1894 Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Rules and Regulations 

1National 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 (hereafter ‘‘Respiratory Health 

Effects of Airborne Hazards’’). 

2 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’’). 3National 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’’). 4NRC, supra. 

5Wang 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/. 

6 Id. 

7American Cancer Society. Military Burn Pits 

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

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

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AS27 

Presumptive Service Connection for 

Leukemias, Multiple Myelomas, 

Myelodysplastic Syndromes, and 

Myelofibrosis 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 acute leukemias, 

chronic leukemias, multiple myelomas, 

myelodysplastic syndromes (MDS), and 

myelofibrosis due to exposure to 

Particulate Matter 2.5 (PM2.5). The new 

presumptions would apply to veterans 

who served on active military, naval, 

air, or space service in the 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. 

DATES: 

Effective date: This interim final rule 

is effective January 10, 2025. 

Comment date: Comments must be 

received on or before March 11, 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–AS27. 

FOR FURTHER INFORMATION CONTACT: 

Amy Davis, Regulations Analyst, and 

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: 

I. Background 

On August 10, 2022, the President 

signed into law the Sergeant First Class 

Heath Robinson Honoring our Promise 

to Address Comprehensive Toxics Act 

of 2022 (PACT Act). Public Law 117– 

168. The PACT Act provided a process 

for VA to establish presumptive service 

connection based on toxic exposures. 38 

U.S.C. 1171–1174. 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). 

One of VA’s priorities is to address 

the long overdue needs of the Gulf War 

cohort and to address the need for these 

veterans to receive timely care, services, 

and benefits. VA has reviewed both 

medical and scientific literature and has 

found sufficient evidence to conclude 

that a positive association exists 

between exposure to PM2.5 and acute 

and chronic leukemias and multiple 

myelomas. Accordingly, VA has 

determined that presumptions of service 

connection for these diseases and two 

precursors to acute myeloid leukemia 

(AML), MDS and myelofibrosis, are 

warranted for certain Gulf War veterans. 

In this IFR, VA adds 38 CFR 3.320b 

to its adjudicatory regulations to 

presume service connection for acute 

leukemias, chronic leukemias, multiple 

myelomas, MDS, and myelofibrosis for 

certain Gulf War veterans. VA adds 

these as presumptive conditions in 38 

CFR 3.320b by IFR so that any veteran 

with these diseases 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; 1

NASEM’s 2011 report, Long-Term 

Health Consequences of Exposure to 

Burn Pits in Iraq and Afghanistan; 2 and 

NASEM’s 2010 report, Review of the 

Department of Defense (DoD) Enhanced 

Particulate Matter Surveillance 

Program.3 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].’’ 4 See 86 FR at 42725. Toxic 

compounds present in burn pit fumes 

include PM2.5.5 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.6 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.7

When promulgating 38 CFR 3.320 in 

August 2021, to determine the 

qualifying periods of service, VA 

primarily considered (1) whether burn 


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Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Rules and Regulations 1895 

8See Letter from Office of Under Secretary of 

Defense to the U.S. House of Representatives 

Committee on Appropriations (May 7, 2021), 

available on the rulemaking docket at 

www.regulations.gov (hereafter ‘‘Defense Letter’’). 

9U.S. Central Command. Area of Responsibility. 

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

10 Department of Defense. Open Burn Pit Report 

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

Downloads/Congress/Open%20Burn%20

Pit%20Report-2019.pdf. 

11See Defense Letter, supra. 

12Center 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. 

13 . 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, US Security Assistance 

to Somalia, https://www.stimson.org/2023/ussecurity-cooperation-with-somalia/. 

14 Department of Defense. Enhanced Particulate 

Matter Surveillance Program Final Report. 2008. 

https://apps.dtic.mil/sti/pdfs/ADA605600.pdf 

(hereafter ‘‘EPMSP Report’’). 

15 Id. 

16 Id. 

17 Id. 

18NASEM 2011 Report, supra. 

19Estrellan, 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. 20EPMSP Report, supra. 

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 

different 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. 

VA’s new presumptions in 38 CFR 

3.320b will include the locations in 

current 38 CFR 3.320(a)(5), and 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 2001.8 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 9 and is the 

only combatant command that conducts 

open burn pit operations.10 Egypt, 

Jordan, Lebanon, and Yemen were 

included as locations with open, active 

burn pits.11 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 1993.12

Additional deployments occurred in 

1992, 1995, 2012, and 2022.13

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.14 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.15 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.16 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.17

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.18 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.’’ 19 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 that can have 

many different components from many 

different sources (for example, sand, 

dust, and smoke) and open burning of 

waste emits toxic combustion emissions 

into the ambient air; VA considers burn 

pit smoke to be a contributor to PM2.5. 

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.20 For 

consistency with the statutory start date 

for service in 38 U.S.C. 1119(c)(1)(B) 

locations (including Afghanistan, Syria, 

Djibouti, and Uzbekistan) back to 

September 11, 2001, new 38 CFR 3.320b 

will presume exposure to PM2.5 for 

those countries back to September 11, 

2001. 

b. The PACT Act Process 

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 

(VSOs) 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 

and potentially other factors, to render 

a conclusion on the strength of the 

evidence and to provide a 

recommendation to the Secretary with 

respect to a presumption. Id. If the 

Secretary decides to accept a 

recommendation to establish a 

presumption, the Rulemaking and 

Implementation Phase then begins. 38 

U.S.C. 1174. 

c. Ongoing Exploratory Surveillance 

Phase 

On July 26, 2023, VA published a 

notice soliciting public comment on its 

plan to assess the scientific literature 


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21Report to the Secretary of Veterans Affairs on 

the Relationship Between Exposure to Fine 

Particulate Matter (PM2.5) in the Southwest Theatre 

of Operations or Somalia on or After August 2, 

1990, or in Afganistan, Egypt, Jordan, Lebanon, 

Syria, Yemen, Djibouti, or Uzbekistan on or After 

September 11, 2001 and Chronic and Acute 

Leukemias and Multiple Myleomas, November 2024 

(hereafter ‘‘Committee report’’), is attached to this 

rulemaking, available at www.regulations.gov. 

