); locations associated with herbicide
exposure (38 U.S.C. 1116); the Persian Gulf (38 U.S.C. 1117; Pub. L
111-275, section (d)); locations associated with exposure to burn pits
(38 U.S.C. 1120); at Camp Lejeune (38 CFR 3.307(a)(7); and any
locations determined by the Secretary pursuant to 38 U.S.C. 1119
(c)(1)(B)(ix). Claims processors should also recognize veterans may
participate in a TERA based on their proximity to environmental hazards
such as asbestos, benzene, PFAS, or other accepted environmental
substances that pose risk to human health, regardless of location or
service era. For example, between 2001 and 2005, the U.S. occupied an
old Soviet-era airbase, Karshi-Khanabad (K2) in Uzbekistan, near
Tajikistan.\12\ The veterans who served at K2 were exposed to jet fuel
as a result of a leaking Soviet era underground jet fuel distribution
system; \13\ volatile organic compounds found in air samples; \14\
particulate matter and dust; \15\ depleted uranium from non-U.S.
ammunition destroyed in fires; \16\ asbestos roofing tiles and lead
based paint; \17\ and lead in water samples,\18\ which VA would
consider TERAs for this population. VA invites public comment on what
should be considered toxic exposure risk activity, and how VA should
determine whether a veteran participated in the same.
---------------------------------------------------------------------------
\12\ ``Military Deployment Periodic Occupational and
Environmental Monitoring Summary (POEMS): Karshi-Khanabad Airbase,
Uzbekistan: 2001 to 2005,'' Department of Defense, <a href="https://ph.health.mil/PHC%20Resource%20Library/U_UZB_Karshi-Khanabad%20POEMS%202001-2005_Public%20Release%20Review.pdf">https://ph.health.mil/PHC%20Resource%20Library/U_UZB_Karshi-Khanabad%20POEMS%202001-2005_Public%20Release%20Review.pdf</a>.
\13\ ``Environmental Conditions at Karshi-Khanabad (K-2) Air
Base Uzbekistan,'' Army Public Health Center, <a href="https://ph.health.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf">https://ph.health.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf</a> ; ``Transmittal of Deployment
Occupational and Environmental Health Site Assessment, Karshi-
Khanabad Airbase, Karshi, Uzbekistan,'' Department of the Army,
<a href="https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-08-doeh-assessment.pdf">https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-08-doeh-assessment.pdf</a>; ``Final Report, Environmental Assessment--Hardened
Aircraft Shelters, Stronghold Freedom, Karshi Khanabad Airfield,
Uzbekistan, 6 June--20 July 2002,'' <a href="https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-05-enviro-assessment-aircraft-shelters.pdf">https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-05-enviro-assessment-aircraft-shelters.pdf</a>.
\14\ ``Transmittal of Deployment Occupational and Environmental
Health Site Assessment, Karshi-Khanabad Airbase, Karshi,
Uzbekistan,'' Department of the Army.
\15\ ``Environmental Conditions at Karshi-Khanabad (K-2) Air
Base Uzbekistan,'' Army Public Health Center.
\16\ ``Transmittal of Deployment Occupational and Environmental
Health Site Assessment, Karshi-Khanabad Airbase, Karshi,
Uzbekistan,'' Department of the Army.
\17\ ``Transmittal of Deployment Occupational and Environmental
Health Site Assessment, Karshi-Khanabad Airbase, Karshi,
Uzbekistan,'' Department of the Army.
\18\ ``Transmittal of Deployment Occupational and Environmental
Health Site Assessment, Karshi-Khanabad Airbase, Karshi,
Uzbekistan,'' Department of the Army.
---------------------------------------------------------------------------
VA also proposes to apply the exception under section 1168(b) where
the only participation in a TERA that is established is based on
entries in an exposure tracking record system that are self-reported
records that cannot be substantiated. That is, the self-reported
records are inconsistent with the information available and
circumstances of the veteran's service or provide insufficient
information to permit reasonable verification. For example, if the only
participation in a TERA that is established is based on a veteran's
statement in a post-service health assessment or an Agent Orange
examination registry that they believe an herbicide exposure occurred,
the record must corroborate that the veteran served in proximity to, or
in an environment in which, an herbicide was present.
VA proposes that an unsubstantiated report is one VA cannot prove
or otherwise accept to be true. (See unsubstantiated definition ``not
proven to be true''. <a href="https://www.merriam-webster.com/dictionary/unsubstantiated">https://www.merriam-webster.com/dictionary/unsubstantiated</a>, reviewed January 11, 2024.) Unsubstantiated would also
be considered unsupported by any facts or evidence, unfounded by the
evidence, or lacking in foundation. This also includes circumstances
where the report in an exposure tracking record system, such as in an
Agent Orange registry exam in ILER, is inconsistent with the
circumstances of service based on the totality of the claimant's
record. Such scenarios could include, for example, inaccurate
information about a veteran's military occupational specialty or
reporting service in an unverifiable location.
VA has determined that there is no indication of an association
between participation in a TERA that is based on an entry in an
exposure tracking record system that is based on uncorroborated
assertions of exposure or unsubstantiated reports and disabilities. VA
notes that it would not be possible for an examiner to provide a
medical opinion on the relationship between a disability and
participation in a TERA that cannot be corroborated or substantiated,
as doing so would require speculation on the examiner's part. Although
a veteran's own statements may have evidentiary value in VA
adjudications, in instances where self-reported records are
inconsistent with the information available and circumstances of the
veteran's service, or provide insufficient information to permit
reasonable verification, such records do not reasonably provide any
[[Page 79821]]
indication of an association between a claimed disability and toxic
exposure risk activity.
The exceptions to the medical examination and medical opinion
requirements under 38 U.S.C. 1168(b) will be applied on a case-by-case
basis and require individualized determinations. In all cases, where
there is reasonable doubt as to whether the exception applies, such
doubt will be resolved in favor of the veteran, and a medical
examination and medical opinion will be provided (38 CFR 3.102).
As noted, VA also invites public comment on whether additional
exceptions under 1168(b) are warranted. For example, the agency invites
comment on the appropriateness of an exception that would apply if a
veteran has not affirmatively indicated the presence of a TERA.
VA proposes to list all medical examination and nexus opinion
exceptions for claims based on TERA under 38 CFR 3.159(c)(4)(iv).
In the interest of implementing the PACT Act as soon as possible
following enactment of the law, VA published Notification of Sub-
regulatory Guidance in the Federal Register on December 22, 2022 (87 FR
78543). The notification includes as an attachment VBA Letter 20-22-10,
which provides sub-regulatory guidance for claims processors
adjudicating disability compensation claims and appeals for veterans
and survivors impacted by the PACT Act prior to implementation of the
Act in regulation. Regarding section 303 of the PACT Act, the policy
letter outlines the procedures for determining when participation in a
TERA will be conceded. The Policy Letter can be found as an attachment
to the notification and can be viewed and downloaded at
<a href="http://Regulations.gov">Regulations.gov</a>.
