World Trade Center Health Program; Petition 012-Atherosclerosis; Finding of Insufficient Evidence, 90295-90297 [2016-29816]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Proposed Rules]
[Pages 90295-90297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 012--Atherosclerosis; 
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 11, 2016, the Administrator of the World Trade Center 
(WTC) Health Program received two petitions (combined into Petition 
012) to add atherosclerosis to the List of WTC-Related Health 
Conditions (List). The Program conducted a literature search for the 
term in response to the Petition and found no relevant studies 
regarding atherosclerosis among 9/11-exposed populations. 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 90296]]

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 December 14, 
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 NIOSHregs@cdc.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

A. WTC Health Program Statutory Authority
B. Petition 012
C. Review of Scientific and Medical Information and Administrator 
Determination
D. Administrator's Final Decision on Whether To Propose the Addition 
of Atherosclerosis to the List
E. Approval To Submit Document to the Office of the Federal Register

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title 
XXXIII to the Public Health Service (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 James Zadroga 9/11 Health and 
Compensation Act of 2010 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 90 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: (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.
    In addition to the regulatory provisions, the WTC Health Program 
has developed policies to guide the review of submissions and petitions 
\2\ and the analysis of evidence supporting the potential addition of a 
non-cancer health condition to the List.\3\ In accordance with the 
aforementioned non-cancer health condition addition policy, the 
Administrator directs the WTC Health Program 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 health condition to the List. A literature review 
includes a search for peer-reviewed, published epidemiologic studies 
(including direct observational studies in the case of health 
conditions such as injuries) about the health condition among 9/11-
exposed populations; such studies are considered ``relevant.'' Relevant 
studies identified in the literature search are further reviewed for 
their 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 
scientific and medical evidence is further assessed 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 
peer-reviewed, published, direct observational or epidemiologic studies 
provide substantial support \4\ 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 \5\ for a causal 
relationship between 9/11 exposures and the health condition, the 
Administrator may then evaluate additional peer-reviewed, published 
epidemiologic studies, conducted among non-9/11-exposed populations, 
evaluating associations between the health condition of interest and 9/
11 agents.\6\ 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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    \2\ See WTC Health Program [2014], Policy and Procedures for 
Handling Submissions and Petitions to Add a Health Condition to the 
List of WTC-Related Health Conditions, May 14, https://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
    \3\ See WTC Health Program [2016], Policy and Procedures for 
Adding Non-Cancer Conditions to the List of WTC-Related Health 
Conditions, May 11, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
    \4\ 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.
    \5\ 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.
    \6\ 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, at the Pentagon site, or at the 
Shanksville, Pennsylvania site, as those locations are defined in 42 
CFR 88.1.
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B. Petition 012

    On April 11, 2016, the Administrator received a petition from a New 
York City Police Department (NYPD) responder who worked at Ground Zero, 
and a second, related petition which requested the addition of 
``atherosclerosis (plaque in arteries),'' and ``atherosclerosis--
arterial plaque,'' respectively, to the List; the petitions provided 
references to the same medical basis, a study by Mani et al. [2013]. 
The petitions together are considered Petition 012 as permitted by 42 
CFR 88.17(a)(3).\7\
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    \7\ See Petition 012, WTC Health Program: Petitions Received, 
https://www.cdc.gov/wtc/received.html.
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    In accordance with 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.\8\ Both of

[[Page 90297]]

the submissions considered in the current petition, Petition 012, 
presented the same single reference to support the request to add 
``Atherosclerosis (plaque in arteries)'' to the List. The reference, a 
study by Mani et al. [2013],\9\ is a pilot study of the ability of 
diagnostic imaging to evaluate differences in atherosclerosis profiles 
in WTC responders exposed to high levels (as found in the initial dust 
cloud) and low levels (found after September 13, 2001) of particulate 
matter. The study evaluated the feasibility of using dynamic contrast 
enhanced MRI, a relatively new imaging method, to evaluate 
atherosclerosis among 31 law enforcement personnel who responded at 
Ground Zero (19 with self-reported high exposures and 12 with self-
reported low exposures). The study population examined in Mani et al. 
[2013] is small and is not fully representative of the greater 9/11 
population, including other non-law enforcement responders and 
survivors. Although the study has attributes of an epidemiologic study, 
the small subset of law enforcement personnel sampled and the non-
random manner in which the sample was obtained prevent extrapolation of 
the findings of Mani et al. [2013] to the whole 9/11-exposed 
population. Moreover, the study does not investigate the causal link 
between 9/11 exposures and atherosclerosis. Therefore, the 
Administrator has determined that while the inclusion of this peer-
reviewed and published study in the submissions provides sufficient 
medical basis to be considered a valid petition, Mani et al. [2013] is 
not an epidemiologic study, cannot be considered relevant, and is not 
further reviewed below.
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    \8\ See supra note 2.
    \9\ Mani V, Wong S, Sawit S, et al. [2013], Relationship between 
Particulate Matter Exposure and Atherogenic Profile in ``Ground 
Zero'' Workers as Shown by Dynamic Contrast Enhanced MR Imaging, Int 
J Cardiovasc Imaging 29:827-833.
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C. Review of Scientific and Medical Information and Administrator 
Determination

    In response to Petition 012, and pursuant to Program policy,\10\ 
the Program conducted a review of the scientific literature on 
atherosclerosis to determine if the available evidence has the 
potential to provide a basis for a decision on whether to add 
atherosclerosis to the List.\11\ The literature search identified one 
citation for atherosclerosis; \12\ upon review, however, it was found 
not to be relevant because it was not a study of atherosclerosis among 
the 9/11-exposed population.
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    \10\ Supra note 3.
    \11\ Databases searched include: CINAHL, Embase, PsycINFO, 
PubMed, and Scopus.
    \12\ Landrigan PJ, Wright RO, Cordero JF, et al. [2015], The 
NIEHS Superfund Research Program: 25 Years of Translational Research 
for Public Health, Environ Health Perspect 123(10):909-918. This 
manuscript describes the successes of the Superfund Research 
Program; although the key terms ``atherosclerosis'' and ``World 
Trade Center'' are both mentioned, they are not discussed in 
relation to each other.
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    Since the literature review did not identify any relevant studies 
of atherosclerosis in the 9/11-exposed population, in accordance with 
the Program policy discussed above, the Program was unable to further 
evaluate Petition 012.

D. Administrator's Final Decision on Whether To Propose the Addition of 
Atherosclerosis to the List

    Finding no relevant studies with regard to Petition 012, the 
Administrator has accordingly determined that insufficient evidence is 
available to take further action at this time, including either 
proposing the addition of atherosclerosis 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 012 
to add atherosclerosis to the List of WTC-Related Health Conditions is 
denied.
    Studies have not yet demonstrated whether 9/11 exposures, including 
inhalational dust/debris exposures or psychological exposures of the 
duration and magnitude experienced on and in the aftermath of September 
11, 2001, could cause the development of atherosclerosis in an 
individual WTC responder or survivor several years later. The 
Administrator looks forward to more definitive studies that directly 
evaluate the causal association between 9/11 exposures, especially 
inhalational dust exposures, and atherosclerosis.

E. 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 December 2, 2016.

    Dated: December 8, 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. 2016-29816 Filed 12-13-16; 8:45 am]
 BILLING CODE 4163-18-P