[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19108-19110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 010--Peripheral 
Neuropathy; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Denial of petition for addition of a health condition.

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SUMMARY: On January 5, 2016, the Administrator of the World Trade 
Center (WTC) Health Program received a petition (Petition 010) to add 
peripheral neuropathy to the List of WTC-Related Health Conditions 
(List). Upon reviewing the scientific and medical literature, including 
information provided by the petitioner, the Administrator has 
determined that the available evidence does not have the potential to 
provide a basis for a decision on whether to add peripheral neuropathy 
to the List. The Administrator finds that insufficient evidence exists 
to request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee (STAC), to publish a proposed rule, or to 
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 April 4, 2016.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

A. WTC Health Program Statutory Authority
B. Approval to Submit Document to the Office of the Federal Register
C. Petition 010
D. Administrator's Determination on Petition 010

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Zadroga Act) Public Law 111-347, as amended by Public Law 114-
113, added Title XXXIII to the Public Health Service Act (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 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,

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Pennsylvania (responders), and 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 (survivors).
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the Zadroga Act found in Titles II 
and III of Public Law 111-347 do not pertain to the WTC Health 
Program and are codified elsewhere.
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    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the Director of the National 
Institute for Occupational Safety and Health (NIOSH) or his or her 
designee.
    Pursuant to 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 88.1. After receipt of a petition to add a condition to 
the List, the Administrator must take one of the following four actions 
described in PHS Act, section 3312(a)(6)(B) and 42 CFR 88.17: (i) 
Request a recommendation of the STAC; (ii) publish a proposed rule in 
the Federal Register to add such health condition; (iii) publish in the 
Federal Register the Administrator's determination not to publish such 
a proposed rule and the basis for such determination; or (iv) publish 
in the Federal Register a determination that insufficient evidence 
exists to take action under (i) through (iii) above.

B. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or her 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. Thomas 
R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, 
approved this document on March 24, 2016, for publication.

C. Petition 010

    On January 5, 2016, the Administrator received a petition to add 
``peripheral neuropathy'' to the List (Petition 010).\2\ The petition 
was submitted by a Fire Department of New York member who responded to 
the September 11, 2001, terrorist attacks in New York City. The 
petitioner indicated that he was diagnosed with peripheral neuropathy 
shortly after the incident. The petitioner described two studies as the 
medical basis for his petition: A study of the short-term effects of 
WTC dust on the sciatic nerve of laboratory rats, and another 
concerning neuropathic symptoms in WTC responders and survivors. Both 
studies, as well as an initial literature search conducted by the WTC 
Health Program, are described below.
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    \2\ See Petition 010, WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
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D. Administrator's Determination on Petition 010

