[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Proposed Rules]
[Pages 17972-17973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Petition 003--Kidney Damage; 
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 22, 2014, the Administrator of the World Trade 
Center (WTC) Health Program received a petition to add ``kidney 
damage'' (Petition 003) to the List of WTC-Related Health Conditions 
(List). The Administrator has not found sufficient scientific evidence 
to conduct an analysis of whether to add kidney damage and/or disease 
to the List. 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 March 31, 2014.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 4674 
Columbia Parkway, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: 

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 (responders) who responded to the 
September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania, and to eligible persons 
(survivors) 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.
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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 003

    On January 22, 2014, the Administrator received a petition to add 
``kidney damage'' to the List (Petition 003).\2\ The petition was 
submitted by a Fire Department of New York (FDNY) firefighter who 
worked at Ground Zero in the aftermath of the September 11, 2001, 
terrorist attacks. The petitioner indicated that he had been diagnosed 
with kidney failure and shared a letter

[[Page 17973]]

from his nephrologist explaining that he has ``chronic kidney disease 
with unknown oetiology [sic].'' Also included in his petition was a 
press release issued by the WTC-CHEST Program at Icahn School of 
Medicine at Mount Sinai (Mount Sinai) describing a forthcoming study by 
Mary Ann McLaughlin and others, finding a ``significant link between a 
high level of exposure to particulate matter by first responders at 
Ground Zero and the increased level of the protein albumin in their 
urine.'' \3\ The anticipated study findings are described in an 
abstract supplement to the Journal of the American Society of 
Nephrology.\4\
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    \2\ See Petition 003. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Mount Sinai Hospital [November 9, 2013]. Kidney Damage in 
First Responders Linked to September 11. http://www.mountsinai.org/about-us/newsroom/press-releases/kidney-damage-in-first-responders-linked-to-september-11.
    \4\ McLaughlin MA, Sanghavi S, Maceda C, Woodward M, Crowley LE, 
Wyatt CM [2013]. New Evidence that Particulate Matter Exposure at 
Ground Zero is Associated with Kidney Damage.'' J Am Soc Nephrol 
24:663A. See http://www.asn-online.org/education/kidneyweek/archives/.
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C. Administrator's Determination on Petition 003

    The Administrator has established a methodology for evaluating 
whether to add non-cancer health conditions to the List of WTC-Related 
Health Conditions.\5\ A health condition may be added to the List if 
published, peer-reviewed epidemiologic evidence provides substantial 
support for a causal relationship between 9/11 exposures and the health 
condition in 9/11-exposed populations.\6\ If the epidemiologic evidence 
provides modest support for a causal relationship between 9/11 
exposures and the health condition, the Administrator may then evaluate 
studies of associations between the health condition 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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    \5\ This methodology, ``Policy and Procedures for Adding Non-
Cancer Conditions to the List of WTC-Related Health Conditions,'' is 
available on the WTC Health Program Web site, at http://www.cdc.gov/wtc/policies.html.
    \6\ 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.
    \7\ 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.
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    In accordance with Sec.  3312(a)(6)(B) of the PHS Act and 42 CFR 
88.17, described above, the Administrator has reviewed the evidence 
presented in Petition 003. The Administrator has also conducted a 
search of the existing scientific/medical literature for evidence that 
could establish a causal relationship between 9/11 exposure and kidney 
damage/disease. He did not find any peer-reviewed, published 
epidemiologic studies of 9/11-exposed populations supporting such an 
relationship. While the information reported in the McLaughlin et al. 
abstract is an important first step in scientific inquiry, the 
Administrator finds that an abstract is insufficient to serve as the 
scientific basis for adding an entire class of health conditions--
chronic kidney damage/disease--to the List.
    Because the McLaughlin et al. abstract is found to be insufficient 
to scientifically support the further consideration of kidney damage/
disease and because it is clear to the Administrator that the 
scientific literature on 9/11 exposed-populations does not support a 
causal relationship between that exposure and kidney damage/disease, 
the Administrator has 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. In prior actions, the Administrator 
requested a recommendation from the STAC when he determined that it 
would assist his evaluation; such as when, for example, the 
Administrator is in need of an interpretation of conflicting or 
inconclusive published scientific evidence.
    Similarly, the Administrator has determined that insufficient 
evidence exists to take further action, including either proposing the 
addition of kidney damage/disease 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)). In order to publish such a proposed addition or a 
determination not to propose a rule, the Administrator would first need 
to find that enough scientific evidence is available to analyze whether 
9/11 exposures are associated with the health condition. Since the 
Administrator is unable to identify sufficient evidence to conduct an 
analysis of whether to add the health condition, the Administrator 
(pursuant to PHS Act, Sec.  3312(a)(6)(B)(iv) and 42 CFR 
88.17(a)(2)(iv)) is publishing a determination that he cannot take any 
of the other statutory and regulatory actions.
    For the reasons discussed above, the request made in Petition 003 
to add kidney damage/disease to the List of WTC-Related Health 
Conditions is denied.

    Dated: March 24, 2014.
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. 2014-06906 Filed 3-28-14; 8:45 am]
BILLING CODE 4163-18-P