Rule2024-31220
Presumptive Service Connection for Bladder, Ureter, and Related Genitourinary Cancers Due to Exposure to Fine Particulate Matter
Primary source
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Published
January 2, 2025
Effective
January 2, 2025
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) is issuing this interim final rule (IFR) to amend its adjudication regulations to establish presumptive service connection for urinary bladder, ureter, and related genitourinary (GU) cancers due to exposure to Particulate Matter 2.5 (PM<INF>2.5</INF>) and to implement certain provisions of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act). The new presumptions would apply to Veterans who served on active military, naval, air, or space service in Southwest Asia theater of operations or Somalia during the Persian Gulf War (hereafter Gulf War) on or after August 2, 1990, and in Afghanistan, Syria, Djibouti, Uzbekistan, Egypt, Jordan, Lebanon, and Yemen during the Gulf War on or after September 11, 2001. This amendment is necessary to provide expeditious health care, services, and benefits to these veterans. This IFR addresses the needs and concerns of Gulf War veterans and Service members who have served and continue to serve in these locations and have been diagnosed with bladder, ureter, and related GU cancers. Neither Congress nor the President has established an end date for the Gulf War. Therefore, to expedite the provision of health care, services, and benefits to current and future Gulf War veterans who may be affected by PM<INF>2.5</INF> due to their military service, VA is establishing presumptive service connection for urinary bladder, ureter, and related GU cancers. This IFR will ease the evidentiary burden of Gulf War Veterans who file claims with VA for these conditions.
Full Text
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<title>Federal Register, Volume 90 Issue 1 (Thursday, January 2, 2025)</title>
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[Federal Register Volume 90, Number 1 (Thursday, January 2, 2025)]
[Rules and Regulations]
[Pages 23-30]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31220]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
2900-AS21
Presumptive Service Connection for Bladder, Ureter, and Related
Genitourinary Cancers Due to Exposure to Fine Particulate Matter
AGENCY: Department of Veterans Affairs.
ACTION: Interim final rule.
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SUMMARY: The Department of Veterans Affairs (VA) is issuing this
interim final rule (IFR) to amend its adjudication regulations to
establish presumptive service connection for urinary bladder, ureter,
and related genitourinary (GU) cancers due to exposure to Particulate
Matter 2.5 (PM<INF>2.5</INF>) and to implement certain provisions of
the Sergeant First Class Heath Robinson Honoring our Promise to Address
Comprehensive Toxics Act of 2022 (PACT Act). The new presumptions would
apply to Veterans who served on active military, naval, air, or space
service in Southwest Asia theater of operations or Somalia during the
Persian Gulf War (hereafter Gulf War) on or after August 2, 1990, and
in Afghanistan, Syria, Djibouti, Uzbekistan, Egypt, Jordan, Lebanon,
and Yemen during the Gulf War on or after September 11, 2001. This
amendment is necessary to provide expeditious health care, services,
and benefits to these veterans. This IFR addresses the needs and
concerns of Gulf War veterans and Service members who have served and
continue to serve in these locations and have been diagnosed with
bladder, ureter, and related GU cancers. Neither Congress nor the
President has established an end date for the Gulf War. Therefore, to
expedite the provision of health care, services, and benefits to
current and future Gulf War veterans who may be affected by
PM<INF>2.5</INF> due to their military service, VA is establishing
presumptive service connection for urinary bladder, ureter, and related
GU cancers. This IFR will ease the evidentiary burden of Gulf War
Veterans who file claims with VA for these conditions.
DATES:
Effective date: This interim final rule is effective January 2,
2025.
Comment date: Comments must be received on or before March 3, 2025.
ADDRESSES: Comments must be submitted through <a href="http://www.regulations.gov">www.regulations.gov</a>.
Except as provided below, comments received before the close of the
comment period will be available at <a href="http://www.regulations.gov">www.regulations.gov</a> for public
viewing, inspection, or copying, including any personally identifiable
or confidential business information that is included in a comment. We
post the comments received before the close of the comment period on
<a href="http://www.regulations.gov">www.regulations.gov</a> as soon as possible after they have been received.
VA will not post on <a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats
to individuals or institutions or suggest that the commenter will take
actions to harm an individual. VA encourages individuals not to submit
duplicative comments; however, 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 interim final rule is available at
<a href="http://www.regulations.gov">www.regulations.gov</a>, under RIN 2900-AS21.
FOR FURTHER INFORMATION CONTACT: Sara Cohen, Lead, Part 3 Regulations
Staff, Robert Parks, Chief, Part 3 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:
[[Page 24]]
I. Background
On August 10, 2022, Congress enacted Public Law 117-168, the PACT
Act. The PACT Act provided a process for VA to establish presumptive
service connection based on toxic exposures. 38 U.S.C. 1171 et seq. The
PACT Act also added a presumption of service connection for certain
diseases associated with exposure to burn pits and other toxins (BPOT)
in 38 U.S.C. 1120. This presumption applies to veterans who served in
locations listed in 38 U.S.C. 1119(c)(1). The diseases subject to the
presumption include kidney cancers and ``[r]eproductive cancer of any
type.'' 38 U.S.C. 1120(b)(2)(E), (G). Kidney and reproductive cancers
are part of genitourinary (GU) tract. Although the GU system is
composed of kidneys, ureters, urinary bladder, urethra,\1\ reproductive
and genital organs, including the ureteric orifice, urachus, and over-
lapping sites of the bladder (the urinary organs), the PACT Act did not
address all these organs.
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\1\ VA does not address urethral cancer in this rulemaking,
because such cancer is a reproductive cancer, and therefore already
subject to presumptive service connection under 38 U.S.C.
1120(b)(2)(E). See 89 FR 79815, 79824 (2024) (proposed rule).
