World Trade Center Health Program; Petition 020-Stroke; Finding of Insufficient Evidence, 5972-5977 [2019-02941]
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beneficiaries regarding grandfathered
status? If not, how could the disclosure
be improved?
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B. General Information About
Grandfathered Group Health Plans and
Group Health Insurance Coverage
1. Other than the Kaiser Family
Foundation’s ‘‘Employer Health Benefits
Annual Survey,’’ and the MEPS–IC
survey, what data resources are
available to help the Departments better
understand how many group health
plans and group health insurance
policies are considered grandfathered
and how many participants and
beneficiaries are enrolled in such plans
and coverage?
2. What are the characteristics (for
example, plan size, geographic areas, or
industries) of grandfathered group
health plans and the plan sponsors and
group health insurance issuers that have
chosen to retain the grandfathered status
of their plans or coverage? Do
grandfathered group health plans or the
plan sponsors and group health
insurance issuers that have chosen to
retain the grandfathered status of their
plans or coverage share common
characteristics?
3. Do group health plan sponsors and
group health insurance issuers that have
chosen to retain grandfathered status for
certain plans, benefit packages, or
policies also offer other plans, benefit
packages, or policies that are not
grandfathered? If so, why?
4. What are the typical differences in
benefits, cost-sharing, and premiums
(including employer contributions,
employee organization contributions,
and employee contributions) associated
with grandfathered group health plans
and grandfathered group health
insurance coverage compared to nongrandfathered group health plans?
5. How many group health plan
sponsors and group health insurance
issuers are considering making changes
to their plans or coverage over the next
few years that are likely to cause loss of
grandfathered status under the
November 2015 final rules? How many
individuals would be affected?
6. What impact do grandfathered
group health plans and grandfathered
group health insurance coverage have
on the individual and small group
market risk pools?
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
However, section II of this document
does contain a general solicitation of
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comments in the form of a request for
information. In accordance with the
implementing regulations of the
Paperwork Reduction Act of 1995
(PRA), specifically 5 CFR 1320.3(h)(4),
this general solicitation is exempt from
the PRA. Facts or opinions submitted in
response to general solicitations of
comments from the public, published in
the Federal Register or other
publications, regardless of the form or
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collections and therefore not subject to
the PRA. Consequently, there is no need
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and Budget under the authority of the
PRA.
Signed at Washington, DC, this 13th day of
February 2019.
Victoria Judson,
Associate Chief Counsel (Employee Benefits,
Exempt Organizations, and Employment
Taxes), Internal Revenue Service, Department
of the Treasury.
Signed at Washington, DC, this 19th day of
February, 2019.
Carol Weiser,
Acting Benefits Tax Counsel, Department of
the Treasury.
Signed at Washington, DC, this 13th day of
February 2019.
Preston Rutledge,
Assistant Secretary, Employee Benefits
Security Administration, Department of
Labor.
Dated: February 13, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: February 13, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–03170 Filed 2–21–19; 4:15 pm]
BILLING CODE 4510–29–P; 4830–01–P; 4120–01–P
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 020—Stroke; Finding of
Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
AGENCY:
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Denial of petition for addition of
a health condition.
ACTION:
On August 26, 2018, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 020) to add ‘‘two
forms of stroke, both ischemic and nonaneurysmal hemorrhagic,’’ 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 stroke 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 February 25, 2019.
ADDRESSES: Visit the WTC Health
Program website at https://
www.cdc.gov/wtc/received.html to
review Petition 020.
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 NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents
A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petition 020
D. Review of Scientific and Medical
Information and Administrator
Determination
E. Administrator’s Final Decision on Whether
To Propose the Addition of Stroke 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
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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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).
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
§ 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.
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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
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,
2 See WTC Health Program [2014], Policy and
Procedures for Handling Submissions and Petitions
to Add a Health Condition to the List of WTCRelated Health Conditions, May 14, 2014, https://
www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandling
Procedures14May2014.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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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 5 to
the petitioned health condition may also
provide sufficient medical basis for a
valid petition.
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; peerreviewed, 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
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,
4 See
supra note 2.
agents are chemical, physical, biological, or
other hazards reported in a published, peerreviewed 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, peerreviewed 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_911_Agents_20180717.pdf.
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.
5 9/11
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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.
C. Petition 020
On August 26, 2018, the
Administrator received a petition
(Petition 020) from a WTC survivor who
resided near Ground Zero, requesting
the addition of ‘‘two forms of stroke,
both ischemic and non-aneurysmal
hemorrhagic,’’ to the List.8 The petition
included eight scientific articles, three
of which provided sufficient medical
basis for the petition to be evaluated
because they are scientific sources that
demonstrate a potential link between 9/
11 exposure and stroke: 9 a 2006 study
by Brackbill et al.,10 a 2013 study by
Jordan et al.,11 and a 2018 study by Yu
et al.12
8 See Petition 020, WTC Health Program: Petitions
Received, https://www.cdc.gov/wtc/received.html.
9 Five of the studies referenced in Petition 020
were insufficient to provide medical basis because
they were not conducted in 9/11 populations nor
did they demonstrate an association between any 9/
11 agents and stroke; these five studies include the
following: Truelsen T, Prescott E, Lange P, Schnohr
P, Boysen G [2001], Lung Function and Risk of Fatal
and Non-Fatal Stroke, The Copenhagen City Heart
Study, Int J Epidemiol 30(1):145–151; Soderholm
M, Zia E, Hedblad B, Engstrom G [2012], Lung
Function as a Risk Factor for Subarachnoid
Hemorrhage, Stroke 43(10):2598–2603; Chen MH,
Pan TL, Li CT, Lin WC, Chen YS, Lee YC, Tsai SJ,
Hsu JW, Huang KL, Tsai CF, Chang WH, Chen TJ,
Su TP, Bai YM [2015], Risk of Stroke Among
Patients with Post-Traumatic Stress Disorder:
Nationwide Longitudinal Study, Br J Psychiatry
206(4):302–307; Austin V, Crack PJ, Bozinovski S,
Miller AA, Vlahos R [2016], COPD and Stroke: Are
Systemic Inflammation and Oxidative Stress the
Missing Links? Clin Sci (Lond), 130(13):1039–1050;
and Lekoubou A, Ovbiagele B [2017], Prevalence
and Influence of Chronic Obstructive Pulmonary
Disease on Stroke Outcomes in Hospitalized Stroke
Patients, eNeurologicalSci 6:21–24.
10 Brackbill RM, Thorpe LE, DiGrande L, Perrin
M, Sapp JH, 2nd, Wu D, Campolucci S, Walker DJ,
Cone J, Pulliam P, Thalji L, Farfel MR, Thomas P
[2006], Surveillance for World Trade Center
Disaster Health Effects among Survivors of
Collapsed and Damaged Buildings, MMWR Surveill
Summ 55: 1–18.
