[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Proposed Rules]
[Pages 41039-41041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 019--Irritable Bowel 
Syndrome; 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 May 17, 2018, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 019) to add 
irritable bowel syndrome (IBS) 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 IBS 
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 August 17, 2018.

ADDRESSES: Visit the WTC Health Program website at https://www.cdc.gov/wtc/received.html to review Petition 019.

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 019
D. Review of Scientific and Medical Information and Administrator 
Determination
E. Administrator's Final Decision on Whether To Propose the Addition 
of IBS to the List
F. Approval To Submit Document to the Office of the Federal Register

[[Page 41040]]

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 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/WTCHP_PP_Adding_NonCancers_14_February_2017.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 to the petitioned health condition may also provide 
sufficient medical basis for a valid petition.
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    \4\ See supra note 2.
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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.\5\ The 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. 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 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 \6\ 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 \7\ 
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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    \5\ See supra note 3.
    \6\ 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.
    \7\ 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.
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C. Petition 019

    On May 17, 2018, the Administrator received a petition (Petition 
019) from a WTC survivor who was caught in the dust cloud near Ground 
Zero, requesting the addition of ``irritable bowel syndrome (IBS)'' to 
the List.\8\ The petition included one scientific article, by 
Marynowski et al. [2015],\9\ reviewing the findings of peer-reviewed, 
published epidemiologic studies concerning the association of IBS with 
environmental pollution (including particulate matter, a 9/11 agent). 
Although the Marynowski article on its own did not provide a sufficient 
medical basis for the submission to be considered a valid petition, the 
article referenced a peer-reviewed, published study by Kaplan et al. 
[2012] \10\ regarding IBS symptoms in non-9/11-exposed populations. 
Kaplan et al. conducted an epidemiologic study to evaluate the 
association between daily concentrations of air pollutants, including 
particulate matter, with emergency department visits for non-specific 
abdominal pain, a symptom necessary for a diagnosis of IBS. The 
inclusion of a reference to this study provides sufficient medical 
basis for the submission to be considered a valid petition.
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    \8\ See Petition 019, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \9\ Marynowski M, Liko[nacute]ska A, Zatorski H, Fichna J 
[2015], Role of Environmental Pollution in Irritable Bowel Syndrome, 
World J Gastroentero 21(40):11371-11378.
    \10\ Kaplan GG, Szyszkowicz M, Fichna J, Rowe BH, Porada E, 
Vincent R, Madsen K, Ghosh S, Storr M [2012], Non-Specific Abdominal 
Pain and Air Pollution: A Novel Association, PLOS ONE 7(10).
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D. Review of Scientific and Medical Information and Administrator 
Determination

    In response to Petition 019, and pursuant to the Program policy on 
the

[[Page 41041]]

addition of non-cancer health conditions to the List,\11\ the Program 
conducted a review of the scientific literature on IBS.\12\ The Program 
was unable to identify any references to the petitioned health 
condition, IBS, in 9/11-exposed populations for further scientific 
evaluation based on the literature search. Since Kaplan et al. [2012] 
is not an epidemiologic study of IBS in 9/11-exposed populations, it 
does not meet the threshold for evaluation established in Program 
policy; therefore, the article was not further reviewed.
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    \11\ Supra note 3.
    \12\ Databases searched include: CINAHL, Embase, NIOSHTIC-2, 
ProQuest Health & Safety, PsycINFO, PubMed, Scopus, and Toxicology 
Abstracts/TOXLINE.
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E. Administrator's Final Decision on Whether To Propose the Addition of 
IBS to the List

    The Administrator has determined that insufficient evidence is 
available to take further action at this time, including proposing the 
addition of IBS 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 019 request to add 
IBS 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 August 10, 2018.

    Dated: August 10, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Delegated the duties of the 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. 2018-17711 Filed 8-16-18; 8:45 am]
 BILLING CODE 4163-18-P