[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Proposed Rules]
[Pages 60329-60332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21070]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 013--Autoimmune 
Disease; 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 4, 2016, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 013) to add 
``relapsing remitting multiple sclerosis (autoimmune)'' to the List of 
WTC-Related Health Conditions (List). Upon reviewing the information 
provided by the petitioner, the Administrator has determined that 
Petition 013 is not substantially different from Petitions

[[Page 60330]]

007, 008, 009, and 011, which also requested the addition of autoimmune 
diseases, including various subtypes. The Administrator recently 
published responses to the four previous petitions in the Federal 
Register and has determined that Petition 013 does not provide 
additional evidence of a causal relationship between 9/11 exposures and 
autoimmune diseases, including multiple sclerosis. 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 September 1, 
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 013
D. Administrator's Determination on Petition 013

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 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, 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 section 3312(a)(6)(B) of the PHS Act, interested 
parties may petition the Administrator to add a health condition to the 
List in 42 CFR 88.1. Within 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 
88.17: (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 88.17(a)(4), the Administrator is required to 
consider a new petition for a previously-evaluated health condition 
determined not to qualify for addition to the List only if the new 
petition 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.

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 for publication on August 24, 2016.

C. Petition 013

    On April 4, 2016, the Administrator received a petition from a 
responder in the WTC Health Program to add ``relapsing remitting 
multiple sclerosis (autoimmune)'' to the List (Petition 013).\2\ 
Because the petitioner identified the requested health condition as 
``the autoimmune disease of multiple sclerosis'' in the petition 
narrative and used a study of autoimmune diseases among WTC responders 
to provide the medical basis for the petition,\3\ the Administrator 
determined that the petitioned health condition is ``autoimmune 
diseases, including multiple sclerosis.''
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    \2\ See Petition 013, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \3\ Id.
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    This is the fifth petition to the Administrator requesting the 
addition of autoimmune diseases, including various subtypes, to the 
List; each of the first four autoimmune disease petitions were denied 
due to insufficient evidence, as described in respective Federal 
Register notices (FRNs).\4\ 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.\5\ In accordance with WTC Health Program 
policy, the Science Team reviews references for relevance, and relevant 
studies are further reviewed for quality and quantity.\6\ The current 
petition, Petition 013, presented five references to support the 
request to add ``relapsing remitting multiple sclerosis (autoimmune)'' 
to the List.
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    \4\ ``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); and ``World Trade Center Health Program; Petition 
011--Autoimmune Diseases; Finding of Insufficient Evidence,'' 81 FR 
24047 (April 25, 2016).
    \5\ See John Howard, Administrator of the WTC Health Program, 
Policy and Procedures for Handling Submissions and Petitions to Add 
a Health Condition to the List of WTC-Related Health Conditions, May 
14, 2014, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
    \6\ Information is determined to be relevant if it is presented 
in peer-reviewed, published, epidemiologic studies of the health 
condition in 9/11-exposed populations. John Howard, Administrator of 
the WTC Health Program, Policy and Procedures for Adding Non-Cancer 
Conditions to the List of WTC-Related Health Conditions, May 11, 
2016, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
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    Petition 013 references 1, 2, and 4 are links to the same newspaper 
article announcing the online publication of a study published in 
2015.\7\ Petition 013

[[Page 60331]]