11 Jordan HT, Stellman SD, Morabia A, MillerArchie SA, Alper H, Laskaris Z, Brackbill RM, Cone
JE [2013], Cardiovascular Disease Hospitalizations
in Relation to Exposure to the September 11, 2001
World Trade Center Disaster and Posttraumatic
Stress Disorder, J Am Heart Assoc 2(5):e000431.
12 Yu S, Alper HE, Nguyen AM, Brackbill RM
[2018], Risk of Stroke Among Survivors of the
September 11, 2001 World Trade Center Disaster, J
Occup Environ Med 60(8):e371–e376.
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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.13 Petition 020
requested the addition of ischemic and
non-aneurysmal hemorrhagic stroke.
Stroke is defined as an acute brain
injury resulting from either too little
blood to supply an adequate amount of
oxygen to the affected part of the brain
or too much blood within the cranial
cavity.14 An ischemic stroke occurs
when there is an inadequate supply of
oxygen-rich blood to the brain, such as
may occur due to thrombosis, embolism,
or systemic hypoperfusion. A
hemorrhagic stroke occurs when blood
builds up and leaks in the brain, such
as may occur due to an intracerebral or
subarachnoid hemorrhage, or an
aneurysm (a balloon-like bulge in an
artery that can stretch and burst). A
transient ischemic attack, also called a
TIA or ‘‘mini-stroke,’’ is similar to a
stroke; it occurs if blood flow to a
portion of the brain is blocked only for
a short time, producing a transient
episode of neurologic dysfunction
without acute infarction or death of
brain tissue.
In response to Petition 020, the
Program conducted a review of the
scientific literature on stroke, including
both ischemic and non-aneurysmal
hemorrhagic, as well as transient
ischemic attack.15 In total, this initial
literature review identified 12 studies
appearing to potentially meet the
Program’s criteria for further evaluation.
Three of the studies identified 16 were
peer-reviewed, published,
epidemiologic studies of stroke in the 9/
11-exposed population eligible, in
accordance with the Program’s policy,17
for further evaluation. The nine
remaining studies identified in the
13 Supra
note 3.
generally National Heart, Lung, and Blood
Institute (NHBLI), Health Topics: Stroke, https://
www.nhlbi.nih.gov/health-topics/stroke (last
accessed on Dec. 12, 2018).
15 Databases searched include: CINAHL, Embase,
NIOSHTIC–2, ProQuest Health & Safety, PsycINFO,
PubMed, Scopus, and Toxicology Abstracts/
TOXLINE. Studies were also identified using the
WTC Health Program Research Compendium.
Keywords used to conduct the search include:
Stroke, cerebrovascular accident, transient ischemic
attack, intracerebral hemorrhage, cerebral
hemorrhage, subarachnoid hemorrhage, brain
ischemia, brain infarction, cerebral infarction. The
literature search was conducted in English-language
journals on September 26, 2018.
16 Two of these three studies, Brackbill et al. and
Yu et al., were also included as medical basis with
the petition.
17 See supra note 3.
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14 See
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literature review did not meet the
Program’s criteria for further
evaluation.18
Evaluation of Three Published, PeerReviewed Epidemiologic Studies of
Stroke in the 9/11 Population
As discussed above, the Program
determined that of the 12 studies
identified in the literature review that
appeared to potentially meet the criteria
for evaluation, only 3 could be fully
evaluated because they are peerreviewed, published, epidemiologic
studies of stroke in the 9/11 population:
Brackbill et al. [2006] and Yu et al.
[2018], which were referenced in
Petition 020, and Remch et al. [2018].19
Study Summaries
1. Brackbill et al. conducted a crosssectional study 20 designed to assess the
physical and mental health conditions
and symptoms reported by survivors of
the WTC towers and nearby buildings
between September 5, 2003 and
November 20, 2004, and to examine the
relationship between their reported 9/11
exposures and health and mental health
outcomes. The study used WTC Health
Registry data from baseline interviews
conducted with 8,418 adult survivors
who had been occupants of collapsed or
damaged buildings. Exposure data were
evaluated and exposures were sorted by
location and time proximity to exposure
events according to whether the
participant was present in the WTC dust
cloud; occupied a collapsed versus
damaged building; or evacuated before
or after the collapse of the first tower.
Health histories were also collected
from Registry interview data, including
self-reports of physician-diagnosed
stroke subsequent to September 11,
2001. The rate of stroke among adult
18 Four of the nine studies, including Jordan et al.
which was submitted as medical basis for the
petition, contained limited findings regarding an
association between 9/11 exposure and stroke that
the Program determined warranted additional
review. Those four studies are summarized in the
docket, as ‘‘background information,’’ to illustrate
their inability to provide dispositive information
about an association between 9/11 exposure and
stroke.
19 Remch M, Laskaris Z, Flory J, MoraMcLaughlin C, Morabia A [2018], Post-Traumatic
Stress Disorder and Cardiovascular Diseases: A
Cohort Study of Men and Women Involved in
Cleaning the Debris of the World Trade Center
Complex, Circ Cardiovasc Qual Outcomes
11(7):e004572.
20 A cross-sectional study is a type of
observational study that evaluates a sample of
persons from a specific population and measures
the sample’s exposures and health outcomes
simultaneously. Because the presence of disease
and the determination of exposure are conducted at
the same specific point in time, the temporal
sequence of cause and effect (i.e. did the disease
appear before or after exposure) generally cannot be
determined.
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survivors of collapsed and damaged
buildings was adjusted for sex and
mode of recruitment (physical and
mental health symptoms tended to be
higher among Registry members who
self-identified than among those
identified from a list of building
survivors with security badges).
Brackbill et al. found a statistically
significant association for stroke among
survivors exposed to the WTC dust
cloud compared to those not exposed to
the WTC dust cloud [adjusted odds ratio
(aOR) = 5.6, 95% CI 1.3–24.4]; however,
the prevalence of stroke among
survivors who evacuated before versus
after the collapse of the first WTC tower
and among those who evacuated from
collapsed buildings versus damaged
buildings was not significantly different
[aOR = 0.6, 95% CI 0.1–4.5, and aOR =
1.5, 95% CI 0.6–4.0, respectively].
According to the authors, this indicated
a ‘‘potential relation’’ between WTC
dust exposure and stroke; this finding
was considered preliminary, however,
meriting continued monitoring, because
the small sample size and crosssectional design limits the interpretation
and generalizability of findings. The
cross-sectional design of this study is a
major limitation because it fails to
establish a temporal relationship
between 9/11 exposure and reported
stroke. Finally, the study did not
differentiate between hemorrhagic and
ischemic stroke, which have different
risk factors.