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Following the 38 U.S.C. 1171 et seq. process, VA determined it was
necessary and clinically appropriate to consider expanding presumptive
status consideration to cancers of these additional organs. One of VA's
priorities is to address the long overdue needs of the Gulf War cohort
and to address the imminent need for these veterans to receive care,
services, and benefits. VA has reviewed both medical and scientific
literature, and concludes that (1) urinary bladder cancer is
sufficiently linked to PM<INF>2.5</INF> and that (2) cancers of the
ureter, ureteric orifice, urachus, and over-lapping sites of the
bladder are closely related to urinary bladder cancer with a common
embryologic, anatomical, structural, and functional relationship.
Moreover, the cancers of the ureter, ureteric orifice, urachus, and
over-lapping sites of the bladder are exposed to toxic waste from the
kidneys and the bladder as part of the GU system's function. Because,
as discussed below, there is a medical nexus between the composition
and duration of PM<INF>2.5</INF> and airborne hazard exposures to the
development of GU cancers, VA has determined that presumptions of
service connection for these cancers are warranted. See 38 U.S.C.
1174(a)(1).
In this IFR, VA adds 38 CFR 3.320a to its adjudicatory regulations
to presume service connection for these cancers for certain Gulf War
Veterans. VA adds these cancers as presumptive in 38 CFR 3.320a by IFR
so that any Veteran with these cancers and who served in a prescribed
location need not wait for benefits.
II. Scientific Background
a. Exposure to Fine Particulate Matter
On August 5, 2021, VA promulgated 38 CFR 3.320 to establish
presumptions of service connection for certain chronic diseases based
on exposure to PM<INF>2.5</INF> during service in the Southwest Asia
theater of operations during the Persian Gulf War, or service in
Afghanistan, Syria, Djibouti, or Uzbekistan, on or after September 19,
2001, during the Persian Gulf War. 86 FR 42724, 42733 (2021) (interim
final rule); see 88 FR 60341 (2023) (adopting the interim final rule
with changes). VA based these presumptions on review and analysis of
airborne hazards in the Southwest Asia theater of operations during the
Persian Gulf War, by examining the National Academies of Science,
Engineering, and Medicine's (NASEM) 2020 report, Respiratory Health
Effects of Airborne Hazards Exposures in the Southwest Asia Theater of
Military Operations; \2\ NASEM's 2011 report, Long-Term Health
Consequences of Exposure to Burn Pits in Iraq and Afghanistan; \3\ and
NASEM's 2010 report, Review of the Department of Defense (DoD) Enhanced
Particulate Matter Surveillance Program.\4\ See 86 FR at 42725-42726.
The 2010 report concluded that Service members deployed to the Middle
East ``are exposed to high concentrations of PM[<INF>2.5</INF>].'' \5\
See 86 FR at 42725. Toxic compounds present in burn pit fumes include
PM<INF>2.5.</INF>\6\ This airborne pollution includes smoke from oil
well fires, sand, dust, mechanical fumes from aircraft, vehicle, and
ship engines, wood, plastic, rubber, metals, munitions, chemicals, and
food and human waste.\7\ 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.\8\
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\2\ National Academies of Sciences, Engineering, and Medicine
2020. Respiratory Health Effects of Airborne Hazards Exposures in
the Southwest Asia Theater of Military Operations. Washington, DC:
The National Academies Press. <a href="https://doi.org/10.17226/25837">https://doi.org/10.17226/25837</a>.
\3\ Institute of Medicine 2011. Long-Term Health Consequences of
Exposure to Burn Pits in Iraq and Afghanistan. Washington, DC: The
National Academies Press. <a href="https://doi.org/10.17226/13209">https://doi.org/10.17226/13209</a>
(hereinafter ``NASEM 2011 Report'').
\4\ National Research Council 2010. Review of the Department of
Defense Enhanced Particulate Matter Surveillance Program Report.
Washington, DC: The National Academies Press. <a href="https://doi.org/10.17226/12911">https://doi.org/10.17226/12911</a> (hereinafter ``NRC'').
\5\ NRC, supra.
\6\ Wang X, Doherty TA, James C. Military burn pit exposure and
airway disease: Implications for our Veteran population. Ann Allergy
Asthma Immunol. 2023 Dec;131(6):720-725. doi: 10.1016/
j.anai.2023.06.012. <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC10728339/">https://pmc.ncbi.nlm.nih.gov/articles/PMC10728339/</a>.
\7\ Id.
\8\ American Cancer Society. Military Burn Pits and Cancer Risk.
2022. <a href="https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html">https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html</a>.
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When promulgating 38 CFR 3.320 in August 2021, to determine the
qualifying periods of service, VA primarily considered (1) whether burn
pits were used in the location, (2) the PM<INF>2.5</INF> levels, and
(3) desert climates according to 86 FR at 42725-42729. However, in
August 2022, the PACT Act created new 38 U.S.C. 1119, ``Presumptions of
toxic exposure,'' with a different list of qualifying periods of
service. Section 1119(c) 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.
In the present rulemaking, after reviewing the three considerations
of burn pit use, PM<INF>2.5</INF> levels, and desert climates, VA has
determined that the qualifying periods of service should include both
those listed in 38 CFR 3.320(a)(5) and those listed in 38 U.S.C.
1119(c) to ensure that (1) veterans currently eligible for the
presumption of exposure to PM<INF>2.5</INF> in 38 CFR 3.320 and (2)
veterans eligible for the presumption of exposure to BPOT in 38 U.S.C.
1119 are both covered in this rulemaking. Thus, VA's new presumptions
in 38 CFR 3.320a will not simply cover the locations in current 38 CFR
3.320(a)(5), but also the locations listed in 38 U.S.C. 1119(c)
(including Egypt, Jordan, Lebanon, Somalia, and Yemen).