IV. Proposed Changes to Sec. 3.317 Compensation for Certain
Disabilities Occurring in Persian Gulf Veterans
Section 3.317(a) governs presumptive service connection for certain
qualifying chronic disabilities based on service in the Southwest Asia
theater of operations during the Gulf War. The controlling statute, 38
U.S.C. 1117, was established in 1994, in response to large numbers of
Gulf War veterans returning from the Southwest Asia theater of
operations with unexplained symptoms of fatigue, skin rash, muscle and
joint pain, headache, loss of memory, shortness of breath, and
gastrointestinal and respiratory symptoms, which could not be diagnosed
or clearly defined. Congress recognized that veterans who deployed
during the Gulf War were exposed to toxic substances, chemicals, and
airborne hazards. However, at the time, there was a lack of scientific
evidence linking toxic exposure during Gulf War service to undiagnosed
illnesses and MUCMIs. Congress also recognized that VA did not have the
authority to provide compensation for these claims because the claimed
conditions could not be attributed to a known diagnosis (Pub. L. 103-
446, title I, sec. 102).
In response to these issues, Congress enacted the Veterans'
Benefits Improvements Act of 1994, Public Law 103-446. The law added 38
U.S.C. 1117, authorizing the Secretary of Veterans Affairs to
compensate any Persian Gulf veteran suffering from a chronic disability
resulting from an undiagnosed illness or MUCMI that became manifest
either during active duty in the Southwest Asia theater of operations
during the Persian Gulf War or to a degree of 10 percent or more within
a presumptive period, as determined by the Secretary, following service
in the Southwest Asia theater of operations during the Persian Gulf
War.
Implementing that statute, 38 CFR 3.317 prohibits compensation for
disabilities that, through medical history, physical examination, and
laboratory tests, are determined to result from any known clinical
diagnosis. Disabilities resulting from a known clinical diagnosis
receive consideration for service connection under other regulations
governing direct service connection or aggravation (38 CFR 3.303,
3.306, 3.310).
Section 405 of the PACT Act amended 38 U.S.C. 1117, Compensation
for disabilities occurring in Persian Gulf War veterans, by removing
the manifestation requirements for claims based on undiagnosed
illnesses and MUCMIs and instead allows compensation to be paid for
qualifying chronic disabilities that become manifest to any degree at
any time. Section 405 also amended the definition of a Persian Gulf
veteran contained in 38 U.S.C. 1117(f) to include veterans with service
in six additional locations: Afghanistan, Israel, Egypt, Turkey, Syria,
and Jordan.
Therefore, VA is proposing to amend 38 CFR 3.317(a)(1) to remove
the requirement that an undiagnosed illness or MUCMI must manifest
either during active military, naval, or air service in the Southwest
Asia theater of operations, or to a degree of 10 percent or more not
later than December 31, 2026. VA proposes to amend 38 CFR 3.317(a)(1)
to state that a qualifying chronic disability under this section may
manifest to any degree at any time, provided that such disability, by
history, physical examination, and laboratory tests, cannot be
attributed to any known clinical diagnosis.
Based on section 405 of the PACT Act, VA also proposes to amend 38
CFR 3.317(e)(1) to update the definition of a Persian Gulf veteran.
Currently, 38 CFR 3.317(e)(1) defines a Persian Gulf veteran as ``a
veteran who served on active military, naval, or air service in the
Southwest Asia theater of operations during the Persian Gulf War.'' The
PACT Act amended 38 U.S.C. 1117(f) to define a Persian Gulf veteran as
``a veteran who served on active duty in the Armed Forces in the
Southwest Asia theater of operations, Afghanistan, Israel, Egypt,
Turkey, Syria, or Jordan, during the Persian Gulf War.'' Therefore, VA
proposes to add these six new locations to the definition of a Persian
Gulf veteran under 38 CFR 3.317(e)(1).
VA recently announced its plans to take steps to consider Veterans
who served in Uzbekistan as Persian Gulf Veterans, therefore making
undiagnosed illness and medically unexplained chronic multi-symptom
illness (also known as Gulf War Illness) presumptive conditions for
those Veterans. VA invites public comment on that issue, as well as
whether VA should also add Somalia, Djibouti, Lebanon, and Yemen as
covered locations in the definition of a Persian Gulf veteran under 38
CFR 3.317(e)(1) based on exposure in these locations to toxic
substances similar to those that were present in currently covered
locations, such as fine particulate matter (PM<INF>2.5</INF>).
Further, because 38 CFR 3.317(c)(3)(ii) defines the qualifying
service for infectious diseases in terms of Sec. 3.317(e), it is
necessary to amend paragraph (c)(3)(ii) to correctly limit the scope of
its application to the Southwest Asia theater of operations during the
Gulf War period as well as on or after September 19, 2001, in
Afghanistan. VA acknowledges that there is overlap in 38 CFR 3.317 with
regard to locations currently covered for undiagnosed illnesses, MUCMIs
and infectious diseases. VA seeks comment as to whether the following
countries should be considered for inclusion under infectious diseases
in 38 CFR 3.317(c): Djibouti, Lebanon, Somalia, Uzbekistan, Yemen,
Israel, Egypt, Turkey, Syria or Jordan. VA is proposing amendments to
the manifestation requirements and the definition of a Persian Gulf
veteran under Sec. 3.317 described above to implement the statutory
changes imposed by the PACT Act.
[[Page 79822]]
V. Proposed Changes to Sec. 3.320 Claims Based on Exposure to Fine
Particulate Matter
VA proposes to amend 38 CFR 3.320 to implement portions of sections
302 and 406 of the PACT Act. VA promulgated 38 CFR 3.320 to establish
presumptions of service connection for certain chronic diseases based
on presumed exposure to fine particulate matter (PM<INF>2.5</INF>)
during service in the Southwest Asia theater of operations during the
Persian Gulf War, and service in Afghanistan, Syria, Djibouti, or
Uzbekistan, on or after September 19, 2001, during the Persian Gulf
War. These presumptions were based on VA's review and analysis of
several reports that focused on airborne hazards in the Southwest Asia
theater of operations during the Persian Gulf War. The primary reports
that informed VA's decision were NASEM's 2020 report, Respiratory
Health Effects of Airborne Hazards Exposures in the Southwest Asia
Theater of Military Operations,\19\ and NASEM's 2011 report, Long-Term
Consequences of Exposure to Burn Pits in Iraq and Afghanistan.\20\ VA's
decision was also informed by NASEM's 2010 report, Review of the
Department of Defense Enhanced Particulate Matter Surveillance Program,
which noted the difficulties associated with conducting exposure
assessments in deployment environments. However, the report concluded
that service members deployed to the Middle East ``are exposed to high
concentrations of PM and that the particle composition varies
considerably over time and space.'' \21\
---------------------------------------------------------------------------
\19\ National Academies of Sciences, Engineering, and Medicine
2020. Respiratory Health Effects of Airborne Hazards Exposures in
the Southwest Asia Theater of Military Operations. Washington, DC:
The National Academies Press. <a href="https://doi.org/10.17226/25837">https://doi.org/10.17226/25837</a>.
\20\ Institute of Medicine 2011. Long-Term Health Consequences
of Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC:
The National Academies Press. <a href="https://doi.org/10.17226/13209">https://doi.org/10.17226/13209</a>.
\21\ National Research Council 2010. Review of the Department of
Defense Enhanced Particulate Matter Surveillance Program Report.