22 Id. 

23 Id. 

24 Id. 

25 Id. 

26Secretary’s Memorandum, signed November 

20, 2024, is attached to this rulemaking, available 

at www.regulations.gov. 

27 Id. 

28Formal Evaluation of the Report to The 

Secretary of Veterans Affairs on The Relationship 

Between Exposure to Fine Particulate Matter (PM2.5) 

in the Southwest Theatre of Operations or Somalia 

on or after August 2, 1990, or In Afghanistan, Egypt, 

Jordan, Lebanon, Syria, Yemen, Djibouti, or 

Uzbekistan on or After September 11, 2001, and 

Acute Leukemias, Chronic Leukemias, and Multiple 

Myelomas, December 6, 2024 (hereafter ‘‘Formal 

Evaluation Report’’) is attached to this rulemaking, 

available at www.regulations.gov. 

29 Id. 

30 Id. 

31 Id. 

32 Id. 

and historical claims data regarding 

multiple myelomas, acute leukemias, 

and chronic leukemias associated with 

specific military environmental 

exposures. 88 FR 73094. On November 

7, 2023, VA’s Health Outcomes Military 

Exposures (HOME) office held a public 

listening session and briefed VSOs and 

Congressional staffers on the plan to 

study leukemias and multiple 

myelomas. Most comments were in 

favor of assessing the scientific 

literature and historic claims data 

regarding multiple myelomas, acute 

leukemias, and chronic leukemias. 89 

FR 33471. 

d. Research and Assessment Phase 

In November 2023, Veterans Health 

Administration (VHA) HOME and 

Veterans Benefits Administration’s 

(VBA) Military Exposure Team (MET) 

(hereafter ‘‘the committee’’) began 

collaboration to evaluate two distinct 

types of information (peer-reviewed 

scientific literature and VBA claims 

data) to determine the strength of the 

evidence supporting an association 

between exposure to PM2.5 in the 

Southwest Asia theater of operations or 

Somalia on or after August 2, 1990, or 

in Afghanistan, Egypt, Jordan, Lebanon, 

Syria, Yemen, Djibouti, or Uzbekistan 

on or after September 11, 2001 and 

chronic and acute leukemias and 

multiple myelomas. The committee 

considered this issue because blood and 

bone marrow cancers were not included 

as presumptions in the PACT Act. The 

committee followed the Patient, 

Exposure, Comparator, Outcomes, 

Timing, Setting (PECOTS) framework to 

guide a literature search and identify 

relevant articles for review—and 

identified 319 peer-reviewed 

publications that met the search criteria, 

of which 154 were deemed relevant.21

To assist in reviewing the relevant 

articles, the committee engaged experts 

including military exposure 

epidemiologists from VHA and the 

Department of Defense, VA scientists, 

VA oncologists/hematologists, boardcertified occupational and 

environmental medicine (OEM) 

physicians, and a senior medical 

advisor from the Commissioned Corps 

of the U.S. Public Health Service.22 Of 

the 154 relevant publications, 42 met 

the desired grade quality of high or 

moderate quality based on the Grading 

of Recommendations Assessment, 

Development, and Evaluation (GRADE) 

guidelines.23 Of the moderate and high 

quality peer-reviewed scientific 

publications, 74% showed a positive 

association between exposure to PM2.5

and development of acute and chronic 

leukemias and multiple myelomas.24

The committee concluded with a 

recommendation that the Secretary 

initiate a formal evaluation of the 

matter.25

e. Formal Evaluation Phase 

On November 20, 2024, the Secretary 

initiated a formal evaluation on chronic 

and acute leukemias and multiple 

myelomas and their possible association 

with exposure to PM2.5 pollution in the 

Southwest Asia theater of Operations.26

At the same time, the Secretary also 

directed a formal evaluation on other 

blood cancers.27

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; be free from suppression 

or distortion of scientific or 

technological findings, data, 

information, conclusions, or technical 

results; 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). 

Here, the formal evaluation team 

(hereinafter ‘‘the team’’) reviewed the 

methods and findings of the 

committee’s report from the Research 

and Assessment phase.28 The team 

included the HOME policy team, and 

hematologists/oncologists, 

epidemiologists, a toxicologist, and VBA 

Compensation Service personnel who 

were not part of the scientific 

assessment.29 The team assessed that 

the committee’s report had three major 

components and was consistent with 

robust scientific methods.30 First, the 

team noted that masters’ trained 

biomedical librarians, not part of the 

scientific assessment committee, had 

followed a PECOTS framework to 

complete an expansive structured 

literature search. Second, the team 

noted that the committee had critically 

reviewed the papers of moderate and 

high-grade quality based on the GRADE 

structure.31 Third, the team noted that 

the committee had reviewed VBA 

claims data on leukemias and multiple 

myelomas from March 2003–March 

2023 for both deployed and nondeployed Gulf War Era veterans, 

including 1990–1991 Gulf War veterans, 

Global War on Terror veterans, and 

Karshi-Khanabad Veterans.32

The team emphasized that the 74% of 

the moderate and high-quality peerreviewed scientific publications 

reviewed by the committee, as 

discussed above, consistently showed a 

positive relationship between exposure 

to PM2.5 and development of leukemias 

and multiple myelomas. The team noted 

that the VBA claims data provided a 

complementary perspective to the 

evidence in the scientific literature and 

showed trends among veterans with 

deployment to countries with 

recognized high levels of PM2.5 and burn 

pit pollution. Notably, veterans 

deployed to the relevant countries were 

granted a higher proportion of claims 

(53% vs. 42% for non-deployed), which 

supports the correlation between PM2.5

and higher risk of service-related 

diagnoses of these conditions. The data 

also showed that the deployed cohort 

filed more claims than non-deployed 


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33 Id. 

