[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Proposed Rules]
[Pages 11267-11268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05690]
[[Page 11267]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 021--Deep Vein
Thrombosis and Pulmonary Embolism; 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 November 28, 2018, the Administrator of the World Trade
Center (WTC) Health Program received a petition (Petition 021) to add
``multiple deep vein thrombosis and pulmonary embolism'' 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
deep vein thrombosis or pulmonary embolism to the List. The
Administrator also 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 26, 2019.
ADDRESSES: Visit the WTC Health Program website at https://www.cdc.gov/wtc/received.html to review Petition 021.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-48, 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. Procedures for Evaluating a Petition
C. Petition 021
D. Review of Scientific and Medical Information and Administrator
Determination
E. Administrator's Final Decision on Whether To Propose the Addition
of Deep Vein Thrombosis and/or Pulmonary Embolism to the List
F. 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 for health conditions on the List 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 document mean the Director of the National
Institute for Occupational Safety and Health (NIOSH) or his 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 88.15. Within 90 days after receipt of a valid 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) of the PHS
Act and Sec. 88.16(a)(2) of the Program regulations: (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.
B. Procedures for Evaluating a Petition
In addition to the regulatory provisions, the WTC Health Program
has developed policies to guide the review of submissions and
petitions,\2\ as well as the analysis of evidence supporting the
potential addition of a non-cancer health condition to the List.\3\
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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, 2014, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
\3\ See WTC Health Program [2017], Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, February 14, 2017, https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancers_14_February_2017-508.pdf.
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A valid petition must include sufficient medical basis for the
association between the September 11, 2001, terrorist attacks and the
health condition to be added; in accordance with WTC Health Program
policy, 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 may demonstrate the required medical basis.\4\ Studies
linking 9/11 agents or hazards \5\ to the petitioned health condition
may also provide sufficient medical basis for a valid petition.
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\4\ See supra note 2.
\5\ 9/11 agents are chemical, physical, biological, or other
hazards reported in a published, peer-reviewed exposure assessment
study of responders, recovery workers, or survivors who were present
in the New York City disaster area, or at the Pentagon site, or the
Shanksville, Pennsylvania site, as those locations are defined in 42
CFR 88.1, as well as those hazards not identified in a published,
peer-reviewed exposure assessment study, but which are reasonably
assumed to have been present at any of the three sites. See WTC
Health Program [2018], Development of the Inventory of 9/11 Agents,
July 17, 2018, https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf.
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After the Program has determined that a petition is valid, the
Administrator must direct the 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.\6\ The literature
review is a keyword search of relevant scientific databases; 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 are
then identified from the initial search results. The Program evaluates
the scientific quality of each peer-reviewed, published, epidemiologic
study of the health condition identified in the literature search; the
Program then compiles the scientific results of each study to assess
whether a causal relationship between 9/11 exposures and the health
condition is supported, and evaluates whether the
[[Page 11268]]
results of the studies are representative of the 9/11-exposed
population of responders and survivors. A health condition may be added
to the List if peer-reviewed, published, epidemiologic studies provide
support that the health condition is substantially likely \7\ to be
causally associated with 9/11 exposures. If the evaluation of evidence
provided in peer-reviewed, published, epidemiologic studies of the
health condition in 9/11 populations demonstrates a high, but not
substantial, likelihood of a causal association between the 9/11
exposures and the health condition, then the Administrator may consider
additional highly relevant scientific evidence regarding exposures to
9/11 agents from sources using non-9/11-exposed populations. If that
additional assessment establishes that the health condition is
substantially likely to be causally associated with 9/11 exposures
among 9/11-exposed populations, the health condition may be added to
the List.
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\6\ See supra note 3.
\7\ The ``substantially likely'' standard is met when the
scientific evidence, taken as a whole, demonstrates a strong
relationship between the 9/11 exposures and the health condition.
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C. Petition 021
On November 28, 2018, the Administrator received a petition
(Petition 021) requesting the addition of ``multiple deep vein
thrombosis and pulmonary embolism'' to the List.\8\ The petition
referenced two scientific articles which provided sufficient medical
basis for the petition to be considered valid because they are
scientific sources that demonstrate a potential link between exposure
to a 9/11 hazard (particulate matter) \9\ and deep vein thrombosis and/
or pulmonary embolism: A 2008 study by Baccarelli et al.,\10\ and a
publication by Franchini et al.\11\
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\8\ See Petition 021, WTC Health Program: Petitions Received,
http://www.cdc.gov/wtc/received.html.