Washington, DC: The National Academies Press. <a href="https://doi.org/10.17226/12911">https://doi.org/10.17226/12911</a>.
---------------------------------------------------------------------------
PM air pollution includes smoke, fumes, soot, and particles from
natural sources such as dust, pollen, sea salt, and forest fires.
Incomplete combustion of organic and inorganic material in burn pits
results in high volumes of toxic PM in the air that includes metals,
benzene, and other toxic compounds.\22\ When VA identified the
qualifying periods of service under 38 CFR 3.320, the three main
considerations were (1) whether burn pits were used in the location,
(2) the PM<INF>2.5</INF> levels, and (3) desert climate. Further, VA
relied on the Secretary's general rulemaking authority at 38 U.S.C.
501(a) when we established 38 CFR 3.320.
---------------------------------------------------------------------------
\22\ American Cancer Society. Military Burn Pits and Cancer
Risk. 2022. Accessed at <a href="https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html">https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html</a> on October 10, 2022.
---------------------------------------------------------------------------
Again, taking into account the three considerations noted above, VA
is proposing to remove the references to qualifying periods of service
and incorporate the definition of ``covered veteran'' from section 302
of the PACT Act into 38 CFR 3.320. Section 302 of the PACT Act created
new 38 U.S.C. 1119, Presumptions of toxic exposure, and defines a
``covered veteran'' as a veteran who served in the following eligible
locations: Bahrain, Iraq, Kuwait, Oman, Qatar, Saudi Arabia, Somalia,
and the United Arab Emirates on or after August 2, 1990, and
Afghanistan, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, and
Uzbekistan on or after September 11, 2001. VA is additionally proposing
to extend the current regulatory presumption of exposure to
PM<INF>2.5</INF> to the five new locations listed in 38 U.S.C. 1119
that are not currently recognized under Sec. 3.320: Somalia, Egypt,
Jordan, Lebanon, and Yemen.
All new locations added by section 302 of the PACT Act have
documented burn pit use. In 2021, DoD provided Congress with a list of
locations within U.S. Central Command where open burn pits have been
used since 2001. The U.S. Central Command's Area of Responsibility
consists of 21 nations that stretch from Northeast Africa across the
Middle East to Central and South Asia \23\ and is the only combatant
command that conducts open burn pit operations.\24\ Egypt, Jordan,
Lebanon, and Yemen were included as locations with open, active burn
pits. Somalia was not included on the list. However, there is evidence
of burn pit use in Somalia prior to 1993, when service members were
deployed in support of Operation Show Care.\25\ Additional deployments
occurred in 1992, 1995, 2012, and 2022; the latter being a ``small
persistent-presence.'' \26\ Available data in ILER provides evidence
that service members deployed to Somalia were exposed to significant
amounts of fugitive dust from airfields, residential fires and burn pit
smoke, and that this contributed to elevated PM levels.
---------------------------------------------------------------------------
\23\ U.S. Central Command. Area of Responsibility. Accessed at
<a href="https://www.centcom.mil/AREA-OF-RESPONSIBILITY/">https://www.centcom.mil/AREA-OF-RESPONSIBILITY/</a> on September 29,
2022.
\24\ Department of Defense. Open Burn Pit Report to Congress.
2019. Accessed at <a href="https://www.acq.osd.mil/eid/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf">https://www.acq.osd.mil/eid/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf</a> on October 1, 2022.
\25\ Center of Military History, United States Army. United
States Forces, Somalia After Action Report and Historical Overview:
The United States Army in Somalia, 1992-1994. <a href="https://www.history.army.mil/html/documents/somalia/index.html">https://www.history.army.mil/html/documents/somalia/index.html</a>.
\26\ CRS Report R42738, Instances of Use of United States Armed
Forces Abroad, 1798-2022, <a href="https://crsreports.congress.gov/product/pdf/R/R42738/38">https://crsreports.congress.gov/product/pdf/R/R42738/38</a>.
---------------------------------------------------------------------------
Additionally, all new locations added by section 302 of the PACT
Act have similar arid desert climate conditions. DoD's 2008 Enhanced
Particulate Matter Surveillance Program studied the chemical and
physical properties of dust at 15 deployment sites in the Middle East,
Central Asia, and Northeast Africa. The study found that Military
Exposure Guideline (MEG) values for PM<INF>2.5</INF> were exceeded at
all 15 sites for the entire one-year sampling period. The study also
demonstrated how ``short-term dust events--exacerbated by dirt roads,
agricultural activities, and disturbance of the desert floor by
motorized vehicles--all contribute to exceedance of both
PM<INF>10</INF> and PM<INF>2.5</INF> mass exposure guidelines and
standards.'' \27\ Finally, DoD's report also stated that PM levels in
the Middle East are as much as ten times greater than the levels at
both urban and rural southwestern U.S. air monitoring sites.
---------------------------------------------------------------------------
\27\ Jiandong Wang et al., Historical Trends in PM2.5-Related
Premature Mortality during 1990-2010 across the Northern Hemisphere.
Environmental Health Perspectives. 2017. 125:3. CID: <a href="https://doi.org/10.1289/EHP298">https://doi.org/10.1289/EHP298</a>; Melanie S. Hammer et al., Global Estimates
and Long-Term Trends of Fine Particulate Matter Concentrations
(1998-2018). Environ. Sci. Technol. 2020, 54, 7879-7890. <a href="https://doi.org/10.1021/acs.est.0c01764">https://doi.org/10.1021/acs.est.0c01764</a>.
---------------------------------------------------------------------------
Dust storms and high windblown dust concentrations are one of many
environmental hazards experienced during deployment to locations within
U.S. Central Command. Windblown dust in these locations is considered
an airborne hazard because it combines with elemental carbon and metals
that arise from transportation and industrial activities.\28\ While
dust in these locations can be toxic based on transportation and
industrial activities alone, open air burn pits increase the
concentration of toxins in PM<INF>2.5</INF>.
---------------------------------------------------------------------------
\28\ Institute of Medicine 2011. Long-Term Health Consequences
of Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC:
The National Academies Press. <a href="https://doi.org/10.17226/13209">https://doi.org/10.17226/13209</a>.
---------------------------------------------------------------------------
All new section 1119 locations have a history of annual
PM<INF>2.5</INF> levels that exceed military and EPA air quality
standards. Not only do they exceed air quality standards, average
PM<INF>2.5</INF> concentrations have been increasing in North Africa
and the Middle East since 1990, while Europe and North America have
experienced decreasing trends in average PM<INF>2.5</INF>
concentrations.\29\ Based on evidence of burn pit use, PM<INF>2.5</INF>
levels
[[Page 79823]]
that exceed military and EPA air quality standards, and their arid
desert climate conditions that exacerbate PM<INF>2.5</INF> levels, VA
finds there is sufficient evidence to extend the presumption of
exposure to PM<INF>2.5</INF> under 38 CFR 3.320 to Somalia, Egypt,
Jordan, Lebanon, and Yemen.
---------------------------------------------------------------------------
\29\ Department of Defense. Enhanced Particulate Matter
Surveillance Program (EPMSP) Final Report. 2008. <a href="https://apps.dtic.mil/sti/pdfs/ADA605600.pdf">https://apps.dtic.mil/sti/pdfs/ADA605600.pdf</a>.