34 Id. 

35 Id. 

36Formal Evaluation Report, supra. 

37MEESC Memorandum, dated December 5, 

2024, is attached to this rulemaking, available at 

www.regulations.gov. 

38A myeloproliferative neoplasm is ‘‘A type of 

disease in which the bone marrow makes too many 

red blood cells, platelets, or certain white blood 

cells.’’ National Cancer Institute Dictionaries, 

myeloproliferative neoplasm, https://

www.cancer.gov/publications/dictionaries/cancerterms/def/myeloproliferative-neoplasm. 

39 Id. 

40HOME Information Paper, dated December 9, 

2024, is attached to this rulemaking, available at 

www.regulations.gov. 

41Secretary’s Memorandum, signed December 13, 

2024, is attached to this rulemaking, available at 

www.regulations.gov. 

42Formal Evaluation Report, supra. 

43 Id; see also Environmental Protection Agency 

Integrated Science Assessment (ISA) for Particulate 

Matter (2019), https://www.epa.gov/isa/integratedscience-assessment-isa-particulate-matter (finding 

the relationship ‘‘likely to be causal’’); World 

Health Organization, International Agency for 

Research on Cancer, Monographs on the Evaluation 

of Carcinogenic Risks to Humans Volume 109, 

2015. https://publications.iarc.fr/Book-And-ReportSeries/Iarc-Monographs-On-The-Identification-OfCarcinogenic-Hazards-To-Humans/Outdoor-AirPollution-2015 (finding that PM was carcinogenic to 

humans and detailing the mechanistic process by 

which PM initiates mutations). 

44 Id. 

45 Id. 

veterans, and also filed claims at a 

younger age, suggesting earlier onset of 

deployment related conditions. The 

team highlighted these data findings as 

supporting the link between PM 

exposure and increased risk for 

hematological cancers.33

As an additional validation step, the 

team analyzed a sample of ten papers 

considered by the scientific review to be 

high-quality studies that reported 

positive associations between exposure 

to PM2.5 and chronic leukemias, acute 

leukemias, and multiple myelomas. The 

team confirmed that, taken as a body of 

literature, the evidence suggested that 

environmental exposure to PM2.5 is 

positively associated with acute and 

chronic leukemias and multiple 

myelomas. In sum, groups of people that 

had measured, documented exposure to 

PM2.5 had a higher risk of developing 

leukemias and multiple myelomas than 

those who did not have a measured, 

documented exposure to PM2.5.34

The team did note certain limitations 

in the data, including that PM is diverse 

and depends on many factors. PM air 

pollution can include smoke, fumes, 

soot, and other products of combustion, 

as well as particles from natural sources, 

including dust and sand. Further, the 

team noted that, of the 42 papers 

deemed to provide high or moderate 

quality evidence, none were done on 

military Service members or in the 

environments in which Service 

members were deployed to the 

Southwest Asia theater of operations or 

Somalia on or after August 2, 1990, or 

in Afghanistan, Egypt, Jordan, Lebanon, 

Syria, Yemen, Djibouti, or Uzbekistan. 

The studies relied upon were conducted 

in other parts of the world, studied 

firefighters, those exposed to ambient 

air pollution or specific pollutants, and 

individuals exposed to the possibly 

unique PM exposures at the WTC. 

Nevertheless, the team found that the 

argument that exposure to PMs creates 

risk for acute and chronic leukemias 

and myelomas is biologically plausible 

and remains regardless of the 

differences in location or particulates.35

Despite these limitations, the team 

concluded that the evidence meets the 

‘‘sufficient’’ category in 38 U.S.C. 

1173(c)(2), where the evidence is 

sufficient to conclude a positive 

association existed. 38 U.S.C. 

1173(c)(2)(A). This is the strongest 

category of positive association under 

the PACT Act’s presumptive decisionmaking process. 38 U.S.C. 1173(c)(2)(A). 

Based on the positive association 

demonstrated, the formal evaluation 

team recommended—in its December 6, 

2024, formal evaluation report—that the 

Secretary initiate rulemaking to 

establish acute leukemias, chronic 

leukemias, and multiple myelomas as 

presumptive service-connected 

conditions for veterans who served in 

the Southwest Asia theater of 

Operations or Somalia on or after 

August 2, 1990, or in Afghanistan, 

Egypt, Jordan, Lebanon, Syria, Yemen, 

Djibouti, or Uzbekistan on or after 

September 11, 2001.36

Regarding the formal evaluation for 

other blood cancers, on December 5, 

2024, the MEESC recommended that the 

formal evaluation team continue to 

research these conditions (Polycythemia 

Vera, MDS, Essential (Hemorrhagic) 

