[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Proposed Rules]
[Pages 65980-65982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 009--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 14, 2015, the Administrator of the World Trade 
Center (WTC) Health Program received a petition (Petition 009) to add 
the autoimmune disease multiple sclerosis to the List of WTC-Related 
Health Conditions (List). Upon reviewing the information provided by 
the petitioner, the Administrator has determined that Petition 009 is 
not substantially different from Petitions 007 and 008, which also 
requested the addition of autoimmune diseases. The Administrator 
recently published responses to both Petition 007 and Petition 008 in 
the Federal Register and has determined that Petition 009 does not 
provide additional evidence of a causal relationship between 9/11 
exposures and autoimmune diseases. 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 October 28, 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 009
C. Administrator's Determination on Petition 009


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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 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 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 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. 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. Petition 009

    On September 14, 2015, the Administrator received a petition to add 
the autoimmune disease multiple sclerosis to the List (Petition 
009).\2\ This is the third petition to the Administrator requesting the 
addition of autoimmune diseases to the List; the first autoimmune 
disease petition, Petition 007, was denied due to insufficient evidence 
as described in a Federal Register notice published on June 8, 2015 (80 
FR 32333); the second, Petition 008, was also denied due to 
insufficient evidence as described in a separate Federal Register 
notice published on July 10, 2015 (80 FR 39720). This petition, 
Petition 009, presented as evidence a newspaper article referencing a 
study recently published in the Journal of Arthritis and Rheumatology 
by Webber et al. [2015],\3\ as well as the journal article itself, 
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 009. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Webber MP, Moir W, Zeig-Owens R, Glaser MS, Jaber N, Hall C, 
Berman J, Qayyum B, Loupasakis K, Kelly K, and Prezant DJ [20015]. 
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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    Although Petition 009 specifically requested the addition of 
multiple sclerosis, an autoimmune condition, the Administrator 
determined that the scope of the petition properly includes only the 
autoimmune diseases identified in Webber et al., cited as evidence in 
Petitions 007, 008, and 009.\4\ Multiple sclerosis is not among the 
autoimmune diseases studied by Webber et al. No other evidence was 
provided in Petition 009 to support the addition of multiple sclerosis 
to the List; therefore, multiple sclerosis is not addressed in this 
action.
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    \4\ This determination is consistent with the Administrator's 
reasoning in the Petition 007 finding of insufficient evidence. 80 
FR 32333, June 8, 2015.
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C. Administrator's Determination on Petition 009

    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.\5\ However, the 
Administrator has determined that the methodology is not triggered in 
this case because Petition 009 requested the addition of the autoimmune 
diseases identified in Webber et al. previously reviewed by the 
Program, and presented no new evidence of a causal association between 
9/11 exposures and autoimmune diseases. In response to Petition 007, 
which also requested the addition of autoimmune diseases, the 
Administrator reviewed the findings presented in the Webber study and 
determined that insufficient evidence exists to take any of the 
following actions: Propose the addition of autoimmune diseases to the 
List (pursuant to PHS Act, section 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, section 
3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)); or request a 
recommendation from the STAC (pursuant to PHS Act, section 
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)). The Webber study was also 
presented as evidence to support Petition 008 regarding autoimmune 
disorders, specifically encephalitis of the brain. Because the 
Administrator recently evaluated the Webber study in responding to 
Petitions 007 and 008, there is no need to reevaluate the same evidence 
again in response to the request to add autoimmune diseases in Petition 
009, which also presented the Webber study as evidence of a causal 
association between 9/11 exposures and autoimmune diseases.
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    \5\ ``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.
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    Accordingly, with regard to Petition 009, the Administrator has 
determined that insufficient evidence exists to take further action, 
including either proposing the addition of autoimmune diseases to the 
List (pursuant to PHS Act, section 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, section 
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, section 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 009 
to add the autoimmune disease multiple sclerosis to the List of WTC-
Related Health Conditions is denied.
    The Administrator is aware that another study of autoimmune 
diseases among WTC Health Program members is

[[Page 65982]]

being conducted by the WTC 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 9/11-exposed populations.

    Dated: October 22, 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. 2015-27435 Filed 10-27-15; 8:45 am]
 BILLING CODE 4163-18-P