---------------------------------------------------------------------------
Additionally, under 38 U.S.C. 1119(b)(2)(A), VA is required to
establish and maintain a list that contains an identification of one or
more such substances, chemicals, and airborne hazards as the Secretary,
in collaboration with the Secretary of Defense, may determine
appropriate for purposes of section 1119. VA proposes to add
PM<INF>2.5</INF> as the first airborne hazard recognized as warranting
a presumption of exposure under 38 U.S.C. 1119(b)(1). As discussed
above, in 2021, VA established a presumption of exposure to
PM<INF>2.5</INF> for veterans who served in the Southwest Asia theater
of operations, Afghanistan, Syria, Djibouti, or Uzbekistan when it
promulgated 38 CFR 3.320. Adding PM<INF>2.5</INF> as the first airborne
hazard recognized under 38 U.S.C. 1119(b)(2)(A) will allow VA to merge
the current presumption of exposure (38 CFR 3.320) with the PACT Act
presumptions of service connection without having to maintain a
separate presumption of exposure to PM<INF>2.5</INF> for the population
currently eligible under 38 CFR 3.320. It avoids VA having to maintain
two separate presumptions of exposure (PM<INF>2.5</INF> and the PACT
Act (sec 406) presumption of exposure to ``burn pits and other
toxins'') with almost identical covered populations. A major aim of the
PACT Act was to streamline VA's decision-making process related to
toxic exposure to provide faster decisions to veterans. Merging the
current presumption of exposure to PM<INF>2.5</INF> with the PACT Act
presumptions of service connection supports this aim and would improve
efficiency and consistency of rating decisions.
Further, under this approach, VA would still be able to study
additional health outcomes that may warrant a presumption of service
connection based on PM<INF>2.5</INF> exposure. This includes reviewing
body systems other than the respiratory system, as this was the main
focus of VA's initial PM research. VA's presumption of exposure to
PM<INF>2.5</INF> was rigorously analyzed through VA's established
presumption process in 2021, and based on the current section 302
requirements, VA has now identified PM<INF>2.5</INF> as an exposure
that was ubiquitous to the entire Gulf War theater of operations. VA's
Health Outcomes and Military Exposures (HOME) office, in collaboration
with DoD, will continue to study and evaluate the substances,
chemicals, and airborne hazards experienced by deployed Gulf War
Veterans. Based on these efforts, VA may add additional substances,
chemicals, and airborne hazards to the list in future rulemaking.
As discussed above, in locations that rely on open burning of
waste, the PM air pollution in that location will contain toxic
combustion emissions. Open burning is the ``burning of any matter in
such a manner that products of combustion resulting from the burning
are emitted directly into the ambient or surrounding outside air
without passing through an adequate stack, duct or chimney.'' \30\ The
Environmental Protection Agency (EPA) defines ``ambient air'' as ``that
portion of the atmosphere, external to buildings, to which the general
public has access.'' (40 CFR 50.1(e)). Because PM<INF>2.5</INF> is a
form of ambient air pollution and open burning of waste emits toxic
combustion emissions into the ambient air, VA considers exposure to
PM<INF>2.5</INF> as encompassing exposure to burn pit smoke. As a
result, VA will no longer maintain a separate presumptive regulation
based on PM exposure, but 38 CFR 3.320 will now cover presumptions of
exposure for various toxic substances, chemicals, and airborne hazards.
This change will supersede the procedural concession of burn pit
exposure in VA's M21-1 Adjudication Procedures Manual. Concession of
burn pit exposure is now covered under the presumption of exposure to
toxic substances, chemicals, and airborne hazards.
---------------------------------------------------------------------------
\30\ Estrellan, C.R. and Iino, F. (2010) Toxic Emissions from
Open Burning. Chemosphere, 80, 193-207. <a href="https://doi.org/10.1016/j.chemosphere.2010.03.057">https://doi.org/10.1016/j.chemosphere.2010.03.057</a>.
---------------------------------------------------------------------------
The new definition of a ``covered veteran'' in section 1119 does
not include all areas historically included in the Southwest Asia
theater of operations. The new definition omits the neutral zone
between Iraq and Saudi Arabia, the Gulf of Aden, the Gulf of Oman, the
Persian Gulf, the Arabian Sea, and the Red Sea. However, VA is
proposing to maintain the current definition of the Southwest Asia
theater of operations under the authority of 38 U.S.C. 501, as this
definition was based on Executive Order 12744 of January 21, 1991,
which designated the combat zone of the Persian Gulf War. Doing so
would allow individuals with service in those locations omitted from
the definition of ``covered veteran'' to still qualify as covered
veterans under the regulation.
Section 406 of the PACT Act established new 38 U.S.C. 1120,
Presumption of service connection for certain diseases associated with
exposure to burn pits and other toxins, which added a presumption of
service connection for 23 diseases. This presumption applies to covered
veterans as defined in 38 U.S.C. 1119(c), as described above. Because
VA is proposing to amend 38 CFR 3.320 to now govern not only claims
based on PM<INF>2.5</INF> exposure, but also claims based on exposure
to toxic substances, chemicals, and additional airborne hazards, VA
proposes to add the following presumptive diseases from 38 U.S.C.
1120(b) to 38 CFR 3.320: (1) asthma; (2) head cancer of any type; (3)
neck cancer of any type; (4) respiratory cancer of any type; (5)
gastrointestinal cancer of any type; (6) reproductive cancer of any
type; (7) lymphoma cancer of any type; (8) kidney cancer; (9) brain
cancer; (10) melanoma; (11) pancreatic cancer; (12) chronic bronchitis;
(13) chronic obstructive pulmonary disease; (14) constrictive
bronchiolitis or obliterative bronchiolitis; (15) emphysema; (16)
granulomatous disease; (17) interstitial lung disease; (18) pleuritis;
(19) pulmonary fibrosis; (20) sarcoidosis; (21) chronic sinusitis; (22)
chronic rhinitis; and (23) glioblastoma. VA notes that although section
406 of the PACT Act included lymphomatic cancer of any type in the list
of presumptions, that term was removed from 38 U.S.C. 1120 pursuant to
section 5124(a) of Public Law 117-263, as it was not a term recognized
by the scientific and medical community Therefore, VA will not include
lymphomatic cancer of any type in the list of presumptions included in
regulation. However, ``lymphoma cancer of any type'' remains a
presumptive condition for covered Gulf War veterans under 38 U.S.C.
1120.
Section 406 of the PACT Act established ``reproductive cancer of
any type'' as a disease presumed to be associated with exposure to burn
pits and other toxins (38 U.S.C. 1120(b)(2)(E)). The phrase
reproductive cancer is not defined in the PACT Act or elsewhere in
statute. As an initial matter, we propose to interpret reproductive
cancer as including breast cancer. Breasts are generally considered a
secondary sex characteristic, and breast tissue has unique attributes
that are responsive to reproductive hormones, including estrogen and
testosterone. Breast disorders may cause reproductive-related impacts.