This approach conforms with the information available regarding
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.\9\ 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 \10\ and is the only combatant
command that conducts
[[Page 25]]
open burn pit operations.\11\ Egypt, Jordan, Lebanon, and Yemen were
included as locations with open, active burn pits.\12\ Somalia was not
included on the list. However, there is evidence of burn pit use in
Somalia when service members were deployed in support of Operation Show
Care in 1993.\13\ Additional deployments occurred in 1992, 1995, 2012,
and 2022.\14\
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\9\ See Letter from Office of Under Secretary of Defense to the
U.S. House of Representatives Committee on Appropriations (May 7,
2001), available on the rulemaking docket at <a href="http://www.regulations.gov">www.regulations.gov</a>
(hereinafter ``Defense Letter'').
\10\ U.S. Central Command. Area of Responsibility. <a href="https://www.centcom.mil/AREA-OF-RESPONSIBILITY/">https://www.centcom.mil/AREA-OF-RESPONSIBILITY/</a>.
\11\ Department of Defense. Open Burn Pit Report to Congress.
2019. <a href="https://www.acq.osd.mil/eie/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf">https://www.acq.osd.mil/eie/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf</a>.
\12\ See Defense Letter, supra.
\13\ Center of Military History, United States Army. United
States Forces, Somalia After Action Report and Historical Overview:
The United States Army in Somalia, 1992-1994. <a href="https://www.history.army.mil/html/documents/somalia/index.html">https://www.history.army.mil/html/documents/somalia/index.html</a>.
\14\ CRS Report R42738, Instances of Use of United States Armed
Forces Abroad, 1798-2022, <a href="https://crsreports.congress.gov/product/pdf/R/R42738/38">https://crsreports.congress.gov/product/pdf/R/R42738/38</a>; Stimson Center, U.S. Security Assistance to
Somalia, <a href="https://www.stimson.org/2023/us-security-cooperation-with-somalia/">https://www.stimson.org/2023/us-security-cooperation-with-somalia/</a>.
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Additionally, all the locations listed in 38 U.S.C. 1119(c) 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.\15\ The study found that Military Exposure
Guideline (MEG) values for PM<INF>2.5</INF> were exceeded at all 15
sites for the entire one-year sampling period.\16\ The study also
demonstrated how short-term dust events--exacerbated by dirt roads,
agricultural activities, and disturbance of the desert floor by
motorized vehicles--all contribute to exceedance of both
PM<INF>10</INF> and PM<INF>2.5</INF> mass exposure guidelines and
standards.\17\ Finally, DoD's report also stated that PM<INF>2.5</INF>
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.\18\
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\15\ Department of Defense. Enhanced Particulate Matter
Surveillance Program Final Report. 2008. <a href="https://apps.dtic.mil/sti/pdfs/ADA605600.pdf">https://apps.dtic.mil/sti/pdfs/ADA605600.pdf</a> (hereinafter ``EPMSP Report'').
\16\ Id.
\17\ Id.
\18\ Id.
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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.\19\ Although
dust in these locations can be toxic based on transportation and
industrial activities alone, open air burn pits increase the
concentration of toxins in PM<INF>2.5</INF>.
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\19\ NASEM 2011 Report, supra.
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As discussed above, in locations that rely on open burning of
waste, the PM<INF>2.5</INF> 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.'' \20\ The
Environmental Protection Agency (EPA) defines ``ambient air'' as ``that
portion of the atmosphere, external to buildings, to which the general
public has access.'' 40 CFR 50.1(e). Because PM<INF>2.5</INF> is a form
of ambient air pollution and open burning of waste emits toxic
combustion emissions into the ambient air, VA considers exposure to
PM<INF>2.5</INF> as encompassing exposure to burn pit smoke.
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\20\ Estrellan, C.R. and Iino, F. (2010) Toxic Emissions from
Open Burning. Chemosphere, 80, 193-207. <a href="https://doi.org/10.1016/j.chemosphere.2010.03.057">https://doi.org/10.1016/j.chemosphere.2010.03.057</a>.
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The 38 U.S.C. 1119(c) locations have a history of annual
PM<INF>2.5</INF> levels that exceed military and EPA air quality
standards. Not only do they exceed air quality standards, average
PM<INF>2.5</INF> concentrations have been increasing in North Africa
and the Middle East since 1990, while Europe and North America have
experienced decreasing trends in average PM<INF>2.5</INF>
concentrations.\21\ Based on evidence of burn pit use, PM<INF>2.5</INF>
levels that exceed military and EPA air quality standards, and their
arid desert climate conditions that exacerbate PM<INF>2.5</INF> levels,
VA finds there is sufficient evidence to extend the presumption of
exposure to PM<INF>2.5</INF> beyond the locations listed in 38 CFR
3.320 to Egypt, Jordan, Lebanon, Somalia, and Yemen. Moreover, for
consistency with 38 U.S.C. 1119(c)(1)(B), which presumes toxic exposure
in certain countries (including Afghanistan, Syria, Djibouti, and
Uzbekistan) back to September 11, 2001, new 38 CFR 3.320a will have a
presumption of exposure for Veterans who served in those countries on
or after September 11, 2001.
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\21\ EPMSP Report, supra.
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VA notes that the PACT Act's definition of a ``covered Veteran'' in
38 U.S.C. 1119(c) does not include all areas historically included in
the Southwest Asia theater of operations, omitting 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, in this IFR,
VA shall maintain the locations currently included in the Southwest
Asia theater of operations under 38 CFR 3.317(e)(2) and 3.320(a)(6), as
that list was based on Executive Order 12744 of January 21, 1991, which
designated the combat zone of the Persian Gulf War. Doing so allows
individuals with service in those locations to still qualify as covered
veterans under 38 CFR 3.320a. VA will carry over the definition of
``Southwest Asia Theater of Operations'' from 38 CFR 3.317(e)(2) and
3.320(a)(6) into 38 CFR 3.320a.
b. Urinary Bladder, Ureter, and Related Cancers
The PACT Act presumption determination process consists of four
phases. The Ongoing Exploratory Surveillance Phase includes
collaborating with VA partners, to include Veterans Service
Organizations and other stakeholders, to identify, monitor, and
investigate potential toxic exposures and adverse health effects. 38
U.S.C. 1172(a). The Research and Assessment Phase involves collecting
information, evidence, and data regarding a particular toxic exposure
and adverse health effect, and potentially conducting a scientific
study and analysis of the data. 38 U.S.C. 1172(c). Based on the
findings, VA's Military Environment Exposures Sub-Council (MEESC) may
recommend that the Secretary initiate a formal evaluation of the issue.