2. Yu et al. conducted a cohort study
to investigate the risk of stroke among
42,527 WTC responders and survivors
who experienced PTSD and who had
intense exposure to WTC dust. Selfreports of WTC dust exposure and
stroke diagnosis subsequent to
September 11, 2001 were obtained from
WTC Health Registry surveys collected
from 2003 to 2016. Intense exposure
was defined as having been in the WTC
dust cloud and reporting at least one of
the following: Inability to see more than
a few feet; difficulty walking; difficulty
finding shelter; being covered with dust;
or loss of hearing. Minimal or noexposure was defined as being in the
WTC dust but without experiencing
intense exposure, or no WTC dust
exposure at all. After adjusting for
sociodemographic characteristics, risk
factors for stroke (smoking and history
of hypertension and/or diabetes), and
PTSD, the study found that WTC dust
cloud exposure was independently
associated with an increased risk for
stroke among WTC responders and
survivors [aHR = 1.2, 95% CI 1.0–1.4].
The study has numerous strengths,
including the longitudinal design,
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adequate control of confounding and a
large number of participants with small
loss to follow up. Limitations included
that stroke was self-reported and the
authors did not distinguish between
hemorrhagic and ischemic stroke.
3. Remch et al. conducted a cohort
study to determine whether PTSD is a
risk factor for myocardial infarction and
stroke. The study used data collected
between January 2012 and June 2013
from World Trade Center (WTC)-Heart,
a WTC Health Program Research
Program-funded cohort study of 6,481
Program members who were nonfirefighter workers and volunteers
engaged in rescue, recovery, restoration
of services, cleanup, or other support
work on or after September 11, 2001.
Exposure was reported in a selfadministered questionnaire, which
asked participants about when they
started to work at Ground Zero, whether
they were in the dust cloud, whether
they worked on or near the pile or the
pit (the remains of the WTC towers),
and whether a respiratory protective
device was worn. Stroke was selfreported and tentatively confirmed by
additional personal interviews
conducted by phone. Approximately 60
percent of self-reported stroke cases
were confirmed by medical records
documenting typical stroke symptoms
and either supportive medical imaging
or sonographic signs. Cases of stroke
were also identified in the New York
State Department of Health’s, Statewide
Planning and Research Cooperative
System (SPARCS) database by searching
for hospitalized cohort members with a
discharge diagnosis of stroke. However,
the study did not report whether the
participants who experienced recurrent
strokes (of the 53 reported strokes, 15
were recurrent) had their first stroke
before September 11, 2001, and whether
the first stroke may have been the cause
of subsequent recurrent strokes. Based
on their analysis, Remch et al.
concluded that none of the 9/11
exposure variables (i.e., timing and
intensity of WTC dust and dust cloud
exposure, use of respiratory protection)
were independently associated with
subsequent stroke. It should be noted,
however, that detailed data to support
these findings were not presented in the
article apart from the finding that the
risk of stroke was not significantly
reduced by the use of a respirator [aHR
= 0.8, 95% CI 0.4–1.8]. The study also
concluded that PTSD was an
independent determinant of stroke in
both men and women, before and after
controlling for use of a respirator during
debris cleanup, cardiovascular risk
factors, and depression. Remch et al. has
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multiple strengths, including the cohortstudy design, active follow-up,
validation of stroke using SPARCS, and
adjustment for cardiovascular risk
factors, including smoking and
depression. Limitations include PTSD
being self-reported, as well as the lack
of distinction between hemorrhagic and
ischemic stroke and the failure to clarify
whether pre-September 11, 2001 and
recurrent strokes were appropriately
analyzed. Moreover, the study focused
on assessing whether those with PTSD
are at increased risk of myocardial
infarction or stroke; determining the
effect of WTC dust exposure on those
outcomes was of secondary importance.
Finally, the authors did not provide
detailed findings using exposure data,
apart from reporting on respirator use
and non-use; even where respirator use
was reported, however, information on
frequency and time of use was not
provided.
Evaluation of Studies Using Select
Bradford Hill Criteria
Together, the three studies by
Brackbill et al., Yu et al., and Remch et
al. were assessed to determine whether
a causal relationship between 9/11
exposures and stroke is supported.21 As
described in the policy on the addition
of non-cancer health conditions to the
List,22 the WTC Health Program uses the
following Bradford Hill criteria to
evaluate studies of 9/11-exposed
populations: strength of association,
precision of the risk estimate,
consistency of association, biological
gradient, and plausibility and
coherence.
Strength of association: 23 Of the three
studies, Brackbill et al. reported a strong
association between exposure to WTC
dust and the risk of stroke in WTC
survivors; Yu et al. reported a moderate
association between WTC dust exposure
and stroke in WTC responders and
survivors; and Remch et al. reported no
association between WTC dust exposure
and risk of stroke in WTC responders.
Precision of risk estimate: 24 Although
both Brackbill et al. and Yu et al. were
21 Although the Brackbill et al. and Yu et al.
studies were both conducted in the WTC Health
Registry population, the Yu et al. study is not a
follow-up to the Brackbill et al. study and each was
evaluated independently in this action.
22 WTC Health Program [2017], Policy and
Procedures for Adding Non-Cancer Conditions to
the List of WTC-Related Health Conditions,
February 14, 2017 at 3–4, https://www.cdc.gov/wtc/
pdfs/policies/WTCHP_PP_Adding_NonCancers_14_
February_2017-508.pdf.
23 It is generally thought that strong associations
are more likely to be causal than weak associations;
however, a weak association does not rule out a
causal relationship.
24 The uncertainty inherent in estimating the
strength of association between exposure and health
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conducted using WTC Health Registry
data, the more recent study by Yu is
more precise because the sample size is
larger; in contrast, Brackbill reported
very wide confidence intervals. Remch
et al. studied a cohort of responders in
the WTC Health Program; despite
reporting a relatively large number of
stroke cases, the precision of the study
findings could not be evaluated because
detailed findings (i.e., number of stroke
cases associated with different levels of
9/11 exposure, risk estimates, and
confidence intervals) regarding possible
association between 9/11 exposure and
stroke were not reported.
Consistency of association: 25 The
findings were not consistent across the
three studies: The WTC Health Registry
studies showed increased risk of stroke
with exposure to the WTC dust cloud;
Remch et al. did not find an association
between intermediate or high exposure
and the risk of stroke.
Biological gradient: 26 None of the
three studies reported exposureresponse. Although Brackbill et al. and
Yu et al. each found a positive
association between 9/11 exposure and
stroke, they both conducted limited,
binary evaluations of exposure
variables: Brackbill et al. sorted
exposures according to location and
temporal proximity to the WTC dust
and dust cloud, and Yu et al. sorted
exposures by determining if study
subjects were intensely exposed to the
dust and dust cloud. Neither study fully
analyzed stroke in the context of a full
exposure-response assessment. Remch
et al., which did not find a positive
association between 9/11 exposure and
stroke, also did not report exposureresponse.