And breast cancer has been considered a reproductive cancer in other
contexts,
[[Page 79824]]
including by the U.S. Department of Health and Human Services.\31\
---------------------------------------------------------------------------
\31\ Reproductive Cancers, HHS Office of Population Affairs,
available at <a href="https://opa.hhs.gov/reproductive-health/reproductive-cancers">https://opa.hhs.gov/reproductive-health/reproductive-cancers</a>, last accessed June 1, 2023.
---------------------------------------------------------------------------
Further, when determining whether to include all breast cancers, VA
considered the similarities between the epidemiology, treatment, and
psychosocial effects of breast cancer in males compared to females.
Mutational signatures found in cancer cells show extensive core
similarities between male and female breast cancer, supporting a view
that these cancers have common etiologic processes. In addition, risk
factors for breast cancer in men are the same as or analogous to risk
factors for breast cancer in women.\32\ Given the marked similarity of
male and female breast cancer across a range of factors, especially
common risk factors and mutational signatures, the Secretary has
determined that VA policy should apply equally to veterans with breast
cancer regardless of sex or gender. Based on the Secretary's decision,
VA is proposing that all breast cancers be considered reproductive
cancer of any type under 38 U.S.C. 1120 and be eligible for presumptive
service connection for covered veterans.
---------------------------------------------------------------------------
\32\ Fentiman IS. The endocrinology of male breast cancer.
Endocr Relat Cancer. 2018 Jun;25(6):R365-R373. doi: 10.1530/ERC-18-
0117. PMID: 29752333; Davey M.G., Davey C.M., Bouz L., Kerin E.,
McFeetors C., Lowery A.J., Kerin M.J., Relevance of the 21-gene
expression assay in male breast cancer: A systematic review and
meta-analysis. Breast. 2022;64:41-46; Valentini V., Silvestri V.,
Bucalo A., Conti G., Karimi M., Di Francesco L., Pomati G., Mezi S.,
Cerbelli B., Pignataro M.G., Nicolussi A., Coppa A., D'Amati G.,
Giannini G., Ottini L. Molecular profiling of male breast cancer by
multigene panel testing: Implications for precision oncology. Front
Oncol. 2023 Jan 6;12:1092201. doi: 10.3389/fonc.2022.1092201.
---------------------------------------------------------------------------
Following VA's review of eligible reproductive cancers under the
PACT Act, VA has also determined that it is reasonable to interpret
``reproductive cancer of any type'' as including cancer of the urethra
and cancer of the paraurethral glands. The urethra is the tube that
carries urine from the bladder to outside the body. In women, the
urethra is about 1\1/2\ inches long and is just above the vagina. In
men, the urethra is about 8 inches long, and goes through the prostate
gland and the penis to the outside of the body. In men, the urethra
also carries semen.\33\ Because it transports seminal fluid, the
urethra is a part of the reproductive system in males. In female human
anatomy, paraurethral glands (also known as the Skene glands or lesser
vestibular glands) are located around the lower end of the urethral
meatus.\34\ The paraurethral glands are located in the vestibule of the
vulva, around the lower end of the urethra. Two ducts lead from the
paraurethral glands to the vulvar vestibule, to the left and right of
the urethral opening, from which they are structurally capable of
secreting fluid. One purpose of the paraurethral glands is to secrete a
fluid that helps lubricate the urethral opening.\35\
---------------------------------------------------------------------------
\33\ National Cancer Institute. <a href="https://www.cancer.gov/types/urethral/patient/urethral-treatment-pdq">https://www.cancer.gov/types/urethral/patient/urethral-treatment-pdq</a>.
\34\ Dorland, W.A. Newman 1864-1956. Dorland's Illustrated
Medical Dictionary. 29th ed. Philadelphia, Saunders, 2000.
\35\ Pastor Z., Chmel R., (2017). ``Differential diagnostics of
female ``sexual'' fluids: a narrative review''. International
Urogynecology Journal. 29 (5): 621-629. doi:10.1007/s00192-017-3527-
9. PMID 29285596. S2CID 5045626.
---------------------------------------------------------------------------
Because the paraurethral glands and the male prostate act similarly
by secreting prostate-specific antigen (PSA), which is an ejaculate
protein produced in males, and of prostate-specific acid phosphatase,
some medical authorities refer to the paraurethral glands as the
``female prostate''.\36\ They are homologous to the male prostate
(developed from the same embryological tissues).
---------------------------------------------------------------------------
\36\ Bullough, Vern L.; Bullough, Bonnie (2014). Human
Sexuality: An Encyclopedia. Routledge. p. 231. ISBN 978-1135825096;
Diane Tomalty, Olivia Giovannetti et al.: Should We Call It a
Prostate? A Review of the Female Periurethral Glandular Tissue
Morphology, Histochemistry, Nomenclature, and Role in Iatrogenic
Sexual Dysfunction. In: Sexual Medicine Reviews. Volume 10, Issue 2,
April 2022, page 183-194.
---------------------------------------------------------------------------
The Secretary has determined that VA policy should apply equally to
Veterans filing claims for service connection regardless of sex, sexual
orientation, gender, and/or or gender identity. Therefore, VA is
proposing that urethral cancers, to include cancer of the paraurethral
glands, be considered reproductive cancer of any type under 38 U.S.C.
1120 and be eligible for presumptive service connection for covered
veterans.
Finally, section 406 adds a distinction after listing asthma as a
presumptive condition under 38 U.S.C. 1120. The PACT Act specifies that
asthma must be ``diagnosed after service of the covered veteran as
specified in section 1119(c).'' This means the presumption only applies
when asthma is diagnosed after service. Per 38 CFR 3.303(d),
presumptive periods are not intended to limit service connection to
diseases diagnosed after service when the evidence warrants direct
service connection. The presumptive regulations are intended as
liberalizations applicable when the evidence would not warrant service
connection without their aid. Therefore, requiring that asthma be
diagnosed after service in order for a presumption of service
connection to apply conflicts with the basic principle of presumptive
service connection. Therefore, VA will implement the PACT Act
presumption for asthma without the qualifying language that requires
the condition to be diagnosed after the covered service in section
1119(c).
VA notes that new sections 1119 and 1120 provide a service-
connection pathway distinct from that provided under section 1117
(undiagnosed illness and MUCMI). Therefore, VA is proposing to codify
new sections 1119 and 1120 under 38 CFR 3.320 rather than 38 CFR 3.317.
VA is proposing to change the heading of 38 CFR 3.320 to replace
the term ``fine particulate matter'' with ``toxic substances,
chemicals, and airborne hazards.'' This change is needed to make clear
that under this proposal, 38 CFR 3.320 would no longer be specific to a
single exposure (PM<INF>2.5</INF>) but would govern all claims based on
exposure to toxic substances, chemicals, and airborne hazards for
covered veterans. VA is proposing to describe the presumption of
exposure in paragraph (a), describe the presumptions of service
connection in paragraph (b), provide the definition of covered veteran
in paragraph (c), and keep the existing exceptions in paragraph (d).
Finally, section 406 of the PACT Act does not require that any of
the listed diseases manifest to a specific level or within a specific
presumptive period for presumptions of service connection under 38
U.S.C. 1120. VA is proposing to codify 38 U.S.C. 1120 under Sec. 3.320
as described above as required by the PACT Act.
