World Trade Center Health Program; Petition 005-Acoustic Neuroma; Finding of Insufficient Evidence, 65369-65371 [2014-26043]
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Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Proposed Rules
applicability limitation (PAL) pollutant
emissions from activities emitting sulfur
dioxide from the combustion of fuel.
These provisions are approvable
because they are an appropriate method
of determining compliance with a PAL
for the narrow activity added by ADEC’s
regulations.
In the State’s July 1, 2014 submittal,
Alaska repealed provisions in 18 AAC
50.040(i), paragraphs (7), (8) and (9),
that related to clean units and pollution
control projects. The comparable
Federal provisions were initially
vacated by a court and then repealed by
the EPA. Repeal of these provisions as
a matter of state law does not affect the
SIP because the EPA had not previously
approved these provisions into the SIP
and because they are no longer elements
of the Federal major NNSR program.
Alaska submitted revisions to two
definitions in 18 AAC 50.990 related to
major NNSR. On October 24, 2014, the
State revised 18 AAC 50.040(i)(1) to
adopt by reference the Federal
definition of ‘‘regulated NSR pollutant’’
at 40 CFR 51.165(a)(1)(xxxvii) and also
repealed the definition ‘‘regulated NSR
pollutant’’ in 18 AAC 50.990(92)
because the State has now adopted the
Federal definition in 18 AAC 50.040(i).
With these revisions, the State’s
definition of ‘‘regulated NSR pollutant’’
at 18 AAC 50.040(i)(1) is consistent with
the current Federal definition of
‘‘regulated NSR pollutant’’ for major
NNSR and is approvable.
On July 1, 2014, Alaska revised its
major NNSR regulations at 18 AAC
50.040(i)(1)(B)(2) to reference the
definition of ‘‘fugitive emissions’’ in 18
AAC 50.990(40). In turn, 18 AAC
50.990(40) was revised to adopt by
reference the Federal definition of
‘‘fugitive emissions’’ at 40 CFR
51.166(b)(20).4 The definition of
‘‘fugitive emissions’’ referenced in 18
AAC 50.990(40) is consistent with the
Federal definition of ‘‘fugitive
emissions’’ for major NNSR and is
approvable.
We note that in the State’s October 24,
2014 submittal, technical corrections
were made to the revisions in 18 AAC
50.040(i)(2), (4), (5) and (6) that were
submitted on July 1, 2014. The effect of
these corrections is that the State has
submitted its repeal of 18 AAC
50.040(i)(4) and no changes were made
to the adoption by reference of Federal
provisions at 18 AAC 50.040(i)(2), (5)
and (6). The repealed provision at 18
AAC 50.040(i)(4) adopted by reference
an exemption for fugitive emissions in
4 The definition of ‘‘fugitive emissions’’ in 40 CFR
51.166(b)(20) is identical to the definition of
‘‘fugitive emissions’’ in 51.165(a)(1)(ix).
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40 CFR 51.165(a)(4) that duplicates an
exemption contained in the State’s
definition of ‘‘major stationary source’’
and its repeal is therefore approvable.
In summary, revisions to Alaska’s
major NNSR regulations in 18 AAC
50.040(i) are approvable because the
submitted revisions bring the State’s
major NNSR program up to date with
current Federal requirements and, as
explained above, represent a
strengthening of Alaska’s currentlyapproved major NNSR program.
V. Proposed Action
Pursuant to section 110 of the CAA
and consistent with the discussion
above, the EPA proposes to approve the
Alaska SIP revisions submitted on
December 11, 2009, November 29, 2010,
December 10, 2012, January 28, 2013,
July 1, 2014, and October 24, 2014 that
update the adoption by reference of the
Federal major NNSR program and revise
the definition of ‘‘regulated NSR
pollutant.’’ The EPA has made the
preliminary determination that these
SIP revisions are approvable because
they are consistent with the CAA and
the current EPA requirements regarding
major NNSR. The EPA intends to
address the remaining portions of the
SIP submittals that are not related to
major NNSR, and have not yet been
addressed, in one or more separate
actions.
VI. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this proposed
action merely approves the state’s law
as meeting Federal requirements and
does not impose additional
requirements beyond those imposed by
the state’s law. For that reason, this
proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
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65369
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
it does not involve technical standards;
and
• Does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any
Indian reservation land or in any other
area where the EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000), nor will it impose substantial
direct costs on tribal governments or
preempt tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Particulate matter, Reporting and
recordkeeping requirements.
Authority: 42 U.S.C. 7401 et seq.
Dated: October 27, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2014–26181 Filed 11–3–14; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
World Trade Center Health Program;
Petition 005—Acoustic Neuroma;
Finding of Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
ACTION: Denial of petition for addition of
a health condition.
AGENCY:
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65370
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Proposed Rules
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 NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
rmajette on DSK3VPTVN1PROD with PROPOSALS
SUMMARY:
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).
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
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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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
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
2 See Petition 005. WTC Health Program: Petitions
Received. https://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.
5 This methodology, ‘‘Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTCRelated Health Conditions,’’ revised October 21,
2014, is available on the WTC Health Program Web
site, at https://www.cdc.gov/wtc/policies.html.
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Sfmt 4702
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.
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.
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.
9 Prochazka M, Feychting M, Ahlbom A, Edwards
´
CG, Nise G, Plato N, Schwartzbaum JA, Forssen UM
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Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Proposed Rules
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 peerreviewed, 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
rmajette on DSK3VPTVN1PROD with PROPOSALS
[2010]. Occupational exposures and risk of acoustic
neuroma. Occup Environ Med. 2010
Nov;67(11):766–71.
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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 WTCRelated 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.
65371
Petition for reconsideration;
correction.
ACTION:
The Federal Communications
Commission published a document in
the Federal Register of October 27, 2014
(79 FR 63883), regarding Petitions for
Reconsideration filed of Action in a
rulemaking proceeding. The document
contained the incorrect deadline for
filing replies to an opposition to the
Petition. This document revises the
deadline for replies to an opposition to
the Petition.
SUMMARY:
Oppositions to the Petitions
must be filed on or before November 12,
2014. Replies to an opposition must be
filed on or before November 24, 2014.
DATES:
Federal Communications
Commission, 445 12th Street SW.,
Washington, DC 20554.
ADDRESSES:
A.J.
Glusman, Wireless Telecommunications
Bureau, (202) 418–1425, email
AJ.Glusman@fcc.gov.
FOR FURTHER INFORMATION CONTACT:
Correction
BILLING CODE 4163–18–P
In the Federal Register of October 27,
2014, in FR Doc. 2014–25456, on page
63883, in the second column, correct
the DATES section to read:
FEDERAL COMMUNICATIONS
COMMISSION
DATES:
[FR Doc. 2014–26043 Filed 11–3–14; 8:45 am]
47 CFR Parts 0, 1, 2, 15, 27, 73, and 74
[GN Docket No. 12–268; Report 3011]
Petitions for Reconsideration of Action
in a Rulemaking Proceeding;
Correction
Federal Communications
Commission.
AGENCY:
PO 00000
Frm 00021
Fmt 4702
Sfmt 9990
Oppositions to the Petitions
must be filed on or before November 12,
2014. Replies to an opposition must be
filed on or before November 24, 2014.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2014–26116 Filed 11–3–14; 8:45 am]
BILLING CODE 6712–01–P
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]]>Agencies
[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Proposed Rules]
[Pages 65369-65371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26043]
=======================================================================
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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 NIOSHregs@cdc.gov.
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.
https://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 https://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
