Notice2026-06728

World Trade Center Health Program; Petitions 029, 034, 035, and 062-Hepatic Steatosis; Finding of Insufficient Evidence

Primary source

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Published
April 7, 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 several petitions (Petitions 029, 034, 035, and 062) to add "hepatic steatosis" or "fatty liver disease" 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 hepatic steatosis. 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 66 (Tuesday, April 7, 2026)</title>
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[Federal Register Volume 91, Number 66 (Tuesday, April 7, 2026)]
[Notices]
[Pages 17650-17654]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06728]


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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 029, 034, 035, and 
062--Hepatic Steatosis; 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 several petitions (Petitions 029, 034, 035, and 
062) to add ``hepatic steatosis'' or ``fatty liver disease'' 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 hepatic steatosis. 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 April 7, 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 029, 034, 035, and 062.

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#307e797f637842555743705354531e575f46"><span class="__cf_email__" data-cfemail="216f686e726953444652614245420f464e57">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petitions 029, 034, 035, and 062
D. Evaluation of Scientific Evidence: Findings and Conclusion

[[Page 17651]]

E. Administrator's Final Decision on Whether To Propose the Addition 
of Hepatic Steatosis 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 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://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 
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 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 id. at 9-10 and footnotes 21-30, 
discussion of Bradford Hill analysis.


[[Page 17652]]


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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. Petitions 029, 034, 035, and 062

    On November 12, 2020, the Administrator received a petition 
(Petition 029) requesting the addition of several conditions, including 
``hepatotoxic injury--fatty liver disease'' to the List.\14\ The 
petition's validity was established by references to one peer-reviewed, 
published, epidemiologic study that provided a medical basis for the 
association between 9/11 exposures and hepatotoxic injury--fatty liver 
disease. The referenced study establishing a medical basis is:
---------------------------------------------------------------------------

    \14\ See Petition 029, 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> Elevated Prevalence of Moderate-to-Severe Hepatic 
Steatosis in World Trade Center General Responder Cohort in a Program 
of CT Lung Screening, by Chen et al. [2020],\15\ a peer-reviewed, 
published cross-sectional study of WTC responders designed to compare 
hepatic steatosis in 9/11-exposed WTC responders compared with non-9/
11-exposed lung cancer screening participants.
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    \15\ Chen X, Ma T, Yip R, Perumalswami PV, Branch AD, Lewis S, 
Crane M, Yankelevitz DF, Henschke CI [2020], Elevated Prevalence of 
Moderate-to-Severe Hepatic Steatosis in World Trade Center General 
Responder Cohort in a Program of CT Lung Screening, Clin Imaging 
60(2):237-243.
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    This study suggests a potential association between exposure to 9/
11 agents and hepatotoxic injury--fatty liver disease, and thus 
provided a sufficient medical basis to consider the submission a valid 
petition.
    On August 4, 2021, the Administrator received a petition (Petition 
034) requesting the addition of ``Hepatic Steatosis (also known as 
Fatty Liver Disease or Non-Alcoholic Liver Disease)'' to the List.\16\ 
The petition's validity was established by reference to two peer-
reviewed, published, epidemiologic studies that provided a medical 
basis for the association between 9/11 exposures and hepatic steatosis. 
The referenced studies each individually establishing a medical basis 
were the study by Chen et al. [2020], described above, and:
---------------------------------------------------------------------------

    \16\ See Petition 034, WTC Health Program: Petitions Received, 
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
---------------------------------------------------------------------------

    <bullet> Dose-Response Relationship between World Trade Center Dust 
Exposure and Hepatic Steatosis, by Jirapatnakul et al. [2021],\17\ 
peer-reviewed, published cross-sectional study to evaluate the 
existence of a dose-response relationship between the intensity of 9/11 
exposures and hepatic steatosis prevalence in WTC responders.
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    \17\ Jirapatnakul A, Yip R, Branch AD, Lewis S, Crane M, 
Yankelevitz DF, Henschke CI [2021], Dose-Response Relationship 
between World Trade Center Dust Exposure and Hepatic Steatosis, Am J 
Ind Med 64(10):837-844.
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    These two studies suggest a potential association between exposure 
to 9/11 agents and hepatic steatosis, and thus provided sufficient 
medical basis to consider the submission a valid petition.
    On November 15, 2021, the Administrator received a petition 
(Petition 035) requesting the addition of ``Hepatic Steatosis/
Cirrhosis'' to the List.\18\ The petition's validity was established by 
reference to one peer-reviewed, published, epidemiologic study that 
demonstrates a positive association between 9/11 exposures and hepatic 
steatosis. The referenced study establishing a medical basis is the 
study by Jirapatnakul et al. [2021],\19\ described above. This study 
suggests a potential association between exposure to 9/11 agents 
(specifically WTC dust) and hepatic steatosis, and thus provided a 
sufficient medical basis to consider the submission a valid petition.
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    \18\ See Petition 035, WTC Health Program: Petitions Received, 
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
    \19\ See supra note 17.
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    Finally, on May 14, 2025, the Administrator received a petition 
(Petition 062) requesting the addition of ``Hepatic Steatosis (Fatty 
Liver Disease)'' to the List.\20\ The petition's validity was also 
established by reference to Jirapatnakul et al. [2021],\21\ described 
above.
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    \20\ See Petition 062, WTC Health Program: Petitions Received, 
<a href="http://www.cdc.gov/wtc/received.html">http://www.cdc.gov/wtc/received.html</a>.
    \21\ See supra note 17.
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D. Evaluation of Scientific Evidence: Findings and Conclusion

