80_FR_32442 80 FR 32333 - World Trade Center Health Program; Petition 007-Autoimmune Diseases; Finding of Insufficient Evidence

80 FR 32333 - World Trade Center Health Program; Petition 007-Autoimmune Diseases; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 109 (June 8, 2015)

Page Range32333-32334
FR Document2015-13914

On April 6, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 007) to add certain autoimmune diseases, including rheumatoid arthritis and connective tissues diseases, 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 certain autoimmune diseases 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 80 Issue 109 (Monday, June 8, 2015)
[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Proposed Rules]
[Pages 32333-32334]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Petition 007--Autoimmune 
Diseases; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

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

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SUMMARY: On April 6, 2015, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 007) to add certain 
autoimmune diseases, including rheumatoid arthritis and connective 
tissues diseases, 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 certain autoimmune 
diseases 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 June 8, 2015.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

A. WTC Health Program Statutory Authority
B. Petition 007
C. Administrator's Determination on Petition 007

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
to add Title XXXIII \1\ establishing the WTC Health Program within the 
Department of Health and Human Services (HHS). The WTC Health Program 
provides medical monitoring and treatment benefits to eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and cleanup workers who responded to the September 
11, 2001, terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania (responders), and to eligible persons who 
were present in the dust or dust cloud on September 11, 2001 or who 
worked, resided, or attended school, childcare, or adult daycare in the 
New York City disaster area (survivors).
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the 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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    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 Sec.  3312(a)(6)(B) of the PHS Act, interested parties 
may petition the Administrator to add a health condition to the List in 
42 CFR 88.1. Within 60 calendar days after receipt of a petition to add 
a condition to the List, the Administrator must take one of the 
following four actions described in Sec.  3312(a)(6)(B) and 42 CFR 
88.17: (i) Request a recommendation of the STAC; (ii) publish a 
proposed rule in the Federal Register to add such health condition; 
(iii) publish in the Federal Register the Administrator's determination 
not to publish such a proposed rule and the basis for such 
determination; or (iv) publish in the Federal Register a determination 
that insufficient evidence exists to take action under (i) through 
(iii) above.

B. Petition 007

    On April 6, 2015, the Administrator received a petition to add 
``autoimmune diseases, such as Rheumatoid Arthritis'' to the List 
(Petition 007).\2\ The petition was submitted by a WTC Health Program 
member who responded to the September 11, 2001, terrorist attacks in 
New York City. The petitioner indicated that she has been diagnosed 
with rheumatoid arthritis, an autoimmune disorder, and is currently 
receiving treatment for a number of other WTC-related health 
conditions. The petitioner described an article published in the 
Journal of Arthritis and Rheumatology by Webber et al. [2015],\3\ which 
was designed to test the hypothesis that acute and chronic 9/11 work-
related exposures were associated with the risk of certain new-onset 
systemic autoimmune diseases.
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    \2\ See Petition 007. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Webber M.P., Moir W., Zeig-Owens R., Glaser M.S., Jaber N., 
Hall C., Berman J., Qayyum B., Loupasakis K., Kelly K., and Prezant 
D.J. [2015]. Nested case-control study of selected systemic 
autoimmune diseases in World Trade Center rescue/recovery workers. 
Journal of Arthritis & Rheumatology 67(5):1369-1376.
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C. Administrator's Determination on Petition 007

    The Administrator has established a methodology 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.\4\ In accordance with the 
methodology, the Administrator directs the WTC Health Program Associate 
Director for Science (ADS) 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 direct observational and/or epidemiological studies 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 ADS further assesses the scientific and medical 
evidence 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 provide

