[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Proposed Rules]
[Pages 65369-65371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26043]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Petition 005--Acoustic 
Neuroma; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

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

-----------------------------------------------------------------------

[[Page 65370]]

SUMMARY: On September 2, 2014, the Administrator of the World Trade 
Center (WTC) Health Program received a petition to add acoustic neuroma 
(Petition 005) to the List of WTC-Related Health Conditions (List). The 
Administrator has not found sufficient scientific evidence to conduct 
an analysis of whether to add acoustic neuroma to the List. 
Accordingly, 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 November 4, 2014.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 4674 
Columbia Parkway, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: 

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
to add Title XXXIII \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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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. Within 60 calendar days after 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 88.17: (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. Petition 005

    On September 2, 2014, the Administrator received a petition to add 
acoustic neuroma to the List (Petition 005).\2\ The petition was 
submitted by a New York City police sergeant who worked at Ground Zero 
in the aftermath of the September 11, 2001, terrorist attacks. The 
petitioner stated that he had been diagnosed with acoustic neuroma and 
shared letters from his personal physicians confirming the diagnosis. 
The petition offered as evidence an article published in the 
International Journal of Adolescent Medicine and Health (IJAMH) linking 
exposure to toxic molds to ``acoustic mycotic neuroma,'' \3\ and a link 
to an Occupational Safety and Health Administration (OSHA) Web page, 
linking benzene exposure to acoustic neuroma.\4\
---------------------------------------------------------------------------

    \2\ See Petition 005. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Anyanwu E, Campbell AW, High W [2002]. Brainstem auditory 
evoked response in adolescents with acoustic mycotic neuroma due to 
environmental exposure to toxic molds. Int J Adolesc Med Health 
14(1):67-76.
    \4\ OSHA, https://www.osha.gov/dts/chemicalsampling/data/CH_220100.html.
---------------------------------------------------------------------------

C. Administrator's Determination on Petition 005

    The Administrator has established a methodology for evaluating 
whether to add non-cancer health conditions to the List of WTC-Related 
Health Conditions.\5\ First, the Administrator determines whether 
published, peer-reviewed studies about the health condition among 9/11-
exposed populations are available to assess evidence for a causal 
relationship and provide a basis for a decision on whether to add the 
condition to the List. If the studies provide sufficient evidence for 
analysis, the Administrator proceeds with an assessment of the 
information. A health condition may be added to the List if published, 
peer-reviewed direct observational or epidemiologic studies provide 
substantial support \6\ for a causal relationship between 9/11 
exposures and the health condition in 9/11-exposed populations. If only 
epidemiologic studies are available and they provide only modest 
support \7\ for a causal relationship between 9/11 exposures and the 
health condition, the Administrator may then evaluate studies of 
associations between the health condition and 9/11 agents.\8\ 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.
---------------------------------------------------------------------------

    \5\ This methodology, ``Policy and Procedures for Adding Non-
Cancer Conditions to the List of WTC-Related Health Conditions,'' 
revised October 21, 2014, is available on the WTC Health Program Web 
site, at http://www.cdc.gov/wtc/policies.html.
    \6\ 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.
    \7\ 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.
    \8\ 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 
either the New York City disaster area, the Pentagon site, or in 
Shanksville, Pennsylvania site as defined in 42 CFR part 88.
---------------------------------------------------------------------------

    In accordance with section 3312(a)(6)(B) of the PHS Act and 42 CFR 
88.17, described above, the Administrator has reviewed the evidence 
presented in Petition 005. Neither the IJAMH article nor the OSHA 
information on benzene provide sufficient evidence of a causal 
relationship between acoustic neuroma and 9/11 exposures to establish a 
basis for a decision on whether to add acoustic neuroma to the List. 
The IJAMH article concerns a study population that is not related to 
the September 11, 2001, terrorist attacks. Moreover, the study related 
to the development of acoustic neuroma among adolescents exposed to 
toxic mold; toxic mold is not considered a 9/11 agent. With regard to 
the second reference provided by the petitioner, although the OSHA Web 
page includes a reference to another published study suggesting an 
association between occupational exposures to benzene (a recognized 9/
11 agent) and acoustic neuroma,\9\ the study population was not 9/11-
exposed.
---------------------------------------------------------------------------

    \9\ Prochazka M, Feychting M, Ahlbom A, Edwards CG, Nise G, 
Plato N, Schwartzbaum JA, Forss[eacute]n UM [2010]. Occupational 
exposures and risk of acoustic neuroma. Occup Environ Med. 2010 
Nov;67(11):766-71.

---------------------------------------------------------------------------

[[Page 65371]]

    In addition to reviewing the evidence provided in Petition 005, the 
Administrator also conducted a search of the existing scientific/
medical literature for evidence that could establish a causal 
relationship between 9/11 exposures and acoustic neuroma, as well as 
the related conditions acoustic neurinoma, acoustic neurilemoma or 
vestibular schwannoma. He did not find any peer-reviewed, published 
epidemiologic studies of 9/11-exposed populations which would support 
such a relationship.
    Because neither the evidence submitted by the Petitioner nor a 
search of published scientific/medical literature provided information 
regarding the occurrence of acoustic neuroma among 9/11-exposed 
populations, the Administrator has determined that requesting a 
recommendation from the STAC (pursuant to PHS Act, section 
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)) is unwarranted. In prior 
actions, the Administrator requested a recommendation from the STAC 
when he determined that it would assist his evaluation; such as when, 
for example, the Administrator is in need of an interpretation of 
conflicting or inconclusive published scientific evidence.
    Similarly, the Administrator has determined that insufficient 
evidence exists to take further action, including either proposing the 
addition of acoustic neuroma to the List (pursuant to PHS Act, section 
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, section 3312(a)(6)(B)(iii) and 42 CFR 
88.17(a)(2)(iii)). In order to publish such a proposed addition or a 
determination not to propose a rule, the Administrator would first need 
to find that enough scientific evidence is available to analyze whether 
9/11 exposures are associated with the health condition. Since the 
Administrator is unable to identify sufficient evidence to conduct an 
analysis of whether to add the health condition, the Administrator 
(pursuant to PHS Act, section 3312(a)(6)(B)(iv) and 42 CFR 
88.17(a)(2)(iv)) is publishing a determination that he cannot take any 
of the other statutory and regulatory actions.
    For the reasons discussed above, the request made in Petition 005 
to add acoustic neuroma to the List of WTC-Related Health Conditions is 
denied.

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. 2014-26043 Filed 11-3-14; 8:45 am]
BILLING CODE 4163-18-P