    The Administrator has established a policy for evaluating whether 
to add non-cancer health conditions to the List of WTC-Related Health 
Conditions, published online in the Policies and Procedures section of 
the WTC Health Program Web site.\3\ In accordance with the policy, the 
Administrator directs the WTC Health Program to conduct a review of the 
scientific literature to determine if the available scientific 
information has the potential to provide a basis for a decision on 
whether to add the condition to the List. The literature review 
includes published, peer-reviewed epidemiologic studies (including 
direct observational studies in the case of health conditions such as 
injuries) about the health condition among 9/11-exposed populations. 
The studies are reviewed for their relevance, quantity, and quality to 
provide a basis for deciding whether to propose adding the health 
condition to the List. Where the available evidence has the potential 
to provide a basis for a decision, the scientific and medical evidence 
is further assessed to determine whether a causal relationship between 
9/11 exposures and the health condition is supported. A health 
condition may be added to the List if published, peer-reviewed, direct 
observational or epidemiologic studies, as appropriate, provide 
substantial support \4\ for a causal relationship between 9/11 
exposures and the health condition in 9/11-exposed populations. If the 
evidence assessment provides only modest support \5\ for a causal 
relationship between 9/11 exposures and the health condition, the 
Administrator may then evaluate additional published, peer-reviewed, 
epidemiologic studies, conducted among non-9/11-exposed populations, 
evaluating associations between the health condition of interest and 9/
11 agents.\6\ If that additional assessment establishes substantial 
support for a causal relationship between a 9/11 agent or agents and 
the health condition, the health condition may be added to the List.
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    \3\ John Howard MD, Administrator of the WTC Health Program, 
Policy and Procedures for Adding Non-Cancer Conditions to the List 
of WTC-Related Health Conditions, October 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
    \4\ The substantial evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with high confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \5\ The modest evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with moderate confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \6\ 9/11 agents are chemical, physical, biological, or other 
agents or hazards reported in a published, peer-reviewed exposure 
assessment study of responders or survivors who were present in the 
New York City disaster area, at the Pentagon site, or at the 
Shanksville, Pennsylvania site, as those locations are defined in 42 
CFR 88.1.
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    In accordance with section 3312(a)(6)(B) of the PHS Act, 42 CFR 
88.17, and the policy for the addition of non-cancer health conditions 
to the List, the Administrator reviewed the evidence presented in 
Petition 010. The WTC Health Program conducted a systematic literature 
search of the published scientific and medical literature \7\ for 
evidence of a causal relationship between 9/11 exposures and peripheral 
neuropathy and reviewed both studies submitted in the petition.
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    \7\ Databases searched include: PubMed, Health & Safety Science 
Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and 
NIOSHTIC-2.
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    The first study cited by the petitioner, ``Analysis of Short-Term 
Effects of World Trade Center Dust on Rat Sciatic Nerve,'' by Stecker 
et al.\8\ investigated the short-term effects of WTC dust on the 
sciatic nerve in laboratory rats. This study was not identified in the 
literature search. Because this study does not meet the policy's 
requirement that the decision to add a health condition to the List 
must be based on epidemiologic studies of 9/11-exposed populations, it 
was not further considered.
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    \8\ Mark Stecker, Jacqueline Segelnick, Marc Wilkenfeld, 
Analysis of Short-Term Effects of World Trade Center Dust on Rat 
Sciatic Nerve, JOEM 56(10):1024-1028, October 2014.
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    The systematic literature search identified only one epidemiologic 
study regarding peripheral neuropathy in 9/11-exposed populations, 
which was the second study cited by the petitioner, ``Neuropathic 
Symptoms in World Trade Center Disaster Survivors and Responders,'' by 
Wilkenfeld et al.\9\ Upon review of the study's relevance, quantity, 
and quality, the paper was found to have numerous limitations, 
including a small sample size; exclusive use of subjective self-
reported outcome and exposure data; lack of information about 
comparability among the groups;

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lack of objective measurements to confirm the presence of peripheral 
neuropathy; and absence of control for key confounders other than the 
comorbidities studied. Each of these limitations affect the strength of 
the study results, and thus the Wilkenfeld et al. study is not 
sufficient to provide the Administrator with a potential basis for 
deciding whether to propose adding peripheral neuropathy to the List.
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    \9\ Marc Wilkenfeld, Melissa Fazzari, Jacqueline Segelnick, and 
Mark Stecker, Neuropathic Symptoms in World Trade Center Disaster 
Survivors and Responders, JOEM 58(1):83-86, January 2016.
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    Due to the substantial limitations inherent in the only available 
study, the Administrator has concluded that the available evidence does 
not have the potential to provide a basis for a decision on whether to 
add peripheral neuropathy to the List.
    The findings described above led the Administrator to determine 
that insufficient evidence exists to take further action, including 
either proposing the addition of peripheral neuropathy to the List 
(pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 
88.17(a)(2)(ii)) or publishing a determination not to publish a 
proposed rule in the Federal Register (pursuant to PHS Act, sec. 
3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)). The Administrator has 
also determined that requesting a recommendation from the STAC 
(pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)) 
is unwarranted.
    For the reasons discussed above, the request made in Petition 010 
to add peripheral neuropathy to the List of WTC-Related Health 
Conditions is denied.

    Dated: March 28, 2016.
John 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. 2016-07567 Filed 4-1-16; 8:45 am]
 BILLING CODE 4163-18-P