World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient Evidence, 19108-19110 [2016-07567]
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19108
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules
SIP submission notes that the following
State regulations and State statutes
provide the Commonwealth the
authority to meet the requirements of
this element: 401 KAR 50:066.
Conformity of transportation plans,
programs, and projects; 401 KAR
52:100. Public, Affected State, and US
EPA Review; and KRS Chapter 77. Air
Pollution Control. EPA has made the
preliminary determination that
Kentucky’s SIP and practices adequately
demonstrate consultation with affected
local entities related to the 2010 1-hour
SO2 NAAQS when necessary.
V. Proposed Action
With the exception of interstate
transport provisions pertaining to the
contribution to nonattainment or
interference with maintenance in other
states and visibility protection
requirements of section 110(a)(2)(D)(i)(I)
and (II) (prongs 1, 2, and 4) and the
minor source program requirements of
section 110(a)(2)(C), EPA is proposing to
approve Kentucky’s April 26, 2013,
infrastructure SIP submission for the
2010 1-hour SO2 NAAQS for the above
described infrastructure SIP
requirements. EPA is proposing to
approve these portions of Kentucky’s
infrastructure SIP submission for the
2010 1-hour SO2 NAAQS because these
aspects of the submission are consistent
with section 110 of the CAA.
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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.
See 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this proposed
action merely approves state law as
meeting federal requirements and does
not impose additional requirements
beyond those imposed by state 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 Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• 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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• 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
application of those requirements would
be inconsistent with the CAA; and
• does not provide 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).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where 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,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: March 25, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2016–07644 Filed 4–1–16; 8:45 am]
BILLING CODE 6560–50–P
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
Centers for Disease Control and
Prevention, HHS.
AGENCY:
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Denial of petition for addition of
a health condition.
ACTION:
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 NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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,
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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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
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.
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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
2 See Petition 010, WTC Health Program: Petitions
Received. https://www.cdc.gov/wtc/received.html.
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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.
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, peerreviewed 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, peerreviewed, 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, peer3 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. https://
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.
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19109
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.
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.
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.
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;
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.
7 Databases searched include: PubMed, Health &
Safety Science Abstracts, Toxicology Abstracts,
Toxline, Scopus, Embase, and NIOSHTIC–2.
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.
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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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.
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
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
43 CFR Parts 3100, 3160, and 3170
[15X.LLWO300000.L13100000.NB0000]
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RIN 1004–AE14
Waste Prevention, Production Subject
to Royalties, and Resource
Conservation
Bureau of Land Management,
Interior.
ACTION: Proposed rule; extension of
public comment period.
AGENCY:
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On February 8, 2016, the
Bureau of Land Management (BLM)
published in the Federal Register a
proposed rule that would reduce waste
of natural gas from venting, flaring, and
leaks during oil and natural gas
production activities on onshore Federal
and Indian leases. The proposed rule
would also clarify when produced gas
lost through venting, flaring, or leaks is
subject to royalties, and when oil and
gas production used on site would be
royalty-free. The proposed rule would
replace existing provisions related to
venting, flaring, and royalty-free use of
gas contained in the 1980 Notice to
Lessees and Operators of Onshore
Federal and Indian Oil and Gas Leases,
Royalty or Compensation for Oil and
Gas Lost (NTL–4A), which is over 3
decades old. Today’s Federal Register
Notice extends the public comment
period for 14 days beyond the initial
comment period deadline.
DATES: The comment period for the
proposed rule published on February 8,
2016 (81 FR 6616) is extended. Send
your comments on this proposed rule to
the BLM on or before April 22, 2016.
The BLM need not consider, or include
in the administrative record for the final
rule, comments that the BLM receives
after the close of the comment period or
comments delivered to an address other
than those listed below (see ADDRESSES).
ADDRESSES: Mail: U.S. Department of
the Interior, Director (630), Bureau of
Land Management, Mail Stop 2134 LM,
1849 C St. NW., Washington, DC 20240,
Attention: 1004–AE14. Personal or
messenger delivery: Bureau of Land
Management, 20 M Street SE., Room
2134 LM, Attention: Regulatory Affairs,
Washington, DC 20003. Federal
eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions at this Web site.
FOR FURTHER INFORMATION CONTACT: Eric
Jones at the BLM Moab Field Office, 82
East Dogwood Ave., Moab, UT 84532, or
by telephone at 435–259–2117; or
Timothy Spisak at the BLM Washington
Office, 20 M Street SE., Room 2134LM,
Washington, DC 20003, or by telephone
at 202–912–7311. For questions relating
to regulatory process issues, please
contact Faith Bremner, BLM
Washington Office, at 202–912–7441.
Persons who use a telecommunications
device for the deaf (TDD) may call the
Federal Information Relay Service
(FIRS) at 1–800–877–8339 to contact the
above individuals during normal
business hours. FIRS is available 24
hours a day, 7 days a week to leave a
message or question with the above
individuals. You will receive a reply
during normal business hours.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
Public Comment Procedures
If you wish to comment, you may
submit your comments by any one of
the methods listed in the ADDRESSES
section above. Please make your
comments as specific as possible by
confining them to issues directly related
to the content of the proposed rule, and
explain the basis for your comments.
The comments and recommendations
that will be most useful and likely to
influence agency decisions are:
1. Those supported by quantitative
information or studies; and
2. Those that include citations to, and
analyses of, the applicable laws and
regulations.
The BLM is not obligated to consider
or include in the Administrative Record
for the rule comments received after the
close of the comment period (see DATES)
or comments delivered to an address
other than those listed above (see
ADDRESSES).
Comments, including names and
street addresses of respondents, will be
available for public review at the
address listed under ADDRESSES during
regular hours (7:45 a.m. to 4:15 p.m.),
Monday through Friday, except
holidays.
Before including your address,
telephone number, email address, or
other personal identifying information
in your comment, be advised that your
entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask in your comment to
withhold from public review your
personal identifying information, we
cannot guarantee that we will be able to
do so.
Background
The proposed rule was published on
February 8, 2016 (81 FR 6616), with a
60-day comment period closing on April
8, 2016. Since publication, the BLM has
received requests to extend the
comment period on the proposed rule,
as well as requests not to extend the
comment period. Commenters
requesting an extension cited the
technical nature and complexity of the
proposed rule; its potential interaction
with the BLM’s proposals to update and
replace oil and gas production
measurement rules currently found in
Onshore Orders 3, 4, and 5; and the
Environmental Protection Agency’s
proposed rule to establish standards for
control of emissions of methane and
volatile organic compounds (VOCs)
from certain oil and gas production
activities, which would be codified as
40 CFR part 60 subpart OOOOa.
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Agencies
[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.
-----------------------------------------------------------------------
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 NIOSHregs@cdc.gov.
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,
[[Page 19109]]
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. 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.
---------------------------------------------------------------------------
\2\ See Petition 010, WTC Health Program: Petitions Received.
https://www.cdc.gov/wtc/received.html.
---------------------------------------------------------------------------
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. https://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;
[[Page 19110]]
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]
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