\9\ The 9/11 hazard identified by the petitioner was
``particulate matter,'' whereas the WTC Health Program Inventory of
9/11 Agents identifies particulate matter more precisely as WTC
Dust: Glass shards, WTC Dust: PM10, WTC Dust:
PM2.5, WTC Dust: Particles >2 [mu]m, and WTC Dust:
Particles >5 [mu]m. See supra note 5.
\10\ Baccarelli A, Martinelli I, Zanobetti A, Grillo P, Hou LF,
Bertazzi PA, Mannucci PM, Schwartz J [2008], Exposure to Particulate
Air Pollution and Risk of Deep Vein Thrombosis, Arch Intern Med
12;168(9).
\11\ The petitioner stated that the ``European Journal of
Medicine published a report and concluded that exposure to high
level of pollutants lead to a high risk of developing DVTs and PEs.
Massimo Franchini, dept [sic] of Transfusion and Hematology.''
However, the Program was unable to identify a publication that met
those criteria, and instead identified two publications which the
petitioner may have intended to reference--a 2016 study and a 2017
letter to the editor. Because it was not possible to determine which
one was intended by the petitioner, the Program determined both
would be considered and that, together, both met the medical basis
requirement. Franchini M, Mengoli C, Cruciani M, Bonfanti C,
Mannucci PM [2016], Association Between Particulate Air Pollution
and Venous Thromboembolism: A Systematic Literature Review, Eur J
Intern Med 27:10-13; Franchini M, Mannucci PM [2017], Letter to the
Editor: More on Air Pollution and Venous Thromboembolism, Eur J
Intern Med 37(2017):e11.
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Because Baccarelli et al. and the two Franchini et al. publications
described in footnote 11 are not epidemiologic studies of deep vein
thrombosis or pulmonary embolism in 9/11-exposed populations, they do
not meet the threshold for inclusion in the evidence evaluation
established in Program policy, as described above, even though they
qualify as sufficient medical basis for the petition to be considered
valid. Therefore, based on Program policy, these articles were not
further reviewed.
D. Review of Scientific and Medical Information and Administrator
Determination
The Program policy on the addition of non-cancer health conditions
to the List directs the Program to conduct a literature review on the
health condition(s) petitioned.\12\ Petition 021 requested the addition
of deep vein thrombosis and pulmonary embolism. Deep vein thrombosis
occurs when a blood clot forms in a deep vein, usually in the legs or
pelvis; a pulmonary embolism occurs when a clot breaks loose and
travels through the bloodstream to an artery in the lungs, causing a
blockage.\13\
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\12\ Supra note 3.
\13\ See https://www.cdc.gov/ncbddd/dvt/facts.html; https://www.nhlbi.nih.gov/health-topics/venous-thromboembolism#Signs,-Symptoms,-and-Complications.
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In response to Petition 021, the Program conducted a review of the
scientific literature on deep vein thrombosis and pulmonary embolism to
identify peer-reviewed, published studies of the health conditions in
the 9/11-exposed population.\14\ No studies meeting the Program's
criteria for further evaluation were identified in this literature
review.
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\14\ Databases searched include: CINAHL, Embase, NIOSHTIC-2,
ProQuest Health & Safety, PsycINFO, Ovid MEDLINE, Scopus, Toxicology
Abstracts/TOXLINE, and WTC Health Program Bibliographic Database.
Keywords used to conduct the search include: Deep vein thrombosis,
venous thromboembolism, venous thrombosis, phlebitis,
thrombophlebitis, venous thrombotic event, pulmonary embolism,
pulmonary infarction, pulmonary thromboembolism, and pulmonary
thrombosis. The literature search was conducted in English-language
journals on January 22, 2019.
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E. Administrator's Final Decision on Whether To Propose the Addition of
Deep Vein Thrombosis and/or Pulmonary Embolism to the List
Pursuant to PHS Act, sec. 3312(a)(6)(B)(iv) and 42 CFR
88.16(a)(2)(iv), the Administrator has determined that insufficient
evidence is available to take further action at this time, including
proposing the addition of deep vein thrombosis and/or pulmonary
embolism to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and
42 CFR 88.16(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 88.16(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 88.16(a)(2)(i))
is unwarranted.
For the reasons discussed above, the Petition 021 request to add
deep vein thrombosis and pulmonary embolism to the List of WTC-Related
Health Conditions is denied.
F. Approval To Submit Document to the Office of the Federal Register
The Secretary, HHS, or his 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. Robert
Redfield M.D., Director, CDC, and Administrator, ATSDR, approved this
document for publication on March 19, 2019.
John J. 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. 2019-05690 Filed 3-25-19; 8:45 am]
BILLING CODE 4163-18-P