Thrombocythemia, Chronic 

Myeloproliferative Disease, 

Myelofibrosis, Histiocytosis, and 

Mastocytosis) and provide a formal 

evaluation report to the Secretary by 

March 20, 2025, i.e., within 120 days of 

the formal evaluation initiation, in 

accord with 38 U.S.C. 1173(d).37 The 

MEESC noted that there were over 

60,000 studies on polycythemia vera 

and millions of studies on 

myeloproliferative neoplasms 38 and, 

with respect to mechanistic studies that 

may establish biological plausibility, 

more investigation was needed.39

To aid an evaluation of the MEESC’s 

recommendation on these ‘‘other blood 

cancers,’’ the Office of the Secretary of 

Veterans Affairs requested additional 

information concerning the survivability 

of those seven diseases. On December 9, 

2024, HOME provided the Secretary an 

information paper on the issue.40 In 

summary, two of the seven other blood 

cancers (MDS and myelofibrosis) may 

progress to acute myeloid leukemia 

(AML), and veterans whose disease so 

progresses often have a very poor 

prognosis. 

The Secretary considered the formal 

evaluation report on acute leukemias, 

chronic leukemias, and multiple 

myelomas; the MEESC’s 

recommendation to continue the formal 

evaluation on other blood cancers; and 

the additional information on 

survivability provided by HOME. On 

December 13, 2024, the Secretary 

directed VA to initiate rulemaking to 

establish acute leukemias, chronic 

leukemias, and multiple myelomas, and 

precursors MDS and myelofibrosis, as 

presumptive service-connected 

conditions related to exposure to PM2.5

in the Southwest Asia theater of 

operations or Somalia on or after August 

2, 1990, or in Afghanistan, Egypt, 

Jordan, Lebanon, Syria, Yemen, 

Djibouti, or Uzbekistan on or after 

September 11, 2001.41

Though much of the evidence 

supporting the Secretary’s decision has 

already been chronicled above, we also 

provide additional information on each 

of the conditions below: 

1. Leukemias 

As noted above, the formal evaluation 

team reviewed the report generated by 

the scientific assessment committee, 

evaluated the methods, findings, and 

conclusions, and validated the 

conclusions.42 Among the pertinent 

findings, the team cited the EPA’s 

determination that there is suggestive 

evidence of a relationship between longterm exposure to PM2.5 and cancers.43

Of the PM components detected in air 

samples taken at Joint Base Balad Iraq 

in 2007 and 2009, some volatile organic 

compounds with documented 

associations with leukemias and other 

hematopoietic cancers, such as benzene 

and 1,3-butadiene, were measured at 

levels that exceed safety thresholds.44

The team also highlighted several highquality papers that reported positive 

associations between exposure to PM2.5

and chronic leukemias and acute 

leukemias, which supported the 

findings that PM2.5 exposure placed 

individuals at increased risk for 

leukemias.45

The team concluded there is sufficient 

evidence supporting the conclusion that 

veterans deployed in the relevant areas 


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1898 Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Rules and Regulations 

46 Id. 

47 G. Visani et al., ‘‘Environmental nanoparticles 

are significantly over-expressed in acute myeloid 

leukemia,’’ Leukemia Research, Volume 50, 2016– 

11–01, https://www.clinicalkey.com/#!/content/ 

playContent/1-s2.0-S014521261

6301916?returnurl=https:%2F%

2Flinkinghub.elsevier.com%2Fretrieve%

2Fpii%2FS0145212616301916%

3Fshowall%3Dtrue&

referrer=https:%2F%2Fpubmed.ncbi.nlm.nih.gov%. 

48 Demers PA, Heyer NJ, Rosenstock L. Mortality 

among firefighters from three northwestern United 

States cities. Br J Ind Med. 1992 Sep;49(9):664–70. 

doi: 10.1136/oem.49.9.664. PMID: 1390274; PMCID: 

PMC1039313. https://pmc.ncbi.nlm.nih.gov/ 

articles/PMC1039313 (hereinafter ‘‘Demers 

Mortality among firefighters’’); Andrea Micheli 

et.al, Risk of death for hematological malignancies 

for residents close to an Italian petrochemical 

refinery: a population-based case-control study, 

https://link.springer.com/article/10.1007/s10552- 

014-0468-1. 

49 Jenny N. Poynter et al., ‘‘Chemical exposures 

and risk of acute myeloid leukemia and 

myelodysplastic syndromes in a population-based 

study,’’ International Journal of Cancer, 140–1, 

2017, https://pmc.ncbi.nlm.nih.gov/articles/ 

PMC5245124. 

50Maro Ohanian et al., ‘‘A heavy metal baseline 

score predicts outcome in acute myeloid leukemia,’’ 

American Journal of Hematology, Volume 95, Issue 

4, 2020, https://onlinelibrary.wiley.com/doi/ 

10.1002/ajh.25731. 

51Formal Evaluation Report, supra. 

52 Jiehui Li et al., ‘‘Association between World 

Trade Center exposure and excess cancer risk,’’ 

JAMA, Volume 308, 2012, https://

jamanetwork.com/journals/jama/fullarticle/ 

1486831 (hereinafter ‘‘Li World Trade Center 

Exposure’’); Demers Mortality among firefighters, 

supra. 

53Samara Solan et al., ‘‘Cancer incidence in 

World Trade Center Rescue and Recovery Workers, 

2001–2008,’’ Environmental Health Perspectives, 

Volume 121,6, 2013, https://pmc.ncbi.nlm.nih.gov/ 

articles/PMC3672914. 

