[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]



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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