Notice2026-18901
World Trade Center Health Program; Petition 048a-Peripheral Artery Disease; Finding of Insufficient Evidence
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 15, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Administrator of the World Trade Center (WTC) Health Program has received a petition (Petition 048a) to add "peripheral vascular disease" (referred to herein as "peripheral artery disease") to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding peripheral artery disease. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee, publish a proposed rule, or publish a determination not to publish a proposed rule.
Full Text
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<title>Federal Register, Volume 91 Issue 177 (Tuesday, September 15, 2026)</title>
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[Federal Register Volume 91, Number 177 (Tuesday, September 15, 2026)]
[Notices]
[Pages 58452-58455]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[NIOSH Docket 094]
World Trade Center Health Program; Petition 048a--Peripheral
Artery Disease; Finding of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Denial of petition for addition of a health condition.
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SUMMARY: The Administrator of the World Trade Center (WTC) Health
Program has received a petition (Petition 048a) to add ``peripheral
vascular disease'' (referred to herein as ``peripheral artery
disease'') to the List of WTC-Related Health Conditions. Upon reviewing
the scientific and medical literature, including information provided
by the petitioner, the Administrator has determined that there is
insufficient evidence available to support taking further action at
this time regarding peripheral artery disease. The Administrator also
finds that insufficient evidence exists to request a recommendation of
the WTC Health Program Scientific/Technical Advisory Committee, publish
a proposed rule, or publish a determination not to publish a proposed
rule.
DATES: The Administrator of the WTC Health Program is denying this
petition for the addition of a health condition as of September 15,
2026.
ADDRESSES: Visit the WTC Health Program website at <a href="https://www.cdc.gov/wtc/received.html">https://www.cdc.gov/wtc/received.html</a> to review Petition 048a.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-48, Cincinnati, OH 45226; telephone (404) 498-
2500 (this is not a toll-free number); email <a href="/cdn-cgi/l/email-protection#cc8285839f84bea9abbf8cafa8afe2aba3ba"><span class="__cf_email__" data-cfemail="642a2d2b372c16010317240700074a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petition 048a
D. Evaluation of Scientific Evidence: Findings and Conclusion
E. Administrator's Final Decision on Whether To Propose the Addition
of Peripheral Artery Disease to the List
F. Approval To Submit Document to the Office of the Federal Register
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59,
Pub. L. 117-328, Pub. L. 118-31, and Pub. L. 119-75), added Title
XXXIII to the Public Health Service (PHS) Act,\1\ establishing the WTC
Health Program within the Department of Health and Human Services
(HHS). The WTC Health Program provides medical monitoring and treatment
benefits for health conditions on the List of WTC-Related Health
Conditions (List) \2\ to eligible firefighters and related personnel,
law enforcement officers, and rescue, recovery, and cleanup workers who
responded to the September 11, 2001, terrorist attacks in New York
City, at the Pentagon, and in Shanksville, Pennsylvania (responders).
The Program also provides benefits to eligible persons who were present
in the dust or dust cloud on September 11, 2001, or who worked,
resided, or attended school, childcare, or adult daycare in the New
York City disaster area \3\ (survivors).
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\1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-64. Those portions of the James Zadroga 9/11 Health and
Compensation Act of 2010 found in Titles II and III of Public Law
111-347 do not pertain to the WTC Health Program and are codified
elsewhere.
\2\ The List of WTC-Related Health Conditions is established in
42 U.S.C. 300mm-22(a)(3)-(4) and 300mm-32(b); additional conditions
may be added through rulemaking, and the complete list is provided
in WTC Health Program regulations at 42 CFR 88.15.
\3\ See 42 U.S.C. 300mm-5(8); 42 CFR 88.1.
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All references to the Administrator of the WTC Health Program
(Administrator) in this document mean the Director of the National
Institute for Occupational Safety and Health (NIOSH) or his designee.
In accordance with section 3312(a)(6)(B) of the PHS Act, interested
parties may petition the Administrator to add a health condition to the
List in 42 CFR 88.15. Within 90 days after receipt of a valid petition
to add a condition to the List, the Administrator must take one of the
following four actions described in section 3312(a)(6)(B) of the PHS
Act and
[[Page 58453]]
Sec. 88.16(a)(2) of the WTC Health Program regulations: (1) Request a
recommendation of the WTC Health Program Scientific/Technical Advisory
Committee (STAC); (2) publish a proposed rule in the Federal Register
to add such health condition; (3) publish in the Federal Register the
Administrator's determination not to publish such a proposed rule and
the basis for such determination; or (4) publish in the Federal
Register a determination that insufficient evidence exists to take
action under (1) through (3) above.