Plausibility and coherence: 27
Brackbill et al. and Yu et al. each
mentioned that other studies have found
an association between stroke and air
pollution, which primarily comprises
effect (effect size) from observational data is
expressed as a confidence interval, illustrating a
range of values that contains the true effect size. A
narrow confidence interval indicates a more precise
measure of the effect size and a wider interval
indicates greater uncertainty. See supra note 22.
25 Consistent findings are demonstrated when
they have been repeatedly reported by multiple
studies.
26 Studies establish an exposure-response
relationship by demonstrating that increases in
exposure (i.e., exposures of greater intensity and/or
longer duration) are associated with a greater
incidence of disease. A thorough evaluation of
exposure-response requires analysis of multiple
levels of exposure such that the investigator can
demonstrate that the risk increases with increasing
levels of exposure.
27 Study findings demonstrate a basis in scientific
theory that supports the relationship between the
exposure and the health effect, and do not conflict
with known facts about the biology of the health
condition.
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Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Proposed Rules
small particulate matter (PM2.5). Both
Brackbill et al. and Yu et al. also noted
that the WTC dust and dust cloud
contained a unique mixture of
construction debris and combustion
products,28 including small particulate
matter (PM2.5) as well as large
particulate matter (>PM10) not typically
found in air pollution.29 Although the
comparison of air pollution to WTC dust
is imperfect because of the high
concentration of >PM10 in WTC dust
and dust cloud samples, it is
nevertheless instructive due to the
documented health effects of PM2.5
exposure, including stroke.30 While the
association between WTC dust and
stroke seems plausible because of the
presence of PM2.5, the underlying
biological mechanisms through which
small particulate matter exerts its effect
on the vascular system is still an area of
study.
amozie on DSK3GDR082PROD with PROPOSALS1
Evaluation of Representativeness of
Studies
Finally, the three studies were
reviewed to determine whether both the
WTC responder and survivor cohorts
studied are representative of the entire
9/11-exposed population, and whether
the results can be extrapolated. The
cohort studied by Brackbill et al.
consisted of survivors enrolled in the
WTC Health Registry; the population
studied by Yu et al. included responders
and survivors enrolled in the WTC
Health Registry; the population studied
by Remch et al. only included non28 The WTC Health Program’s Inventory of 9/11
Agents (available at https://wwwn.cdc.gov/Research
Gateway/Content/pdfs/Development_of_the_
Inventory_of_9-11_Agents_20180717.pdf) identifies
chemical, physical, biologic, and other hazards as
having been present at any of the three disaster
sites. Of the 352 chemical 9/11 agents identified
from air and settled dust sampling studies and from
biological monitoring studies, five are types of WTC
dust, including: WTC Dust: Glass shards, WTC
Dust: PM10, WTC Dust: PM2.5, WTC Dust: Particles
>2 mm, and WTC Dust: Particles >5 mm. The
remaining 347 chemicals are identified by name.
See supra note 5.
29 Brackbill et al. [2006] supra note 10 at 12; Yu
et al. [2018] supra note 11 at e375, and Lioy PJ,
Weisel CP, Millette JR, Eisenreich S, Vallero D,
Offenberg J, Buckley B, Turpin B, Zhong M, Cohen
MD, Prophete C, Yang I, Stiles R, Chee G, Johnson
W, Porcja R, Alimokhtari S, Hale RC, Weschler C,
Chen LC [2002], Characterization of the dust/smoke
aerosol that settled east of the World Trade Center
(WTC) in Lower Manhattan after the collapse of the
WTC 11 September 2001, Env Health Perspect
110:703–714.
30 Feigin VL, Roth GA, Naghavi M, Parmar P,
Krishnamurthi R, Chugh S, Mensah GA, Norrving
B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL,
Forouzanfar MH [2016], Global Burden of Stroke
and Risk Factors in 188 Countries, During 1990–
2013: A Systematic Analysis for the Global Burden
of Disease Study 2013, Lancet Neurol 15(9):913–
924; Be´jot Y, Reis J, Giroud M, Feigin V [2018], A
Review of Epidemiological Research on Stroke and
Dementia and Exposure to Air Pollution, Int J
Stroke 13(7):687–695.
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firefighter responders who were
members of the WTC-Heart cohort
within the WTC Health Program.
Although Brackbill et al. and Yu et al.
consisted of Registry members, the
former only included 8,418 adult
survivors of collapsed buildings and
buildings with major or moderate
damage, while the latter included
42,527 survivors and responders of the
WTC attack.31 According to an
assessment of the WTC Health Registry
by Kim et al. [2018],32 although
enrollment was voluntary, extensive
outreach efforts show that selection bias
is unlikely for this cohort. The cohort
studied by Remch et al. is nested within
the WTC Health Program and appears to
be representative of the population
served by the clinics where recruitment
took place. As a result, the Program
determined that the results of the three
evaluated studies can be extrapolated to
the entire 9/11-exposed population.
between hemorrhagic and ischemic
stroke; these two variants have different
pathophysiology and causes, and
therefore it is not clear if the reported
incidence of stroke refers to one or both
types of stroke. Finally, the absence of
an exposure-response analysis in all of
the studies means that the biological
gradient is not adequately assessed. In
conclusion, when all three studies are
considered together, their limitations
and lack of consistent findings do not
provide adequate evidence to propose
the addition of stroke to the List.
Without significant positive findings
from studies with sufficient sample size,
objective confirmation of stroke, and an
assessment of exposure-response, the
available evidence does not demonstrate
that stroke is either substantially likely
or highly likely to be causally associated
with 9/11 exposures among 9/11exposed populations.
Summary of Evaluation
Although the studies described and
evaluated above provide evidence that
suggests a possible association between
9/11 exposure and stroke, the evidence
is insufficient to conclude that stroke is
either substantially likely 33 or highly
likely 34 to be causally associated with
9/11 exposures among 9/11-exposed
populations. The evidence provided by
the three studies is insufficient to
support an addition to the List for
several reasons. Most importantly, the
results of the three studies lacked
consistency: Two studies found a
positive association between 9/11
exposure and stroke (Brackbill et al. and
Yu et al.), and one did not (Remch et
al.). The two studies that found a
positive association between 9/11
exposure and stroke relied on selfreported stroke, which may be prone to
recall bias and the imperfections of
human memory. In contrast, Remch et
al. confirmed the presence of stroke
using medical records and SPARCS
data, but failed to find an association
between 9/11 exposure and stroke.