    In response to Petitions 029, 034, 035, and 062 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 hepatic steatosis among 9/11-exposed 
populations. Identified studies were assessed for quality; those 
studies determined to be high-quality were then 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 Hepatic Steatosis to the List of WTC-Related Health 
Conditions. This paper 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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    The literature search conducted by the WTC Health Program 
identified two peer-reviewed, published, epidemiologic studies of 
hepatic steatosis in 9/11-exposed populations: Chen et al. [2020] and 
Jirapatnakul et al. [2021], discussed above. These two studies were 
determined to have

[[Page 17653]]

sufficient validity indicators to be considered high-quality studies 
eligible for further evaluation in accordance with the Program's Policy 
and Procedures.\24\ The Science Team conducted an evaluation, 
separately and together, of the two studies to determine the likelihood 
of a causal association between 9/11 exposures and the petitioned 
health condition. The systematic literature search, the Science Team's 
evaluation and synthesis of the available literature, and the Science 
Team's conclusions regarding the association between 9/11 exposure and 
hepatic steatosis are described in full in the Science Team's 
Evaluation of Scientific Evidence Supporting the Addition of Hepatic 
Steatosis to the List of WTC-Related Health Conditions.
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    \24\ See supra note 5 at 7-8.
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    In accordance with the Policy and Procedures,\25\ the WTC Health 
Program uses the following Bradford Hill criteria to evaluate studies 
of 9/11-exposed populations: strength of association,\26\ precision of 
the risk estimate,\27\ consistency of associations,\28\ 
temporality,\29\ biological gradient,\30\ biological plausibility,\31\ 
coherence,\32\ and analogy.\33\ As discussed in full in the Evaluation 
of Scientific Evidence Supporting the Addition of Hepatic Steatosis to 
the List of WTC-Related Health Conditions, the Science Team assessed 
each criterion as follows:
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    \25\ Supra note 5 at 9-10.
    \26\ It is generally thought that strong associations are more 
likely to be causal than weak associations; however, a weak 
association does not rule out a causal relationship.
    \27\ Precision of the risk estimate describes the uncertainty 
inherent in estimating the strength of association (the effect size) 
between exposure and health effect from observational data. It is 
expressed as a confidence interval illustrating a range of values 
that contains the true effect size. A narrow confidence interval 
indicates a more precise measure of the effect size, and a wider 
interval indicates greater uncertainty. While precision is not a 
Bradford Hill criterion, the Science Team takes it into 
consideration to evaluate the existence of random error in a study.
    \28\ Consistent findings are demonstrated when they have been 
repeatedly reported by multiple studies.
    \29\ Temporality is the condition that the 9/11 exposure must 
precede the health condition of interest and is typically assessed 
when considering aspects of exposure in the study design.
    \30\ Studies establish an exposure-response relationship by 
demonstrating that increases in exposure (i.e., exposures of greater 
intensity and/or longer duration) are associated with a greater 
incidence of disease. A thorough evaluation of exposure-response 
requires analysis of multiple levels of exposure such that the 
investigator can demonstrate that the risk increases with increasing 
levels of exposure.
    \31\ Study findings demonstrate a basis in scientific theory 
that supports the relationship between the exposure and the health 
effect and do not conflict with known facts about the biology of the 
health condition.
    \32\ Coherence implies that the interpretation of a causal 
association agrees with known disease etiology.
    \33\ Analogy is used to inform on biological plausibility and 
coherence by contrasting the evidence on the suspected causal 
association with that from an established association between 
similar (analogous) causes or effects.