[[Page 32334]]

substantial support \5\ 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 \6\ 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.\7\ 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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    \4\ ``Policy and Procedures for Adding Non-Cancer Conditions to 
the List of WTC-Related Health Conditions,'' John Howard, MD, 
Administrator of the WTC Health Program, October 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
    \5\ 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.
    \6\ 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.
    \7\ 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, or at the Pentagon site, or in 
Shanksville, Pennsylvania site as those locations are defined in 42 
CFR 88.1.
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    In accordance with Sec.  3312(a)(6)(B) of the PHS Act, 42 CFR 
88.17, and the methodology for the addition of non-cancer health 
conditions to the List, the Administrator reviewed the evidence 
presented in Petition 007. Although the petitioner specifically 
requested the addition of certain autoimmune diseases such as 
rheumatoid arthritis and connective tissue diseases, the Administrator 
determined that the scope of the petition properly includes all of the 
autoimmune diseases identified in Webber et al. Accordingly, the ADS 
conducted a systematic literature search of the published scientific 
and medical literature for evidence of a causal relationship between 9/
11 exposures and the autoimmune disorders described in Webber et al.\8\ 
Those autoimmune disorders include: Systemic lupus erythematosus, 
antiphospholipid syndrome, systemic sclerosis, inflammatory myositis, 
Sj[ouml]gren's syndrome, rheumatoid arthritis, spondyloarthritis, 
granulomatosis with polyangiitis (Wegener's), and eosinophilic 
granulomatosis with polyangiitis (Churg-Strauss).
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    \8\ Databases searched include: PubMed, Health & Safety Science 
Abstracts, Toxicology Abstracts, Toxline, Scopus, and Embase.
---------------------------------------------------------------------------

    Other than the Webber study, the literature search yielded no 
relevant epidemiologic studies, and no direct observational studies.\9\ 
In accordance with the methodology described above, the ADS assessed 
Webber et al. for quality and found significant limitations. Those 
limitations include low statistical power (due to the small number of 
cases); lack of information about other key confounders (e.g., family 
history of autoimmune diseases, history of viral infections or 
vaccination preceding diagnosis of the autoimmune disease, use of 
pharmaceutical agents and non-WTC-related exposures, both work-related 
and recreational); and potential for measurement error of chronic 
exposure (i.e., because a month of 9/11-related exposures was 
represented by at least 1 day spent at the WTC site, the duration 
variable did not differentiate between those with one day and those 
with many days of exposure in a given month; however, this measurement 
approach was non-differential between the cases and controls). Finally, 
participants were from the Fire Department of New York cohort only and 
predominantly a white male population which raises concern for 
generalizability to other 9/11-exposed groups, including female 
responders and survivors. Thus, the ADS concluded that the available 
information did not have the potential to form the basis for a decision 
on whether to propose adding the following conditions to the List of 
WTC-Related Health Conditions: Systemic lupus erythematosus, 
antiphospholipid syndrome, systemic sclerosis, inflammatory myositis, 
Sj[ouml]gren's syndrome, rheumatoid arthritis, spondyloarthritis, 
granulomatosis with polyangiitis (Wegener's), or eosinophilic 
granulomatosis with polyangiitis (Churg-Strauss).
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    \9\ Only epidemiologic studies of 9/11-exposed populations were 
considered to be relevant.
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    The findings described above led the Administrator to determine 
that insufficient evidence exists to take further action, including 
either proposing the addition of the autoimmune diseases identified 
above 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 007 
to add certain autoimmune diseases to the List of WTC-Related Health 
Conditions, including: Systemic lupus erythematosus, antiphospholipid 
syndrome, systemic sclerosis, inflammatory myositis, Sj[ouml]gren's 
syndrome, rheumatoid arthritis, spondyloarthritis, granulomatosis with 
polyangiitis (Wegener's), and eosinophilic granulomatosis with 
polyangiitis (Churg-Strauss), is denied.
    The Administrator is aware that another study of autoimmune 
diseases among World Trade Center enrollees is being conducted by the 
World Trade Center Health Registry; however, results from this study 
are not yet available in the scientific literature. The Administrator 
will monitor the scientific literature for publication of the results 
of this study and any other studies that address autoimmune diseases 
among World Trade Center exposed populations.