Another limitation common to all three
studies was the lack of differentiation
E. Administrator’s Final Decision on
Whether To Propose the Addition of
Stroke to the List
31 For more information on the WTC Health
Registry cohort and recruitment methods, see:
Farfel M, DiGrande L, Brackbill R, Prann A, Cone
J, Friedman S, Walker DJ, Pezeshki G, Thomas P,
Galea S, Williamson D, Frieden TR, Thorpe L
[2008], An Overview of 9/11 Experiences and
Respiratory and Mental Health Conditions among
World Trade Center Health Registry Enrollees, J
Urban Health 85(6):880–909.
32 Kim H, Baidwan NK, Kriebel D, Cifuentes M,
Baron S [2018], Asthma among World Trade Center
First Responders: A Qualitative Synthesis and Bias
Assessment, Int J Environ Res Public Health
15(6):1053.
33 See supra note 3 at sec. III.B.1.c.(1).
34 See supra note 3 at sec. III.B.1.c.(2).
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Pursuant to PHS Act,
§ 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 stroke to the List (pursuant to PHS
Act, § 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, § 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, § 3312(a)(6)(B)(i)
and 42 CFR 88.16(a)(2)(i)) is
unwarranted.
For the reasons discussed above, the
Petition 020 request to add stroke 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
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Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Proposed Rules
this document for publication on
February 14, 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. 2019–02941 Filed 2–22–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 216
RIN 0648–XG809
Notification of Receipt of a Petition To
Ban Imports of All Fish and Fish
Products From New Zealand That Do
Not Satisfy the Marine Mammal
Protection Act
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Receipt of petition to ban
imports through emergency rulemaking;
request for information and comments.
AGENCY:
NMFS announces receipt of a
petition for emergency rulemaking
under the Administrative Procedure
Act. Sea Shepherd Legal, Sea Shepherd
New Zealand Ltd., and Sea Shepherd
Conservation Society petitioned the U.S.
Department of Commerce and other
relevant Departments to initiate
emergency rulemaking under the
Marine Mammal Protection Act
(‘‘MMPA’’), to ban importation of
commercial fish or products from fish
that have been caught with commercial
fishing technology that results in
incidental mortality or serious injury of
Ma¯ui dolphin in excess of United States
standards.
DATES: Written comments must be
received by 5 p.m. Eastern Time on
March 27, 2019.
ADDRESSES: You may submit comments
on this document, identified by NOAA–
NMFS–2019–0013, by either of the
following methods:
1. Electronic Submissions: Submit all
electronic comments via the Federal eRulemaking Portal. Go to
www.regulations.gov/
#!docketDetail;D=NOAA-NMFS-20190013, click the ‘‘Comment Now!’’ icon,
complete the required fields and enter
or attach your comments.
2. Mail: Submit written comments to:
Director, Office of International Affairs
amozie on DSK3GDR082PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
16:08 Feb 22, 2019
Jkt 247001
and Seafood Inspection, Attn: MMPA
Petition, NMFS, F/IASI, 1315 East-West
Highway, Silver Spring, MD 20910.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered. All comments received are
a part of the public record and will
generally be posted for public viewing
on https://www.regulations.gov without
change. All personal identifying
information (e.g., name, address, etc.),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter
‘‘N/A’’ in the required fields if you wish
to remain anonymous).
Attachments to electronic comments
will be accepted in Microsoft Word,
Excel, or Adobe portable document file
(PDF) formats only. The complete text of
the petition is available via the internet
at the following web address: https://
www.nmfs.noaa.gov/ia/. In addition,
copies of this petition may be obtained
by contacting NMFS at the above
address.
FOR FURTHER INFORMATION CONTACT:
Nina Young, NMFS F/IASI at
Nina.Young@noaa.gov or 301–427–
8383.
SUPPLEMENTARY INFORMATION:
Background
Section 101(a)(2) of the Marine
Mammal Protection Act (MMPA), 16
U.S.C. 1371(a)(2), states that: ‘‘The
Secretary of the Treasury shall ban the
importation of commercial fish or
products from fish which have been
caught with commercial fishing
technology which results in the
incidental kill or incidental serious
injury of ocean mammals in excess of
United States standards.’’ In August
2016, NMFS published a final rule (81
FR 54390; August 15, 2016)
implementing the fish and fish product
import provisions in section 101(a)(2) of
the MMPA. This rule established
conditions for evaluating a harvesting
nation’s regulatory programs to address
incidental and intentional mortality and
serious injury of marine mammals in
fisheries operated by nations that export
fish and fish products to the United
States. In that rule’s preamble, NMFS
stated that it may consider emergency
rulemaking to ban imports of fish and
fish products from an export or exempt
fishery having or likely to have an
immediate and significant adverse
impact on a marine mammal stock.
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5977
Information in the Petition
NMFS received the petition on
February 6, 2019. The petition alleges
that the Secretaries of Commerce and
other relevant federal Departments are
required to carry out non-discretionary
duties under section 101(a)(2) of the
MMPA (16 U.S.C. 1371(a)(2)), to ‘‘ban
the importation of commercial fish or
products from fish’’ sourced in a
manner that ‘‘results in the incidental
kill or incidental serious injury’’ of
Ma¯ui dolphin ‘‘in excess of United
States standards.’’ The petition
requested that the relevant Secretary
ban the importation of all fish and fish
products caught in set nets or trawls
inside the Ma¯ui dolphin’s range and
from either the west coast of New
Zealand’s North Island or the Cook
Strait, unless affirmatively identified as
having been caught with a gear type
other than set nets or trawls or
affirmatively identified as caught
outside the Ma¯ui dolphin’s range.
As support for the need for this
action, the petition cites several reports
and studies noting various estimates of
decline. The petitioners assert that for
the Ma¯ui dolphin, set net and trawl
bycatch has driven the species from a
population of approximately 2,000
individuals in 1971, to 111 in 2004, to
55 in 2011. Further, the petition notes
that in 2018 the Scientific Committee of
the International Whaling Commission
reported an abundance estimate of 57
individuals, with a 95% confidence
interval of 44 to 75 individuals, which
equates to an average decline of 2%
every year and a total decline of 59%
over the 31-year period from 1985 to
2016.
The petitioners maintain that any
fishery using set nets, trawls, or gillnets
in the Ma¯ui dolphin range along the
west coast of New Zealand’s North
Island violates U.S. standards under the
MMPA. The petitioners provide a list of
11 fish species harvested within the
Ma¯ui dolphin range by set nets, trawls,
or gillnets that are potentially imported
into the U.S. as fish or fish products.