------------------------------------------------------------------------
   Aspect of associative causal
             inference                       Evaluation findings
------------------------------------------------------------------------
Strength of Association...........  Two high-quality studies were
                                     available for evaluation [Chen et
                                     al. 2020; Jirapatnakul et al.
                                     2021]. Both studies reported
                                     statistically significant estimates
                                     of increased prevalence of hepatic
                                     steatosis in the 9/11 responder
                                     population. Chen et al. [2020]
                                     found that the prevalence of
                                     moderate-to-severe hepatic
                                     steatosis was more than 3-fold
                                     higher in the WTC-participant group
                                     compared with non-WTC participants,
                                     while the linear regression
                                     estimates reported by Jirapatnakul
                                     et al. [2021] for liver attenuation
                                     were lower among those with earlier
                                     arrival dates, suggesting an
                                     exposure-response of more hepatic
                                     steatosis among those with higher 9/
                                     11 exposures (liver attenuation is
                                     inversely related to hepatic
                                     steatosis, meaning that lower liver
                                     attenuation demonstrates higher
                                     amounts of hepatic steatosis).
Precision of the Risk Estimate....  The confidence interval for the risk
                                     estimate in the Chen et al. [2020]
                                     study is wide but does not include
                                     the null value. Likewise, the
                                     multivariable regression estimates
                                     in the Jirapatnakul et al. [2021]
                                     study were above the statistical
                                     significance level of 0.05, except
                                     for the exposure category of those
                                     arriving on or after September 14,
                                     2001.
Consistency of Associations.......  The findings are consistent among
                                     both studies, but the study by Chen
                                     et al. [2020] includes only a small
                                     sample of heavy smokers. Further
                                     studies, particularly among other 9/
                                     11 populations (e.g., survivors,
                                     responders from the Fire Department
                                     of the City of New York [FDNY]),
                                     are needed to confirm the findings
                                     reported by Jirapatnakul et al.
                                     [2021].
Temporality.......................  Both studies were cross-sectional;
                                     therefore, information on
                                     temporality was limited. It is
                                     unclear in either study whether
                                     occupational and environmental
                                     exposures occurring prior to 9/11
                                     or unmeasured exposures after 9/11
                                     may have contributed to the
                                     observed health conditions.
Biological Gradient...............  The study by Jirapatnakul et al.
                                     [2021] suggests a trend of
                                     increasing hepatic steatosis
                                     prevalence with earlier arrival
                                     dates. However, no such gradient
                                     was found among those who arrived
                                     on 9/11 and had extensive dust
                                     cloud exposure versus those who
                                     arrived on 9/11 but did not have
                                     extensive dust cloud exposure
                                     [Jirapatnakul et al. 2021]. The
                                     study by Chen et al. [2020] did not
                                     report biological gradient
                                     findings.
Plausibility, Coherence, and        An association between 9/11 agents
 Analogy.                            such as trichloroethylene,
                                     tetrachloroethylene,
                                     trichloroethane, carbon
                                     tetrachloride, polychlorinated
                                     biphenyls, arsenic, thallium,
                                     phosphorus, dioxin, lead, and
                                     chloroform, and hepatic steatosis
                                     satisfies these criteria and agrees
                                     with the available evidence.
Representativeness................  The two studies examined persons in
                                     the General Responder Cohort. There
                                     were no studies of hepatic
                                     steatosis in the survivor
                                     population nor from the FDNY,
                                     Pentagon, or Shanksville responder
                                     cohorts. The findings of the
                                     evaluated studies might not be
                                     generalizable to other 9/11-exposed
                                     groups.
------------------------------------------------------------------------

    As summarized above, the Science Team evaluated the studies by Chen 
et al. [2020] and Jirapatnakul et al. [2021] using the Bradford Hill 
criteria to determine whether a causal association between 9/11 
exposures and hepatic steatosis is supported. The Science Team 
concluded that the information available in these studies is 
insufficient to support a claim for causation using these criteria.
    Only the study by Jirapatnakul et al. [2021] reported an exposure-
response gradient with hepatic steatosis prevalence. However, 
Jirapatnakul et al. [2021] found no such gradient among those who 
arrived on 9/11 and had extensive dust cloud exposure versus those who 
arrived on 9/11 but did not have extensive dust cloud exposure. Even 
though both studies showed positive associations, the risk estimate in 
the study by Chen et al. [2020] lacked precision and is subject to 
potential selection bias. Both studies controlled for some, but not 
all, important confounders, and misclassification of

[[Page 17654]]

exposure and outcome is possible. Consequently, chance, bias, and 
confounding could not be ruled out with reasonable confidence for 
either study. The known information on mechanisms of action supports an 
association between certain 9/11 agents and hepatic steatosis. However, 
given the significant limitations discussed above, the Science Team 
concluded that the available evidence is inadequate to determine the 
likelihood of a causal association between 9/11 exposures and hepatic 
steatosis.
    Upon review of the evidence available in high-quality studies 
regarding hepatic steatosis among 9/11-exposed populations, the Science 
Team concluded that there is inadequate evidence to determine the 
likelihood of a causal association between 9/11 exposures and hepatic 
steatosis (Category V).\34\
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    \34\ See Policy and Procedures 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 
Hepatic Steatosis 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 hepatic steatosis 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 029, 034, 
035, and 062 to add hepatic steatosis 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 
April 2, 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. 2026-06728 Filed 4-6-26; 8:45 am]
BILLING CODE 4163-18-P


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Indexed from Federal Register on April 7, 2026.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.