[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24047-24050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 011--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 January 25, 2016, the Administrator of the World Trade 
Center (WTC) Health Program received a petition (Petition 011) to add 
``autoimmune disease, lupus, and 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 011 is not substantially different from Petitions 007, 008, 
and 009, which also requested the addition of autoimmune diseases. The 
Administrator recently published responses to Petitions 007, 008, and 
009 in the Federal Register and has determined that Petition 011 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 24048]]

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 April 25, 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 011
D. Administrator's Determination on Petition 011

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Zadroga Act), Public Law 111-347, as amended by Public Law 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. 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 April 18, 2016.

C. Petition 011

    On January 25, 2016, the Administrator received a petition from a 
responder in the WTC Health Program to add autoimmune disease, lupus, 
and rheumatoid arthritis to the List (Petition 011).\2\ This is the 
fourth petition to the Administrator requesting the addition of 
autoimmune diseases to the List; the first three autoimmune disease 
petitions, Petition 007, Petition 008, and Petition 009, were each 
denied due to insufficient evidence as described in Federal Register 
notices published on June 8, 2015,\3\ July 10, 2015,\4\ and October 28, 
2015,\5\ respectively.
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    \2\ See Petition 011. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ 80 FR 32333.
    \4\ 80 FR 39720.
    \5\ 80 FR 73667.
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    The current petition, Petition 011, presented eight references to 
support the request to add ``autoimmune disease, lupus, and rheumatoid 
arthritis'' to the List. Pursuant to 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.\6\ Of the 
references provided, references 1-5, 7, and an unnumbered 8th reference 
do not identify peer-reviewed, published studies or clinical case 
reports about autoimmune disease, lupus, or rheumatoid arthritis among 
9/11-exposed responders and survivors. Reference 6 is a study that has 
already been evaluated by the Administrator in consideration of other 
autoimmune disease petitions.
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    \6\ See John Howard, Administrator, 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.
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    In addition to a review of the studies presented in Petition 011, 
the WTC Health Program Associate Director for Science (ADS) 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. The ADS 
previously conducted such a literature review for autoimmune disorders 
in response to Petition 007.\7\ In reviewing Petition 011, the ADS 
conducted an additional search to update the results of the previous 
literature review.\8\ The new literature search identified six studies 
published in 2015 and 2016.
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    \7\ See 80 FR 32333 at 32334.
    \8\ Databases searched include: PubMed, Health & Safety Science 
Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and 
NIOSHTIC-2.
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    In accordance with WTC Health Program policy, the ADS reviewed the 
eight references in Petition 011 and the six studies identified in the 
literature review for relevance, and then relevant studies were further 
reviewed for quality, and quantity.\9\ The ADS review is discussed 
below.
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    \9\ See John Howard, Administrator of the WTC Health Program, 
Policy and Procedures for Adding Non-Cancer Conditions to the List 
of WTC-Related Health Conditions, Oct. 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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    Petition references 1, 2, and 3 are the Web sites of the S.L.E. 
Lupus Foundation,\10\ Molly's Fund Fighting Lupus,\11\ and the Johns 
Hopkins Lupus Center,\12\ respectively. The referenced Web pages 
discuss the development of lupus in general terms, but do not reference 
9/11 exposure-related causation specifically. The Johns Hopkins Web 
page includes references to book chapters about lupus, none of

[[Page 24049]]

