81_FR_19172 81 FR 19108 - World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient Evidence

81 FR 19108 - World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 64 (April 4, 2016)

Page Range19108-19110
FR Document2016-07567

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.

Federal Register, Volume 81 Issue 64 (Monday, April 4, 2016)
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19108-19110]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

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

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Zadroga Act) Public Law 111-347, as amended by Public Law 114-
113, added Title XXXIII to the Public Health Service Act (PHS Act) \1\ 
establishing the WTC Health Program within the Department of Health and 
Human Services (HHS). The WTC Health Program provides medical 
monitoring and treatment benefits to eligible firefighters and related 
personnel, law enforcement officers, and rescue, recovery, and cleanup 
workers who responded to the September 11, 2001, terrorist attacks in 
New York City, at the Pentagon, and in Shanksville,

[[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. 
http://www.cdc.gov/wtc/received.html.
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D. Administrator's Determination on Petition 010

    The Administrator has established a policy for evaluating whether 
to add non-cancer health conditions to the List of WTC-Related Health 
Conditions, published online in the Policies and Procedures section of 
the WTC Health Program Web site.\3\ In accordance with the policy, the 
Administrator directs the WTC Health Program to conduct a review of the 
scientific literature to determine if the available scientific 
information has the potential to provide a basis for a decision on 
whether to add the condition to the List. The literature review 
includes published, peer-reviewed epidemiologic studies (including 
direct observational studies in the case of health conditions such as 
injuries) about the health condition among 9/11-exposed populations. 
The studies are reviewed for their relevance, quantity, and quality to 
provide a basis for deciding whether to propose adding the health 
condition to the List. Where the available evidence has the potential 
to provide a basis for a decision, the scientific and medical evidence 
is further assessed to determine whether a causal relationship between 
9/11 exposures and the health condition is supported. A health 
condition may be added to the List if published, peer-reviewed, direct 
observational or epidemiologic studies, as appropriate, provide 
substantial support \4\ for a causal relationship between 9/11 
exposures and the health condition in 9/11-exposed populations. If the 
evidence assessment provides only modest support \5\ for a causal 
relationship between 9/11 exposures and the health condition, the 
Administrator may then evaluate additional published, peer-reviewed, 
epidemiologic studies, conducted among non-9/11-exposed populations, 
evaluating associations between the health condition of interest and 9/
11 agents.\6\ If that additional assessment establishes substantial 
support for a causal relationship between a 9/11 agent or agents and 
the health condition, the health condition may be added to the List.
---------------------------------------------------------------------------

    \3\ John Howard MD, Administrator of the WTC Health Program, 
Policy and Procedures for Adding Non-Cancer Conditions to the List 
of WTC-Related Health Conditions, October 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
    \4\ The substantial evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with high confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \5\ The modest evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with moderate confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \6\ 9/11 agents are chemical, physical, biological, or other 
agents or hazards reported in a published, peer-reviewed exposure 
assessment study of responders or survivors who were present in the 
New York City disaster area, at the Pentagon site, or at the 
Shanksville, Pennsylvania site, as those locations are defined in 42 
CFR 88.1.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \7\ Databases searched include: PubMed, Health & Safety Science 
Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and 
NIOSHTIC-2.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

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

    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.
---------------------------------------------------------------------------

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

    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



                                                    19108                     Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules

                                                    SIP submission notes that the following                    • does not contain any unfunded                     ACTION: Denial of petition for addition of
                                                    State regulations and State statutes                    mandate or significantly or uniquely                   a health condition.
                                                    provide the Commonwealth the                            affect small governments, as described
                                                    authority to meet the requirements of                   in the Unfunded Mandates Reform Act                    SUMMARY:   On January 5, 2016, the
                                                    this element: 401 KAR 50:066.                           of 1995 (Pub. L. 104–4);                               Administrator of the World Trade
                                                    Conformity of transportation plans,                        • does not have Federalism                          Center (WTC) Health Program received
                                                    programs, and projects; 401 KAR                         implications as specified in Executive                 a petition (Petition 010) to add
                                                    52:100. Public, Affected State, and US                  Order 13132 (64 FR 43255, August 10,                   peripheral neuropathy to the List of
                                                    EPA Review; and KRS Chapter 77. Air                     1999);                                                 WTC-Related Health Conditions (List).
                                                    Pollution Control. EPA has made the                        • is not an economically significant                Upon reviewing the scientific and
                                                    preliminary determination that                          regulatory action based on health or                   medical literature, including
                                                    Kentucky’s SIP and practices adequately                 safety risks subject to Executive Order                information provided by the petitioner,
                                                    demonstrate consultation with affected                  13045 (62 FR 19885, April 23, 1997);                   the Administrator has determined that
                                                    local entities related to the 2010 1-hour                  • is not a significant regulatory action            the available evidence does not have the
                                                    SO2 NAAQS when necessary.                               subject to Executive Order 13211 (66 FR                potential to provide a basis for a
                                                                                                            28355, May 22, 2001);                                  decision on whether to add peripheral
                                                    V. Proposed Action                                         • is not subject to requirements of                 neuropathy to the List. The
                                                       With the exception of interstate                     Section 12(d) of the National                          Administrator finds that insufficient
                                                    transport provisions pertaining to the                  Technology Transfer and Advancement                    evidence exists to request a
                                                    contribution to nonattainment or                        Act of 1995 (15 U.S.C. 272 note) because               recommendation of the WTC Health
                                                    interference with maintenance in other                  application of those requirements would                Program Scientific/Technical Advisory
                                                    states and visibility protection                        be inconsistent with the CAA; and                      Committee (STAC), to publish a
                                                    requirements of section 110(a)(2)(D)(i)(I)                 • does not provide EPA with the                     proposed rule, or to publish a
                                                    and (II) (prongs 1, 2, and 4) and the                   discretionary authority to address, as                 determination not to publish a proposed
                                                    minor source program requirements of                    appropriate, disproportionate human                    rule.
                                                    section 110(a)(2)(C), EPA is proposing to               health or environmental effects, using                 DATES: The Administrator of the WTC
                                                    approve Kentucky’s April 26, 2013,                      practicable and legally permissible                    Health Program is denying this petition
                                                    infrastructure SIP submission for the                   methods, under Executive Order 12898                   for the addition of a health condition as
                                                    2010 1-hour SO2 NAAQS for the above                     (59 FR 7629, February 16, 1994).                       of April 4, 2016.
                                                    described infrastructure SIP                               In addition, the SIP is not approved                FOR FURTHER INFORMATION CONTACT:
                                                    requirements. EPA is proposing to                       to apply on any Indian reservation land                Rachel Weiss, Program Analyst, 1090
                                                    approve these portions of Kentucky’s                    or in any other area where EPA or an                   Tusculum Avenue, MS: C–46,
                                                    infrastructure SIP submission for the                   Indian tribe has demonstrated that a                   Cincinnati, OH 45226; telephone (855)
                                                    2010 1-hour SO2 NAAQS because these                     tribe has jurisdiction. In those areas of              818–1629 (this is a toll-free number);
                                                    aspects of the submission are consistent                Indian country, the rule does not have                 email NIOSHregs@cdc.gov.
                                                    with section 110 of the CAA.                            tribal implications as specified by                    SUPPLEMENTARY INFORMATION:
                                                                                                            Executive Order 13175 (65 FR 67249,
                                                    VI. Statutory and Executive Order                       November 9, 2000), nor will it impose                  Table of Contents
