VA Adjudication Regulations for Disability or Death Benefit Claims Based on Toxic Exposure, 79815-79828 [2024-21852]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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 [www.gpo.gov]
[FR Doc No: 2024-21852]


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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.

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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 www.regulations.gov. 
Except as provided below, comments received before the close of the 
comment period will be available at www.regulations.gov 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 
www.regulations.gov as soon as possible after they have been received. 
VA will not post on Regulations.gov 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 
www.regulations.gov, 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.
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    \1\ National Institute of General Medical Sciences. Physical 
Trauma. Accessed at https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx on November 18, 2022.
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    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.
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    \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 https://www.nigms.nih.gov/education/fact-sheets/Pages/physical-trauma.aspx on November 18, 2022.
    \5\ Department of Veterans Affairs. Toxic Embedded Fragment 
Surveillance Center Information For Veterans. 2014. Accessed at 
https://www.publichealth.va.gov/docs/exposures/TEFSC-veterans-fact-sheet.pdf on October 11, 2022.
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    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: 
https://www.va.gov/resources/the-pact-act-and-your-va-benefits/. 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\
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    \6\ VA Public Health. Gulf War Health and Medicine Division 
Reports. Accessed at https://www.publichealth.va.gov/exposures/gulfwar/reports/health-and-medicine-division.asp 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. https://doi.org/10.17226/21840.
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    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.
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    \8\ VA Public Health. Health and Medicine Division Reports on 
Agent Orange. Accessed at https://www.publichealth.va.gov/exposures/agentorange/publications/health-and-medicine-division.asp 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).
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    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.
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    \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. https://doi.org/10.1289/EHP6334.
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    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, https://ph.health.mil/PHC%20Resource%20Library/U_UZB_Karshi-Khanabad%20POEMS%202001-2005_Public%20Release%20Review.pdf.
    \13\ ``Environmental Conditions at Karshi-Khanabad (K-2) Air 
Base Uzbekistan,'' Army Public Health Center, https://ph.health.mil/PHC%20Resource%20Library/EnvironmentalConditionsatK-2AirBaseUzbekistan_FS_64-038-0617.pdf ; ``Transmittal of Deployment 
Occupational and Environmental Health Site Assessment, Karshi-
Khanabad Airbase, Karshi, Uzbekistan,'' Department of the Army, 
https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-08-doeh-assessment.pdf; ``Final Report, Environmental Assessment--Hardened 
Aircraft Shelters, Stronghold Freedom, Karshi Khanabad Airfield, 
Uzbekistan, 6 June--20 July 2002,'' https://ph.health.mil/PHC%20Resource%20Library/ehse-k2-05-enviro-assessment-aircraft-shelters.pdf.
    \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''. https://www.merriam-webster.com/dictionary/unsubstantiated, 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 
Regulations.gov.

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 (PM2.5).
    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 (PM2.5) 
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. https://doi.org/10.17226/25837.
    \20\ Institute of Medicine 2011. Long-Term Health Consequences 
of Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC: 
The National Academies Press. https://doi.org/10.17226/13209.
    \21\ National Research Council 2010. Review of the Department of 
Defense Enhanced Particulate Matter Surveillance Program Report. 
Washington, DC: The National Academies Press. https://doi.org/10.17226/12911.
---------------------------------------------------------------------------

    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 PM2.5 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 https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html 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 
PM2.5 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 
https://www.centcom.mil/AREA-OF-RESPONSIBILITY/ on September 29, 
2022.
    \24\ Department of Defense. Open Burn Pit Report to Congress. 
2019. Accessed at https://www.acq.osd.mil/eid/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf 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. https://www.history.army.mil/html/documents/somalia/.
    \26\ CRS Report R42738, Instances of Use of United States Armed 
Forces Abroad, 1798-2022, https://crsreports.congress.gov/product/pdf/R/R42738/38.
---------------------------------------------------------------------------

    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 PM2.5 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 
PM10 and PM2.5 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: https://doi.org/10.1289/EHP298; 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. https://doi.org/10.1021/acs.est.0c01764.
---------------------------------------------------------------------------

    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 PM2.5.
---------------------------------------------------------------------------

    \28\ Institute of Medicine 2011. Long-Term Health Consequences 
of Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC: 
The National Academies Press. https://doi.org/10.17226/13209.
---------------------------------------------------------------------------

    All new section 1119 locations have a history of annual 
PM2.5 levels that exceed military and EPA air quality 
standards. Not only do they exceed air quality standards, average 
PM2.5 concentrations have been increasing in North Africa 
and the Middle East since 1990, while Europe and North America have 
experienced decreasing trends in average PM2.5 
concentrations.\29\ Based on evidence of burn pit use, PM2.5 
levels

[[Page 79823]]

that exceed military and EPA air quality standards, and their arid 
desert climate conditions that exacerbate PM2.5 levels, VA 
finds there is sufficient evidence to extend the presumption of 
exposure to PM2.5 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. https://apps.dtic.mil/sti/pdfs/ADA605600.pdf.
---------------------------------------------------------------------------

    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 
PM2.5 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 
PM2.5 for veterans who served in the Southwest Asia theater 
of operations, Afghanistan, Syria, Djibouti, or Uzbekistan when it 
promulgated 38 CFR 3.320. Adding PM2.5 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 PM2.5 for the population 
currently eligible under 38 CFR 3.320. It avoids VA having to maintain 
two separate presumptions of exposure (PM2.5 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 PM2.5 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 PM2.5 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 
PM2.5 was rigorously analyzed through VA's established 
presumption process in 2021, and based on the current section 302 
requirements, VA has now identified PM2.5 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 PM2.5 is a 
form of ambient air pollution and open burning of waste emits toxic 
combustion emissions into the ambient air, VA considers exposure to 
PM2.5 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. https://doi.org/10.1016/j.chemosphere.2010.03.057.
---------------------------------------------------------------------------

    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 PM2.5 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 https://opa.hhs.gov/reproductive-health/reproductive-cancers, 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. https://www.cancer.gov/types/urethral/patient/urethral-treatment-pdq.
    \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 (PM2.5) 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 www.regulations.gov.

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