Notice2026-05421
World Trade Center (WTC) Health Program; Petition 026-Anti-Glomerular Basement Membrane (Anti-GBM) Glomerulonephritis; Finding of Insufficient Evidence
Primary source
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Published
March 19, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Administrator of the WTC Health Program received a petition (Petition 026) to add "Anti GBM Disease Glomerulonephritis (Anti-Glomerular Basement Membrane 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 anti- GBM glomerulonephritis. 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 53 (Thursday, March 19, 2026)</title>
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[Federal Register Volume 91, Number 53 (Thursday, March 19, 2026)]
[Notices]
[Pages 13308-13310]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05421]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[NIOSH Docket 094]
World Trade Center (WTC) Health Program; Petition 026--Anti-
Glomerular Basement Membrane (Anti-GBM) Glomerulonephritis; 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 WTC Health Program received a
petition (Petition 026) to add ``Anti GBM Disease Glomerulonephritis
(Anti-Glomerular Basement Membrane 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 anti-
GBM glomerulonephritis. 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 March 19, 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 026.
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#5d1314120e152f383a2e1d3e393e733a322b"><span class="__cf_email__" data-cfemail="b4fafdfbe7fcc6d1d3c7f4d7d0d79ad3dbc2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petition 026
D. Evaluation of Scientific Evidence: Findings and Conclusion
E. Administrator's Final Decision on Whether To Propose the Addition
of Anti-GBM Glomerulonephritis 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
[[Page 13309]]
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
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.
\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 for Adding Non-Cancer Conditions to the List of WTC-
Related Health Conditions, 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, discussion of Bradford Hill analysis in 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 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 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. Petition 026
On March 12, 2020, the Administrator received a petition (Petition
026) requesting the addition of ``Anti GBM Disease Glomerulonephritis
(Anti-
[[Page 13310]]
Glomerular Basement Membrane Disease)'' to the List.\14\ The petition's
validity was established by references to two peer-reviewed, published
studies that provide a medical basis for the association between anti-
GBM glomerulonephritis--a type of kidney disease--and hydrocarbon
exposure. Several hydrocarbons (including organic solvents and fuels
such as pristane, phytane, and benzo(a)pyrene) are identified as 9/11
agents. The following referenced studies (a literature review and a
case study) each individually establish a medical basis:
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\14\ See Petition 026, WTC Health Program: Petitions Received,
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
<bullet> Hydrocarbon Exposure May Cause Glomerulonephritis and
Worsen Renal Function: Evidence Based on Hill's Criteria for
Causality, by Ravnskov [2000],\15\ is a peer-reviewed, published
literature review discussing the role of hydrocarbons in causing
glomerulonephritis and end-stage renal failure.
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\15\ Ravnskov U [2000], Hydrocarbon Exposure May Cause
Glomerulonephritis and Worsen Renal Function: Evidence Based on
Hill's Criteria for Causality, Q J Med 93(8):551-556.
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<bullet> Anti-Glomerular Basement Membrane Disease, by Pusey
[2003],\16\ is a peer-reviewed, published case review discussing the
role of hydrocarbons in anti-GBM disease.
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\16\ Pusey CD [2003], Anti-Glomerular Basement Membrane Disease,
Kidney Int 64(4):1535-1550.
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These two studies suggest a potential association between exposure
to 9/11 agents (specific hydrocarbons) and anti-GBM glomerulonephritis
and thus provided a sufficient medical basis to consider the submission
a valid petition.
D. Evaluation of Scientific Evidence: Findings and Conclusion
In response to Petition 026, 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 anti-GBM glomerulonephritis among 9/11-exposed populations.
These types of studies are evaluated to determine if they provide
evidence to support the likelihood of a causal association between 9/11
exposure and the health condition under consideration. The Science Team
provided a paper to the Administrator describing its findings,
Evaluation of Scientific Evidence Supporting the Addition of Anti-
Glomerular Basement Membrane Disease (Anti-GBM) Glomerulonephritis to
the List of WTC-Related Health Conditions. This paper is available in
the docket for this activity \17\ and on the Program's website.\18\
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\17\ <a href="https://www.cdc.gov/niosh/docket/archive/docket094.html">https://www.cdc.gov/niosh/docket/archive/docket094.html</a>.
\18\ <a href="https://www.cdc.gov/wtc/received.html">https://www.cdc.gov/wtc/received.html</a>.
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Neither the systematic literature search nor the references
provided in the petition, including those described above, identified
any peer-reviewed, published, epidemiologic studies of anti-GBM
glomerulonephritis in 9/11-exposed populations. In accordance with the
WTC Health Program's Policy and Procedures, because no such peer-
reviewed, published, epidemiologic studies of anti-GBM
glomerulonephritis in 9/11-exposed populations were found, the Program
was unable to conduct an evaluation of scientific evidence to determine
the likelihood of a causal association between 9/11 exposures and the
petitioned health condition.
Upon finding no evidence available in peer-reviewed, published,
epidemiological studies regarding anti-GBM glomerulonephritis among 9/
11-exposed populations, the Science Team concluded that there is
inadequate evidence to determine the likelihood of a causal association
\19\ between 9/11 exposures and anti-GBM glomerulonephritis (Category
V).
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\19\ See supra note 5 at 17.
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E. Administrator's Final Decision on Whether To Propose the Addition of
Anti-GBM Glomerulonephritis 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 anti-GBM glomerulonephritis 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 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 Petition 026 request to add
``Anti GBM Disease Glomerulonephritis (Anti-Glomerular Basement
Membrane Disease)'' 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. Acting
CDC Director Jay Bhattacharya, MD, Ph.D., approved this document for
publication on March 11, 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. 2026-05421 Filed 3-18-26; 8:45 am]
BILLING CODE 4163-18-P
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