which associate the disease with 9/11 exposure. These references are 
not considered relevant under the policy for adding non-cancers to the 
List because they are not published, peer-reviewed epidemiologic 
studies of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/
11-exposed populations and, therefore, they were not further reviewed.
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    \10\ http://www.lupusny.org.
    \11\ http://www.mollysfund.org.
    \12\ http://www.hopkinslupus.org.
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    Petition reference 4 is the Fire Department of New York (FDNY) EMS 
Retirees Association's Web page on WTC Monitoring and Treatment 
Centers, which mentions lupus and rheumatoid arthritis and is relevant 
to the 9/11 population, but does not identify a published, peer-
reviewed epidemiologic study or clinical case report. This reference is 
not considered relevant under the policy for adding non-cancers to the 
List because it is not a published, peer-reviewed epidemiologic study 
of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-
exposed populations and, therefore, it was not further reviewed.
    Petition reference 5 is a 2011 Medical News Today Web page that 
summarizes a study by Zeig-Owens, et al., ``Early Assessment of Cancer 
Outcomes in New York City Firefighters after the 9/11 Attacks: An 
Observational Cohort Study,'' apparently for the premise that 9/11 
exposures could also trigger chronic inflammation through autoimmune 
disease.\13\ Although the Zeig-Owens study is a published, peer-
reviewed epidemiologic study relevant to the 9/11 population, it does 
not include any discussion of the basis for a causal association 
between the September 11, 2001, terrorist attacks and autoimmune 
disease, lupus, and/or rheumatoid arthritis. Thus, this reference is 
not considered relevant under the policy for adding non-cancers to the 
List because it is not a published, peer-reviewed epidemiologic study 
of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-
exposed populations and, therefore, it was not further reviewed.
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    \13\ Rachel Zeig-Owens, Mayris Webber, Charles Hall, et al., 
Early Assessment of Cancer Outcomes in New York City Firefighters 
after the 9/11 Attacks: An Observational Cohort Study, The Lancet 
2011;378(9794):898-905 at 904.
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    Petition reference 7 is an abstract for a NIOSH-funded study 
titled, ``Autoimmune Disease among WTCHR [WTC Health Registry] 
Registrants: Survey Design and Preliminary Response Rates.'' \14\ 
Because the study is on-going and not yet published, it is not 
considered relevant under the policy for adding non-cancers to the List 
because it is not a published, peer-reviewed epidemiologic study of 
autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-exposed 
populations and, therefore, it was not further reviewed.
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    \14\ WTC Health Program, Research Meeting Proceedings; June 17-
18, 2014. www.cdc.gov/wtc/proceedings.html.
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    Petition reference 8 (unnumbered in the petition) is two excerpts 
from an HHS publication entitled, ``The Future Directions of Lupus 
Research.'' \15\ Neither the topic of the first excerpt, concerning 
environmental factors leading to the development of lupus, nor the 
second, concerning the role of crystalline silica in the development of 
lupus, addresses this disease among 9/11-exposed populations. Similar 
to the references discussed above, this reference is not considered 
relevant under the policy for adding non-cancers to the List because it 
is not a published, peer-reviewed epidemiologic study of autoimmune 
disease, lupus, and/or rheumatoid arthritis in 9/11-exposed populations 
and, therefore, it was not further reviewed.
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    \15\ National Institutes of Health, HHS, The Future Directions 
of Lupus Research, Aug. 2007. http://www.niams.nih.gov/About_Us/Mission_and_Purpose/lupus_plan.pdf.
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    The remaining petition reference, reference 6, is a 2015 study by 
Webber et al., titled ``Nested Case-Control Study of Selected Systemic 
Autoimmune Diseases in World Trade Center Rescue/Recovery Workers.'' 
\16\ The 2015 Webber study assessed whether 9/11-related exposure was 
associated with new-onset systemic autoimmune disease (including 
rheumatoid arthritis and systemic lupus erythematosus, or SLE \17\) 
using a nested case-control study of male 9/11-exposed Fire Department 
of New York (FDNY) rescue/recovery workers. In reviewing the 2015 
Webber study in consideration of Petition 007, the ADS found that the 
study was relevant and conducted further review for quantity and 
quality of evidence in the study. Ultimately, the ADS found that the 
study lacked information on other important confounders that could 
explain associations between 9/11-related exposures and systemic 
autoimmune diseases; in addition, there were limitations regarding the 
sample size, methods used to quantify exposure, and generalizability. 
Taken together, these limitations led the ADS to conclude that the 
available information did not 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 for Petition 007.\18\
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    \16\ 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, Journal of Arthritis 
& Rheumatology 2015;67(5):1369-1376.
    \17\ Systematic lupus erythematosus is the most common type of 
lupus. See CDC: Lupus. http://www.cdc.gov/lupus/index.htm.
    \18\ See 80 FR 32333 at 32334.
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    The ADS identified six references in the literature review 
performed pursuant to the policy for adding non-cancer health 
conditions to the List. Four were found to be not relevant because they 
were not epidemiologic studies, therefore they were not further 
assessed. One study was the 2015 Webber et al. study reviewed by the 
Administrator in consideration of Petition 007, discussed above.
    The final study identified in the literature review was a 2016 
epidemiologic study by Webber et al.\19\ The 2016 Webber study is a 
follow-up to the 2015 Webber study, which looked at the association 
between 9/11-related exposures and systemic autoimmune diseases. The 
2016 Webber study looked at the same cohort of FDNY rescue/recovery 
workers included in the 2015 study to estimate the incidence of 
systemic autoimmune diseases from September 12, 2001, through September 
11, 2014, in the cohort of FDNY rescue/recovery workers. The authors 
also compared the FDNY incidence rates to rates from demographically 
similar men included in the Rochester Epidemiology Project (REP) and to 
other published rates, in order to measure observed FDNY cases against 
the number of cases expected. Because this study was found relevant, it 
was further reviewed and evaluated for quantity and quality to provide 
a sufficient basis for deciding whether to propose an addition to the 
List.
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    \19\ 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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    In the 2016 study, Webber et al. confirmed cases of systemic 
autoimmune diseases in the FDNY cohort either through medical records 
review using the American College of Rheumatology criteria or based on 
self-reports deemed ``probable'' by two board certified 
rheumatologists. The study identified 97 cases of systemic autoimmune 
diseases among the FDNY cohort (63 medical record-confirmed cases and 
34 probable self-report cases). The authors next calculated incidence 
for each specific autoimmune disease identified in the study among the 
FDNY cohort, and also calculated the incidence for all systemic 
autoimmune diseases combined.