38 U.S.C. 1172(d).
If the Secretary adopts that recommendation, the Formal Evaluation
Phase begins. 38 U.S.C. 1173. In this phase, a technical working group
is convened to conduct an evaluation of the evidence and research
collected in the prior phases, as well as claims data, to render a
conclusion on the strength of the evidence, and to provide a
recommendation to the Secretary with respect to a presumption. 38
U.S.C. 1173. If the Secretary decides to accept the recommendation, the
Rulemaking and Implementation Phase then begins. 38 U.S.C. 1174.
Here, after research and assessment, and at the MEESC's
recommendation, on February 26, 2024, the Secretary initiated a formal
evaluation of GU cancers and their possible association with exposure
to PM<INF>2.5</INF> pollution in the Southwest Asia Theater of
Operations. In April 2024, the formal evaluation concluded and the
recommendation was to establish a presumption.\22\ On June 25, 2024,
the recommendation was conveyed to the Secretary. On October 25, 2024,
the Secretary accepted the
[[Page 26]]
recommendation, paving the way for this rulemaking.
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\22\ The MEESC report (hereinafter MEESC Report) is attached to
this rulemaking, available at <a href="http://www.regulations.gov">www.regulations.gov</a>.
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Under 38 U.S.C. 1173(b), a formal evaluation shall be based on the
review of available scientific literature, including human,
toxicological, animal, and methodological studies, and other factors,
and must consider claims data including claim rate, grant rate, and
service connection prevalence. It can also consider the level of
disability and mortality caused by the health effects related to the
case of toxic exposure being evaluated; the quantity and quality of the
information available and reviewed; the feasibility of and period for
generating relevant information and evidence; whether such health
effects are combat or deployment related; the ubiquity or rarity of the
health effects; and any time frame during which a health effect must
become manifest.
A formal evaluation shall review scientific evidence in a manner
that conforms to principles of scientific and data integrity; must be
free from suppression or distortion of scientific or technological
findings, data, information, conclusions, or technical results; must
evaluate the likelihood that a positive association exists between an
illness and a toxic exposure while serving in the active military,
naval, air, or space service; and determine whether the evidence
supports a finding of a positive association between the toxic exposure
and the illness. 38 U.S.C. 1173(c).
The Secretary had 160 days from June 25, 2024 (i.e., until December
2, 2024) to make a decision on the formal evaluation's recommendation.
38 U.S.C. 1174(a). The Secretary accepted the recommendation long
before the 160 days, on October 25, 2024, paving the way for this
rulemaking.
Throughout this process, the MEESC considered whether VA should
expand the PACT Act's existing organ-specific presumptions to organ-
system presumptions based on common embryologic development, proximity
to each other, and use of common structural pathways. For example,
kidney/renal cancers are covered under the PACT Act, as are all
reproductive organs. The MEESC considered whether it made sense from a
clinical and/or scientific standpoint to cover a significant portion of
the GU system (made up of the urinary and reproductive systems) but
exclude other organs within this same system.
As further discussed below, the GU system is composed of kidneys,
ureters, urinary bladder, urethra, reproductive, and genital organs.
The PACT Act provided a presumption for kidney/renal cancer and all
reproductive organ cancers for certain veterans; however, it did not
include ureteral, urinary bladder, and several related cancers of the
GU system. VA has determined it is necessary and clinically appropriate
to consider expanding presumptive status to cancers of these additional
organs for specific veteran populations. Clinical and scientific review
provides a strong scientific rationale to add the urinary bladder,
ureters, and associated structures.
The GU system as a whole encompasses the reproductive and urinary
system organs. These organs are usually grouped together because of a
common embryological origin, proximity to each other, and use of common
structural pathways.\23\ The GU system shares common embryologic,
anatomic, structural, and functional relationships through the
intermediate mesoderm, splanchnopleuric mesoderm, and the endoderm.\24\
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\23\ Genitourinary System, Science Direct. <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/genitourinary-system">https://www.sciencedirect.com/topics/medicine-and-dentistry/genitourinary-system</a>.
\24\ Rehman S, Ahmed D, (Aug 8, 2023). Embryology, Kidney,
Bladder, and Ureter. StatPearls [internet]. <a href="https://www.ncbi.nlm.nih.gov/books/NBK547747/">https://www.ncbi.nlm.nih.gov/books/NBK547747/</a> (hereinafter ``Rehman'').
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The urinary system's function is to filter blood and create urine
as a waste by-product. The organs of the urinary system include the
kidneys, renal pelvis, ureters, bladder, and urethra.\25\ The kidneys
and ureters form early in the embryotic period, after which the bladder
and urethra are formed.\26\ Week four of gestation commences with the
development of the urinary tract, which includes the kidney, ureter,
and urinary bladder. Bladder development is comprised of the
intermediate mesenchyme (embryonic connective tissue in the mesoderm)
and occurs when the urogenital septum divides.\27\ Once the bladder is
formed, it connects to the other organs. As the kidneys ascend, the
ureters elongate and open into the bladder superiorly, while the roots
of the mesonephric ducts are carried inferiorly, before fusing to form
the trigone region. Endodermal cells from the urogenital sinus soon
replace the mesodermal cells epithelium of the trigone region, thus
completing development.
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\25\ Anatomy of the Urinary System. <a href="https://www.hopkinsmedicine.org/health/wellness-and-prevention/anatomy-of-the-urinary-system">https://www.hopkinsmedicine.org/health/wellness-and-prevention/anatomy-of-the-urinary-system</a>.