reference 3 is a different newspaper article announcing the online 
publication of the same study.\8\ These four references identify a 2015 
study by Webber et al., a peer-reviewed, published epidemiologic study 
of autoimmune diseases among 9/11-exposed responders and survivors, 
titled ``Nested Case-Control Study of Selected Systemic Autoimmune 
Diseases in World Trade Center Rescue/Recovery Workers.'' \9\ The 2015 
Webber et al. study has already been evaluated by the Administrator in 
consideration of the other four autoimmune disease petitions, and is 
discussed below.
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    \7\ The article, by Amy Norton, is published in reference 1, New 
Health Worry for 9/11 Recovery Workers, HealthDay, March 19, 2015, 
in www.cbsnews.com/news/ground-zero-workers-at-risk-of-autoimmune-diseases; reference 2, `Ground Zero' Workers at Risk of Autoimmune 
Diseases: Study, HealthDay, March 19, 2015, in http://www.medicinenet.com/script/main/art.asp?articlekey=187534; and 
reference 4, `Ground Zero' Workers at Risk of Autoimmune Diseases: 
Study, HealthDay, March 19, 2015, https://consumer.healthday.com/senior-citizen-information-31/misc-arthritis-news-41/ground-zero-workers-at-risk-of-autoimmune-diseases-study-697581.html. The study 
announced in the Norton article is the 2015 study by Webber et al., 
cited infra note 9.
    \8\ Nancy Walsh, Autoimmunity Rising in 9/11 Workers, MedPage 
Today, March 19, 2015, http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/50548.
    \9\ Mayris Webber, William Moir, Rachel Zeig-Owens, et al., 
Nested Case-Control Study of Selected Systemic Autoimmune Diseases 
in World Trade Center Rescue/Recovery Workers, Arthritis Rheumatol 
2015;67(5):1369-1376.
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    The fifth reference provided in Petition 013 does not specifically 
identify a peer-reviewed, published epidemiologic study of the health 
condition among 9/11-exposed populations, nor is it a clinical case 
report of the health condition in WTC responders or survivors. Petition 
013 reference 5 is a link to the proceedings of a research meeting 
conducted by the WTC Health Program in 2014.\10\ Two abstracts found in 
the proceedings address the topic of autoimmune disease among the 9/11 
population--``Autoimmune Disease among WTCHR [World Trade Center Health 
Registry] Registrants: Survey Design and Preliminary Response Rates,'' 
and ``Post-9/11 Incidence of Systemic Autoimmune Diseases in the FDNY 
Cohort.'' The former abstract references an unpublished study; because 
unpublished studies do not meet the Program's standard for relevance, 
it was not further considered. The latter abstract describes a study 
that resulted in the 2015 Webber et al. publication discussed in this 
action and reviewed in full in the April 2016 FRN for Petition 011.
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    \10\ WTC Health Program, Research Meeting Proceedings, June 17-
18, 2014, www.cdc.gov/wtc/proceedings.html.
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    As discussed in the April 2016 FRN finding of insufficient evidence 
for Petition 011, the 2015 Webber et al. study looked at the 
association between 9/11-related exposures and systemic autoimmune 
diseases. It was found to be a published, peer-reviewed epidemiologic 
study of autoimmune diseases in the 9/11 population, and therefore 
deemed relevant. However, the study was found to exhibit substantial 
limitations, and it was ultimately concluded not to have the potential 
to form the basis for a decision on whether to propose adding 
autoimmune diseases to the List of WTC-Related Health Conditions.\11\
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    \11\ 81 FR 24047 at 24049.
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    In addition to a review of the studies presented in Petition 013, 
the WTC Health Program Science Team conducted 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. A previously conducted 
literature review for autoimmune diseases in response to Petition 007 
\12\ included all of the autoimmune conditions in the 2015 Webber et 
al. study.\13\ In reviewing Petition 013, the Science Team conducted a 
search 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, and also conducted a separate search for published, peer-
reviewed studies of multiple sclerosis in 9/11 populations.\14\
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    \12\ See 80 FR 32333 at 32334.
    \13\ 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).
    \14\ Databases searched include: CINAHL, Embase, NIOSHTIC-2, 
PsycINFO, PubMed, Scopus, Toxicology Abstracts, and TOXLINE.
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    The Science Team identified five additional references to review 
for relevance. Of the five additional references, only one study, 
published in 2016 by Webber et al.,\15\ was found to be a relevant, 
published, peer-reviewed study of autoimmune diseases in 9/11-exposed 
populations. No published, peer-reviewed epidemiologic studies of 
multiple sclerosis in 9/11-exposed populations were identified in the 
literature search.
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    \15\ Mayris Webber, William Moir, Cynthia Crowson, et al., 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.
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    The 2016 Webber et al. study is a follow-up to the 2015 Webber et 
al. study discussed above. The 2016 Webber et al. study looked at the 
same cohort of FDNY rescue/recovery workers included in the 2015 study 
to estimate the incidence of systemic autoimmune diseases in the cohort 
of FDNY rescue/recovery workers and to compare the FDNY incidence rates 
to demographically similar men and other published rates. This 
additional reference, the 2016 Webber et al. study, was also identified 
as relevant in the literature search for Petition 011. As a result, it 
was further reviewed in the April 2016 FRN for Petition 011 and, along 
with the 2015 Webber et al. study, evaluated for quantity and quality 
to provide a sufficient basis for deciding whether to propose an 
addition to the List. Significant limitations, discussed in the April 
2016 FRN for Petition 011, led the WTC Health Program to conclude that 
the 2015 Webber et al., and the 2016 Webber et al. study together do 
not have the potential to provide a basis for a decision on whether to 
propose adding autoimmune diseases to the List.
    All of the references and potential medical bases presented in 
Petition 013 were previously identified and assessed in Petition 011; 
as discussed above, these medical bases had significant limitations 
that prevented them from having the potential to provide a basis to 
propose adding autoimmune diseases to the List. The Science Team did 
not find any information during their review of Petition 013 which 
would alter the assessment of the previously reviewed studies. 
Moreover, none of the studies identified, including the 2015 and 2016 
Webber et al. studies, include multiple sclerosis. Thus, no evidence 
was found specific to multiple sclerosis which would have the potential 
to form the basis for a decision on whether to propose adding multiple 
sclerosis to the List.

