Notice2026-09245
World Trade Center Health Program; Petitions 032, 033, and 068-Peripheral Neuropathy; Finding of Insufficient Evidence
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Published
May 11, 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 three petitions (Petitions 032, 033, and 068) to add "peripheral neuropathy" to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioners, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding peripheral neuropathy. 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 90 (Monday, May 11, 2026)</title>
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[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Pages 25573-25576]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09245]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[NIOSH Docket 094]
World Trade Center Health Program; Petitions 032, 033, and 068--
Peripheral Neuropathy; Finding of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Denial of petitions for addition of a health condition.
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SUMMARY: The Administrator of the World Trade Center (WTC) Health
Program has received three petitions (Petitions 032, 033, and 068) to
add ``peripheral neuropathy'' to the List of WTC-Related Health
Conditions. Upon reviewing the scientific and medical literature,
including information provided by the petitioners, the Administrator
has determined that there is insufficient evidence available to support
taking further action at this time regarding peripheral neuropathy. 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 these
petitions for the addition of a health condition as of May 11, 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 Petitions 032, 033, and 068.
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#e4aaadabb7ac96818397a4878087ca838b92"><span class="__cf_email__" data-cfemail="dd9394928e95afb8baae9dbeb9bef3bab2ab">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petitions 032, 033, and 068
D. Evaluation of Scientific Evidence: Findings and Conclusion
E. Administrator's Final Decision on Whether To Propose the Addition
of Peripheral Neuropathy 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 25574]]
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 [2024], Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, October 18, 2024, <a href="https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancer_Health_Conditions_20241018.pdf">https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancer_Health_Conditions_20241018.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://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf">https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/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
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 is 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
discussion of Bradford Hill analysis at footnote 21.
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 9/11
exposures and the health condition (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 health condition for addition 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. Petitions 032, 033, and 068
On July 29, 2021, the Administrator received a petition (Petition
032) requesting the addition of ``neuropathy and paresthesias'' to the
List.\14\ Because paresthesia is a symptom of sensory neuropathy, the
Program considered the
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petitioned health condition to be neuropathy. The petition's validity
was established by reference to one peer-reviewed, published,
epidemiologic study demonstrating a positive association between 9/11
exposures and peripheral neuropathy: Case-Control Study of Paresthesia
Among World Trade Center-Exposed Community Members, by Marmor M, et al.
[2020],\15\ a peer-reviewed, published case-control study. The study
found ``increased prevalence of clinical and laboratory-test
abnormalities indicative of neuropathy among individuals with WTC
exposure and paresthesia of the lower extremities.''
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\14\ See Petition 032, WTC Health Program: Petitions Received,
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
\15\ Marmor M, Thawani S, Cotrina ML, Shao Y, Wong ES, Stecker
MM, Wang B, Allen A, Wilkenfeld M, Vinik EJ, Vinik AI, Reibman J
[2020], Case-Control Study of Paresthesia among World Trade Center-
Exposed Community Members, J Occup Environ Med 62(4):307-316.
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On September 2, 2021, the Administrator received a second petition
(Petition 033) requesting the addition of peripheral neuropathy to the
List.\16\ The petition's validity was established by reference to five
peer-reviewed, published, epidemiologic studies demonstrating a
positive association between 9/11 exposures and peripheral neuropathy.
The following referenced publications each individually establish a
medical basis:
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\16\ See Petition 033, WTC Health Program: Petitions Received,
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
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<bullet> Case-Control Study of Paresthesia Among World Trade
Center-Exposed Community Members, by Marmor M et al. [2020], discussed
above.
<bullet> Post-9/11 Peripheral Neuropathy Symptoms among World Trade
Center-Exposed Firefighters and Emergency Medical Service Workers, by
Colbeth HL et al. [2019],\17\ a peer-reviewed, published cross-
sectional study which found increased reporting of peripheral
neuropathy symptoms among 9/11-exposed responders.
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\17\ Colbeth HL, Zeig-Owens R, Webber MP, Goldfarb DG, Schwartz
TM, Hall CB, Prezant DJ [2019], Post-9/11 Peripheral Neuropathy
Symptoms among World Trade Center-Exposed Firefighters and Emergency
Medical Service Workers, Int J Environ Res Public Health
16(10):1727.
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<bullet> Peripheral Neuropathy Due to Vitamin Deficiency, Toxins,
and Medications, by Staff NP and Windebank AJ, [2014],\18\ a peer-
reviewed, published systematic review which described positive
associations between 9/11 agents identified in the Inventory of 9/11
Agents,\19\ including heavy metals, and peripheral neuropathy.
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\18\ Staff NP and Windebank AJ [2014], Peripheral Neuropathy Due
to Vitamin Deficiency, Toxins, and Medications, Continuum
(Minneapolis, Minn.) 20(5):1293-1306.
\19\ 9/11 agents are listed in the Development of the Inventory
of 9/11 Agents. See supra note 8.
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<bullet> Increased Risk of Sensory Neuropathy in Workers with
Chloracne after Exposure to 2,3,7,8-Polychlorinated Dioxins and Furans,
by Th[ouml]mke F et al. [1999],\20\ a peer-reviewed, published cross
sectional study which found a positive association between exposure to
polychlorinated dioxins and furans (PCDD/F), 9/11 agents identified in
the Inventory of 9/11 Agents, and neuropathy in pesticide plant
workers.