\26\ Kucharz, E.J. (1992). Urinary and Reproductive Systems. In:
The Collagens: Biochemistry and Pathophysiology. Springer, Berlin,
Heidelberg. <a href="https://doi.org/10.1007/978-3-642-76197-3_18">https://doi.org/10.1007/978-3-642-76197-3_18</a>.
\27\ Rehman, supra.
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Between 32-36 weeks gestation, this development is completed and
the organs become distinct. The urachus, an embryonic remnant, connects
the bladder to the umbilical cord during fetal development and is the
main fetal excretory organ. After birth, this tube closes and becomes a
ligament, although it fails to close some cases.\28\
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\28\ See MEESC memorandum, ``Additional Clarification and
Details on Genitourinary Cancer Formal Evaluation in Support of
Rulemaking'' dated November 6, 2024 (hereinafter MEESC Memorandum),
attached to this rulemaking, available at <a href="http://www.regulations.gov">www.regulations.gov</a>.
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The kidney consists of various cell types originating from the
ureteric bud and the metanephrogenic mesenchyme, which differentiate
into more than 26 different cell types in the kidney. The ureteric bud
contributes to the development of the ureter and parts of the kidney,
which serves a critical role in the formation of the renal collecting
system.\29\ Embryologically, the urothelium of the urinary bladder and
urethra is derived from the ventral urogenital sinus, like the
epithelium in the renal pelvis and ureters.\30\ In utero, the
intermediate mesoderm forms the kidneys, ureters, and renal
vasculature. The splanchnopleuric mesoderm forms the smooth muscle and
connective tissue of the bladder. The endoderm forms the inner bladder
and urethra.\31\ The development of the ureter and kidney cells are
closely linked through the interaction of the ureteric bud and
metanephric mesenchyme, leading to the formation of the complex
structures of the urinary system.\32\ The urethra in the neck of the
bladder develops into the male urethra prostatic part, and female
urethra.\33\
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\29\ Qais Al-Awqati; Juan A. Oliver, (February 2002). Stem Cells
in the Kidney. Kidney International, Volume 61, Issue 2. <a href="https://www.sciencedirect.com/science/article/pii/S0085253815482262?via%3Dihub">https://www.sciencedirect.com/science/article/pii/S0085253815482262?via%3Dihub</a>.
\30\ Guo-Xia Tong, Woojin M Yu, Nike T Beaubier, et al.,
(September 2009) Expression of PAX8 in Normal and Neoplastic Renal
Tissues: An Immunohistochemical Study. Modern Pathology, Volume 22,
Issue 9, 1218-1227. <a href="https://www.sciencedirect.com/science/article/pii/S0893395222024747?via%3Dihub">https://www.sciencedirect.com/science/article/pii/S0893395222024747?via%3Dihub</a>.
\31\ Rehman, supra.
\32\ Shah MM, Tee JB, Meyer T, Meyer-Schwesinger C, Choi Y,
Sweeney DE, Gallegos TF, Johkura K, Rosines E, Kouznetsova V, Rose
DW, Bush KT, Sakurai H, Nigam SK. The instructive role of
metanephric mesenchyme in ureteric bud patterning, sculpting, and
maturation and its potential ability to buffer ureteric bud
branching defects. Am J Physiol Renal Physiol. 2009
Nov;297(5):F1330-41. doi: 10.1152/ajprenal.00125.2009. Epub 2009 Sep
2. Erratum in: Am J Physiol Renal Physiol. 2010 May;298(5):F1285.
PMID: 19726549; PMCID: PMC2781331, <a href="https://pubmed.ncbi.nlm.nih.gov/19726549/">https://pubmed.ncbi.nlm.nih.gov/19726549/</a>.
\33\ Rehman, supra.
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The organs of the GU system are necessarily interrelated. The
kidneys filter waste and fluid, including toxic exposures that get into
the body, to produce urine. Once the kidneys produce the urine, it is
transported from
[[Page 27]]
the kidneys to the urinary bladder by the ureters, which are bilateral
tubular structures that connect the kidneys to the urinary bladder. The
openings of the ureters into the urinary bladder are called the
ureteric orifices. The urine, which contains the waste that was
filtered from the body by the kidneys, is stored in the urinary bladder
until it is time to urinate. When it is time to urinate, the urethra, a
small tube, allows the urine to pass outside the body.
As discussed, the GU system cancers share common embryologic,
anatomic, structural, and functional relationships. Necessarily, each
of these organs is exposed to the waste/toxins, starting in the
kidneys, which is turned into urine. The urothelium is exposed to
toxins in the urine, so that any carcinogenic effect would also be
expected in the bladder and ureter. The urine exposes the remaining GU
structures to the toxins and any resultant carcinogens, including
PM<INF>2.5</INF>.\34\ Hence, any carcinogens in the kidneys or bladder
necessarily pass through the remainder of the GU system, providing the
exposure to carcinogens to each part of the GU system.
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\34\ MEESC Report, supra.
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1. Association Between PM<INF>2.5</INF> and Urinary Bladder Cancer
In support of this rulemaking, as required by 38 U.S.C. 1173, VA
conducted a formal evaluation of whether a sufficient association
between PM<INF>2.5</INF> and bladder cancer existed. The results of the
studies reviewed by VA's experts showed an association between
PM<INF>2.5</INF> and bladder cancer and that 6-19% of bladder cancers
are attributable to occupational exposures. Studies from 2003 to 2022
supported the association between PM<INF>2.5</INF> and bladder cancer.