    Dated: June 1, 2015.
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. 2015-13914 Filed 6-5-15; 8:45 am]
BILLING CODE 4163-18P



                                                                              Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Proposed Rules                                                   32333

                                                    substantial direct costs on Tribal                      SUPPLEMENTARY INFORMATION:                             to the List (Petition 007).2 The petition
                                                    governments or preempt Tribal law.                                                                             was submitted by a WTC Health
                                                                                                            Table of Contents
                                                                                                                                                                   Program member who responded to the
                                                    List of Subjects in 40 CFR Part 52                      A. WTC Health Program Statutory Authority              September 11, 2001, terrorist attacks in
                                                      Environmental protection, Air                         B. Petition 007                                        New York City. The petitioner indicated
                                                    pollution control, Carbon monoxide,                     C. Administrator’s Determination on Petition           that she has been diagnosed with
                                                    Incorporation by reference,                               007                                                  rheumatoid arthritis, an autoimmune
                                                    Intergovernmental relations, Lead,                      A. WTC Health Program Statutory                        disorder, and is currently receiving
                                                    Nitrogen dioxide, Ozone, Particulate                    Authority                                              treatment for a number of other WTC-
                                                    matter, Reporting and recordkeeping                                                                            related health conditions. The petitioner
                                                    requirements, Sulfur oxides, Volatile                      Title I of the James Zadroga 9/11                   described an article published in the
                                                    organic compounds.                                      Health and Compensation Act of 2010                    Journal of Arthritis and Rheumatology
                                                                                                            (Pub. L. 111–347), amended the Public                  by Webber et al. [2015],3 which was
                                                       Authority: 42 U.S.C. 7401 et seq.
                                                                                                            Health Service Act (PHS Act) to add                    designed to test the hypothesis that
                                                      Dated: May 28, 2015.                                  Title XXXIII 1 establishing the WTC                    acute and chronic 9/11 work-related
                                                    Heather McTeer Toney,                                   Health Program within the Department                   exposures were associated with the risk
                                                    Regional Administrator, Region 4.                       of Health and Human Services (HHS).                    of certain new-onset systemic
                                                    [FR Doc. 2015–13947 Filed 6–5–15; 8:45 am]              The WTC Health Program provides                        autoimmune diseases.
                                                    BILLING CODE 6560–50–P                                  medical monitoring and treatment
                                                                                                            benefits to eligible firefighters and                  C. Administrator’s Determination on
                                                                                                            related personnel, law enforcement                     Petition 007
                                                    DEPARTMENT OF HEALTH AND                                officers, and rescue, recovery, and                       The Administrator has established a
                                                    HUMAN SERVICES                                          cleanup workers who responded to the                   methodology for evaluating whether to
                                                                                                            September 11, 2001, terrorist attacks in               add non-cancer health conditions to the
                                                    42 CFR Part 88                                          New York City, at the Pentagon, and in                 List of WTC-Related Health Conditions,
                                                                                                            Shanksville, Pennsylvania (responders),                published online in the Policies and
                                                    World Trade Center Health Program;                      and to eligible persons who were                       Procedures section of the WTC Health
                                                    Petition 007—Autoimmune Diseases;                       present in the dust or dust cloud on                   Program Web site.4 In accordance with
                                                    Finding of Insufficient Evidence                        September 11, 2001 or who worked,                      the methodology, the Administrator
                                                    AGENCY:  Centers for Disease Control and                resided, or attended school, childcare,                directs the WTC Health Program
                                                    Prevention, HHS.                                        or adult daycare in the New York City                  Associate Director for Science (ADS) to
                                                                                                            disaster area (survivors).                             conduct a review of the scientific
                                                    ACTION: Denial of petition for addition of
                                                                                                               All references to the Administrator of              literature to determine if the available
                                                    a health condition.
                                                                                                            the WTC Health Program                                 scientific information has the potential
                                                    SUMMARY:    On April 6, 2015, the                       (Administrator) in this notice mean the                to provide a basis for a decision on
                                                    Administrator of the World Trade                        Director of the National Institute for                 whether to add the condition to the List.
                                                    Center (WTC) Health Program received                    Occupational Safety and Health                         The literature review includes
                                                    a petition (Petition 007) to add certain                (NIOSH) or his or her designee.                        published, peer-reviewed direct
                                                    autoimmune diseases, including                             Pursuant to § 3312(a)(6)(B) of the PHS              observational and/or epidemiological
                                                    rheumatoid arthritis and connective                     Act, interested parties may petition the               studies about the health condition
                                                    tissues diseases, to the List of WTC-                   Administrator to add a health condition                among 9/11-exposed populations. The
                                                    Related Health Conditions (List). Upon                  to the List in 42 CFR 88.1. Within 60                  studies are reviewed for their relevance,
                                                    reviewing the scientific and medical                    calendar days after receipt of a petition              quantity, and quality to provide a basis
                                                    literature, including information                       to add a condition to the List, the                    for deciding whether to propose adding
                                                    provided by the petitioner, the                         Administrator must take one of the                     the health condition to the List. Where
                                                    Administrator has determined that the                   following four actions described in                    the available evidence has the potential
                                                    available evidence does not have the                    § 3312(a)(6)(B) and 42 CFR 88.17: (i)                  to provide a basis for a decision, the
                                                    potential to provide a basis for a                      Request a recommendation of the STAC;                  ADS further assesses the scientific and
                                                    decision on whether to add certain                      (ii) publish a proposed rule in the                    medical evidence to determine whether
                                                    autoimmune diseases to the List. The                    Federal Register to add such health                    a causal relationship between 9/11
                                                    Administrator finds that insufficient                   condition; (iii) publish in the Federal                exposures and the health condition is
                                                    evidence exists to request a                            Register the Administrator’s                           supported. A health condition may be
                                                    recommendation of the WTC Health                        determination not to publish such a                    added to the List if published, peer-
                                                    Program Scientific/Technical Advisory                   proposed rule and the basis for such                   reviewed direct observational or
                                                    Committee (STAC), to publish a                          determination; or (iv) publish in the                  epidemiologic studies provide
                                                    proposed rule, or to publish a                          Federal Register a determination that
                                                    determination not to publish a proposed                 insufficient evidence exists to take                     2 See Petition 007. WTC Health Program: Petitions