As noted in the petition, New Zealand
has attempted to address the bycatch
problem by (1) restricting set nets and
trawls in certain areas, and (2)
increasing observer coverage and other
monitoring mechanisms. In the case of
gear and area/seasonal restrictions,
trawling has been banned in
approximately 5% of the habitat of Ma¯ui
dolphin, while gillnets are banned in an
additional 14% of that habitat. In
addition, New Zealand’s Hector’s and
Ma¯ui dolphin Threat Management Plan
is currently under review for updates,
with decision documents scheduled to
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]]>Agencies
[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Proposed Rules]
[Pages 5972-5977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02941]
=======================================================================
-----------------------------------------------------------------------
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 020--Stroke; Finding
of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Denial of petition for addition of a health condition.
-----------------------------------------------------------------------
SUMMARY: On August 26, 2018, the Administrator of the World Trade
Center (WTC) Health Program received a petition (Petition 020) to add
``two forms of stroke, both ischemic and non-aneurysmal hemorrhagic,''
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 stroke 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 February 25,
2019.
ADDRESSES: Visit the WTC Health Program website at https://www.cdc.gov/wtc/received.html to review Petition 020.
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 NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Procedures for Evaluating a Petition
C. Petition 020
D. Review of Scientific and Medical Information and Administrator
Determination
E. Administrator's Final Decision on Whether To Propose the Addition
of Stroke 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
[[Page 5973]]
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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, https://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.
---------------------------------------------------------------------------
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 \5\ to the petitioned health condition may also
provide sufficient medical basis for a valid petition.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
C. Petition 020
On August 26, 2018, the Administrator received a petition (Petition
020) from a WTC survivor who resided near Ground Zero, requesting the
addition of ``two forms of stroke, both ischemic and non-aneurysmal
hemorrhagic,'' to the List.\8\ The petition included eight scientific
articles, three of which provided sufficient medical basis for the
petition to be evaluated because they are scientific sources that
demonstrate a potential link between 9/11 exposure and stroke: \9\ a
2006 study by Brackbill et al.,\10\ a 2013 study by Jordan et al.,\11\
and a 2018 study by Yu et al.\12\
---------------------------------------------------------------------------
\8\ See Petition 020, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
\9\ Five of the studies referenced in Petition 020 were
insufficient to provide medical basis because they were not
conducted in 9/11 populations nor did they demonstrate an
association between any 9/11 agents and stroke; these five studies
include the following: Truelsen T, Prescott E, Lange P, Schnohr P,
Boysen G [2001], Lung Function and Risk of Fatal and Non-Fatal
Stroke, The Copenhagen City Heart Study, Int J Epidemiol 30(1):145-
151; Soderholm M, Zia E, Hedblad B, Engstrom G [2012], Lung Function
as a Risk Factor for Subarachnoid Hemorrhage, Stroke 43(10):2598-
2603; Chen MH, Pan TL, Li CT, Lin WC, Chen YS, Lee YC, Tsai SJ, Hsu
JW, Huang KL, Tsai CF, Chang WH, Chen TJ, Su TP, Bai YM [2015], Risk
of Stroke Among Patients with Post-Traumatic Stress Disorder:
Nationwide Longitudinal Study, Br J Psychiatry 206(4):302-307;
Austin V, Crack PJ, Bozinovski S, Miller AA, Vlahos R [2016], COPD
and Stroke: Are Systemic Inflammation and Oxidative Stress the
Missing Links? Clin Sci (Lond), 130(13):1039-1050; and Lekoubou A,
Ovbiagele B [2017], Prevalence and Influence of Chronic Obstructive
Pulmonary Disease on Stroke Outcomes in Hospitalized Stroke
Patients, eNeurologicalSci 6:21-24.
\10\ Brackbill RM, Thorpe LE, DiGrande L, Perrin M, Sapp JH,
2nd, Wu D, Campolucci S, Walker DJ, Cone J, Pulliam P, Thalji L,
Farfel MR, Thomas P [2006], Surveillance for World Trade Center
Disaster Health Effects among Survivors of Collapsed and Damaged
Buildings, MMWR Surveill Summ 55: 1-18.
\11\ Jordan HT, Stellman SD, Morabia A, Miller-Archie SA, Alper
H, Laskaris Z, Brackbill RM, Cone JE [2013], Cardiovascular Disease
Hospitalizations in Relation to Exposure to the September 11, 2001
World Trade Center Disaster and Posttraumatic Stress Disorder, J Am
Heart Assoc 2(5):e000431.
\12\ Yu S, Alper HE, Nguyen AM, Brackbill RM [2018], Risk of
Stroke Among Survivors of the September 11, 2001 World Trade Center
Disaster, J Occup Environ Med 60(8):e371-e376.
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[[Page 5974]]
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.\13\ Petition 020 requested the addition
of ischemic and non-aneurysmal hemorrhagic stroke. Stroke is defined as
an acute brain injury resulting from either too little blood to supply
an adequate amount of oxygen to the affected part of the brain or too
much blood within the cranial cavity.\14\ An ischemic stroke occurs
when there is an inadequate supply of oxygen-rich blood to the brain,
such as may occur due to thrombosis, embolism, or systemic
hypoperfusion. A hemorrhagic stroke occurs when blood builds up and
leaks in the brain, such as may occur due to an intracerebral or
subarachnoid hemorrhage, or an aneurysm (a balloon-like bulge in an
artery that can stretch and burst). A transient ischemic attack, also
called a TIA or ``mini-stroke,'' is similar to a stroke; it occurs if
blood flow to a portion of the brain is blocked only for a short time,
producing a transient episode of neurologic dysfunction without acute
infarction or death of brain tissue.
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\13\ Supra note 3.
\14\ See generally National Heart, Lung, and Blood Institute
(NHBLI), Health Topics: Stroke, https://www.nhlbi.nih.gov/health-topics/stroke (last accessed on Dec. 12, 2018).
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In response to Petition 020, the Program conducted a review of the
scientific literature on stroke, including both ischemic and non-
aneurysmal hemorrhagic, as well as transient ischemic attack.\15\ In
total, this initial literature review identified 12 studies appearing
to potentially meet the Program's criteria for further evaluation.
Three of the studies identified \16\ were peer-reviewed, published,
epidemiologic studies of stroke in the 9/11-exposed population
eligible, in accordance with the Program's policy,\17\ for further
evaluation. The nine remaining studies identified in the literature
review did not meet the Program's criteria for further evaluation.\18\
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\15\ Databases searched include: CINAHL, Embase, NIOSHTIC-2,
ProQuest Health & Safety, PsycINFO, PubMed, Scopus, and Toxicology
Abstracts/TOXLINE. Studies were also identified using the WTC Health
Program Research Compendium. Keywords used to conduct the search
include: Stroke, cerebrovascular accident, transient ischemic
attack, intracerebral hemorrhage, cerebral hemorrhage, subarachnoid
hemorrhage, brain ischemia, brain infarction, cerebral infarction.