A 2003 study estimated occupational exposure caused death due to
bladder cancer for 534 to 1,451 men and 116 to 740 women annually.\35\
Nine years later, the International Association for Research on Cancer
(IARC) also found evidence that air pollution was associated with
developing bladder cancer.\36\ In 2017, another study positively
correlated the concentration of ambient PM<INF>2.5</INF> with
development of, and death from, bladder cancer.\37\ That same year a
study also found airborne pollution and particulate matter posed an
elevated risk for bladder cancer.\38\ Two 2020 studies similarly found
an elevated hazard ratio between exposure to air pollution and PM and
the development of bladder cancer, concluding such exposures may be a
risk factor for bladder cancer.\39\ According to a 2020 scientific
review of bladder and kidney cancer, studies suggested positive, even
though mostly non-significant, associations between air pollution
exposure, including PM<INF>2.5</INF>, and bladder cancer mortality and
kidney cancer incidence. Bladder cancer showed a positive association:
bladder cancer mortality had an adjusted odds-ratio of an average of
13% percent with a slight increase of PM<INF>2.5.</INF> r.\40\
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\35\ Steenland K, Burnett C, Lalich, et al., (May, 2003). Dying
for work: The magnitude of US mortality from selected causes of
death associated with occupation. Am J Ind Med. 43(5):461-82.
<a href="https://pubmed.ncbi.nlm.nih.gov/12704620/">https://pubmed.ncbi.nlm.nih.gov/12704620/</a>.
\36\ IARC (International Association for Research on Cancer).
Air Pollution and Cancer, IARC Scientific Publication No. 161, 2013.
<a href="https://publications.iarc.fr/Book-And-Report-Series/Iarc-Scientific-Publications/Air-Pollution-And-Cancer-2013">https://publications.iarc.fr/Book-And-Report-Series/Iarc-Scientific-Publications/Air-Pollution-And-Cancer-2013</a>.
\37\ Yeh, H.L., Hsu, S.W., Chang, Y.C., Chan, T.C., Tsou, H.C.,
Chang, Y.C., & Chiang, P.H. (2017). Spatial Analysis of Ambient
PM<INF>2.5</INF> Exposure and Bladder Cancer Mortality in Taiwan.
International journal of environmental research and public health,
14(5), 508; <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC5451959">https://pmc.ncbi.nlm.nih.gov/articles/PMC5451959</a>.
\38\ Turner MC, Krewski D, Diver WR, Pope CA 3rd, Burnett RT,
Jerrett M, Marshall JD, Gapstur SM. Ambient Air Pollution and Cancer
Mortality in the Cancer Prevention Study II. Environ Health
Perspect. 2017 Aug 21;125(8):087013; <a href="https://ehp.niehs.nih.gov/doi/10.1289/EHP1249">https://ehp.niehs.nih.gov/doi/10.1289/EHP1249</a>.
\39\ Coleman NC, Burnett RT, Higbee JD, Lefler JS, Merrill RM,
Ezzati M, Marshall JD, Kim SY, Bechle M, Robinson AL, Pope CA 3rd.
Cancer mortality risk, fine particulate air pollution, and smoking
in a large, representative cohort of US adults. Cancer Causes
Control. 2020 Aug;31(8):767-776. (hereafter Cancer mortality risk);
<a href="https://pubmed.ncbi.nlm.nih.gov/32462559">https://pubmed.ncbi.nlm.nih.gov/32462559</a>.
\40\ Zare Sakhvidi MJ, Lequy E, Goldberg M, Jacquemin B. Air
pollution exposure and bladder, kidney and urinary tract cancer
risk: A systematic review. Environ Pollut. 2020 Dec;267:115328;
<a href="https://www.sciencedirect.com/science/article/abs/pii/S0269749120360164?via%3Dihub">https://www.sciencedirect.com/science/article/abs/pii/S0269749120360164?via%3Dihub</a>.
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The EPA also concluded that long-term exposure to PM<INF>2.5</INF>,
in the form of diesel exhaust emissions, has a likely causal
relationship to the development of bladder cancer.\41\ This is
supported by a 2022 EPA study.\42\ Supporting the previous studies, a
2022 large pooled study found evidence of an association between long-
term PM<INF>2.5</INF> mass exposure and bladder cancer. A 2024 study
performed a meta-analysis which combined the results of from 18 cohort
studies, 10 case-control studies, and nine ecological studies, studies
published through early 2024. The authors stated that a 5 microgram
increase per cubic meter in the atmosphere in PM<INF>2.5</INF> was
significantly associated with an increased relative risk for bladder
cancer of 7%.\43\
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\41\ EPA Supplement to the 2019 Integrated Science Assessment
for Particulate Matter (Final Report, 2022) <a href="https://www.epa.gov/isa/integrated-science-assessment-isa-particulate-matter">https://www.epa.gov/isa/integrated-science-assessment-isa-particulate-matter</a> (hereafter
``EPA supplement'').
\42\ Id.
\43\ Li J, Deng Z, Soerensen SJC, Kachuri L, Cardenas A, Graff
RE, Leppert JT, Langston ME, Chung BI. Ambient air pollution and
urological cancer risk: A systematic review and meta-analysis of
epidemiological evidence. Nat Commun. 2024 Jun 15;15(1):5116,
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC11180144/">https://pmc.ncbi.nlm.nih.gov/articles/PMC11180144/</a>.
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PM<INF>2.5</INF> exposure is of concern for those deployed to the
Southwest Asia Theater of operations and other known BPOT locations. VA
has already examined studies by NASEM on the contribution of air
pollution to adverse health effects among U.S. Service members serving
in the Middle East.\44\ 86 FR at 42725-42726. Thus, VA has determined
that it will consider bladder cancers for this population to be
associated with exposure to PM<INF>2.5</INF>. Accordingly, VA concludes
it is appropriate to add bladder cancer to 38 CFR 3.320a.
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\44\ NASEM, Gulf War and Health Series: Volume 3: Fuels and
Products of Combustion (2005), https://doi.org/10.17226/11180 and
Volume 11: Generational Health Effects of Serving in the Gulf War
(2018), <a href="https://doi.org/10.17226/25162">https://doi.org/10.17226/25162</a>. NASEM, Respiratory Health
Effects of Airborne Hazards Exposures in the Southwest Asia Theater
of Military Operations (2020), <a href="https://doi.org/10.17226/25837">https://doi.org/10.17226/25837</a>.