                                                    Reviews                                                 substantial direct costs on tribal                     A. WTC Health Program Statutory Authority
                                                      Under the CAA, the Administrator is                   governments or preempt tribal law.                     B. Approval to Submit Document to the
                                                    required to approve a SIP submission                                                                             Office of the Federal Register
                                                                                                            List of Subjects in 40 CFR Part 52                     C. Petition 010
                                                    that complies with the provisions of the                                                                       D. Administrator’s Determination on Petition
                                                    Act and applicable Federal regulations.                   Environmental protection, Air
                                                                                                            pollution control, Incorporation by                      010
                                                    See 42 U.S.C. 7410(k); 40 CFR 52.02(a).
                                                    Thus, in reviewing SIP submissions,                     reference, Intergovernmental relations,                A. WTC Health Program Statutory
                                                    EPA’s role is to approve state choices,                 Nitrogen dioxide, Ozone, Reporting and                 Authority
                                                    provided that they meet the criteria of                 recordkeeping requirements, Volatile
                                                                                                                                                                      Title I of the James Zadroga 9/11
                                                    the CAA. Accordingly, this proposed                     organic compounds.
                                                                                                                                                                   Health and Compensation Act of 2010
                                                    action merely approves state law as                       Authority: 42 U.S.C. 7401 et seq.                    (Zadroga Act) Public Law 111–347, as
                                                    meeting federal requirements and does                     Dated: March 25, 2016.                               amended by Public Law 114–113, added
                                                    not impose additional requirements                      Heather McTeer Toney,                                  Title XXXIII to the Public Health
                                                    beyond those imposed by state law. For                  Regional Administrator, Region 4.                      Service Act (PHS Act) 1 establishing the
                                                    that reason, this proposed action:                                                                             WTC Health Program within the
                                                                                                            [FR Doc. 2016–07644 Filed 4–1–16; 8:45 am]
                                                      • Is not a significant regulatory action                                                                     Department of Health and Human
                                                                                                            BILLING CODE 6560–50–P
                                                    subject to review by the Office of                                                                             Services (HHS). The WTC Health
                                                    Management and Budget under                                                                                    Program provides medical monitoring
                                                    Executive Orders 12866 (58 FR 51735,                                                                           and treatment benefits to eligible
                                                    October 4, 1993) and 13563 (76 FR 3821,                 DEPARTMENT OF HEALTH AND                               firefighters and related personnel, law
                                                    January 21, 2011);                                      HUMAN SERVICES                                         enforcement officers, and rescue,
                                                      • does not impose an information                                                                             recovery, and cleanup workers who
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                                                                                                            42 CFR Part 88
                                                    collection burden under the provisions                                                                         responded to the September 11, 2001,
                                                    of the Paperwork Reduction Act (44                      [NIOSH Docket 094]                                     terrorist attacks in New York City, at the
                                                    U.S.C. 3501 et seq.);                                                                                          Pentagon, and in Shanksville,
                                                                                                            World Trade Center Health Program;
                                                      • is certified as not having a
                                                                                                            Petition 010—Peripheral Neuropathy;                      1 Title XXXIII of the PHS Act is codified at 42
                                                    significant economic impact on a
                                                                                                            Finding of Insufficient Evidence                       U.S.C. 300mm to 300mm–61. Those portions of the
                                                    substantial number of small entities                                                                           Zadroga Act found in Titles II and III of Public Law
                                                    under the Regulatory Flexibility Act (5                 AGENCY: Centers for Disease Control and                111–347 do not pertain to the WTC Health Program
                                                    U.S.C. 601 et seq.);                                    Prevention, HHS.                                       and are codified elsewhere.