VI. Severability
The purpose of this section is to clarify the agencies' intent with
respect to the severability of provisions of this proposed rule. Each
provision that the agency has proposed is capable of operating
independently. If any provision of this proposed rule is determined by
judicial review or operation of law to be invalid, that partial
invalidation will not render the remainder of this proposed rule
invalid. Likewise, if the application of any portion of this proposed
rule to a particular circumstance is determined to be invalid, the
agencies intend that the rulemaking remain applicable to all other
circumstances.
VII. Effective Date and Applicability
Section 406 of the PACT Act prescribed phased-in and criteria-based
applicability dates for 11 of the 23 new presumptive conditions. All
claims
[[Page 79825]]
based on section 406 will be effective on the date of enactment of the
Act; however, section 406 would stagger the dates that VA would be
required to effectuate payment of compensation. The Act provides an
exception to the phased-in applicability dates for veterans meeting
certain priority criteria. Specifically, new presumptions under section
406 are applicable on the date of enactment of the Act for claims for
dependency and indemnity compensation (DIC) and for veterans whom the
Secretary determines are terminally ill, homeless, under extreme
financial hardship, more than 85 years old, or capable of demonstrating
other sufficient cause. For claimants not meeting one of the priority-
based criteria, the applicability date of the presumption would be
established as one of the following staggered dates: October 1, 2022,
October 1, 2023, October 1, 2024, October 1, 2025, and October 1, 2026.
As stated above, these phased-in applicability dates apply to 11 of the
23 new presumptive conditions under 38 U.S.C. 1120.
However, the Secretary has determined that the text of the PACT Act
provides VA with authority to treat all new presumptions in section 406
of the PACT Act as immediately applicable, and the Secretary has chosen
to exercise this authority. The Secretary has determined that all
veterans presenting a claim for disability compensation for which
service connection could be established based on the presumptions in
section 406 are ``capable of demonstrating other sufficient cause,''
entitling those veterans to an applicability date concurrent with the
date of enactment of the PACT Act. While the Secretary recognizes that
Congress enumerated phased-in applicability dates, Congress also
provided an extremely broad ``catch-all'' at the end of categories of
cases that would justify immediate applicability of an otherwise
phased-in presumption. This final category is textually broad and left
undefined, providing the Secretary with significant discretion to
expand the universe of cases for which otherwise phased-in presumptions
under section 406 can be treated as immediately applicable. In making
this determination, the Secretary considered first and foremost the
health and economic needs of veterans, and specifically the serious
nature of exposure to toxins in combat zones and the associated health
effects from such exposures. Additionally, while phased-in
applicability dates intuitively might help manage the significant
increase in claims inventory that will result from the Act, VA
estimates that phased-in applicability dates would result in between
900,000 and 1.5 million veterans having to wait up to four years for a
decision on their claim, whereas acceleration of the applicability
dates would avoid making veterans wait years. Further, rather than the
administrative complexity and claimant confusion that would inevitably
be created by having to hold many thousands of claims pending arrival
of the phased-in applicability dates, immediate applicability ensures a
simple, streamlined policy that will be easy for veterans and their
families to understand and for VA to implement with consistency and
efficiency.
For these reasons, the Secretary has determined to treat all
presumptions in the PACT Act as applicable upon enactment and is
proposing to add a new paragraph (e) to Sec. 3.320 to reflect this
determination.
VIII. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written comments, recommendations, and
data on any topic covered in this proposal. In addition, VA invites
comments specifically on the following questions related to this
rulemaking:
(1) What other factors and/or types of evidence should be
considered when determining if participation in a TERA should be
conceded?
(2) Are there additional TERA examination exceptions that should be
implemented? If so, what are some examples of exceptions that should be
considered? For example, the agency invites comment on the
appropriateness of an exception that would apply if a veteran has not
affirmatively indicated the presence of a TERA.
(3) Considering that the definition of TERA has an impact on the
provision of medical examinations and nexus opinions under 38 U.S.C.
1168 and the provision of health care pursuant to 38 U.S.C.
1710(e)(4)(C), what additional activities or factors should the
Secretary consider when determining what qualifies as TERA?
(4) Would it be appropriate to require that the veteran
affirmatively assert the existence of a TERA in order for their claim
to be considered under 38 U.S.C. 1168/TERA procedure?
VA welcomes comments from the public on all aspects of this
proposed rule. This information will be utilized by VA to enhance our
sub-regulatory guidance, inform the final rule, and improve consistency
and transparency in our decision-making. All comments received by the
closing date will be considered prior to final action.
IX. Revise Remainder of 38 CFR 3.1
Because VA is amending 38 CFR 3.1, VA is also required to bring the
authority citations for the entirety of the regulation into compliance
with 1 CFR 21.43. For Sec. 3.1, VA is proposing to revise Sec.
3.1(d), (j), (m), (r), (s), (t), (x), (y), (aa)(1) and (2) to amend the
authority citations. These are not substantive changes, but rather
changing the placement of the authority in regulation. Although VA is
also making changes to Sec. Sec. 3.159, 3.317, and 3.320, VA is
addressing the changes to authority to Sec. 3.159 in a separate
rulemaking, and there are no authority changes required for Sec. Sec.
3.317 or 3.320.
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 of September 30,
1993 (Regulatory Planning and Review), and Executive Order 13563 of
January 18, 2011 (Improving Regulation and Regulatory Review). 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 associated with this rulemaking can be found
as a supporting document at <a href="http://www.regulations.gov">www.regulations.gov</a>.
Regulatory Flexibility Act (RFA)
The Secretary hereby certifies that this proposed rule would 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 factual basis for this certification is that no
small entities or businesses provide Federal compensation or pension
[[Page 79826]]
benefits to veterans, and such entities or businesses therefore would
be unaffected by the proposed rule. Therefore, pursuant to 5 U.S.C.
605(b), the initial and final regulatory flexibility analysis
requirements of 5 U.S.C. 603 and 604 do not apply.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on State, local, and Tribal governments, or on the private
sector.
Paperwork Reduction Act (PRA)
Although this proposed rule contains a collection of information
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521), there are no provisions associated with this rulemaking
constituting any new collection of information or any revisions to the
current collection of information. The collection of information for 38
CFR 3.1, 3.159, 3.307, 3.309, 3.311, 3.317, 3.320, is currently
approved by the Office of Management and Budget (OMB) and has a valid
OMB control number of 2900-0747 and 2900-0886.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Health care, Pensions, Radioactive materials, Veterans, Vietnam.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved and signed
this document on September 19, 2024, 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 Department of Veterans
Affairs proposes to amend 38 CFR part 3 as set forth below:
PART 3--ADJUDICATION
Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation
0
1. The authority citation for part 3, subpart A continues to read as
follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
0
2. Amend Sec. 3.1 by:
0
a. Revising paragraphs (d) introductory text, (j), (m), (r), (s), (t),
(x), (y) introductory text, and (aa)(1) and (2); and
0
3. Adding paragraphs (bb) through (dd).
The revisions and additions read as follows:
Sec. 3.1 Definitions.
* * * * *
(d) Veteran means a person who served in the active military,
naval, air, or space service and who was discharged or released under
conditions other than dishonorable under 38 U.S.C. 101(2).
* * * * *
(j) Marriage means a marriage valid under the law of the place
where the parties resided at the time of marriage, or the law of the
place where the parties resided when the right to benefits accrued
under 38 U.S.C. 103(c)).