The literature search was conducted in English-language journals on
September 26, 2018.
\16\ Two of these three studies, Brackbill et al. and Yu et al.,
were also included as medical basis with the petition.
\17\ See supra note 3.
\18\ Four of the nine studies, including Jordan et al. which was
submitted as medical basis for the petition, contained limited
findings regarding an association between 9/11 exposure and stroke
that the Program determined warranted additional review. Those four
studies are summarized in the docket, as ``background information,''
to illustrate their inability to provide dispositive information
about an association between 9/11 exposure and stroke.
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Evaluation of Three Published, Peer-Reviewed Epidemiologic Studies of
Stroke in the 9/11 Population
As discussed above, the Program determined that of the 12 studies
identified in the literature review that appeared to potentially meet
the criteria for evaluation, only 3 could be fully evaluated because
they are peer-reviewed, published, epidemiologic studies of stroke in
the 9/11 population: Brackbill et al. [2006] and Yu et al. [2018],
which were referenced in Petition 020, and Remch et al. [2018].\19\
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\19\ Remch M, Laskaris Z, Flory J, Mora-McLaughlin C, Morabia A
[2018], Post-Traumatic Stress Disorder and Cardiovascular Diseases:
A Cohort Study of Men and Women Involved in Cleaning the Debris of
the World Trade Center Complex, Circ Cardiovasc Qual Outcomes
11(7):e004572.
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Study Summaries
1. Brackbill et al. conducted a cross-sectional study \20\ designed
to assess the physical and mental health conditions and symptoms
reported by survivors of the WTC towers and nearby buildings between
September 5, 2003 and November 20, 2004, and to examine the
relationship between their reported 9/11 exposures and health and
mental health outcomes. The study used WTC Health Registry data from
baseline interviews conducted with 8,418 adult survivors who had been
occupants of collapsed or damaged buildings. Exposure data were
evaluated and exposures were sorted by location and time proximity to
exposure events according to whether the participant was present in the
WTC dust cloud; occupied a collapsed versus damaged building; or
evacuated before or after the collapse of the first tower. Health
histories were also collected from Registry interview data, including
self-reports of physician-diagnosed stroke subsequent to September 11,
2001. The rate of stroke among adult survivors of collapsed and damaged
buildings was adjusted for sex and mode of recruitment (physical and
mental health symptoms tended to be higher among Registry members who
self-identified than among those identified from a list of building
survivors with security badges). Brackbill et al. found a statistically
significant association for stroke among survivors exposed to the WTC
dust cloud compared to those not exposed to the WTC dust cloud
[adjusted odds ratio (aOR) = 5.6, 95% CI 1.3-24.4]; however, the
prevalence of stroke among survivors who evacuated before versus after
the collapse of the first WTC tower and among those who evacuated from
collapsed buildings versus damaged buildings was not significantly
different [aOR = 0.6, 95% CI 0.1-4.5, and aOR = 1.5, 95% CI 0.6-4.0,
respectively]. According to the authors, this indicated a ``potential
relation'' between WTC dust exposure and stroke; this finding was
considered preliminary, however, meriting continued monitoring, because
the small sample size and cross-sectional design limits the
interpretation and generalizability of findings. The cross-sectional
design of this study is a major limitation because it fails to
establish a temporal relationship between 9/11 exposure and reported
stroke. Finally, the study did not differentiate between hemorrhagic
and ischemic stroke, which have different risk factors.
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\20\ A cross-sectional study is a type of observational study
that evaluates a sample of persons from a specific population and
measures the sample's exposures and health outcomes simultaneously.
Because the presence of disease and the determination of exposure
are conducted at the same specific point in time, the temporal
sequence of cause and effect (i.e. did the disease appear before or
after exposure) generally cannot be determined.
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2. Yu et al. conducted a cohort study to investigate the risk of
stroke among 42,527 WTC responders and survivors who experienced PTSD
and who had intense exposure to WTC dust. Self-reports of WTC dust
exposure and stroke diagnosis subsequent to September 11, 2001 were
obtained from WTC Health Registry surveys collected from 2003 to 2016.
Intense exposure was defined as having been in the WTC dust cloud and
reporting at least one of the following: Inability to see more than a
few feet; difficulty walking; difficulty finding shelter; being covered
with dust; or loss of hearing. Minimal or no-exposure was defined as
being in the WTC dust but without experiencing intense exposure, or no
WTC dust exposure at all. After adjusting for sociodemographic
characteristics, risk factors for stroke (smoking and history of
hypertension and/or diabetes), and PTSD, the study found that WTC dust
cloud exposure was independently associated with an increased risk for
stroke among WTC responders and survivors [aHR = 1.2, 95% CI 1.0-1.4].
The study has numerous strengths, including the longitudinal design,
[[Page 5975]]
adequate control of confounding and a large number of participants with
small loss to follow up. Limitations included that stroke was self-
reported and the authors did not distinguish between hemorrhagic and
ischemic stroke.
3. Remch et al. conducted a cohort study to determine whether PTSD
is a risk factor for myocardial infarction and stroke. The study used
data collected between January 2012 and June 2013 from World Trade
Center (WTC)-Heart, a WTC Health Program Research Program-funded cohort
study of 6,481 Program members who were non-firefighter workers and
volunteers engaged in rescue, recovery, restoration of services,
cleanup, or other support work on or after September 11, 2001. Exposure
was reported in a self-administered questionnaire, which asked
participants about when they started to work at Ground Zero, whether
they were in the dust cloud, whether they worked on or near the pile or
the pit (the remains of the WTC towers), and whether a respiratory
protective device was worn. Stroke was self-reported and tentatively
confirmed by additional personal interviews conducted by phone.
Approximately 60 percent of self-reported stroke cases were confirmed
by medical records documenting typical stroke symptoms and either
supportive medical imaging or sonographic signs. Cases of stroke were
also identified in the New York State Department of Health's, Statewide
Planning and Research Cooperative System (SPARCS) database by searching
for hospitalized cohort members with a discharge diagnosis of stroke.
However, the study did not report whether the participants who
experienced recurrent strokes (of the 53 reported strokes, 15 were
recurrent) had their first stroke before September 11, 2001, and
whether the first stroke may have been the cause of subsequent
recurrent strokes. Based on their analysis, Remch et al. concluded that
none of the 9/11 exposure variables (i.e., timing and intensity of WTC
dust and dust cloud exposure, use of respiratory protection) were
independently associated with subsequent stroke. It should be noted,
however, that detailed data to support these findings were not
presented in the article apart from the finding that the risk of stroke
was not significantly reduced by the use of a respirator [aHR = 0.8,
95% CI 0.4-1.8]. The study also concluded that PTSD was an independent
determinant of stroke in both men and women, before and after
controlling for use of a respirator during debris cleanup,
cardiovascular risk factors, and depression. Remch et al. has multiple
strengths, including the cohort-study design, active follow-up,
validation of stroke using SPARCS, and adjustment for cardiovascular
risk factors, including smoking and depression. Limitations include
PTSD being self-reported, as well as the lack of distinction between
hemorrhagic and ischemic stroke and the failure to clarify whether pre-
September 11, 2001 and recurrent strokes were appropriately analyzed.