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                                                                              Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules                                                      19109

                                                    Pennsylvania (responders), and to                       sciatic nerve of laboratory rats, and                  reviewed, epidemiologic studies,
                                                    eligible persons who were present in the                another concerning neuropathic                         conducted among non-9/11-exposed
                                                    dust or dust cloud on September 11,                     symptoms in WTC responders and                         populations, evaluating associations
                                                    2001 or who worked, resided, or                         survivors. Both studies, as well as an                 between the health condition of interest
                                                    attended school, childcare, or adult                    initial literature search conducted by                 and 9/11 agents.6 If that additional
                                                    daycare in the New York City disaster                   the WTC Health Program, are described                  assessment establishes substantial
                                                    area (survivors).                                       below.                                                 support for a causal relationship
                                                       All references to the Administrator of                                                                      between a 9/11 agent or agents and the
                                                                                                            D. Administrator’s Determination on
                                                    the WTC Health Program                                                                                         health condition, the health condition
                                                                                                            Petition 010
                                                    (Administrator) in this notice mean the                                                                        may be added to the List.
                                                    Director of the National Institute for                     The Administrator has established a                    In accordance with section
                                                    Occupational Safety and Health                          policy for evaluating whether to add                   3312(a)(6)(B) of the PHS Act, 42 CFR
                                                    (NIOSH) or his or her designee.                         non-cancer health conditions to the List               88.17, and the policy for the addition of
                                                       Pursuant to section 3312(a)(6)(B) of                 of WTC-Related Health Conditions,                      non-cancer health conditions to the List,
                                                    the PHS Act, interested parties may                     published online in the Policies and                   the Administrator reviewed the
                                                    petition the Administrator to add a                     Procedures section of the WTC Health                   evidence presented in Petition 010. The
                                                    health condition to the List in 42 CFR                  Program Web site.3 In accordance with                  WTC Health Program conducted a
                                                    88.1. After receipt of a petition to add                the policy, the Administrator directs the              systematic literature search of the
                                                    a condition to the List, the                            WTC Health Program to conduct a                        published scientific and medical
                                                    Administrator must take one of the                      review of the scientific literature to                 literature 7 for evidence of a causal
                                                    following four actions described in PHS                 determine if the available scientific                  relationship between 9/11 exposures
                                                    Act, section 3312(a)(6)(B) and 42 CFR                   information has the potential to provide               and peripheral neuropathy and
                                                    88.17: (i) Request a recommendation of                  a basis for a decision on whether to add               reviewed both studies submitted in the
                                                    the STAC; (ii) publish a proposed rule                  the condition to the List. The literature              petition.
                                                    in the Federal Register to add such                     review includes published, peer-                          The first study cited by the petitioner,
                                                    health condition; (iii) publish in the                  reviewed epidemiologic studies                         ‘‘Analysis of Short-Term Effects of
                                                    Federal Register the Administrator’s                    (including direct observational studies                World Trade Center Dust on Rat Sciatic
                                                    determination not to publish such a                     in the case of health conditions such as               Nerve,’’ by Stecker et al.8 investigated
                                                    proposed rule and the basis for such                    injuries) about the health condition                   the short-term effects of WTC dust on
                                                    determination; or (iv) publish in the                   among 9/11-exposed populations. The                    the sciatic nerve in laboratory rats. This
                                                    Federal Register a determination that                   studies are reviewed for their relevance,              study was not identified in the literature
                                                    insufficient evidence exists to take                    quantity, and quality to provide a basis               search. Because this study does not
                                                    action under (i) through (iii) above.                   for deciding whether to propose adding                 meet the policy’s requirement that the
                                                                                                            the health condition to the List. Where                decision to add a health condition to the
                                                    B. Approval To Submit Document to the                   the available evidence has the potential               List must be based on epidemiologic
                                                    Office of the Federal Register                          to provide a basis for a decision, the                 studies of 9/11-exposed populations, it
                                                      The Secretary, HHS, or her designee,                  scientific and medical evidence is                     was not further considered.
                                                    the Director, Centers for Disease Control               further assessed to determine whether a                   The systematic literature search
                                                    and Prevention (CDC) and                                causal relationship between 9/11                       identified only one epidemiologic study
                                                    Administrator, Agency for Toxic                         exposures and the health condition is                  regarding peripheral neuropathy in 9/
                                                    Substances and Disease Registry                         supported. A health condition may be                   11-exposed populations, which was the
                                                    (ATSDR), authorized the undersigned,                    added to the List if published, peer-                  second study cited by the petitioner,
                                                    the Administrator of the WTC Health                     reviewed, direct observational or                      ‘‘Neuropathic Symptoms in World
                                                    Program, to sign and submit the                         epidemiologic studies, as appropriate,                 Trade Center Disaster Survivors and
                                                    document to the Office of the Federal                   provide substantial support 4 for a                    Responders,’’ by Wilkenfeld et al.9
                                                    Register for publication as an official                 causal relationship between 9/11                       Upon review of the study’s relevance,
                                                    document of the WTC Health Program.                     exposures and the health condition in 9/               quantity, and quality, the paper was
                                                    Thomas R. Frieden, M.D., M.P.H.,                        11-exposed populations. If the evidence                found to have numerous limitations,
                                                    Director, CDC, and Administrator,                       assessment provides only modest                        including a small sample size; exclusive
                                                    ATSDR, approved this document on                        support 5 for a causal relationship                    use of subjective self-reported outcome
                                                    March 24, 2016, for publication.                        between 9/11 exposures and the health                  and exposure data; lack of information
                                                                                                            condition, the Administrator may then                  about comparability among the groups;
                                                    C. Petition 010                                         evaluate additional published, peer-
                                                      On January 5, 2016, the Administrator                                                                          6 9/11 agents are chemical, physical, biological, or