54Robin C. Puett et al., ‘‘Relationship of 

leukaemias with long-term ambient air pollution 

exposures in the adult Danish population,’’ British 

Journal of Cancer, Volume 123, 12, 2020, https://

pmc.ncbi.nlm.nih.gov/articles/PMC7722932/. 55NASEM, 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; 

Respiratory Health Effects of Airborne Hazards, 

supra. 56Committee Report, supra; Formal Evaluation 

Report, supra. 57Sunita Ghosh et al., Multiple myeloma and 

occupational exposures: a population-based casecontrol study https://pubmed.ncbi.nlm.nih.gov/ 

21654434/; B. Charbotel et al., ‘‘Occupational 

exposures in rare cancers: A critical review of the 

literature,’’ Critical Reviews in Oncology and 

Hematology, Volume 90, Issue 2, https://

www.clinicalkey.com/#!/content/playContent/1- 

s2.0-S104084281300259X (hereafter ‘‘Occupational 

exposures in rare cancers’’). 

58 Jacqueline Moline, et.al. Multiple Myeloma in 

World Trade Center Responders: A Case Series, 

https://journals.lww.com/joem/fulltext/2009/08000/ 

multiple_myeloma_in_world_trade_center_

responders_.7.aspx (hereafter ‘‘Moline, Multiple 

Myeloma’’). 

59 Kai Wu, et al. Proteomic Characterization of the 

World Trade Center dust-activated mdig and c-myc 

signaling circuit linked to multiple myeloma, 

https://pmc.ncbi.nlm.nih.gov/articles/PMC5105131/ 

(hereinafter ‘‘Wu’’). 

60 Id. 

61Moline, Multiple Myeloma, supra. 

62Wu, supra. 

63Eugenia Marine Barjoan et al., ‘‘Cancer 

incidence in the vicinity of a waste incineration 

plant in the Nice area between 2005 and 2014,’’ 

Environmental Research, Volume 188, 2020, 

109681, https://www.sciencedirect.com/science/ 

article/pii/S0013935120305740?via%3Dihub. 

64HOME Information Paper, supra; Secretary’s 

December 13, 2024 Memorandum, supra. 

65Menssen AJ, Walter MJ. Genetics of progression 

from MDS to secondary leukemia. Blood. 2020 Jul; 

https://pubmed.ncbi.nlm.nih.gov/32430504/ 

(hereinafter ‘‘Menssen’’); Akriti Jain et al. Patterns 

of lower risk myelodysplastic syndrome 

progression: factors predicting progression to highrisk myelodysplastic syndrome and acute myeloid 

leukemia, https://pmc.ncbi.nlm.nih.gov/articles/ 

PMC11215361/ (hereinafter ‘‘Jain’’). 

66 Jennifer L. Dotson et al. Myelodysplastic 

Syndrome, https://www.ncbi.nlm.nih.gov/books/ 

NBK534126/ (hereafter ‘‘Dotson’’). 

develop leukemia earlier in their lives 

than those who did not deploy.46

Among other findings, the studies cited 

show PM2.5 exposure plays a major role 

in the process of activating or 

maintaining gene expression, leading to 

the development of leukemia.47

Exposure to benzene, which may be 

absorbed by particulates as a result of 

burn pits, significantly increases the risk 

of developing leukemia.48 Additional 

associative environmental causes are 

soot 49 and toxic metals,50 which are 

known airborne hazards.51 Further, 

excessive exposure to carcinogens due 

to inhalation of PM, such as fire, smoke, 

dust, and burning debris, leads to 

increased rates of leukemia.52 Moreover, 

pollutants at the World Trade Center 

(WTC) recovery site were similar to 

PM2.5, and the workers who engaged in 

onsite recovery efforts developed 

hematological cancers, including 

myeloma, leukemia, and lymphoma at a 

higher rate than those who did not.53

The studies cited also show that the 

higher the exposure to PM2.5 in the year 

prior to diagnosis, the more likely a 

leukemia diagnosis would occur.54

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.55 86 FR at 42725– 

42726. Thus, VA has determined that it 

will consider chronic and acute 

leukemias for this population to be 

associated with exposure to PM2.5. 

Accordingly, VA concludes it is 

appropriate to add chronic leukemias 

and acute leukemias to 38 CFR 3.320b. 

2. Multiple Myelomas 

Similar to leukemia, the scientific 

committee and formal evaluation team 

found strong scientific evidence linking 

exposure to PM2.5 to the development of 

multiple myelomas.56 The studies cited 

show that exposure to coal dust, coke 

dust, crude petroleum, iron, lubricants, 

and solvents found in PM2.5 was a 

probable carcinogen causing multiple 

myelomas.57 Another study noted 

higher than normal diagnoses of 

multiple myelomas occurred in WTC 

responders. These responders were 

exposed to a complex mix of pollutants, 

including benzene and polycyclic 

aromatic hydrocarbons, asbestos, paint 

and solvent vapors, aromatic 

hydrocarbons, polychlorinated 

biphenyls, pesticides, microscopic 

shards of glass, polychlorinated 

biphenyls, other organochlorines, 

dioxins, furans, engine exhaust, and 

metals, which previous studies had 

associated with higher rates of multiple 

myelomas.58 The dust carrying PM2.5 at 

the WTC recovery site was potent in 

inducing change in multiple myeloma 

cells, increasing risk for the disease.59

First responders were diagnosed with 

multiple myelomas at a higher rate than 

the general population.60 An excess 

number of cases of multiple myeloma 

were observed among first responders, 

in particular among those younger than 

45 years of age.61 The environmental 

etiology at the WTC may be similar to 

exposure to pollutants, including 

PM2.5.62 Another study showed that 

both men and women who lived near a 

waste incineration plant had increased 

rates of multiple myelomas compared to 

those who did not.63

For these reasons, VA concludes that 

the evidence is sufficient to warrant a 

presumption of multiple myelomas due 

to PM2.5 for the affected population. As 

stated above, VA recognizes the adverse 

health effects of PM2.5 exposure on U.S. 