* * * * *
(m) In line of duty, per 38 U.S.C. 105, means an injury or disease
incurred or aggravated during a period of active military, naval, air,
or space service unless such injury or disease was the result of the
veteran's own willful misconduct or, for claims filed after October 31,
1990, was a result of his or her abuse of alcohol or drugs. A service
department finding that injury, disease or death occurred in line of
duty will be binding on the Department of Veterans Affairs unless it is
patently inconsistent with the requirements of laws administered by the
Department of Veterans Affairs. Requirements as to line of duty are not
met if at the time the injury was suffered or disease contracted the
veteran was:
* * * * *
(r) Date of receipt means the date on which a claim, information or
evidence was received in the Department of Veterans Affairs, except as
to specific provisions for claims or evidence received in the State
Department (Sec. 3.108), or in the Social Security Administration
(Sec. Sec. 3.153, 3.201), or Department of Defense as to initial
claims filed at or prior to separation. However, the Under Secretary
for Benefits may establish, by notice published in the Federal
Register, exceptions to this rule, using factors such as postmark or
the date the claimant signed the correspondence, when he or she
determines that a natural or man-made interference with the normal
channels through which the Veterans Benefits Administration ordinarily
receives correspondence has resulted in one or more Veterans Benefits
Administration offices experiencing extended delays in receipt of
claims, information, or evidence from claimants served by the affected
office or offices to an extent that, if not addressed, would adversely
affect such claimants through no fault of their own (38 U.S.C. 512(a),
5110).
(s) On the borders thereof means, with regard to service during the
Mexican border period, the States of Arizona, California, New Mexico,
and Texas, and the nations of Guatemala and British Honduras (38 U.S.C.
101(30)).
(t) In the waters adjacent thereto means, with regard to service
during the Mexican border period, the waters (including the islands
therein) which are within 750 nautical miles (863 statute miles) of the
coast of the mainland of Mexico (38 U.S.C. 101(30)).
* * * * *
(x) Service pension is the name given to Spanish-American War
pension. It is referred to as a service pension because entitlement is
based solely on service without regard to nonservice-connected
disability, income and net worth. (38 U.S.C. 1512, 1536).
(y) Former prisoner of war. The term former prisoner of war means a
person who, while serving in the active military, naval, air, or space
service, was forcibly detained or interned in the line of duty by an
enemy or foreign government, the agents of either, or a hostile force
under 38 U.S.C. 101(32).
* * * * *
(aa) * * *
(1) As used in 38 U.S.C. 103 and implementing regulations, fraud
means an intentional misrepresentation of fact, or the intentional
failure to disclose pertinent facts, for the purpose of obtaining, or
assisting an individual to obtain an annulment or divorce, with
knowledge that the misrepresentation or failure to disclose may result
in the erroneous granting of an annulment or divorce; and
(2) As used in 38 U.S.C. 110 and 1159 and implementing regulations,
fraud means an intentional misrepresentation of fact, or the
intentional failure to disclose pertinent facts, for the purpose of
obtaining or retaining, or assisting an individual to obtain or retain,
eligibility for Department of Veterans Affairs
[[Page 79827]]
benefits, with knowledge that the misrepresentation or failure to
disclose may result in the erroneous award or retention of such
benefits.
(bb) Toxic exposure risk activity means:
(1) Any activity that requires a corresponding entry in an exposure
tracking record system for the veteran who carried out the activity; or
(2) Any activity that the Secretary determines qualifies for
purposes of this section when taking into account what is reasonably
prudent to protect the health of veterans.
(cc) Exposure tracking record system means:
(1) Any system, program, or pilot program used by the Secretary of
Veterans Affairs or the Secretary of Defense to track how veterans or
members of the Armed Forces have been exposed to various occupational
or environmental hazards; and
(2) Includes the Individual Longitudinal Exposure Record, or
successor system.
(dd) Physical trauma means a serious injury to the body. The three
types of physical trauma are as follows:
(i) Blunt force trauma--when an object or force strikes the body,
often causing concussions, deep cuts, or broken bones;
(ii) Trauma due to repetitive use--when repeated stress to the
body's soft tissue structures, including muscles, tendons, and nerves,
results in repetitive strain injuries; and
(iii) Penetrating trauma--when an object pierces the skin or body,
usually creating an open wound. Penetrating trauma due to embedded
fragments (to include shrapnel) does not fall under this definition.
(Authority: 38 U.S.C. 101, 103, 105, 110, 501, 512, 1159, 1168,
1512, 1536, 1742, 5110)
0
4. Amend Sec. 3.159 by:
0
a. Revising paragraphs (c)(4)(i) and (ii);
0
b. Redesignating paragraphs (c)(4)(iii) and (iv) as paragraphs
(c)(4)(v) and (vi), respectively; and
0
c. Adding new paragraphs (c)(4)(iii) and (iv).
The revisions and additions read as follows:
Sec. 3.159 Department of Veterans Affairs assistance in developing
claims.
* * * * *
(c) * * *
(4) Providing medical examinations or obtaining medical opinions.
(i) Except as provided in paragraphs (c)(4)(iii) and (iv) of this
section, in a claim for disability compensation, VA will provide a
medical examination or obtain a medical opinion based upon a review of
the evidence of record if VA determines it is necessary to decide the
claim. A medical examination or medical opinion is necessary if the
information and evidence of record does not contain sufficient
competent medical evidence to decide the claim, but:
(A) Contains competent lay or medical evidence of a currently
diagnosed disability or persistent or recurrent symptoms of disability;
(B) Establishes that the veteran suffered an event, injury or
disease in service, or has a disease or symptoms of a disease listed in
Sec. Sec. 3.309, 3.313, 3.316, 3.317, and 3.320 manifesting during an
applicable presumptive period provided the claimant has the required
service or triggering event to qualify for that presumption; and
(C) Indicates that the claimed disability or symptoms may be
associated with the established event, injury, or disease in service or
with another service-connected disability.
(ii) Paragraph (c)(4)(i)(C) of this section could be satisfied by
competent evidence showing post-service treatment for a condition, or
other possible association with military service.
(iii) Except as provided in paragraph (c)(4)(iv) of this section,
when a claim that cannot be considered on a presumptive basis is
received, VA will provide a medical examination and medical nexus
opinion if the evidence of record does not contain sufficient competent
medical evidence to establish service connection, but only if the
claim:
(A) Contains competent lay or medical evidence of a current
disability; and
(B) Establishes that the veteran participated in a toxic exposure
risk activity as defined in Sec. 3.1(bb).