D. Administrator's Determination on Petition 013

    The Administrator has established a policy for evaluating whether 
to propose the addition of non-cancer health conditions to the List of 
WTC-Related Health Conditions.\16\ Petition 013 requested the addition 
of ``relapsing remitting multiple sclerosis (autoimmune)'' to the List. 
The Administrator previously reviewed the category of ``autoimmune 
diseases,'' which includes multiple sclerosis, for Petitions 007, 008, 
009, and 011. Neither the references included in Petition 013 nor the 
studies found in the literature review conducted by the Science Team 
presented evidence of a causal association between 9/11 exposures and

[[Page 60332]]

autoimmune diseases, including multiple sclerosis.
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    \16\ Supra note 6.
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    The Administrator initially reviewed the findings presented in the 
2015 Webber et al. study in response to Petition 007, which also 
requested the addition of autoimmune diseases, including rheumatoid 
arthritis and connective tissue diseases. In that review, due to 
limitations in the 2015 Webber et al. study, the Administrator 
determined that insufficient evidence existed to take any of the 
following actions: Propose the addition of autoimmune diseases to the 
List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 
88.17(a)(2)(ii)); publish 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)); or request a 
recommendation from the STAC (pursuant to PHS Act, sec. 
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)). The 2015 Webber et al. 
study was also presented as evidence to support the Petition 008 
request for autoimmune disorders, specifically encephalitis of the 
brain, the Petition 009 request for autoimmune disorders, including 
multiple sclerosis, as well as the Petition 011 request for autoimmune 
disorders, including lupus and rheumatoid arthritis. The 2016 Webber et 
al. study was also presented as evidence to support Petition 011. As 
concluded in the April 2016 FRN for Petition 011, the two Webber et al. 
studies, taken together, while meeting the relevance threshold of being 
published, peer-reviewed epidemiologic studies of autoimmune diseases 
in 9/11-exposed populations, were found to exhibit significant 
limitations and were thus insufficient to provide a potential basis for 
a decision on whether to propose adding the requested health conditions 
to the List.\17\
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    \17\ 81 FR 24047 at 24050.
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    Finding no additional relevant studies with regard to Petition 013, 
the Administrator has accordingly determined that insufficient evidence 
exists to take further action at this time, including either proposing 
the addition of autoimmune diseases, including multiple sclerosis, 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 013 
to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the 
List of WTC-Related Health Conditions is denied.
    The Administrator will continue to monitor the scientific 
literature for publication of the results of the ongoing WTC Health 
Registry study discussed above (reference 5 in the petition) and any 
other studies that address autoimmune diseases among 9/11-exposed 
populations.

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. 2016-21070 Filed 8-31-16; 8:45 am]
 BILLING CODE 4163-18-P