                                                    rule.                                                   action under (i) through (iii) above.                  Received. http://www.cdc.gov/wtc/received.html.
                                                                                                                                                                     3 Webber M.P., Moir W., Zeig-Owens R., Glaser
                                                    DATES: The Administrator of the WTC                     B. Petition 007                                        M.S., Jaber N., Hall C., Berman J., Qayyum B.,
                                                    Health Program is denying this petition                                                                        Loupasakis K., Kelly K., and Prezant D.J. [2015].
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                                                    for the addition of a health condition as                 On April 6, 2015, the Administrator                  Nested case-control study of selected systemic
                                                                                                            received a petition to add ‘‘autoimmune                autoimmune diseases in World Trade Center
                                                    of June 8, 2015.                                                                                               rescue/recovery workers. Journal of Arthritis &
                                                    FOR FURTHER INFORMATION CONTACT:                        diseases, such as Rheumatoid Arthritis’’               Rheumatology 67(5):1369–1376.
                                                    Rachel Weiss, Program Analyst, 1090                                                                              4 ‘‘Policy and Procedures for Adding Non-Cancer
                                                                                                              1 Title XXXIII of the PHS Act is codified at 42      Conditions to the List of WTC-Related Health
                                                    Tusculum Avenue, MS: C–46,
                                                                                                            U.S.C. 300mm to 300mm–61. Those portions of the        Conditions,’’ John Howard, MD, Administrator of
                                                    Cincinnati, OH 45226; telephone (855)                   Zadroga Act found in Titles II and III of Public Law   the WTC Health Program, October 21, 2014.
                                                    818–1629 (this is a toll-free number);                  111–347 do not pertain to the WTC Health Program       http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
                                                    email NIOSHregs@cdc.gov.                                and are codified elsewhere.                            NonCancers_21_Oct_2014.pdf.



