[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Proposed Rules]
[Pages 32333-32334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
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    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