More information about the WTC Health Program, including the List
and the petition process, is available at <a href="http://www.cdc.gov/wtc/">www.cdc.gov/wtc/</a>.
B. Procedures for Evaluating a Petition
In addition to the regulatory provisions, the WTC Health Program
has developed policies to guide the review of submissions and
petitions,\4\ as well as the analysis of evidence supporting the
potential addition of a non-cancer health condition to the List.\5\
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\4\ See WTC Health Program [2026], Policy and Procedures for
Handling Submissions and Petitions to Add a Health Condition to the
List of WTC-Related Health Conditions, January 22, 2026, <a href="https://www.cdc.gov/wtc/pdfs/policies/PNP_SubmissionsPetitions%20_20260122-508.pdf">https://www.cdc.gov/wtc/pdfs/policies/PNP_SubmissionsPetitions%20_20260122-508.pdf</a>.
\5\ See WTC Health Program [2026], Policy and Procedures for
Adding Non-Cancer Health Conditions to the List of WTC-Related
Health Conditions, May 14, 2026, <a href="https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancer_Health_Conditions_20260514.pdf">https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancer_Health_Conditions_20260514.pdf</a>.
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A valid petition must include sufficient medical basis for the
association between the September 11, 2001, terrorist attacks and the
health condition to be added. In accordance with WTC Health Program
Policy and Procedures for Handling Submissions and Petitions to Add a
Health Condition to the List of WTC-Related Health Conditions,\6\
reference to a peer-reviewed, published, epidemiologic study about the
health condition among 9/11-exposed populations or clinical case
reports of health conditions in WTC responders or survivors may
demonstrate the required medical basis.\7\ Studies linking 9/11 agents
or hazards \8\ to the petitioned health condition may also provide
sufficient medical basis for a valid petition.\9\ In accordance with 42
CFR 88.16(a)(5), the Administrator is required to consider a new
petition for a previously evaluated health condition determined not to
qualify for addition to the List only if the new petition presents a
new medical basis for the association between 9/11 exposures and the
condition to be added. A new medical basis is evidence not previously
reviewed by the Administrator.
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\6\ Supra note 4.
\7\ Id. at 7.
\8\ 9/11 agents are chemical, physical, biological, or other
hazards reported in a published, peer-reviewed exposure assessment
study of responders, recovery workers, or survivors who were present
in the New York City disaster area, or at the Pentagon site, or the
Shanksville, Pennsylvania site, as those locations are defined in 42
CFR 88.1, as well as those hazards not identified in a published,
peer-reviewed exposure assessment study, but which are reasonably
assumed to have been present at any of the three sites. See WTC
Health Program [2018], Development of the Inventory of 9/11 Agents,
July 17, 2018, <a href="https://www.cdc.gov/wtc/pdfs/policies/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf">https://www.cdc.gov/wtc/pdfs/policies/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf</a>.
\9\ Supra note 4 at 7.
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After the Program has determined that a petition is valid, and in
accordance with the Policy and Procedures for Adding Non-Cancer Health
Conditions to the List of WTC-Related Health Conditions (Policy and
Procedures), the Administrator directs the WTC Health Program Science
Team (Science Team) to conduct a review of the scientific literature.
The literature review includes a keyword search of relevant scientific
databases intended to identify peer-reviewed, published, epidemiologic
studies about the health condition among 9/11-exposed populations.
The Science Team evaluates the scientific quality of each peer-
reviewed, published, epidemiologic study of the health condition
identified in the literature search using validity indicators described
in the Policy and Procedures.\10\ Studies exhibiting sufficient
validity indicators have the potential to provide a basis for deciding
whether to propose adding the health condition to the List and are
considered ``high-quality'' studies. The Science Team then evaluates
the identified high-quality studies, individually and together, to
characterize the evidence of a causal association between 9/11
exposures and the health condition. As part of this evaluation, the
Science Team considers the Bradford Hill weight of evidence
criteria,\11\ study limitations, and whether the studies are
representative of the 9/11-exposed population of responders and
survivors. After evaluating the totality of the evidence, the Science
Team assesses the degree to which the evidence supports a causal
association between 9/11 exposures and the health condition and assigns
the evidence to one of the following five categories:
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\10\ Supra note 5 at 7-8.