Service Members serving in the Middle 

East. VA concludes it is appropriate to 

add multiple myelomas to 38 CFR 

3.320b. 

3. Myelodysplastic Syndromes (MDS) 

and Myelofibrosis 

MDS and myelofibrosis are rare blood 

cancers that can progress to AML, a 

condition which will be presumptive 

under this rule. In addition to the 

presumptions above, VA has examined 

MDS and myelofibrosis and concluded 

that these diseases warrant presumptive 

service connection because they can 

progress to AML, and veterans whose 

disease so progresses often have a very 

poor prognosis.64

Approximately 30% to 40% of 

individuals with MDS will eventually 

progress to AML 65 and ‘‘often have a 

very poor prognosis.’’ 66 The majority of 


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67Elias Jabbour et al. Acute Myeloid Leukemia 

Following Myelodysplastic Syndrome and Failure 

of Therapy with Hypomethylating Agents: An 

Emerging Entity With a Poor Prognosis, https://

pmc.ncbi.nlm.nih.gov/articles/PMC4098769/ 

(‘‘hereinafter ‘‘Jabbour’’). 

68 Jain, supra. 

69Mikkael Sekeres et al. Diagnosis and Treatment 

of Myelodysplastic Syndromes, https://jama

network.com/journals/jama/fullarticle/2795886 

(hereafter ‘‘Sekeres’’). 

70Barbara Mora et al. Prognostic and Predictive 

Models in Myelofibrosis, https://pubmed.ncbi.nlm.

nih.gov/39179882/ (hereafter ‘‘Mora’’). 

71Ayalew Tefferi et al., One Thousand Patients 

With Primary Myelofibrosis: The Mayo Clinic 

Experience, https://pmc.ncbi.nlm.nih.gov/articles/ 

PMC3538387/ (hereafter ‘‘Tefferi’’). 

72Srdan Verstovsek et al. Changes in the 

incidence and overall survival of patients with 

myeloproliferative neoplasms between 2002 and 

2016 in the United States, https://pubmed.ncbi.nlm.

nih.gov/34689695/ (hereafter ‘‘Verstovsek’’). 

73 Dotson, supra. 

74 Id. 

75 Id. 

76 Id. 

77 Id. 

78HOME Information Paper, supra. 

79Sekeres, supra. 

80 Id. 

81National Cancer Institute, ‘‘Myelofibrosis,’’ 

https://www.cancer.gov/search/results?swKeyword=

Myelofibrosis; Orpha.net, Knowledge on rare 

diseases and orphan drugs, ‘‘Myelofibrosis,’’ 

https://www.orpha.net/en/disease/detail/ 

824?name=myelofibrosis&mode=name. 

82 Id. 

83HOME Information Paper, supra. 

84 Domenico Penna et al., 20+ Years and alive 

with primary myelofibrosis: Phenotypic signature of 

very long-lived patients, https://onlinelibrary.

wiley.com/doi/full/10.1002/ajh.25351#xd_co_

f=ZDY0YjJhMDEtN2RlYS00MWM0L

WJkZDUtZjNlNTcyN2IxNmE4∼ (hereafter ‘‘Penna’’). 

85Tefferi, supra. 

86HOME Information Paper, supra. 

87The PACT Act added MGUS as a condition 

presumptive to herbicide exposure. 38 U.S.C. 

1116(a)(2)(L). 

patients with both MDS and AML fail to 

respond to available therapies 67 and 

often die from complications and/or 

disease progression.68 Even among 

those with MDS who do not progress to 

AML, the five-year survival rate is only 

37%69, meaning that 2 of 3 individuals 

with MDS will not survive 5 years. Like 

MDS, patients diagnosed with 

myelofibrosis can progress to AML 

based on their risk.70 For low-risk 

patients, the five-year AML 

transformation rate is 6%, but it is 21% 

for high-risk patients (and 37% of 

patients diagnosed with myelofibrosis 

are high risk).71 Even for those 

individuals who do not progress to 

AML, the five-year mortality is 

nonetheless relatively high at 51%.72

Accordingly, VA has determined that 

expanding the presumptions to include 

these two conditions is necessary to 

ensure veterans diagnosed with MDS 

and myelofibrosis are given the benefit 

of a presumption before these diseases 

progress. 