                                                    received a petition to add ‘‘peripheral                   3 John Howard MD, Administrator of the WTC           other agents or hazards reported in a published,
                                                                                                            Health Program, Policy and Procedures for Adding       peer-reviewed exposure assessment study of
                                                    neuropathy’’ to the List (Petition 010).2                                                                      responders or survivors who were present in the
                                                                                                            Non-Cancer Conditions to the List of WTC-Related
                                                    The petition was submitted by a Fire                    Health Conditions, October 21, 2014. http://           New York City disaster area, at the Pentagon site,
                                                    Department of New York member who                       www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_                  or at the Shanksville, Pennsylvania site, as those
                                                    responded to the September 11, 2001,                    NonCancers_21_Oct_2014.pdf.                            locations are defined in 42 CFR 88.1.
                                                                                                              4 The substantial evidence standard is met when        7 Databases searched include: PubMed, Health &
                                                    terrorist attacks in New York City. The
                                                                                                            the Program assesses all of the available, relevant    Safety Science Abstracts, Toxicology Abstracts,
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                                                    petitioner indicated that he was                        information and determines with high confidence        Toxline, Scopus, Embase, and NIOSHTIC–2.
                                                    diagnosed with peripheral neuropathy                    that the evidence supports its findings regarding a      8 Mark Stecker, Jacqueline Segelnick, Marc

                                                    shortly after the incident. The petitioner              causal association between the 9/11 exposure(s) and    Wilkenfeld, Analysis of Short-Term Effects of World
                                                    described two studies as the medical                    the health condition.                                  Trade Center Dust on Rat Sciatic Nerve, JOEM
                                                                                                              5 The modest evidence standard is met when the       56(10):1024–1028, October 2014.
                                                    basis for his petition: A study of the
                                                                                                            Program assesses all of the available, relevant          9 Marc Wilkenfeld, Melissa Fazzari, Jacqueline
                                                    short-term effects of WTC dust on the                   information and determines with moderate               Segelnick, and Mark Stecker, Neuropathic
                                                                                                            confidence that the evidence supports its findings     Symptoms in World Trade Center Disaster
                                                      2 See Petition 010, WTC Health Program: Petitions     regarding a causal association between the 9/11        Survivors and Responders, JOEM 58(1):83–86,
                                                    Received. http://www.cdc.gov/wtc/received.html.         exposure(s) and the health condition.                  January 2016.