\11\ Hill AB [1965], The Environment and Disease: Association or
Causation? Proc R Soc Med 58(5):295-300.
According to the Policy and Procedures, the Bradford Hill
criteria are a leading weight of evidence framework ``which
comprises nine aspects of association. These aspects comprise
strength of association, consistency, specificity, temporality,
biological gradient, plausibility, coherence, experiment, and
analogy.'' See supra note 5 at 9-10 and footnotes 21-30, discussion
of Bradford Hill analysis.
Category I--Evidence supports substantial likelihood of causal
association
Category II--Evidence supports high likelihood of causal association
Category III--Evidence supports limited likelihood of causal
association
Category IV--Evidence does not support causal association
Category V--Evidence is inadequate to determine the likelihood of
causal association.
The Science Team provides the outcome of its evaluation to the
Administrator. A health condition may be added to the List if peer-
reviewed, published, epidemiologic studies provide support that there
is a substantial likelihood of a causal association between the health
condition and 9/11 exposures (Category I).\12\ If the evaluation of
evidence provided in peer-reviewed, published, epidemiologic studies of
the health condition in 9/11 populations shows a high, but not
substantial, likelihood of a causal association between the 9/11
exposures and the health condition (Category II),\13\ then the
Administrator may consider additional highly relevant scientific
evidence regarding exposures to 9/11 agents in non-9/11 exposure
scenarios. If that additional assessment establishes that there is now
sufficient evidence to support the conclusion that a causal association
between the 9/11 exposures and the health condition is substantially
likely among 9/11-exposed populations (Category I), then the
Administrator may propose the addition of the health condition to the
List.
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\12\ Substantial likelihood of causal association means that the
association is strongly supported by evidence from high-quality,
peer-reviewed, published epidemiologic studies of the health
condition in 9/11-exposed populations and there is high confidence
that the association cannot be explained by chance, bias,
confounding, or any other alternative explanation. See supra note 5
at 12.
\13\ High likelihood of causal association means that the
scientific evidence, taken as a whole, demonstrates that the
likelihood of a causal association is less than substantial, but
definitively more than limited. Therefore, there is some meaningful
likelihood that the association can be explained by chance, bias,
confounding, or another alternative explanation. See supra note 5 at
12.
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C. Petition 048a
On September 3, 2023, the Administrator received a submission
(Petition 048a) requesting the addition of several cardiovascular
conditions, including ``peripheral vascular disease''
[[Page 58454]]
to the List.\14\ The Administrator understands the term ``peripheral
vascular disease'' to mean the health condition commonly known as
``peripheral artery disease'' (PAD). The petition's validity was
established by references to seven peer-reviewed, published,
epidemiologic studies that provided a medical basis for the association
between 9/11 exposures and PAD. The referenced studies establishing a
medical basis are as follows:
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\14\ See Petition 048a, WTC Health Program: Petitions Received,
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>. The submission received on
September 3, 2023, requested the addition of three discrete health
condition groupings: (1) ``myocardial infraction (sic), unstable
angina, obstructive coronary artery disease, ischemic
cardiomyopathy, ischemic congestive heart failure, arrythmias (due
to any of the above);'' (2) ``stroke;'' and (3) ``peripheral
vascular disease.'' Because the submission was found to be valid for
each group of health conditions, the Administrator exercised his
discretion to separate the conditions into three separate petitions
and evaluations. Group (1) health conditions were evaluated as
``ischemic heart disease'' under Petition 047, addressed in a
Federal Register notice published on June 30, 2026 (91 FR 39616).
The second condition, stroke, was evaluated under Petition 048, and
is addressed in a Federal Register notice published in this issue.
The third condition, peripheral vascular disease (commonly referred
to as peripheral artery disease, ``PAD''), is assessed in the
current evaluation under Petition 048a.
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<bullet<ls-thn-eq> Particulate Matter Air Pollution and
Cardiovascular Disease: An Update to the Scientific Statement from the
American Heart Association, by Brook et al. [2010],\15\ an updated
scientific statement concluding that modest epidemiologic evidence
supports a causal relationship between exposure to particulate matter
(PM) <2.5 micrometers ([micro]m) in diameter (PM<INF>2.5</INF>) and
increased PAD morbidity.