(iv). The Secretary has determined that there is no indication of
an association between toxic exposure risk activities and the
disabilities, conditions, and circumstances listed in paragraphs
(c)(4)(iv)(A) through (D) of this section. A VA examination and medical
nexus opinion will not be required for claims that cannot be considered
on a presumptive basis and evidence establishes that the veteran
participated in a toxic exposure risk activity if evidence shows:
(A) The disability is the result of physical trauma as defined in
Sec. 3.1(dd); or
(B) The claimed condition is a mental disorder; or
(C) The disability manifested during military service or has an
etiology not associated with toxic exposure; or
(D) The only participation in a toxic exposure risk activity that
is established relates to herbicide exposure and the veteran claims any
of the following conditions:
(1) Cancers of the oral cavity (including lips and tongue), pharynx
(including tonsils), and nasal cavity (including ears and sinuses);
(2) Cancers of the pleura, mediastinum, and other unspecified sites
within the respiratory system and intrathoracic organs;
(3) Cancers of the digestive organs (esophageal cancer; stomach
cancer; colorectal cancer (including small intestine and anus),
hepatobiliary cancers (liver, gallbladder, and bile ducts), and
pancreatic cancer);
(4) Bone and connective tissue cancer;
(5) Melanoma;
(6) Nonmelanoma skin cancer (basal cell and squamous cell);
(7) Cancers of the reproductive organs (cervix, uterus, ovary,
breast, testes, and penis; not including prostate);
(8) Cancers of the brain and nervous system (including eye);
(9) Endocrine cancers (including thyroid and thymus);
(10) Leukemia (other than all chronic B-cell leukemias including
chronic lymphocytic leukemia and hairy cell leukemia);
(11) Neurobehavioral disorders (cognitive and neuropsychiatric);
Neurodegenerative diseases (including amyotrophic lateral sclerosis
(ALS) but not including Parkinson's disease and Parkinsonism);
(12) Chronic peripheral nervous system disorders (other than early-
onset peripheral neuropathy);
(13) Asthma;
(14) Chronic obstructive pulmonary disease;
(15) Farmer's lung;
(16) Gastrointestinal, metabolic, and digestive disorders;
(17) Immune system disorders (immune suppression, allergy, and
autoimmunity);
(18) Circulatory disorders (other than hypertension, ischemic heart
disease, and stroke);
(19) Endometriosis;
(20) Hearing loss;
(21) Diseases of the eye; and
(22) Osteoporosis.
(E) The exceptions under paragraphs (c)(4)(iv)(A) through (D) of
this section will not apply if the veteran submits competent scientific
or medical evidence that indicates that the claimed disability or
condition may be associated with the in-service toxic exposure risk
activity.
[[Page 79828]]
(F) The only participation in a toxic exposure risk activity that
is established is based on an entry in an exposure tracking record
system, as defined in Sec. 3.1(cc), that does not corroborate a
veteran's potential exposure to toxic substances, chemicals, or
airborne hazards during military service.
(G) The only participation in a toxic exposure risk activity that
is established is based on an entry in an exposure tracking record
system, as defined in Sec. 3.1(cc), that is based on the veteran's
report of exposure to toxic substances, chemicals, or airborne hazards
that cannot be substantiated.
* * * * *
0
4. Amend Sec. 3.317 by revising the section heading and paragraphs
(a)(1), (c)(3)(ii), and (e)(1) to read as follows:
Sec. 3.317 Presumption of service connection for certain undiagnosed
illnesses and medically unexplained chronic multi-symptom illnesses
occurring in Persian Gulf veterans.
(a) * * *
(1) Except as provided in paragraph (a)(7) of this section, VA will
pay compensation in accordance with 38 U.S.C. chapter 11, to a Persian
Gulf veteran who exhibits objective indications of a qualifying chronic
disability that became manifest to any degree at any time, provided
that such disability, by history, physical examination, and laboratory
tests, cannot be attributed to any known clinical diagnosis.
* * * * *
(c) * * *
(3) * * *
(ii) For purposes of this paragraph (c), the term qualifying period
of service means service in the Southwest Asia theater of operations
during the Gulf War or a period of active military, naval, or air
service on or after September 19, 2001, in Afghanistan.
* * * * *
(e) Service. For purposes of this section:
(1) The term Persian Gulf veteran means a veteran who served on
active military, naval, or air service in the Southwest Asia theater of
operations, Afghanistan, Israel, Egypt, Turkey, Syria, or Jordan,
during the Persian Gulf War.
* * * * *
0
5. Revise Sec. 3.320 to read as follows:
Sec. 3.320 Presumptive service connection based on exposure to toxic
substances, chemicals, and airborne hazards.
(a) Presumption of exposure. A covered veteran as defined in
paragraph (c) of this section, and required by 38 U.S.C. 1119(b), shall
be presumed to have been exposed to the following toxic substances,
chemicals, and airborne hazards during such service, unless there is
affirmative evidence to establish that the veteran was not exposed to
any such toxic substances, chemicals, and airborne hazards during that
service.
(1) Fine particulate matter.
(2) [Reserved]
(b) Presumption of service connection. Except as provided in
paragraph (d) of this section, the following diseases becoming manifest
in a covered veteran, as defined in paragraph (c) of this section,
shall be considered to have been incurred in or aggravated during
active military, naval, air, or space service, notwithstanding that
there is no record of evidence of such disease during the period of
such service.
(1) Asthma.
(2) Head cancer of any type.
(3) Neck cancer of any type.
(4) Respiratory cancer of any type.
(5) Gastrointestinal cancer of any type.
(6) Reproductive cancer of any type.
(7) Lymphoma cancer of any type.
(8) Kidney cancer.
(9) Brain cancer.
(10) Melanoma.
(11) Pancreatic cancer.
(12) Chronic bronchitis.
(13) Chronic obstructive pulmonary disease.
(14) Constrictive bronchiolitis or obliterative bronchiolitis.
(15) Emphysema.
(16) Granulomatous disease.
(17) Interstitial lung disease.
(18) Pleuritis.
(19) Pulmonary fibrosis.
(20) Sarcoidosis.
(21) Chronic sinusitis.
(22) Chronic rhinitis.
(23) Glioblastoma.
(c) Covered veteran. For purposes of this section, the term covered
veteran means any veteran who:
(1) On or after August 2, 1990, performed active military, naval,
air, or space service while assigned to a duty station in, including
airspace above:
(i) The Southwest Asia theater of operations as defined in Sec.
3.317(e)(2); or
(ii) Somalia; or
(2) On or after September 11, 2001, performed active military,
naval, air, or space service while assigned to a duty station in,
including airspace above:
(i) Afghanistan;
(ii) Djibouti;
(iii) Egypt;
(iv) Jordan;
(v) Lebanon;
(vi) Syria;
(vii) Yemen; or
(viii) Uzbekistan.
(d) Exceptions. A disease listed in paragraph (b) of this section
shall not be presumed service connected if there is affirmative
evidence that:
(1) The disease was not incurred or aggravated during active
military, naval, air, or space service; or
(2) The disease was caused by a supervening condition or event that
occurred between the veteran's most recent departure from active
military, naval, air, or space service and the onset of the disease; or
(3) The disease is the result of the veteran's own willful
misconduct.
(e) Special applicability date provision. The Secretary has
determined that all veterans presenting a claim for disability
compensation for which service connection could be established based on
the presumptions in section 406 of Public Law 117-168 are ``capable of
demonstrating other sufficient cause,'' entitling those veterans to an
applicability date for the presumptions concurrent with the date of
enactment of Public Law 117-168.
(Authority: 38 U.S.C. 501, 1119, 1120)
[FR Doc. 2024-21852 Filed 9-30-24; 8:45 am]
BILLING CODE 8320-01-P
</pre></body>
</html>Indexed from Federal Register on October 1, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.