80 FR 39720 - World Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 132 (July 10, 2015)

On May 11, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 008) to add autoimmune diseases to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 008 is not substantially different from Petition 007, which also requested the addition of autoimmune diseases. The Administrator recently published a response to Petition 007 in the Federal Register and has determined that Petition 008 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.

[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Proposed Rules]
[Pages 39720-39722]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 008--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 May 11, 2015, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 008) to add 
autoimmune diseases to the List of WTC-Related Health Conditions 
(List). Upon reviewing the information provided by the petitioner, the 
Administrator has determined that Petition 008 is not substantially 
different from Petition 007, which also requested the addition of 
autoimmune diseases. The Administrator recently published a response to 
Petition 007 in the Federal Register and has determined that Petition 
008 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

[[Page 39721]]

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 July 10, 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 008
C. Administrator's Determination on Petition 008

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 008

    On May 11, 2015, the Administrator received a petition to add 
``autoimmune disease--encephalitis of the brain'' to the List (Petition 
008).\2\ This is the second 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). Petition 008, which is addressed in this notice, 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 encephalitis as well as two WTC-
related health conditions. The petition presented as evidence several 
newspaper articles referencing a study recently 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 008. 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 008 specifically requested the addition of 
``autoimmune disease--encephalitis of the brain,'' the Administrator 
determined that the scope of the petition properly includes only the 
autoimmune diseases identified in Webber et al., cited as evidence in 
both Petition 007 and Petition 008.\4\ Encephalitis is not among the 
autoimmune diseases studied by Webber et al. No other evidence was 
provided in Petition 008 to support the addition of encephalitis to the 
List; therefore, encephalitis 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 008

    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 008 requested the addition of a health 
condition that was previously reviewed by the Program, and presented no 
new evidence of a causal association between 9/11 exposures and 
autoimmune diseases. In a response to Petition 007, which also 
requested the addition of autoimmune diseases, published in the Federal 
Register on June 8, 2015 (80 FR 32333), 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)). 
Because the Administrator recently evaluated the Webber study, 
presented as evidence for the addition of autoimmune conditions in 
Petition 007, there is no need to reevaluate the same evidence again in 
response to the request to add autoimmune diseases in Petition 008, 
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 008, the Administrator has 
determined that insufficient evidence exists to take further action, 
including either proposing the addition of autoimmune

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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 008 
to add autoimmune diseases 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 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: July 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. 2015-16942 Filed 7-9-15; 8:45 am]
 BILLING CODE 4163-18-P