Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 23 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Requirements 

Except as specified in paragraph (h) of this 

AD: Comply with all required actions and 

compliance times specified in, and in 

accordance with European Union Aviation 

Safety Agency Emergency AD 2024–0206–E, 

dated October 22, 2024 (EASA AD 2024– 

0206–E). 

(h) Exceptions to EASA AD 2024–0206–E 

(1) Where EASA AD 2024–0206–E requires 

compliance in terms of flight hours, this AD 

requires using hours time-in-service. 

(2) Where EASA AD 2024–0206–E refers to 

its effective date, this AD requires using the 

effective date of this AD. 

(3) Paragraph (5) EASA AD 2024–0206–E 

specifies to report inspection results to AH 

[Airbus Helicopters] within certain 

compliance times. For this AD, report 

inspection results at the applicable times 

specified in paragraph (h)(3)(i) or (ii) of this 

AD. 

(i) For an inspection done on or after the 

effective date of this AD: Submit the report 

within 7 days after the inspection. 

(ii) For an inspection done before the 

effective date of this AD: Submit the report 

within 7 days after the effective date of this 

AD. 

(4) This AD does not adopt the ‘‘Remarks’’ 

section of EASA AD 2024–0206–E. 

(i) Special Flight Permits 

Special flight permits are prohibited. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, International Validation 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the International Validation 

Branch, send it to the attention of the person 

identified in paragraph (k) of this AD and 

email to: AMOC@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(k) Additional Information 

For more information about this AD, 

contact Michael Mueller, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; phone: (847) 294– 

7543; email: Michael.J.Mueller@faa.gov. 

(l) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

the material listed in this paragraph under 5 

U.S.C. 552(a) and 1 CFR part 51. 

(2) You must use this material as 

applicable to do the actions required by this 

AD, unless the AD specifies otherwise. 

(i) European Union Aviation Safety Agency 

(EASA) Emergency AD 2024–0206–E, dated 

October 22, 2024. 

(ii) [Reserved] 

(3) For EASA material identified in this 

AD, contact EASA, Konrad-Adenauer-Ufer 3, 

50668 Cologne, Germany; phone: +49 221 

8999 000; email: ADs@easa.europa.eu; 

website: easa.europa.eu. You may find the 

EASA material on the EASA website at 

ad.easa.europa.eu. 

(4) You may view this material at the FAA, 

Office of the Regional Counsel, Southwest 

Region, 10101 Hillwood Parkway, Room 6N– 

321, Fort Worth, TX 76177. For information 

on the availability of this material at the 

FAA, call (817) 222–5110. 

(5) You may view this material at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

visit www.archives.gov/federal-register/cfr/ 

ibr-locations or email fr.inspection@nara.gov. 

Issued on December 17, 2024. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2024–31510 Filed 12–30–24; 11:15 am] 

BILLING CODE 4910–13–P 

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. 

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: 


ddrumheller on DSK120RN23PROD with RULES1
24 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 

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). 

2National 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’’). 

4National 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’’). 

5NRC, supra. 

6Wang 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. 

8American Cancer Society. Military Burn Pits 

and Cancer Risk. 2022. https://www.cancer.org/ 

healthy/cancer-causes/chemicals/burn-pits.html. 

9See 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’’). 

10U.S. Central Command. Area of Responsibility. 

https://www.centcom.mil/AREA-OFRESPONSIBILITY/. 

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. 

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

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 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 25 

11 Department of Defense. Open Burn Pit Report 

to Congress. 2019. https://www.acq.osd.mil/eie/ 

Downloads/Congress/Open%20Burn%20Pit%20

Report-2019.pdf. 

12See Defense Letter, supra. 

13Center 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. 

14CRS 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-securitycooperation-with-somalia/. 

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. 

19NASEM 2011 Report, supra. 

20Estrellan, 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. 

21EPMSP Report, supra. 

22The MEESC report (hereinafter MEESC Report) 

is attached to this rulemaking, available at 

www.regulations.gov. 

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

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

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. 

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. 

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. 