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                                                    32334                      Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Proposed Rules

                                                    substantial support 5 for a causal                          Other than the Webber study, the                     For the reasons discussed above, the
                                                    relationship between 9/11 exposures                      literature search yielded no relevant                 request made in Petition 007 to add
                                                    and the health condition in 9/11-                        epidemiologic studies, and no direct                  certain autoimmune diseases to the List
                                                    exposed populations. If the evidence                     observational studies.9 In accordance                 of WTC-Related Health Conditions,
                                                    assessment provides only modest                          with the methodology described above,                 including: Systemic lupus
                                                    support 6 for a causal relationship                      the ADS assessed Webber et al. for                    erythematosus, antiphospholipid
                                                    between 9/11 exposures and the health                    quality and found significant                         syndrome, systemic sclerosis,
                                                    condition, the Administrator may then                    limitations. Those limitations include                inflammatory myositis, Sjögren’s
                                                    evaluate additional published, peer-                     low statistical power (due to the small               syndrome, rheumatoid arthritis,
                                                    reviewed epidemiologic studies,                          number of cases); lack of information                 spondyloarthritis, granulomatosis with
                                                    conducted among non-9/11-exposed                         about other key confounders (e.g.,                    polyangiitis (Wegener’s), and
                                                    populations, evaluating associations                     family history of autoimmune diseases,                eosinophilic granulomatosis with
                                                    between the health condition of interest                 history of viral infections or vaccination            polyangiitis (Churg-Strauss), is denied.
                                                    and 9/11 agents.7 If that additional                     preceding diagnosis of the autoimmune                    The Administrator is aware that
                                                    assessment establishes substantial                       disease, use of pharmaceutical agents                 another study of autoimmune diseases
                                                    support for a causal relationship                        and non-WTC-related exposures, both                   among World Trade Center enrollees is
                                                    between a 9/11 agent or agents and the                   work-related and recreational); and                   being conducted by the World Trade
                                                    health condition, the health condition                   potential for measurement error of                    Center Health Registry; however, results
                                                    may be added to the List.                                chronic exposure (i.e., because a month               from this study are not yet available in
                                                       In accordance with § 3312(a)(6)(B) of                 of 9/11-related exposures was                         the scientific literature. The
                                                    the PHS Act, 42 CFR 88.17, and the                       represented by at least 1 day spent at the            Administrator will monitor the
                                                    methodology for the addition of non-                     WTC site, the duration variable did not               scientific literature for publication of
                                                    cancer health conditions to the List, the                differentiate between those with one                  the results of this study and any other
                                                    Administrator reviewed the evidence                      day and those with many days of                       studies that address autoimmune
                                                    presented in Petition 007. Although the                  exposure in a given month; however,                   diseases among World Trade Center
                                                    petitioner specifically requested the                    this measurement approach was non-                    exposed populations.
                                                    addition of certain autoimmune diseases                  differential between the cases and
                                                                                                                                                                      Dated: June 1, 2015.
                                                    such as rheumatoid arthritis and                         controls). Finally, participants were
                                                                                                             from the Fire Department of New York                  John Howard,
                                                    connective tissue diseases, the
                                                                                                             cohort only and predominantly a white                 Administrator, World Trade Center Health
                                                    Administrator determined that the                                                                              Program and Director, National Institute for
                                                    scope of the petition properly includes                  male population which raises concern
                                                                                                             for generalizability to other 9/11-                   Occupational Safety and Health, Centers for
                                                    all of the autoimmune diseases                                                                                 Disease Control and Prevention, Department
                                                    identified in Webber et al. Accordingly,                 exposed groups, including female                      of Health and Human Services.
                                                    the ADS conducted a systematic                           responders and survivors. Thus, the
                                                                                                                                                                   [FR Doc. 2015–13914 Filed 6–5–15; 8:45 am]
                                                    literature search of the published                       ADS concluded that the available
                                                                                                                                                                   BILLING CODE 4163–18P
                                                    scientific and medical literature for                    information did not have the potential