MDS are a group of rare cancers that 

occur when the blood-forming cells in 

the bone marrow become abnormal.73

The blood cells produced by the 

abnormal bone marrow cells are 

damaged and accumulate in the bone 

marrow engulfing the normal blood 

cells.74 As a result, individuals with 

MDS do not produce enough normal, 

healthy blood cells.75 Most cases arise 

after age 65.76 In the U.S. population, 

annually, 4.9 out of every 100,000 

persons will develop MDS (i.e., 20,451 

annually).77 The five-year prevalence 

(FY18–FY23) among post-9/11 veterans 

enrolled in VHA for health care is 10.78 

out of 100,000. Given that data, it is 

estimated that approximately 102 to 136 

post-9/11 deployed veterans with MDS 

could eventually have their disease 

progress to AML.78

MDS are categorized into subtypes of 

those individuals who have a lower or 

higher risk for progressing to AML.79

For those with lower risk for AML, 

median survival is three to 10 years, 

whereas patients with higher-risk 

disease have a median survival of less 

than three years.80

Myelofibrosis is also a rare blood 

cancer that occurs when scar tissue 

forms in the bone marrow, disrupting 

the production of heathy blood cells.81

The prevalence for developing 

myelofibrosis is one to nine out of every 

100,000 in the U.S.82 The five-year 

(FY18–FY23) prevalence rate of 

myelofibrosis among post 9–11 veterans 

enrolled in VA health care was 4.26/ 

100,000.83 The overall life expectancy 

depends on the severity of the disease, 

with an overall median survival 

estimated at six years.84 The overall 10- 

year survival rate from one study 

showed that intermediate risk patients 

had a 30% survival rate and high risk 

patients had a 0% to 13% survival 

rate.85 Based on the five-year veteran 

prevalence data cited above, it is 

estimated that approximately 14 to 27 

post-9/11 deployed veterans with 

myelofibrosis could eventually have 

their disease progress to AML.86

As discussed above, PM2.5 exposure 

has been shown to be associated with 

the development of leukemias and 

multiple myelomas. Because a 

significant number of cases of MDS and 

myelofibrosis progress to leukemia, and 

because these diseases have a severe 

outcome and significant mortality rates 

on their own, VA has determined a 

presumption of service connection is 

warranted for MDS and myelofibrosis as 

precursors to AML. 

IV. Addition of Leukemias, Multiple 

Myelomas, MDS, and Myelofibrosis to 

38 CFR 3.320b 

In the PACT Act, 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 the 

evidence shows a positive association 

between exposure to PM2.5 and acute 

leukemias, chronic leukemias, and 

multiple myelomas, VA concludes that 

these conditions and MDS and 

myelofibrosis, as precursors to AML, 

should be extended a presumption of 

service connection in new 38 CFR 

3.320b. VA includes monoclonal 

gammopathy of undetermined 

significance (MGUS) 87 as part of 

multiple myelomas because the VA 

Schedule of Rating Disabilities places 

MGUS as part of the same diagnostic 

code as multiple myeloma. 38 CFR 

4.117, Diagnostic Code 7712. 

VA will use the heading of 

‘‘[p]resumptive service connection for 

leukemias, multiple myelomas, 

myelodysplastic syndromes and 

myelofibrosis’’ for 38 CFR 3.320b. VA 

will describe the presumption of 

exposure in paragraph (a), describe the 

presumptions of service connection in 

paragraph (b), and provide the standard 

exceptions for presumptions in 

paragraph (c). 

Although this rulemaking is based on 

current medical and scientific evidence 

related to the health effects of PM2.5 on 

veterans who served during the Gulf 

War, 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. Authority 

As discussed above, VA is enacting 

these presumptions pursuant to the 38 

U.S.C. 1171 et seq. process or 

alternatively 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 to establish rights to benefits, 

such as presumptions of service 

connection. 

VI. 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 the agency of this 

rule can operate independently. If any 


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88National Cancer Institute, Cancer Stat Facts: 

Leukemia, https://seer.cancer.gov/statfacts/html/ 

leuks.html; National Cancer Institute, Cancer Stat 

Facts: Myeloma, https://seer.cancer.gov/statfacts/ 

html/mulmy.html (hereafter ‘‘NCI, supra’’); Sekeres, 

supra; Tefferi, supra; Penna, supra. 

89 Jonathan Vespa, ‘‘Aging Veterans: America’s 

Veteran Population in Later Life,’’ American 

Community Survey Reports, July 2023, https://

www.census.gov/content/dam/Census/library/ 

publications/2023/acs/acs-54.pdf. 

90CDC National Center for Health Statistics, ‘‘Life 

expectancy in the U.S. dropped for the second year 

in a row in 2021,’’ CDC National Center for Health 

Statistics, August 31, 2022, https://www.cdc.gov/ 

nchs/pressroom/nchs_press_releases/2022/ 

20220831.htm. 91 Department of Veterans Affairs, National 

Center for Veterans Analysis and Statistics, 

‘‘Mortality rates and life expectancy of Veterans 

from 1980 to 2014, and by education and income’’ 

April 2017, https://www.va.gov/vetdata/docs/ 

SpecialReports/Mortality_study_USVETS_2015_

1980_2014.pdf. 92NCI, supra. 93 Id. 

94 Id. 

95 Id. 

96 Id. 

97 Id. 

98 Id. 

99American Cancer Society, Key Statistics for 

Myelodysplastic Syndromes (MDS), https://

www.cancer.org/cancer/types/myelodysplasticsyndrome/about/key-statistics.html; Dotson, supra. 

100Menssen supra; Dotson, supra, 

101Sekeres, supra, 

102 Id. 

103 Id. 

104National Organization for Rare Diseases, 

‘‘Primary Myelofibrosis,’’ https://rarediseases.org/ 

rare-diseases/primary-myelofibrosis/. 

105 Id. 

106 Verstovesek, supra; Penna 20+ Years, supra. 

107Primary myelofibrosis, supra. 

108Mora, supra. 

109Primary myelofibrosis, supra. 

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 rule 

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. 

Moreover, we clarify here that VA 

benefits standards are distinct from the 

applicable standards for civil litigation, 

such that this final rule should have no 

effect on civil actions, to include Camp 

Lejeune Justice Act litigation. 

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. 

