```

[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 [www.gpo.gov]
[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 (PM2.5) 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 
PM2.5 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 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 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 
www.regulations.gov, 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 PM2.5 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 PM2.5 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 PM2.5 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[2.5].'' \5\ 
See 86 FR at 42725. Toxic compounds present in burn pit fumes include 
PM2.5.\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. https://doi.org/10.17226/25837.
    \3\ 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 
(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. https://doi.org/10.17226/12911 (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. https://pmc.ncbi.nlm.nih.gov/articles/PMC10728339/.
    \7\ Id.
    \8\ American Cancer Society. Military Burn Pits and Cancer Risk. 
2022. https://www.cancer.org/healthy/cancer-causes/chemicals/burn-pits.html.
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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 PM2.5 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, PM2.5 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 PM2.5 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 www.regulations.gov 
(hereinafter ``Defense Letter'').
    \10\ U.S. Central Command. Area of Responsibility. https://www.centcom.mil/AREA-OF-RESPONSIBILITY/.
    \11\ Department of Defense. Open Burn Pit Report to Congress. 
2019. https://www.acq.osd.mil/eie/Downloads/Congress/Open%20Burn%20Pit%20Report-2019.pdf.
    \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. https://www.history.army.mil/html/documents/somalia/index.html.
    \14\ CRS Report R42738, Instances of Use of United States Armed 
Forces Abroad, 1798-2022, https://crsreports.congress.gov/product/pdf/R/R42738/38; Stimson Center, U.S. Security Assistance to 
Somalia, https://www.stimson.org/2023/us-security-cooperation-with-somalia/.
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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 PM2.5 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 
PM10 and PM2.5 mass exposure guidelines and 
standards.\17\ Finally, DoD's report also stated that PM2.5 
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. https://apps.dtic.mil/sti/pdfs/ADA605600.pdf (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 PM2.5.
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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 PM2.5 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 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.
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    \20\ 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.
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    The 38 U.S.C. 1119(c) 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.\21\ Based on evidence of burn pit use, PM2.5 
levels 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 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 PM2.5 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 www.regulations.gov.
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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. https://www.sciencedirect.com/topics/medicine-and-dentistry/genitourinary-system.
    \24\ Rehman S, Ahmed D, (Aug 8, 2023). Embryology, Kidney, 
Bladder, and Ureter. StatPearls [internet]. https://www.ncbi.nlm.nih.gov/books/NBK547747/ (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. https://www.hopkinsmedicine.org/health/wellness-and-prevention/anatomy-of-the-urinary-system.
    \26\ Kucharz, E.J. (1992). Urinary and Reproductive Systems. In: 
The Collagens: Biochemistry and Pathophysiology. Springer, Berlin, 
Heidelberg. https://doi.org/10.1007/978-3-642-76197-3_18.
    \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 www.regulations.gov.
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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. https://www.sciencedirect.com/science/article/pii/S0085253815482262?via%3Dihub.
    \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. https://www.sciencedirect.com/science/article/pii/S0893395222024747?via%3Dihub.
    \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, https://pubmed.ncbi.nlm.nih.gov/19726549/.
    \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 
PM2.5.\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 PM2.5 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 PM2.5 and bladder cancer existed. The results of the 
studies reviewed by VA's experts showed an association between 
PM2.5 and bladder cancer and that 6-19% of bladder cancers 
are attributable to occupational exposures. Studies from 2003 to 2022 
supported the association between PM2.5 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 PM2.5 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 PM2.5, 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 PM2.5. r.\40\
---------------------------------------------------------------------------

    \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. 
https://pubmed.ncbi.nlm.nih.gov/12704620/.
    \36\ IARC (International Association for Research on Cancer). 
Air Pollution and Cancer, IARC Scientific Publication No. 161, 2013. 
https://publications.iarc.fr/Book-And-Report-Series/Iarc-Scientific-Publications/Air-Pollution-And-Cancer-2013.
    \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 
PM2.5 Exposure and Bladder Cancer Mortality in Taiwan. 
International journal of environmental research and public health, 
14(5), 508; https://pmc.ncbi.nlm.nih.gov/articles/PMC5451959.
    \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; https://ehp.niehs.nih.gov/doi/10.1289/EHP1249.
    \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); 
https://pubmed.ncbi.nlm.nih.gov/32462559.
    \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; 
https://www.sciencedirect.com/science/article/abs/pii/S0269749120360164?via%3Dihub.
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    The EPA also concluded that long-term exposure to PM2.5, 
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 PM2.5 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 PM2.5 was 
significantly associated with an increased relative risk for bladder 
cancer of 7%.\43\
---------------------------------------------------------------------------

    \41\ EPA Supplement to the 2019 Integrated Science Assessment 
for Particulate Matter (Final Report, 2022) https://www.epa.gov/isa/integrated-science-assessment-isa-particulate-matter (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, 
https://pmc.ncbi.nlm.nih.gov/articles/PMC11180144/.
---------------------------------------------------------------------------

    PM2.5 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 PM2.5. Accordingly, VA concludes 
it is appropriate to add bladder cancer to 38 CFR 3.320a.
---------------------------------------------------------------------------

    \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), https://doi.org/10.17226/25162. NASEM, Respiratory Health 
Effects of Airborne Hazards Exposures in the Southwest Asia Theater 
of Military Operations (2020), https://doi.org/10.17226/25837.
---------------------------------------------------------------------------

2. Association Between PM2.5 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.
---------------------------------------------------------------------------

    \45\ Saint John's Cancer Institute. Ureteral Cancer and Ureteral 
Urothelial Carcinoma (UTUC).https://www.saintjohnscancer.org/urology/conditions/ureteral-cancer/.
---------------------------------------------------------------------------

    The PACT Act has associated kidney cancer with PM2.5 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 PM2.5 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.
---------------------------------------------------------------------------

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 PM2.5. 38 
CFR 3.320(a)(2); 86 FR at 42732-42733. VA added nine rare cancers to 
the list of disabilities presumptively associated with PM2.5 
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 PM2.5 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 PM2.5 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.
---------------------------------------------------------------------------

    \50\ MEESC Report, supra.
---------------------------------------------------------------------------

    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 PM2.5 
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 PM2.5. 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., 
PM2.5, 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, 
https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/.
    \52\ Id.
    \53\ Id.
    \54\ Id.
    \55\ Social Security Administration, Program Operations Manual 
System, https://secure.ssa.gov/poms.nsf/lnx/0423022345.
---------------------------------------------------------------------------

    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 PM2.5 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 www.regulations.gov.

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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