[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Pages 22004-22006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[NIOSH Docket 094]


World Trade Center Health Program; Petition 015--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 November 25, 2016, the Administrator of the World Trade 
Center (WTC) Health Program received a petition (Petition 015) to add 
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 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 May 11, 2017.

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. Petition 015
C. Review of Scientific and Medical Information and Administrator 
Determination
D. Administrator's Final Decision on Whether to Propose the Addition 
of Neuropathy to the List
E. 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), 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 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), 
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 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.
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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 88.15 (2017). Within 90 days after

[[Page 22005]]

receipt of a 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) and 42 CFR 88.16(a)(2): (1) Request a recommendation of 
the 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. However, 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--evidence not previously reviewed by the Administrator--
for the association between 9/11 exposures and the condition to be 
added.
    In addition to the regulatory provisions, the WTC Health Program 
has developed policies to guide the review of submissions and 
petitions,\2\ as well as the analysis of evidence supporting the 
potential addition of a non-cancer health condition to the List.\3\ In 
accordance with the aforementioned non-cancer health condition addition 
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 health condition to the List. A 
literature review includes a search for peer-reviewed, published 
epidemiologic studies (including direct observational studies in the 
case of health conditions such as injuries) about the health condition 
among 9/11-exposed populations; such studies are considered 
``relevant.'' Relevant studies identified in the literature search are 
further reviewed for their 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 peer-reviewed, published, direct observational or epidemiologic 
studies 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 peer-
reviewed, published 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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    \2\ See WTC Health Program [2014], Policy and Procedures for 
Handling Submissions and Petitions to Add a Health Condition to the 
List of WTC-Related Health Conditions, May 14, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
    \3\ See WTC Health Program [2016], Policy and Procedures for 
Adding Non-Cancer Conditions to the List of WTC-Related Health 
Conditions, May 11, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf. Since 
the date of receipt of Petition 015, the Administrator has revised 
the policy and procedures for addition of non-cancer health 
conditions. Petition 015 was evaluated using the May 11, 2016 
version of the policy and procedures in place at the time of receipt 
of the petition.
    \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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B. Petition 015

    On November 25, 2016, the Administrator received a petition from a 
New York City Police Department (NYPD) responder who worked at Ground 
Zero, requesting the addition of neuropathy to the List. The petition 
referenced studies conducted by researchers from Winthrop University 
which, according to the petitioner, found that 9/11 exposures led to 
nerve damage.\7\
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    \7\ See Petition 015, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
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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, reference to a peer-reviewed, published, epidemiologic study 
about the health condition among 9/11-exposed populations or to 
clinical case reports of health conditions in WTC responders or 
survivors may demonstrate the required medical basis.\8\ Based on the 
information provided by the petitioner, who referred to ``medical 
studies by Winthrop University doctors'' concerning 9/11 exposure and 
nerve damage, the Program identified three studies by Winthrop 
University researchers concerning 9/11 exposure and nerve damage 
(neuropathy). The first reference, ``Analysis of Short-Term Effects of 
World Trade Center Dust on Rat Sciatic Nerve,'' by Stecker et al. 
[2014] \9\ investigated the short-term effects of WTC dust on the 
sciatic nerve in laboratory rats. ``Neuropathic Symptoms in World Trade 
Center Disaster Survivors and Responders,'' by Wilkenfeld et al. 
[2016],\10\ investigated whether neuropathic symptoms were more 
prevalent in 9/11-exposed patients than non-exposed patients; and 
``Neurologic Evaluations of Patients Exposed to the World Trade Center 
Disaster,'' by Stecker et al. [2016], looked for objective evidence of 
neurologic injury in 9/11-exposed patients.\11\ These three studies 
suggested a potential association between 9/11 exposures and neuropathy 
and were thus considered to establish a sufficient medical basis to 
consider the submission a valid petition.
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    \8\ See supra note 2.
    \9\ Stecker M, Segelnick J, Wilkenfeld M [2014], Analysis of 
Short-Term Effects of World Trade Center Dust on Rat Sciatic Nerve, 
JOEM 56(10):1024-1028.
    \10\ Wilkenfeld M, Fazzari M, Segelnick J, and Stecker M [2016], 
Neuropathic Symptoms in World Trade Center Disaster Survivors and 
Responders, JOEM 58(1):83-86.
    \11\ Stecker M, Yu H, Barlev R, et al. [2016], Neurologic 
Evaluations of Patients Exposed to the World Trade Center Disaster, 
JOEM 58(11):1150-1154.
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C. Review of Scientific and Medical Information and Administrator 
Determination