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\15\ Brook RD, Rajagopalan S, Pope CA, Brook JR, Bhatnagar A,
Diez-Roux AV, Holguin F, Hong Y, Luepker RV, Mittleman MA, Peters A,
Siscovick D, Smith SC, Whitsel L, Kaufman JD, and on behalf of the
American Heart Association Council on Epidemiology and Prevention,
Council on the Kidney in Cardiovascular Disease, and Council on
Nutrition, Physical Activity and Metabolism [2010], Particulate
Matter Air Pollution and Cardiovascular Disease: An Update to the
Scientific Statement from the American Heart Association,
Circulation 121(21):2331-2378.
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<bullet<ls-thn-eq> Expert Position Paper on Air Pollution and
Cardiovascular Disease, by Newby et al. [2015],\16\ a scientific review
and consensus document by the European Society of Cardiology that
evaluated the evidence linking air pollution (comprising the 9/11
agents PM<INF>2.5</INF> and PM <=10 [micro]m (PM<INF>10</INF>), ozone,
nitrogen dioxide (NO<INF>2</INF>), volatile organic compounds
(including benzene), carbon monoxide (CO), and sulfur dioxide
(SO<INF>2</INF>)) to cardiovascular disease (CVD) outcomes including
PAD.
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\16\ Newby DE, Mannucci PM, Tell GS, Baccarelli AA, Brook RD,
Donaldson K, Forastiere F, Franchini M, Franco OH, Graham I, Hoek G,
Hoffmann B, Hoylaerts MF, K[uuml]nzli N, Mills N, Pekkanen J, Peters
A, Piepoli MF, Rajagopalan S, Storey RF, on behalf of ESC Working
Group on Thrombosis, European Association for Cardiovascular
Prevention and Rehabilitation and ESC Heart Failure Association
[2014], Expert Position Paper on Air Pollution and Cardiovascular
Disease, Eur Heart J 36(2):83-93.
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<bullet<ls-thn-eq> A Joint ERS/ATS Policy Statement: What
Constitutes an Adverse Health Effect of Air Pollution? An Analytical
Framework, by Thurston et al. [2017],\17\ a joint European Respiratory
Society/American Thoracic Society policy statement on what constitutes
an adverse health effect of air pollution. It provides an analytical
framework for interpreting scientific evidence on the health effects of
air pollution for risk management purposes and references to papers
that describe increased risks of impaired vascular function--a
manifestation of PAD--and increased carotid artery stenosis from
PM<INF>2.5</INF> exposure.
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\17\ Thurston GD, Kipen H, Annesi-Maesano I, Balmes J, Brook RD,
Cromar K, DeMatteis S, Forastiere F, Forsberg B, Frampton MW, Grigg
J, Heederik D, Kelly FJ, Kuenzli N, Laumbach R, Peters A,
Rajagopalan ST, Rich D, Ritz B, Samet JM, Sandstrom T, Sigsgaard T,
Sunyer J, Brunekreef B [2017], A Joint ERS/ATS Policy Statement:
What Constitutes an Adverse Health Effect of Air Pollution? An
Analytical Framework, Eur Respir J 49(1):1600419.
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<bullet<ls-thn-eq> Ambient Air Quality and Cardiovascular Health:
Translation of Environmental Research for Public Health and Clinical
Care, by Cascio and Long [2018],\18\ a non-systematic review on CVD
outcomes, including PAD, associated with air pollution. The review
reported that residential proximity to major roads is associated with
increased PAD risk. Traffic-related air pollution includes several 9/11
agents, e.g., PM<INF>2.5</INF>, PM<INF>10</INF>, nitrogen oxides,
sulfur dioxide, and carbon monoxide.
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\18\ Cascio WE, Long TC [2018], Ambient Air Quality and
Cardiovascular Health: Translation of Environmental Research for
Public Health and Clinical Care, NC Med J 79(5):306-312.
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<bullet<ls-thn-eq> Long-Term Cardiovascular Disease Risk among
Firefighters after the World Trade Center Disaster, by Cohen et al.
[2019],\19\ a peer-reviewed, published longitudinal cohort study of
Fire Department of New York (FDNY) firefighters designed to assess
whether 9/11 exposures were associated with elevated CVD risk,
including a composite outcome variable. Among firefighters with the
composite outcome, very few had PAD, however, the study found positive
associations between this composite cardiovascular outcome and 9/11
exposures related to time of arrival and length of response.