Given the nature of the diseases at 

issue, VA concludes that the ordinary 

notice-and-comment procedures here 

would be impracticable, in that they 

would cause veterans serious harm by 

delaying and in certain situations 

entirely denying veterans the benefits of 

these presumptions. In particular, good 

cause exists because this veteran 

population is aging and leukemias, 

multiple myelomas, MDS, and 

myelofibrosis are diseases of significant 

morbidity and mortality.88

For the population who served from 

August 1990 to present, which are the 

veterans affected by this rulemaking, 

there are 551,000 veterans aged 65 and 

older.89 Per the most recent data 

available from the U.S. Centers for 

Disease Control and Prevention, which 

was from 2020 to 2021, the life 

expectancy for the overall United States 

population has dropped from 77 years 

to 76.1 years. The life expectancy of 

men dropped from 74.2 years to 73.2 

years and women from 79.9 years to 

79.1 years.90 According to a 2017 VA 

National Center for Veterans Analysis 

and Statistics report, life expectancy is 

0.8 and 1.2 life years shorter for male 

and female veterans, respectively, than 

the general U.S. population.91

Leukemias account for 3.1% of all 

new cancer cases each year and account 

for 3.9% of all cancer deaths each 

year.92 The age adjusted rate of new 

cases of leukemias is about 14.1 per 

100,000 per year, and the age-adjusted 

death rate is about 5.9 per 100,000 per 

year.93 The five-year overall survival 

rate is about 67%, such that one out of 

every three veterans with leukemia will 

not live five more years. The survival 

rate varies across different types of 

leukemias because some types of 

leukemia are more aggressive and fatal 

than others. The median age at 

diagnosis of leukemias is 67, and the 

median age at death is 76, with the 

highest proportion of deaths among 

those between the ages of 75 and 84.94

As highlighted above, there are 551,000 

Veterans who served after 1990 in this 

65+ age range. 

Myelomas are rarer than leukemias, 

with a lifetime risk of 0.8%.95 The ageadjusted rate of new cases of myelomas 

is 7.2 per 100,000 and the age-adjusted 

death rate is 3.0 per 100,000; myelomas 

account for 1.8% of all new cancer 

cases, and 2.0% of all cancer deaths.96

The five-year survival rate for those 

with myelomas is 61.1%, such that 

more than one out of every three 

veterans with myelomas will not live 

five more years, though the rate varies 

by stage at diagnosis.97 The median age 

at diagnosis for myelomas is 69 and the 

median age at death is 76, with the 

highest proportion of deaths among 

those between 75 and 84.98

MDS are uncommon and are typically 

diagnosed in individuals after age 65.99

Approximately 30% to 40% of MDS 

patients eventually progress to AML.100

Once the disease has progressed to 

AML, patients have a very poor 

prognosis.101 Those with higher-risk 

disease have a median survival of less 

than three years.102 For those with MDS 

who do not progress to leukemia, the 

overall five-year survival rate in the U.S. 

is approximately 37%.103

The median age of diagnosis for 

myelofibrosis is 65.104 Approximately 

37% of the patients will be high risk.105

The overall five-year mortality rate for 

myelofibrosis is 51%, and the overall 

life expectancy depends on the severity 

of the disease, with a median survival 

estimated at six years.106 The overall 10- 

year survival rate from one study was 

30% for the intermediate risk 

population and 0% to 13% for high risk 

population.107

Those with myelofibrosis also may 

develop AML,108 with the same poor 

prognosis. For high-risk patients, the 

five-year transformation rate is 21 109

Given this population’s life 

expectancy, it is not served by waiting 

for a notice and comment period before 

obtaining the benefits of this 

presumption. Indeed, delaying this 

rulemaking for notice and comment 

runs the real risk of harming the very 

population this rulemaking intends to 

help. 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 


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prevent imposing 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 

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. 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 interim final rule will 

have no such effect on State, local, and 

tribal governments, or on the private 

sector. 

Paperwork Reduction Act (PRA) 

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 3.320b is 

currently approved by the Office of 

Management and Budget (OMB) and has 

been assigned OMB control numbers 

2900–0747, 2900–0886, and 2900–0004. 

Congressional Review Act 

Pursuant to Subtitle E of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (known as the 

Congressional Review Act) (5 U.S.C. 801 

et seq.), the Office of Information and 

Regulatory Affairs designated this rule 

as satisfying the criteria under 5 U.S.C. 

804(2). 

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, approved and signed 

this document on December 31, 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. 

Consuela Benjamin, 

Regulation Development Coordinator, 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 subpart A 

continues to read as follows: 

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

otherwise noted. 

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

§ 3.320b Presumptive service connection 

for leukemias, multiple myelomas, 

myelodysplastic syndromes, and 

myelofibrosis. 

(a) Presumption of exposure. A 

covered veteran as defined in § 3.320a(c) 

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 (c) of 

this section, the following diseases 

becoming manifest in a covered veteran, 

as defined in § 3.320a(c), 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) Acute leukemias. 

(2) Chronic leukemias. 

(3) Multiple myelomas, including 

monoclonal gammopathy of 

undetermined significance (MGUS). 

(4) Myelodysplastic Syndromes 

(MDS). 

(5) Myelofibrosis. 

(c) Exceptions. A disease listed in 

paragraph (b) of this section shall not be 

presumed service connected if there is 

affirmative evidence that: 

(1) The disease was not incurred or 

aggravated during active military, naval, 

air, or space service; or 

(2) The disease was caused by a 

supervening condition or event that 

occurred between the veteran’s most 

recent departure from active military, 

naval, air, or space service and the onset 

of the disease; or 

(3) The disease is the result of the 

veteran’s own willful misconduct. 

(Authority: 38 U.S.C. 501, 1119, 1171, 1172, 

1173, 1174) 

[FR Doc. 2024–31776 Filed 1–8–25; 8:45 am] 

BILLING CODE 8320–01–P 


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