    In response to Petition 015, and pursuant to the Program policy on 
addition of non-cancer health conditions to the List,\12\ the Program 
conducted a review of the scientific literature on neuropathy to 
determine if the available evidence has the potential to provide a 
basis for a decision on whether to add neuropathy to the List.\13\
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    \12\ Supra note 3.
    \13\ Databases searched include: Embase, NIOSHTIC-2, ProQuest 
Health & Safety, PubMed, Scopus, Toxicology Abstracts, and TOXLINE.
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    The literature search identified two relevant citations for 
neuropathy, the studies by Wilkenfeld et al. [2016] and Stecker et al. 
[2016] referenced by the petitioner. The third study referenced

[[Page 22006]]

by the petitioner, Stecker et al. [2014], does not meet the policy's 
relevance requirement of being an epidemiologic study of a 9/11-exposed 
population, because it was an in vitro study conducted in rat tissues; 
\14\ therefore, it was not further considered. The Program also 
identified a study by Marmor et al. [2017] \15\ which reported on the 
prevalence and risk factors for paresthesia, a condition related to and 
at times a symptom of neuropathy, among community members who attended 
the WTC Environmental Health Center for treatment of health outcomes 
resulting from 9/11 exposures. Since the Marmor et al. [2017] study 
concerns paresthesia rather than neuropathy, it is not considered 
``relevant'' and, per Program policy,\16\ cannot provide potential 
support for deciding whether to propose adding neuropathy to the 
List.\17\
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    \14\ Only epidemiologic studies of the health condition in human 
9/11-exposed populations are considered relevant.
    \15\ Marmor M, Shao Y, Bhatt DH, et al. [2017], Paresthesias 
among Community Members Exposed to the World Trade Center Disaster, 
JOEM article in press.
    \16\ See supra note 3 and Section A.
    \17\ Paresthesia refers to abnormal sensations such as 
prickling, tingling, itching, burning or cold, skin crawling or 
impaired sensations. Although paresthesia symptoms could arise from 
nerve damage, including neuropathy, other conditions can also 
produce paresthesia, such as anxiety, metabolic derangements, and 
certain infectious diseases such as Lyme disease. Because 
paresthesia is not exclusively associated with neuropathy, 
paresthesia is not a proxy for neuropathy.
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    The Wilkenfeld et al. study was previously reviewed for quality as 
part of the Program's evaluation of Petition 010, which requested the 
addition of peripheral neuropathy to the List. As discussed in the 
Federal Register notice regarding Petition 010, the Wilkenfeld et al. 
[2016] study was found to have numerous limitations preventing further 
evaluation.\18\
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    \18\ See 81 FR 19108 (April 4, 2016).
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    Upon review, the Stecker et al. [2016] study also exhibited 
significant limitations, including flawed study design and selection 
bias. Similar to the study by Wilkenfeld et al. [2016], the Stecker et 
al. [2016] study was cross-sectional and did not include appropriate 
population sampling criteria. Although Stecker et al. [2016] used an 
objective measure of neuropathy, the comparison group was inadequate. 
The small exposure group and multiple statistical tests may have 
limited the study power. Neither the Wilkenfeld et al. [2016] nor the 
Stecker et al. [2016] study addressed potential exposures to toxins 
outside of 9/11 exposures and other confounders that could explain the 
findings.
    The studies by Wilkenfeld et al. [2016] and Stecker et al. [2016] 
exhibited many significant limitations and were found, individually and 
together, not to provide a basis for deciding whether to propose adding 
neuropathy to the List.

D. Administrator's Final Decision on Whether To Propose the Addition of 
Neuropathy to the List

    In accordance with the review and determination discussed above, 
the Administrator has concluded that the available evidence does not 
have the potential to provide a basis for a decision on whether to add 
neuropathy to the List. Accordingly, the Administrator has determined 
that insufficient evidence is available to take further action at this 
time, including either proposing the addition of neuropathy to the List 
(pursuant to 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 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 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 015 request to add 
neuropathy to the List of WTC-Related Health Conditions is denied.

E. 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. Anne 
Schuchat, M.D., Acting Director, CDC, and Acting Administrator, ATSDR, 
approved this document for publication on May 2, 2017.

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. 2017-09551 Filed 5-10-17; 8:45 am]
 BILLING CODE 4163-18-P