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\19\ Cohen HW, Zeig-Owens R, Joe C, Hall CB, Webber MP, Weiden
MD, Cleven KL, Jaber N, Skerker M, Yip J, Schwartz T, Prezant DJ
[2019], Long-Term Cardiovascular Disease Risk among Firefighters
after the World Trade Center Disaster, JAMA Netw Open 2(9):e199775.
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<bullet<ls-thn-eq> Integrated Science Assessment (ISA) for
Particulate Matter, by EPA's Center for Public Health and Environmental
Assessment [2019],\20\ a detailed integrated science assessment that
examined the impact of PM, including PM<INF>2.5</INF>, on CVD outcomes
including PAD. The assessment summarized several studies that found
increased PAD risk associated with PM<INF>2.5</INF> exposure.
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\20\ EPA [2019], Integrated Science Assessment (ISA) for
Particulate Matter (Final Report, Dec 2019), EPA/600/R-19/188.
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<bullet<ls-thn-eq> Environmental Pollution and Peripheral Artery
Disease, by Serra et al. [2021],\21\ provided a review of environmental
pollutant exposures associated with PAD. This study provided evidence
supporting an association between exposure to PM<INF>10</INF> and
increased PAD risk.
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\21\ Serra R, Abramo A, Ielapi N, Procopio S, Marino P [2021],
Environmental Pollution and Peripheral Artery Disease, Risk Manag
Healthc Policy 14:2181-2190.
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These studies suggest a potential association between exposure to
9/11 agents and PAD and thus provided sufficient medical basis to
consider the submission a valid petition.
D. Evaluation of Scientific Evidence: Findings and Conclusion
In response to Petition 048a and pursuant to the Policy and
Procedures, the Administrator of the WTC Health Program directed the
Science Team to conduct a systematic search of the scientific
literature to identify all peer-reviewed, published, epidemiologic
studies of PAD among 9/11-exposed populations. Identified studies were
assessed for quality; any studies determined to be high-quality would
then be evaluated to determine if they provide evidence to support a
likelihood of a causal association between 9/11 exposure and the health
condition under consideration. The Science Team provided the
Administrator with a paper describing its findings, Evaluation of
Scientific Evidence Supporting the Addition of Peripheral Artery
Disease to the List of WTC-Related Health Conditions. This evaluation
builds on a previous evaluation of atherosclerosis, an antecedent
health condition leading to the development of PAD, conducted in
response to Petition 012. The current evaluation for Petition 048a is
available in the docket for this activity \22\ and on the Program's
website.\23\
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\22\ <a href="https://www.cdc.gov/niosh/docket/archive/docket094.html">https://www.cdc.gov/niosh/docket/archive/docket094.html</a>.
\23\ <a href="https://www.cdc.gov/wtc/received.html">https://www.cdc.gov/wtc/received.html</a>.
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[[Page 58455]]
The literature search conducted by the WTC Health Program
identified nine peer-reviewed, published, epidemiologic studies of PAD
in 9/11-exposed populations (including one study by Mani et al. [2013]
that was reviewed in the Petition 012 evaluation). None of the nine
identified studies, however, demonstrate sufficient validity indicators
to be considered high-quality studies.\24\ Accordingly, the Science
Team did not conduct further evaluation of the studies identified in
the literature search described above.