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2. Association Between PM<INF>2.5</INF> and Cancers of the Ureter,
Ureteric Orifice, Urachus, Over-Lapping and Sites of the Bladder
Ureter cancer is a rare type of cancer; however, between 5% and 10%
of all urothelial cancers start in the ureter.\45\ As discussed above,
all parts of the GU system share the same embryonic origin. The
development of ureter and kidney cells is closely linked through the
interaction of the ureteric bud and metanephric mesenchyme, leading to
the formation of the complex structures of the urinary system.
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\45\ Saint John's Cancer Institute. Ureteral Cancer and Ureteral
Urothelial Carcinoma (UTUC).<a href="https://www.saintjohnscancer.org/urology/conditions/ureteral-cancer/">https://www.saintjohnscancer.org/urology/conditions/ureteral-cancer/</a>.
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The PACT Act has associated kidney cancer with PM<INF>2.5</INF> for
certain Veterans. The kidneys transport waste into the ureters.\46\
From the ureters, the ureteric orifices empty the urine into the
urinary bladder. Each of these organs is exposed to waste and toxins
produced by the kidneys, thus exposing them to any carcinogens.\47\
Accordingly, the same PM<INF>2.5</INF> that affected the kidneys
necessarily affects the entire GU tract. Because individuals with renal
pelvis or ureter cancer can develop cancer in the kidneys and/or
bladder over time,\48\ there are common risk factors for cancer
development throughout the uroepithelium. As such, VA concludes
[[Page 28]]
that bladder, ureter, and kidney cancers should all be treated the same
for purposes of the presumption.\49\
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\46\ MEESC Memorandum, supra.
\47\ Id.
\48\ MEESC Report, supra.
\49\ Id.
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III. Addition of Urinary Bladder, Ureter, and Related Cancers to 38 CFR
3.320a
Since August 5, 2021, VA has presumed for certain Veterans that
asthma, rhinitis, or sinusitis are associated with PM<INF>2.5</INF>. 38
CFR 3.320(a)(2); 86 FR at 42732-42733. VA added nine rare cancers to
the list of disabilities presumptively associated with PM<INF>2.5</INF>
on April 26, 2022. 38 CFR 3.320(a)(3); 87 FR 24421, 24429 (2022). VA
instituted these presumptions based on scientific and medical studies,
which focused on the respiratory effects of PM<INF>2.5</INF> for
veterans who served in the Southwest Asia theater of operations,
Afghanistan, Syria, Djibouti, and Uzbekistan during the Gulf War. 86 FR
at 42729; 87 FR at 24424-24525.
As discussed above, in the PACT Act, Congress enacted a presumption
associating kidney cancer and reproductive cancers (which includes male
urethra and prostate cancer) with toxic exposures in covered locations.
38 U.S.C. 1120(b)(2)(E), (G). Although the PACT Act covers almost 73%
of existing cancers, it did not include all genitourinary tract
cancers.\50\ Yet Congress authorized VA to enact additional
presumptions based on a positive association with a substance,
chemical, or airborne hazard. 38 U.S.C. 1120(b)(15). Because urinary
bladder cancer is related to PM<INF>2.5</INF> inhalation and BPOT
exposure, and cancers of the ureter and related cancers receive toxins
in the same manner as the bladder, VA concludes they should be extended
a presumption in new 38 CFR 3.320a.
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\50\ MEESC Report, supra.
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As discussed above, VA is enacting this presumption pursuant to the
38 U.S.C. 1171 et seq. process. But VA also notes the alternative
authority to add these presumptions under 38 U.S.C. 501(a)(1), which
permits VA to issue necessary or appropriate regulations with respect
to the nature and extent of proof and evidence in order to establish
rights to benefits, such as presumptions of service connection.
IV. New 38 CFR 3.320a
VA will use the heading of ``[p]resumptive service connection for
bladder, ureter, and related genitourinary cancers'' for 38 CFR 3.320a.
VA will 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 provide the
standard exceptions for presumptions in paragraph (d).
Although this rulemaking is based on current medical and scientific
evidence related to the respiratory health effects of PM<INF>2.5</INF>
on veterans who served during the Gulf War and are otherwise covered by
the PACT Act, VA will continue to review new scientific evidence as it
develops regarding all health effects resulting from exposure to BPOT,
including PM<INF>2.5</INF>. This rulemaking does not limit the future
establishment of additional presumptions of service connection.
V. Severability
The purpose of this section is to clarify the agency's intent with
respect to the severability of provisions of this rule. Each provision
of this rule is capable of operating independently. If any provision of
this rule is determined by judicial review or operation of law to be
invalid, that partial invalidation will not render the remainder of
this rulemaking invalid. Likewise, if the application of any portion of
this rule to a particular circumstance is determined to be invalid, the
agency intends that the rule remain applicable to all other
circumstances.
Administrative Procedure Act
Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), VA has concluded that
there is good cause to publish the IFR without prior opportunity for
comment and to publish the rule with an immediate effective date. There
is good cause to immediately address the needs of Service members and
veterans who have been exposed to airborne hazards, i.e.,
PM<INF>2.5</INF>, due to their service in the Southwest Asia theater of
operations, Afghanistan, Syria, Djibouti, Uzbekistan, Somalia, Egypt,
Jordan, Lebanon, and Yemen.