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                                                    19110                     Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules

                                                    lack of objective measurements to                       SUMMARY:    On February 8, 2016, the                   SUPPLEMENTARY INFORMATION:
                                                    confirm the presence of peripheral                      Bureau of Land Management (BLM)
                                                                                                                                                                   Public Comment Procedures
                                                    neuropathy; and absence of control for                  published in the Federal Register a
                                                    key confounders other than the                          proposed rule that would reduce waste                     If you wish to comment, you may
                                                    comorbidities studied. Each of these                    of natural gas from venting, flaring, and              submit your comments by any one of
                                                    limitations affect the strength of the                  leaks during oil and natural gas                       the methods listed in the ADDRESSES
                                                    study results, and thus the Wilkenfeld et               production activities on onshore Federal               section above. Please make your
                                                    al. study is not sufficient to provide the              and Indian leases. The proposed rule                   comments as specific as possible by
                                                    Administrator with a potential basis for                would also clarify when produced gas                   confining them to issues directly related
                                                    deciding whether to propose adding                      lost through venting, flaring, or leaks is             to the content of the proposed rule, and
                                                    peripheral neuropathy to the List.                      subject to royalties, and when oil and                 explain the basis for your comments.
                                                      Due to the substantial limitations                    gas production used on site would be                   The comments and recommendations
                                                    inherent in the only available study, the               royalty-free. The proposed rule would                  that will be most useful and likely to
                                                    Administrator has concluded that the                    replace existing provisions related to                 influence agency decisions are:
                                                    available evidence does not have the                    venting, flaring, and royalty-free use of                 1. Those supported by quantitative
                                                    potential to provide a basis for a                      gas contained in the 1980 Notice to                    information or studies; and
                                                    decision on whether to add peripheral                   Lessees and Operators of Onshore                          2. Those that include citations to, and
                                                    neuropathy to the List.                                 Federal and Indian Oil and Gas Leases,                 analyses of, the applicable laws and
                                                      The findings described above led the                  Royalty or Compensation for Oil and                    regulations.
                                                    Administrator to determine that                         Gas Lost (NTL–4A), which is over 3                        The BLM is not obligated to consider
                                                    insufficient evidence exists to take                    decades old. Today’s Federal Register                  or include in the Administrative Record
                                                    further action, including either                        Notice extends the public comment                      for the rule comments received after the
                                                    proposing the addition of peripheral                    period for 14 days beyond the initial                  close of the comment period (see DATES)
                                                    neuropathy to the List (pursuant to PHS                 comment period deadline.                               or comments delivered to an address
                                                    Act, sec. 3312(a)(6)(B)(ii) and 42 CFR                  DATES: The comment period for the
                                                                                                                                                                   other than those listed above (see
                                                                                                                                                                   ADDRESSES).
                                                    88.17(a)(2)(ii)) or publishing a                        proposed rule published on February 8,
                                                                                                                                                                      Comments, including names and
                                                    determination not to publish a proposed                 2016 (81 FR 6616) is extended. Send
                                                                                                                                                                   street addresses of respondents, will be
                                                    rule in the Federal Register (pursuant to               your comments on this proposed rule to
                                                                                                                                                                   available for public review at the
                                                    PHS Act, sec. 3312(a)(6)(B)(iii) and 42                 the BLM on or before April 22, 2016.
                                                                                                                                                                   address listed under ADDRESSES during
                                                    CFR 88.17(a)(2)(iii)). The Administrator                The BLM need not consider, or include
                                                                                                                                                                   regular hours (7:45 a.m. to 4:15 p.m.),
                                                    has also determined that requesting a                   in the administrative record for the final
                                                                                                                                                                   Monday through Friday, except
                                                    recommendation from the STAC                            rule, comments that the BLM receives
                                                                                                                                                                   holidays.