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 SubCouncil (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 


ddrumheller on DSK120RN23PROD with RULES1
26 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 

23 Genitourinary System, Science Direct. https:// 

www.sciencedirect.com/topics/medicine-anddentistry/genitourinary-system. 

24Rehman S, Ahmed D, (Aug 8, 2023). 

Embryology, Kidney, Bladder, and Ureter. 

StatPearls [internet]. https://www.ncbi.nlm.nih.gov/ 

books/NBK547747/ (hereinafter ‘‘Rehman’’). 

25Anatomy of the Urinary System. https://

www.hopkinsmedicine.org/health/wellness-andprevention/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. 

27Rehman, supra. 

28See 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. 

29Qais 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. 

31Rehman, supra. 

32Shah 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/. 

33Rehman, supra. 

recommendation, paving the way for 

this rulemaking. 

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

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. 

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

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

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 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 27 

34MEESC Report, supra. 

35Steenland 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/IarcScientific-Publications/Air-Pollution-And-Cancer2013. 

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. 

38Turner 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. 

39Coleman 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. 

40Zare 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. 

41EPA Supplement to the 2019 Integrated 

Science Assessment for Particulate Matter (Final 

Report, 2022) https://www.epa.gov/isa/integratedscience-assessment-isa-particulate-matter (hereafter 

‘‘EPA supplement’’). 

42 Id. 

43Li 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/. 

44NASEM, 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. 

45Saint John’s Cancer Institute. Ureteral Cancer 

and Ureteral Urothelial Carcinoma (UTUC).https:// 

www.saintjohnscancer.org/urology/conditions/ 

ureteral-cancer/. 

46MEESC Memorandum, supra. 

47 Id. 

48MEESC Report, supra. 

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. 

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 oddsratio of an average of 13% percent with 

a slight increase of PM2.5. r.40

The EPA also concluded that longterm 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

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. 

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. 

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 


ddrumheller on DSK120RN23PROD with RULES1
28 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 

49 Id. 

50MEESC Report, supra. 

51United States Cancer Statistics: Data 

Visualizations, https://gis.cdc.gov/Cancer/USCS/#/ 

AtAGlance/. 

52 Id. 

53 Id. 

54 Id. 

55Social Security Administration, Program 

Operations Manual System, https://secure.ssa.gov/ 

poms.nsf/lnx/0423022345. 

that bladder, ureter, and kidney cancers 

should all be treated the same for 

purposes of the presumption.49

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. 

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

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 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 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 

■ 1. The authority citation for part 3 

continues to read as follows: 

Authority: 38 U.S.C. 501(a), unless 

otherwise noted. 

■ 2. Add § 3.320a to read as follows: 

§ 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 § 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 


ddrumheller on DSK120RN23PROD with RULES1
30 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Rules and Regulations 

(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 

FEDERAL MARITIME COMMISSION 

46 CFR Part 542 

[Docket No. FMC–2023–0010] 

RIN 3072–AC92 

Definition of Unreasonable Refusal To 

Deal or Negotiate With Respect to 

Vessel Space Accommodations 

Provided by an Ocean Common Carrier 

AGENCY: Federal Maritime Commission. 

ACTION: Final rule; announcement of 

effective date; correction. 

SUMMARY: The Federal Maritime 

Commission (FMC or Commission) 

received approval from the Office of 

Management and Budget (OMB) for an 

information collection request 

associated with the final rule, 

‘‘Definition of Unreasonable Refusal to 

Deal or Negotiate with Respect to Vessel 

Space Accommodations Provided by an 

Ocean Common Carrier.’’ This rule 

announces the effective date for the 

requirements for ocean common carriers 

to annually file a documented export 

policy with the Commission and 

provides implementing instructions. In 

the final rule published July 23, 2024, 

the Commission stated it would publish 

a document in the Federal Register (FR) 

announcing the effective date of the 

collection-of-information-related 

sections upon OMB approval. This rule 

establishes the effective date of the 

relevant provisions. It also corrects an 

error in the regulatory text. 