                                                    evidence of a causal relationship                        to form the basis for a decision on
                                                    between 9/11 exposures and the                           whether to propose adding the
                                                                                                             following conditions to the List of WTC-              DEPARTMENT OF HOMELAND
                                                    autoimmune disorders described in                                                                              SECURITY
                                                    Webber et al.8 Those autoimmune                          Related Health Conditions: Systemic
                                                    disorders include: Systemic lupus                        lupus erythematosus, antiphospholipid
                                                                                                             syndrome, systemic sclerosis,                         Federal Emergency Management
                                                    erythematosus, antiphospholipid                                                                                Agency
                                                    syndrome, systemic sclerosis,                            inflammatory myositis, Sjögren’s
                                                    inflammatory myositis, Sjögren’s                        syndrome, rheumatoid arthritis,
                                                                                                             spondyloarthritis, granulomatosis with                44 CFR Part 67
                                                    syndrome, rheumatoid arthritis,
                                                    spondyloarthritis, granulomatosis with                   polyangiitis (Wegener’s), or eosinophilic             [Docket ID FEMA–2015–0001; Internal
                                                                                                             granulomatosis with polyangiitis                      Agency Docket Nos. FEMA–B–7759, FEMA–
                                                    polyangiitis (Wegener’s), and
                                                                                                             (Churg-Strauss).                                      B–1138 and FEMA–B–1208]
                                                    eosinophilic granulomatosis with
                                                                                                                The findings described above led the
                                                    polyangiitis (Churg-Strauss).                                                                                  Proposed Flood Elevation
                                                                                                             Administrator to determine that
                                                                                                             insufficient evidence exists to take                  Determinations for Lafayette Parish,
                                                      5 The substantial evidence standard is met when
                                                                                                             further action, including either                      Louisiana, and Incorporated Areas
                                                    the Program assesses all of the available, relevant
                                                    information and determines with high confidence          proposing the addition of the                         AGENCY:  Federal Emergency
                                                    that the evidence supports its findings regarding a      autoimmune diseases identified above                  Management Agency, DHS.
                                                    causal association between the 9/11 exposure(s) and      to the List (pursuant to PHS Act,
                                                    the health condition.                                                                                          ACTION: Proposed rule; withdrawal.
                                                      6 The modest evidence standard is met when the
                                                                                                             § 3312(a)(6)(B)(ii) and 42 CFR
                                                    Program assesses all of the available, relevant          88.17(a)(2)(ii)) or publishing a                      SUMMARY:   The Federal Emergency
                                                    information and determines with moderate                 determination not to publish a proposed               Management Agency (FEMA) is
                                                    confidence that the evidence supports its findings       rule in the Federal Register (pursuant to             withdrawing its proposed rule
                                                    regarding a causal association between the 9/11          PHS Act, § 3312(a)(6)(B)(iii) and 42 CFR
                                                    exposure(s) and the health condition.                                                                          concerning proposed flood elevation
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                                                      7 9/11 agents are chemical, physical, biological, or
                                                                                                             88.17(a)(2)(iii)). The Administrator has              determinations for Lafayette Parish,
                                                    other agents or hazards reported in a published,         also determined that requesting a                     Louisiana, and Incorporated Areas.
                                                    peer-reviewed exposure assessment study of               recommendation from the STAC
                                                    responders or survivors who were present in the                                                                DATES: This withdrawal is effective on
                                                                                                             (pursuant to PHS Act, § 3312(a)(6)(B)(i)
                                                    New York City disaster area, or at the Pentagon site,
                                                                                                             and 42 CFR 88.17(a)(2)(i)) is                         June 8, 2015.
                                                    or in Shanksville, Pennsylvania site as those                                                                  ADDRESSES: You may submit comments,
                                                    locations are defined in 42 CFR 88.1.                    unwarranted.
                                                      8 Databases searched include: PubMed, Health &                                                               identified by Docket Nos. FEMA–B–
                                                    Safety Science Abstracts, Toxicology Abstracts,            9 Only epidemiologic studies of 9/11-exposed        7759, FEMA–B–1138 and FEMA–B–
                                                    Toxline, Scopus, and Embase.                             populations were considered to be relevant.           1208, to Luis Rodriguez, Chief,


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Document Created: 2018-02-22 10:12:51
Document Modified: 2018-02-22 10:12:51
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 June 8, 2015.
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 Citation80 FR 32333 

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