[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Proposed Rules]
[Pages 11164-11166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 014--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 September 29, 2016, the Administrator of the World Trade 
Center (WTC) Health Program received a petition to add autoimmune 
diseases, including rheumatoid arthritis, to the List of WTC-Related 
Health Conditions (List). Upon reviewing the information provided by 
the petitioner, the Administrator has determined that Petition 014 is 
not substantially different from Petitions 007, 008, 009, 011, and 013, 
which also requested the addition of autoimmune diseases, including 
various subtypes. The Administrator has published responses to the five 
previous petitions in the Federal Register and has determined that 
Petition 014 does not provide additional evidence of a causal 
relationship between 9/11 exposures and autoimmune diseases, including 
rheumatoid arthritis. Accordingly, the Administrator finds that 
insufficient evidence exists to request a recommendation of the WTC 
Health Program Scientific/Technical Advisory Committee (STAC), to 
publish a proposed rule, or to publish a determination not to publish a 
proposed rule.

DATES: The Administrator of the WTC Health Program is denying this 
petition for the addition of a health condition as of February 21, 
2017.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855)

[[Page 11165]]

818-1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

A. WTC Health Program Statutory Authority
B. Petition 014
C. Review of Scientific and Medical Information and Administrator 
Determination
D. Administrator's Final Decision on Whether To Propose the Addition 
of Autoimmune Diseases to the List
E. Approval To Submit Document to the Office of the Federal Register

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title 
XXXIII to the Public Health Service (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, 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 James Zadroga 9/11 Health and 
Compensation Act of 2010 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 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 88.15. Within 90 days after receipt of a petition to add 
a condition to the List, the Administrator must take one of the 
following four actions described in section 3312(a)(6)(B) and 42 CFR 
88.16: (1) Request a recommendation of the STAC; (2) publish a proposed 
rule in the Federal Register to add such health condition; (3) publish 
in the Federal Register the Administrator's determination not to 
publish such a proposed rule and the basis for such determination; or 
(4) publish in the Federal Register a determination that insufficient 
evidence exists to take action under (1) through (3) above. However, in 
accordance with 42 CFR 88.16(a)(5), the Administrator is required to 
consider a new submission for a previously-evaluated health condition 
determined not to qualify for addition to the List as a valid new 
petition only if the submission presents a new medical basis--evidence 
not previously reviewed by the Administrator--for the association 
between 9/11 exposures and the condition to be added.\2\
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    \2\ 42 CFR 88.16(a)(5) further allows that a ``submission that 
provides no new medical basis and is received after the publication 
of a response in the Federal Register to a petition requesting the 
addition of the same health condition will not be considered a valid 
petition and will not be answered in a Federal Register notice. . . 
. The interested party will be informed of the . . . decision in 
writing.''
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    In addition to the regulatory provisions, the WTC Health Program 
has developed policies to guide the review of submissions and petitions 
\3\ and the analysis of evidence supporting the potential addition of a 
non-cancer health condition to the List.\4\ In accordance with the non-
cancer health condition 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 health condition 
to the List. A literature review includes a search for peer-reviewed, 
published epidemiologic studies (including direct observational studies 
in the case of health conditions such as injuries) about the health 
condition among 9/11-exposed populations; such studies are considered 
``relevant.'' Relevant studies identified in the literature search are 
further reviewed for their 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 peer-reviewed, published epidemiologic studies (including 
direct observational studies in the case of health conditions such as 
injuries) provide 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 peer-
reviewed, published 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 
adds enough support for the Administrator to determine there is 
substantial support \8\ for a causal relationship between a 9/11 agent 
or agents and the health condition, the health condition may be added 
to the List.
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    \3\ See WTC Health Program [2014], Policy and Procedures for 
Handling Submissions and Petitions to Add a Health Condition to the 
List of WTC-Related Health Conditions, May 14, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
    \4\ See WTC Health Program [2016], Policy and Procedures for 
Adding Non-Cancer Conditions to the List of WTC-Related Health 
Conditions, May 11, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.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, at the Pentagon site, or at the 
Shanksville, Pennsylvania site, as those locations are defined in 42 
CFR 88.1.
    \8\ See supra note 5.
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B. Petition 014

    On September 29, 2016, the Administrator received a petition from a 
WTC Health Program member to add ``autoimmune conditions like 
Rheumatoid Arthritis'' to the List, considered Petition 014.\9\ This is 
the sixth petition to the Administrator requesting the addition of 
autoimmune diseases, including various subtypes, to the List; each of 
the first five autoimmune disease petitions were denied due to 
insufficient evidence, as described in respective Federal Register 
notices (FRNs).\10\ Petition 014 was