DATES: The amendments adding 46 CFR 

542.1(j) (instruction 2) and 46 CFR 

542.99 (instruction 3), published on July 

23, 2024 (89 FR 59648), are effective on 

February 3, 2025. The correction to 46 

CFR 542.99 is effective February 3, 

2025. 

Parties required to file a documented 

export policy must file their initial 

documented export policy with the 

Commission on or before March 1, 2025. 

Subsequent annual documented export 

policies must subsequently be filed on 

or before March 1 for each calendar 

year. 

ADDRESSES: Background documents 

associated with this collection are 

available on www.reginfo.gov (search 

OMB Control No. 3072–0076) and 

www.regulations.gov (search Docket No. 

FMC–2023–0010). 

FOR FURTHER INFORMATION CONTACT: 

David Eng, Secretary; Phone: (202) 523– 

5725; Email: secretary@fmc.gov. 

SUPPLEMENTARY INFORMATION: On July 

23, 2024, in accordance with the Ocean 

Shipping Reform Act of 2022, the 

Federal Maritime Commission 

published the final rule, ‘‘Definition of 

Unreasonable Refusal to Deal or 

Negotiate with Respect to Vessel Space 

Accommodations Provided by an Ocean 

Common Carrier.’’ The final rule 

contained two provisions, 46 CFR 

542.1(j), and 46 CFR 542.99, that were 

delayed indefinitely, pending 

information collection approval from 

OMB under the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501–3520. On 

September 27, 2024, OMB, Office of 

Information and Regulatory Affairs, 

approved the information collection 

requirements (https://www.reginfo.gov/ 

public/do/PRAViewICR?ref_

nbr=202407-3072-001). The assigned 

OMB Control Number is 3072–0076. 

Accordingly, FMC announces that 46 

CFR 542.1(j) and 46 CFR 542.99 are 

effective February 3, 2025. FMC is also 

making a minor correction to 46 CFR 

542.99. 

Filing Instructions 

Unless superseded by subsequent 

Commission order or filing instructions 

issued by the Commission: 

1. Parties required under 46 CFR 

542.4(j) to file a documented export 

policy must file their initial 

documented export policy with the 

Commission on or before March 1, 2025. 

Subsequent annual documented export 

policies must be filed with the 

Commission on or before March 1 of 

each calendar year. A documented 

export policy should cover the time 

period until the next policy is due for 

submission; carriers may file updated 

versions more frequently as needed. 

2. Documents must be submitted in 

English, and any monetary terms shall 

be expressed in terms of U.S. currency. 

3. If any topics listed under 

541.2(j)(1)(i), 541.2(j)(1)(ii), and/or 

541.2(j)(1)(iii) are not addressed in a 

documented export policy because they 

are not applicable, the documented 

export policy should attest to this 

inapplicability clearly and 

unambiguously and provide an 

explanation for non-applicability. 

4. Submissions shall be signed by a 

duly authorized officer of the regulated 

party with a copy of evidence of the 

officer’s authority. 

List of Subjects in 46 CFR Part 542 

Administrative practice and 

procedure, Non-vessel-operating 

common carriers, Ocean common 

carrier, Refusal to deal or negotiate, 

Vessel-operating common carriers, 

Vessel space accommodations. 

For the reasons set forth in the 

preamble, FMC corrects 46 CFR part 542 

by making the following correcting 

amendment: 

■ 1. The authority citation for part 542 

continues to read as follows: 

Authority: 5 U.S.C. 553; and 46 U.S.C. 

40104, 46105, 40307, 40501–40503, 40901– 

40904, 41101–41106. 

■ 2. Revise § 542.99 to read as follows: 

§ 542.99 OMB control number assigned 

pursuant to the Paperwork Reduction Act. 

The Commission has received Office 

of Management and Budget approval for 

the collection of information in 

§ 542.1(j) of this part pursuant to the 

Paperwork Reduction Act of 1995, as 

amended. The valid control number for 

this collection is 3072–0076. 

By the Commission. 

David Eng, 

Secretary. 

[FR Doc. 2024–31017 Filed 12–31–24; 8:45 am] 

BILLING CODE 6730–02–P 


ddrumheller on DSK120RN23PROD with RULES1