VA concludes that the ordinary notice-and-comment procedures here
would be impracticable, in that they would cause Veterans serious harm
by further delaying and in some cases outright preventing Veterans from
receiving the benefits of these presumptions given the nature of the
diseases at issue. In particular, bladder and ureter cancers are
diseases of significant morbidity and mortality. Bladder cancer alone
is fairly common and causes morbidity and mortality. According to the
latest national statistics available from the Centers for Disease
Control and Prevention (CDC) which were from 2021, bladder cancer is
the seventh most common cancer in the U.S. with a rate of 18.1 cases
per 100.000 persons.\51\ In 2021, 75,450 new cases of urinary bladder
cancer were reported in the U.S.\52\ In 2022, which is the latest year
for which CDC has available mortality data, 17,334 people died of
urinary bladder cancer in the U.S. Most of the deaths were in men,
according to the CDC.\53\ In 2022, the latest year for which mortality
data are available, in the United States, 12,460 men died of urinary
cancer.\54\ For ureter cancer, the five-year survival rate is 5% or
less.\55\
---------------------------------------------------------------------------
\51\ United States Cancer Statistics: Data Visualizations,
<a href="https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/">https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/</a>.
\52\ Id.
\53\ Id.
\54\ Id.
\55\ Social Security Administration, Program Operations Manual
System, <a href="https://secure.ssa.gov/poms.nsf/lnx/0423022345">https://secure.ssa.gov/poms.nsf/lnx/0423022345</a>.
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Overall, delaying this rulemaking for notice and comment runs the
real risk of harming the very population this rulemaking intends to
help. Moreover, the 38 U.S.C. 1119(c) locations are dictated by
Congress; they cannot be removed by either VA or public comment.
The new presumptions are entirely pro-claimant in nature. They do
not adversely affect any person. And because VA has a sufficient
scientific basis to support the new presumptions, withholding the
presumptions during the notice and comment process could unnecessarily
deprive veterans and beneficiaries of benefits to which they would
otherwise be entitled and prolong their inability to timely receive
benefits. Additionally, this could create risks to beneficiaries'
welfare and health that would be exacerbated by any additional delay in
implementation. Due to the complexity and the historical scientific
uncertainty surrounding these issues of airborne hazard exposures and
disease, many veterans who will be affected by this rule have long
borne the burden and expense of their disabilities while awaiting the
results of research and investigation. Under these circumstances, there
is good cause to avoid further delay on their receipt of benefits,
potentially at the risk of their welfare and health.
Overall, the Secretary's decision to extend new presumptions to
veterans who have been exposed to PM<INF>2.5</INF> due to their service
in the Southwest Asia theater of operations, and Somalia, Afghanistan,
Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, and Uzbekistan requires
immediate effect to help them access these benefits without undue
delay. For veterans that are not otherwise eligible for health care,
these presumptions could result in needed
[[Page 29]]
health care eligibility based on service connection.
Section 553(d) of 5 U.S.C. also requires a 30-day delayed effective
date following publication of a rule, except for ``(1) a substantive
rule which grants or recognizes an exemption or relieves a restriction,
(2) interpretative rules and statements of policy, or (3) as otherwise
provided by the agency for good cause found and published with the
rule.'' Pursuant to section 553(d)(3), the Secretary finds that there
is good cause to make the rule effective upon publication, for the
reasons discussed above.
For the foregoing reasons, and as explained in further detail in
the IFR, the Secretary of Veterans Affairs is issuing this rule as an
IFR with an immediate effective date. However, VA will consider and
address comments that are received within 60 days of the date this IFR
is published in the Federal Register.
Executive Orders 12866, 13563, and 14094
Executive Order 12866 (Regulatory Planning and Review) directs
agencies to assess the costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, and other advantages;
distributive impacts; and equity). Executive Order 13563 (Improving
Regulation and Regulatory Review) emphasizes the importance of
quantifying both costs and benefits, reducing costs, harmonizing rules,
and promoting flexibility. Executive Order 14094 (Executive Order on
Modernizing Regulatory Review) supplements and reaffirms the
principles, structures, and definitions governing contemporary
regulatory review established in Executive Order 12866 of September 30,
1993 (Regulatory Planning and Review), and Executive Order 13563 of
January 18, 2011 (Improving Regulation and Regulatory Review). The
Office of Information and Regulatory Affairs has determined that this
rulemaking is a significant regulatory action under Executive Order
12866, Section 3(f)(1), as amended by Executive Order 14094. The
Regulatory Impact Analysis associated with this rulemaking can be found
as a supporting document at <a href="http://www.regulations.gov">www.regulations.gov</a>.
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 IFR will have no such effect on state,
local, and tribal governments, or on the private sector.
Paperwork Reduction Act
Although this interim final rule contains provisions constituting
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 existing collection of information.
The collection of information for 38 CFR 3.320a is currently approved
by the Office of Management and Budget (OMB) and has been assigned OMB
control numbers 2900-0747, 2900-0886, 2900-0004, and 2900-0002.
Congressional Review Act
Under the Congressional Review Act, this regulatory action may
result in an annual effect on the economy of $100 million or more, 5
U.S.C. 804(2), and so is subject to the 60-day delay in effective date
under 5 U.S.C. 801(a)(3). In accordance with 5 U.S.C. 801(a)(1), VA
will submit to the Comptroller General and to Congress a copy of this
Regulation and the Regulatory Impact Analysis (RIA) associated with the
Regulation.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Health care, Pensions, Veterans.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, signed and approved
this document on December 20, 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.
Michael P. Shores,
Director, Office of Regulation Policy & Management, Office of General
Counsel, Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans
Affairs amends 38 CFR part 3 as set forth below:
PART 3--ADJUDICATION
Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation
0
1. The authority citation for part 3 continues to read as follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
0
2. Add Sec. 3.320a to read as follows:
Sec. 3.320a Presumptive service connection for bladder, ureter, and
related genitourinary cancers.
(a) Presumption of exposure. A covered veteran as defined in
paragraph (c) of this section shall be presumed to have been exposed to
certain toxic substances, chemicals, and airborne hazards, including
fine particulate matter, 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.
(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) Urinary bladder cancer, including over-lapping sites of the
bladder.
(2) Ureter cancer, including the ureteric orifice, and urachus.
(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
[[Page 30]]
(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.
(Authority: 38 U.S.C. 501, 1119, 1120, 1174)
[FR Doc. 2024-31220 Filed 12-31-24; 8:45 am]
BILLING CODE 8320-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.