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received prior to recent amendments to WTC Health Program regulations 
regarding petitions for additions to the List taking effect.\11\ The 
Petition was evaluated pursuant to the regulations and policies in 
effect at the time of its receipt \12\ and, therefore, Petition 014 was 
considered valid. Future such submissions requesting the addition of 
autoimmune diseases to the List and providing the same peer-reviewed, 
published, epidemiologic evidence, however, may not be considered valid 
in accordance with 42 CFR 88.16(a)(5), as amended.
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    \9\ See Petition 014, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \10\ ``World Trade Center Health Program; Petition 007--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 32333 
(June 8, 2015); ``World Trade Center Health Program; Petition 008--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 39720 
(July 10, 2015); ``World Trade Center Health Program; Petition 009--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 65980 
(Oct. 28, 2015); ``World Trade Center Health Program; Petition 011--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 81 FR 24047 
(April 25, 2016); and ``World Trade Center Health Program; Petition 
013--Autoimmune Disease; Finding of Insufficient Evidence,'' 81 FR 
60329 (Sept. 1, 2016).
    \11\ See ``World Trade Center Health Program; Amendments to 
Definitions, Appeals, and Other Requirements; Final Rule,'' 81 FR 
90926 (Dec. 15, 2016), effective Jan. 17, 2017.
    \12\ See 42 CFR 88.17 (2016); see also 77 FR 24628 (Apr. 25, 
2012).
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    In accordance with WTC Health Program policy, the medical basis for 
a potential addition to the List may be demonstrated by reference to a 
peer-reviewed, published epidemiologic study about the health condition 
among 9/11-exposed populations or to clinical case reports of health 
conditions in WTC responders or survivors.\13\ Petition 014 presented 
an online news article \14\ announcing the online publication of a 
study published by Webber et al. [2015], entitled ``Nested Case-Control 
Study of Selected Systemic Autoimmune Diseases in World Trade Center 
Rescue/Recovery Workers.'' \15\ Because Webber et al. [2015] is a peer-
reviewed, published epidemiologic study of autoimmune diseases among 9/
11-exposed responders and survivors, the petition was considered valid. 
Accordingly, the Program conducted a review of available scientific 
information regarding the causal association between 9/11 exposure and 
autoimmune diseases, including rheumatoid arthritis.
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    \13\ See supra note 2.
    \14\ Boynes-Shuck A [2015], Why Rheumatoid Arthritis Is Plaguing 
9/11 First Responders, Healthline News, http://www.healthline.com/health-news/why-rheumatoid-arthritis-is-plaguing-9-11-first-responders-040415#1.
    \15\ Webber M, Moir W, Zeig-Owens R, et al. [2015], Nested Case-
Control Study of Selected Systemic Autoimmune Diseases in World 
Trade Center Rescue/Recovery Workers, Arthritis Rheumatol 
67(5):1369-1376.
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C. Review of Scientific and Medical Information and Administrator 
Determination

    A literature search conducted in response to Petition 007 \16\ 
included all of the autoimmune conditions in the 2015 Webber study; the 
Program conducted updates of that literature search in response to 
Petition 011 and Petition 013, looking for relevant studies published 
since the date of the previous literature search.\17\ In reviewing 
Petition 014, the Program conducted a search \18\ to update the results 
of the previous literature review for all of the types of autoimmune 
diseases identified in the 2015 Webber et al. study.\19\ The Program 
identified one new reference since the publication of the Petition 013 
FRN in September 2016, a conference abstract regarding sarcoidosis in 
9/11-exposed firefighters.\20\ Upon review, the abstract was determined 
not to be relevant because it is not a published epidemiologic study in 
a peer-reviewed scientific journal.
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    \16\ 80 FR 32333 (June 8, 2015).
    \17\ See 81 FR 24047 (April 25, 2016) and 81 FR 60329 (Sept. 1, 
2016), respectively.
    \18\ Databases searched include: CINAHL, Embase, NIOSHTIC-2, 
ProQuest Health and Safety Science Abstracts, PubMed, Scopus, 
Toxicology Abstracts, and TOXLINE.
    \19\ Rheumatoid arthritis; spondyloarthritis; inflammatory 
myositis (polymyositis and dermatomyositis); systemic lupus 
erythematosus; systemic sclerosis (scleroderma); Sjogren's syndrome; 
antiphospholipid syndrome; granulomatosis with polyangiitis 
(Wegener's); and eosinophilic granulomatosis with polyangiitis 
(Churg-Strauss).
    \20\ Hena K, Yip J, Jaber N, et al. [2016], Clinical 
Characteristics of Sarcoidosis in World Trade Center (WTC) Exposed 
Fire Department of the City of New York (FDNY) Firefighters, Chest 
150(4S):514A.
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    The literature review did not identify any newly-published, 
relevant studies of autoimmune diseases, including rheumatoid 
arthritis, in the 9/11-exposed population.\21\ Therefore, in accordance 
with the Program policy discussed above, the Program was unable to 
further evaluate Petition 014.
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    \21\ Two relevant studies identified in previous FRNs, Webber et 
al. [2015] and Webber M, Moir W, Crowson C, et al. [2016], Post-
September 11, 2001, Incidence of Systemic Autoimmune Diseases in 
World Trade Center-Exposed Firefighters and Emergency Medical 
Service Workers, Mayo Clin Proc 2016;91(1):23-32, were reviewed in 
the Petition 011 and Petition 013 FRNs and found not to have the 
potential to provide a basis for a decision on whether to propose 
adding autoimmune diseases to the List. These studies are not 
further discussed in this notice; discussions of the Administrator's 
findings with regard to these studies may be found in previous 
notices for Petition 011, 81 FR 24047 (April 25, 2016) and Petition 
013, 81 FR 60329 (Sept. 1, 2016).
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D. Administrator's Final Decision on Whether To Propose the Addition of 
Autoimmune Diseases to the List

    Finding no newly-published, relevant studies with regard to 
Petition 014, the Administrator has accordingly determined that 
insufficient evidence is available to take further action at this time, 
including either proposing the addition of autoimmune diseases, 
including rheumatoid arthritis, to the List (pursuant to PHS Act, sec. 
3312(a)(6)(B)(ii) and 42 CFR 88.16(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 
88.16(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 88.16(a)(2)(i)) is unwarranted.
    For the reasons discussed above, the Petition 014 request to add 
autoimmune diseases, including rheumatoid arthritis, to the List of 
WTC-Related Health Conditions is denied.

E. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or her/his 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. Anne 
Schuchat, M.D., Acting Director, CDC, and Acting Administrator, ATSDR, 
approved this document for publication on February 9, 2017.

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. 2017-03336 Filed 2-17-17; 8:45 am]
 BILLING CODE 4163-18-P