[[Page 24050]]

    The 2016 Webber study then looked to the REP comparison group to 
provide age- and sex-specific incidence rates during a similar time 
period as reviewed for the FDNY cases. Incidence rates for the REP 
comparison group were only available, however, for a limited subset of 
five autoimmune conditions: Rheumatoid arthritis, psoriatic arthritis, 
ankylosing spondylitis, SLE, and scleroderma. By applying the REP 
incidence rates to the FDNY cohort, the study authors were able to 
generate age-specific expected numbers of cases for the FDNY cohort. 
The observed incidence rates in the FDNY cohort were then compared with 
the expected numbers of cases for the FDNY cohort derived from the REP 
rates. Standardized ratios, which are the ratios of the observed number 
of cases in the FDNY cohort to the expected number of cases (based on 
the REP rates) were then calculated. Overall, FDNY rates for the five 
types of autoimmune disease compared were not significantly different 
from expected rates (SIR, 0.97; 95% CI, 0.77-1.21). Only SLE had a 
standardized incidence ratio that was statistically significantly 
greater among the entire FDNY cohort. Other ratios were either reduced 
or not statistically significant.
    Limitations similar to those found in the 2015 Webber study, 
discussed above, were seen in the 2016 Webber study, including the lack 
of information on potential confounders such as family history of 
autoimmune disease and both work-related and recreational non-9/11-
related exposures, and poor generalizability to other 9/11-exposed 
groups. The 2016 Webber study did not include new or additional 
information or controls that would avoid or mitigate the limitations 
found in the 2015 study. Consistent with the assessment of Petition 
007,\20\ the ADS disagreed with the method for measuring chronic 
exposure with a duration variable that did not differentiate between 
those with one day versus many days of exposure in a given month. 
Furthermore, the lack of information about occupational history and 
other potential confounders among the REP cohort calls into question 
the applicability and comparability of the rates used in the 2016 
Webber study.
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    \20\ See 80 FR 32333 at 32334.
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D. Administrator's Determination on Petition 011

    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.\21\ Petition 011 requested the addition 
of autoimmune diseases which were previously reviewed by the 
Administrator for Petition 007, and neither the references included in 
the petition nor the studies found in the literature review conducted 
by the ADS presented evidence of a causal association between 9/11 
exposures and autoimmune diseases, lupus, and/or rheumatoid arthritis. 
The Administrator initially reviewed the findings presented in the 2015 
Webber 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 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 study was 
also presented as evidence to support Petition 008 regarding autoimmune 
disorders, specifically encephalitis of the brain, as well as Petition 
009 regarding the autoimmune disorder multiple sclerosis.
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    \21\ John Howard, Administrator of the WTC Health Program, 
Policy and Procedures for Adding Non-Cancer Conditions to the List 
of WTC-Related Health Conditions, Oct. 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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    In reviewing the 2016 Webber study for potential support for 
Petition 011, the ADS concluded that similar inadequacies existed for 
the 2016 study as those seen in the 2015 Webber study. Taken together, 
the two Webber studies, while meeting the relevance threshold of being 
published, peer-reviewed epidemiologic studies of autoimmune disease, 
including lupus and rheumatoid arthritis, 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.
    Accordingly, with regard to Petition 011, the Administrator has 
determined that insufficient evidence exists to take further action at 
this time, including either proposing 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)) 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 011 
to add autoimmune disease, lupus, and rheumatoid arthritis 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 7 in the petition) and any 
other studies that address autoimmune diseases among 9/11-exposed 
populations.

    Dated: April 20, 2016.
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. 2016-09527 Filed 4-22-16; 8:45 am]
BILLING CODE 4163-18-P