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\20\ Th[ouml]mke F, Jung D, Besser R, Roder R, Konietzko J, Hopf
HC [1999], Increased Risk of Sensory Neuropathy in Workers with
Chloracne after Exposure to 2,3,7,8-Polychlorinated Dioxins and
Furans, Acta Neurol Scand 100(1):1-5.
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<bullet> Neurological Studies on Polychlorinated Biphenyl (PCB)-
Poisoned Patients, by Chia LG and Chu FL [1984],\21\ a peer-reviewed,
published epidemiologic study, which found a positive association
between exposure to polychlorinated biphenyl (PCB), a 9/11 agent
identified in the Inventory of 9/11 Agents, and peripheral neuropathy
in Taiwan residents.
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\21\ Chia LG, Chu FL [1984], Neurological Studies on
Polychlorinated Biphenyl (PCB)-Poisoned Patients, Am J Ind Med 5(1-
2):117-126.
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Finally, the Administrator received Petition 068, requesting the
addition of ``bilateral neuropathy'' to the List, on September 3,
2025.\22\ Petition validity was established by reference to the study
by Colbeth et al. [2019], described above.
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\22\ See Petition 068, WTC Health Program: Petitions Received,
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
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The five studies submitted by the petitioners described above
provided sufficient medical basis suggest a positive association
between exposures to 9/11 agents and peripheral neuropathy and thus
provided a sufficient medical basis to consider the submissions valid
petitions.
The WTC Health Program previously evaluated the available
scientific literature regarding peripheral neuropathy in response to
Petitions 010 and 015 and found that the literature did not have the
potential to provide a basis on whether to add the health condition to
the List. A Federal Register notice denying Petition 010 was published
on April 4, 2016 (81 FR 19108), and a notice denying Petition 015 was
published on May 11, 2017 (82 FR 22004). The studies by Marmor M et al.
[2020]; Colbeth HL et al. [2019], Staff NP and Windebank AJ [2014],
Th[ouml]mke F et al. [1999], and Chia LG and Chu FL [1984], discussed
above, provided a new medical basis for the petitions reviewed in this
notice.
D. Evaluation of Scientific Evidence: Findings and Conclusion
In response to Petitions 032, 033, and 068, and pursuant to the
Policy and Procedures, the Administrator of the WTC Health Program
directed the Science Team to conduct a systematic literature search to
identify all peer-reviewed, published, epidemiologic studies of
peripheral neuropathy 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 Neuropathy to
the List of WTC-Related Health Conditions. This paper is available in
the docket for this activity \23\ and on the Program's website.\24\
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\23\ <a href="https://www.cdc.gov/niosh/docket/archive/docket094.html">https://www.cdc.gov/niosh/docket/archive/docket094.html</a>.
\24\ <a href="https://www.cdc.gov/wtc/received.html">https://www.cdc.gov/wtc/received.html</a>.
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The literature search conducted by the Science Team identified six
peer-reviewed, published, epidemiologic studies of peripheral
neuropathy in 9/11-exposed populations. Three of the identified studies
were previously reviewed in support of already-evaluated Petitions 010
and 015 and found to be inadequate to provide a basis for a causal
association between exposure to 9/11 agents and peripheral
neuropathy.\25\ The remaining three studies identified by the
literature search \26\ were determined not to have sufficient validity
indicators to be considered high-quality studies, and thus were not
found eligible for further evaluation in accordance the Program's
Policy and Procedures.\27\ Accordingly, the Science Team did not
conduct
[[Page 25576]]
further evaluation of the three new studies described above.
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\25\ Stecker MM, Yu H, Barlev R, Marmor M, Wilkenfeld M [2016],
Neurologic Evaluations of Patients Exposed to the World Trade Center
Disaster, JOEM 58(11):1150-1154; Wilkenfeld M, Fazzari M, Segelnick
J, Stecker M [2016], Neuropathic Symptoms in World Trade Center
Disaster Survivors and Responders, JOEM 58(1):83-86; Marmor M, Shao
Y, Bhatt DH, Stecker M, Berger K, Goldring R, Rosen R, Caplan-Shaw
C, Kazeros A, Pradhan D, Wilkenfeld M, Reibman J [2017],
Paresthesias Among Community Members Exposed to the World Trade
Center Disaster, JOEM 59(4):389-396.
\26\ Colbeth et al. [2019], supra note 17; Marmor et al. [2020],
supra note 15; and Thawani S, Wang B, Shao Y, Reibman J, Marmor M
[2019], Time to Onset of Paresthesia Among Community Members Exposed
to the World Trade Center Disaster, Int J Environ Res Public Health
16(8):1429.
\27\ See supra note 5 at 7-8.
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Upon review of the evidence available in peer-reviewed, published,
epidemiologic studies regarding peripheral neuropathy among 9/11-
exposed populations, the Science Team found that there is inadequate
evidence to determine a causal association \28\ between 9/11 exposures
and peripheral neuropathy (Category V).
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\28\ 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 Neuropathy 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 peripheral neuropathy 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 Petitions 032, 033,
and 068 to add peripheral neuropathy 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. Jay
Bhattacharya MD, Ph.D., Senior Official Carrying out the Delegable
Duties of the CDC Director, approved this document for publication on
May 1, 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. 2026-09245 Filed 5-8-26; 8:45 am]
BILLING CODE 4163-18-P
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