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\24\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L,
Stellman SD [2011a], Mortality Among Survivors of the Sept 11, 2001,
World Trade Center Disaster: Results from the World Trade Center
Health Registry Cohort, Lancet 378(9794):879-887; Mani V, Wong SK,
Sawitt ST, Calcagno C, Maceda C, Ramachandran S, Fayad ZA, Moline J,
McLaughlin MA [2013], Relationship Between Particulate Matter
Exposure and Atherogenic Profile in ``Ground Zero'' Workers as Shown
by Dynamic Contrast Enhanced MR Imaging, Int J Cardiovasc Imaging
29:827-833; Stein CR, Wallenstein S, Shapiro M, Hashim D, Moline JM,
Udasin I, Crane MA, Luft BJ, Lucchini RG, Holden WL [2016],
Mortality Among World Trade Center Rescue and Recovery Workers,
2002-2011, Am J Ind Med 59(2):87-95; Jordan HT, Stein CR, Li J, Cone
JE, Stayner L, Hadler JL, Brackbill RM, Farfel MR [2018], Mortality
Among Rescue and Recovery Workers and Community Members Exposed to
the September 11, 2001 World Trade Center Terrorist Attacks, 2003-
2014, Environ Res 163:270-279; Cohen HW, Zeig-Owens R, Joe C, Hall
CB, Webber MP, Weiden MD, Cleven KL, Jaber N, Skerker M, Yip J,
Schwartz T, Prezant DJ [2019], Long-Term Cardiovascular Disease Risk
among Firefighters after the World Trade Center Disaster, JAMA Netw
Open 2(9):e199775; Colbeth HL, Zeig-Owens R, Hall CB, Webber MP,
Schwartz TM, Prezant DJ [2020]; Mortality Among Fire Department of
the City of New York Rescue and Recovery Workers Exposed to the
World Trade Center Disaster, 2001-2017, Int J Environ Res Public
Health 17(17):6266; Li J, Hall CB, Yung J, Kehm RD, Zeig-Owens R,
Singh A, Cone JE, Brackbill RM, Farfel MR, Qiao B, Schymura MJ,
Shapiro MZ, Dasaro CR, Todd AC, Prezant DJ, Boffetta P [2023], A 15-
Year Follow-Up Study of Mortality in a Pooled Cohort of World Trade
Center Rescue and Recovery Workers, Environ Res 219:115116; Singh A,
Zeig-Owens R, Cannon M, Webber MP, Goldfarb DG, Daniels RD, Prezant
DJ, Boffetta P, Hall CB [2023], All-Cause and Cause-Specific
Mortality in a Cohort of WTC-Exposed and Non-WTC-Exposed
Firefighters, Occup Environ Med 80(6):297-303; Parvin A, Kehm RD,
Qiao B, Cone JE, Farfel MR, Zeig-Owens R, Goldfarb DG, Shapiro MZ,
Todd AC, Insaf T, Hall CB, Boffetta P, Li J [2026], Effect of World
Trade Center Health Program on Mortality Among 9/11 Responders, Ann
Epidemiol 115:8-14.
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Upon review of the evidence available in peer-reviewed, published,
epidemiologic studies regarding PAD among 9/11-exposed populations, the
Science Team found that there is inadequate evidence to determine a
causal association \25\ between 9/11 exposures and PAD (Category V).
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\25\ See supra note 5 at Sec. V.E.--Evidence is Inadequate to
Determine a Causal Association.
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E. Administrator's Final Decision on Whether To Propose the Addition of
Peripheral Artery Disease to the List
Pursuant to the PHS Act, sec. 3312(a)(6)(B)(iv) and 42 CFR
88.16(a)(2)(iv), and in accordance with Sec. VIII.B. of the Policy and
Procedures, the Administrator has determined that insufficient evidence
is available to take further action at this time, including proposing
the addition of PAD to the List (pursuant to the PHS Act, sec.
3312(a)(6)(B)(ii) and 42 CFR 88.16(a)(2)(ii)) or publishing a
determination not to publish a proposed rule in the Federal Register
(pursuant to the PHS Act, sec. 3312(a)(6)(B)(iii) and 42 CFR
88.16(a)(2)(iii)). The Administrator has also determined that
requesting a recommendation from the STAC (pursuant to the PHS Act,
sec. 3312(a)(6)(B)(i) and 42 CFR 88.16(a)(2)(i)) is unwarranted.
For the reasons discussed above, the request in Petition 048a to
add PAD to the List of WTC-Related Health Conditions is denied.
F. Approval To Submit Document to the Office of the Federal Register
The Secretary, HHS, or his designee, the Director, Centers for
Disease Control and Prevention (CDC) and Administrator, Agency for
Toxic Substances and Disease Registry (ATSDR), authorized the
undersigned, the Administrator of the WTC Health Program, to sign and
submit the document to the Office of the Federal Register for
publication as an official document of the WTC Health Program. Erica
Schwartz, MD, MPH, JD, RADM, USPHS (ret), Director, CDC, and
Administrator, ATSDR, approved this document for publication on
September 8, 2026.
John J. Howard,
Administrator, World Trade Center Health Program and Director, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2026-18901 Filed 9-14-26; 8:45 am]
BILLING CODE 4163-18-P
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