                                                    (pursuant to PHS Act, sec.                              after the close of the comment period or                  Before including your address,
                                                    3312(a)(6)(B)(i) and 42 CFR                             comments delivered to an address other                 telephone number, email address, or
                                                    88.17(a)(2)(i)) is unwarranted.                         than those listed below (see ADDRESSES).               other personal identifying information
                                                      For the reasons discussed above, the                  ADDRESSES: Mail: U.S. Department of                    in your comment, be advised that your
                                                    request made in Petition 010 to add                     the Interior, Director (630), Bureau of                entire comment—including your
                                                    peripheral neuropathy to the List of                    Land Management, Mail Stop 2134 LM,                    personal identifying information—may
                                                    WTC-Related Health Conditions is                        1849 C St. NW., Washington, DC 20240,                  be made publicly available at any time.
                                                    denied.                                                 Attention: 1004–AE14. Personal or                      While you can ask in your comment to
                                                       Dated: March 28, 2016.                               messenger delivery: Bureau of Land                     withhold from public review your
                                                    John Howard,                                            Management, 20 M Street SE., Room                      personal identifying information, we
                                                    Administrator, World Trade Center Health
                                                                                                            2134 LM, Attention: Regulatory Affairs,                cannot guarantee that we will be able to
                                                    Program and Director, National Institute for            Washington, DC 20003. Federal                          do so.
                                                    Occupational Safety and Health, Centers for             eRulemaking Portal: http://
                                                    Disease Control and Prevention, Department              www.regulations.gov. Follow the                        Background
                                                    of Health and Human Services.                           instructions at this Web site.                            The proposed rule was published on
                                                    [FR Doc. 2016–07567 Filed 4–1–16; 8:45 am]              FOR FURTHER INFORMATION CONTACT: Eric                  February 8, 2016 (81 FR 6616), with a
                                                    BILLING CODE 4163–18–P                                  Jones at the BLM Moab Field Office, 82                 60-day comment period closing on April
                                                                                                            East Dogwood Ave., Moab, UT 84532, or                  8, 2016. Since publication, the BLM has
                                                                                                            by telephone at 435–259–2117; or                       received requests to extend the
                                                    DEPARTMENT OF THE INTERIOR                              Timothy Spisak at the BLM Washington                   comment period on the proposed rule,
                                                                                                            Office, 20 M Street SE., Room 2134LM,                  as well as requests not to extend the
                                                    Bureau of Land Management                               Washington, DC 20003, or by telephone                  comment period. Commenters
                                                                                                            at 202–912–7311. For questions relating                requesting an extension cited the
                                                    43 CFR Parts 3100, 3160, and 3170                       to regulatory process issues, please                   technical nature and complexity of the
                                                    [15X.LLWO300000.L13100000.NB0000]
                                                                                                            contact Faith Bremner, BLM                             proposed rule; its potential interaction
                                                                                                            Washington Office, at 202–912–7441.                    with the BLM’s proposals to update and
                                                    RIN 1004–AE14                                           Persons who use a telecommunications                   replace oil and gas production
                                                                                                            device for the deaf (TDD) may call the                 measurement rules currently found in
mstockstill on DSK4VPTVN1PROD with PROPOSALS




                                                    Waste Prevention, Production Subject                    Federal Information Relay Service                      Onshore Orders 3, 4, and 5; and the
                                                    to Royalties, and Resource                              (FIRS) at 1–800–877–8339 to contact the                Environmental Protection Agency’s
                                                    Conservation                                            above individuals during normal                        proposed rule to establish standards for
                                                    AGENCY:   Bureau of Land Management,                    business hours. FIRS is available 24                   control of emissions of methane and
                                                    Interior.                                               hours a day, 7 days a week to leave a                  volatile organic compounds (VOCs)
                                                                                                            message or question with the above                     from certain oil and gas production
                                                    ACTION: Proposed rule; extension of
                                                                                                            individuals. You will receive a reply                  activities, which would be codified as
                                                    public comment period.
                                                                                                            during normal business hours.                          40 CFR part 60 subpart OOOOa.


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Document Created: 2016-04-02 03:54:34
Document Modified: 2016-04-02 03:54:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionDenial of petition for addition of a health condition.
DatesThe Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of April 4, 2016.
ContactRachel 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]
FR Citation81 FR 19108 

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