Moreover, the study focused on assessing whether those with PTSD are at
increased risk of myocardial infarction or stroke; determining the
effect of WTC dust exposure on those outcomes was of secondary
importance. Finally, the authors did not provide detailed findings
using exposure data, apart from reporting on respirator use and non-
use; even where respirator use was reported, however, information on
frequency and time of use was not provided.
Evaluation of Studies Using Select Bradford Hill Criteria
Together, the three studies by Brackbill et al., Yu et al., and
Remch et al. were assessed to determine whether a causal relationship
between 9/11 exposures and stroke is supported.\21\ As described in the
policy on the addition of non-cancer health conditions to the List,\22\
the WTC Health Program uses the following Bradford Hill criteria to
evaluate studies of 9/11-exposed populations: strength of association,
precision of the risk estimate, consistency of association, biological
gradient, and plausibility and coherence.
---------------------------------------------------------------------------
\21\ Although the Brackbill et al. and Yu et al. studies were
both conducted in the WTC Health Registry population, the Yu et al.
study is not a follow-up to the Brackbill et al. study and each was
evaluated independently in this action.
\22\ WTC Health Program [2017], Policy and Procedures for Adding
Non-Cancer Conditions to the List of WTC-Related Health Conditions,
February 14, 2017 at 3-4, https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancers_14_February_2017-508.pdf.
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Strength of association: \23\ Of the three studies, Brackbill et
al. reported a strong association between exposure to WTC dust and the
risk of stroke in WTC survivors; Yu et al. reported a moderate
association between WTC dust exposure and stroke in WTC responders and
survivors; and Remch et al. reported no association between WTC dust
exposure and risk of stroke in WTC responders.
---------------------------------------------------------------------------
\23\ It is generally thought that strong associations are more
likely to be causal than weak associations; however, a weak
association does not rule out a causal relationship.
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Precision of risk estimate: \24\ Although both Brackbill et al. and
Yu et al. were conducted using WTC Health Registry data, the more
recent study by Yu is more precise because the sample size is larger;
in contrast, Brackbill reported very wide confidence intervals. Remch
et al. studied a cohort of responders in the WTC Health Program;
despite reporting a relatively large number of stroke cases, the
precision of the study findings could not be evaluated because detailed
findings (i.e., number of stroke cases associated with different levels
of 9/11 exposure, risk estimates, and confidence intervals) regarding
possible association between 9/11 exposure and stroke were not
reported.
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\24\ The uncertainty inherent in estimating the strength of
association between exposure and health effect (effect size) from
observational data is expressed as a confidence interval,
illustrating a range of values that contains the true effect size. A
narrow confidence interval indicates a more precise measure of the
effect size and a wider interval indicates greater uncertainty. See
supra note 22.
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Consistency of association: \25\ The findings were not consistent
across the three studies: The WTC Health Registry studies showed
increased risk of stroke with exposure to the WTC dust cloud; Remch et
al. did not find an association between intermediate or high exposure
and the risk of stroke.
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\25\ Consistent findings are demonstrated when they have been
repeatedly reported by multiple studies.
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Biological gradient: \26\ None of the three studies reported
exposure-response. Although Brackbill et al. and Yu et al. each found a
positive association between 9/11 exposure and stroke, they both
conducted limited, binary evaluations of exposure variables: Brackbill
et al. sorted exposures according to location and temporal proximity to
the WTC dust and dust cloud, and Yu et al. sorted exposures by
determining if study subjects were intensely exposed to the dust and
dust cloud. Neither study fully analyzed stroke in the context of a
full exposure-response assessment. Remch et al., which did not find a
positive association between 9/11 exposure and stroke, also did not
report exposure-response.
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\26\ Studies establish an exposure-response relationship by
demonstrating that increases in exposure (i.e., exposures of greater
intensity and/or longer duration) are associated with a greater
incidence of disease. A thorough evaluation of exposure-response
requires analysis of multiple levels of exposure such that the
investigator can demonstrate that the risk increases with increasing
levels of exposure.
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Plausibility and coherence: \27\ Brackbill et al. and Yu et al.
each mentioned that other studies have found an association between
stroke and air pollution, which primarily comprises
[[Page 5976]]
small particulate matter (PM2.5). Both Brackbill et al. and
Yu et al. also noted that the WTC dust and dust cloud contained a
unique mixture of construction debris and combustion products,\28\
including small particulate matter (PM2.5) as well as large
particulate matter (>PM10) not typically found in air
pollution.\29\ Although the comparison of air pollution to WTC dust is
imperfect because of the high concentration of >PM10 in WTC
dust and dust cloud samples, it is nevertheless instructive due to the
documented health effects of PM2.5 exposure, including
stroke.\30\ While the association between WTC dust and stroke seems
plausible because of the presence of PM2.5, the underlying
biological mechanisms through which small particulate matter exerts its
effect on the vascular system is still an area of study.
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\27\ Study findings demonstrate a basis in scientific theory
that supports the relationship between the exposure and the health
effect, and do not conflict with known facts about the biology of
the health condition.
\28\ The WTC Health Program's Inventory of 9/11 Agents
(available at https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf) identifies
chemical, physical, biologic, and other hazards as having been
present at any of the three disaster sites. Of the 352 chemical 9/11
agents identified from air and settled dust sampling studies and
from biological monitoring studies, five are types of WTC dust,
including: WTC Dust: Glass shards, WTC Dust: PM10, WTC
Dust: PM2.5, WTC Dust: Particles >2 [mu]m, and WTC Dust:
Particles >5 [mu]m. The remaining 347 chemicals are identified by
name. See supra note 5.
\29\ Brackbill et al. [2006] supra note 10 at 12; Yu et al.
[2018] supra note 11 at e375, and Lioy PJ, Weisel CP, Millette JR,
Eisenreich S, Vallero D, Offenberg J, Buckley B, Turpin B, Zhong M,
Cohen MD, Prophete C, Yang I, Stiles R, Chee G, Johnson W, Porcja R,
Alimokhtari S, Hale RC, Weschler C, Chen LC [2002], Characterization
of the dust/smoke aerosol that settled east of the World Trade
Center (WTC) in Lower Manhattan after the collapse of the WTC 11
September 2001, Env Health Perspect 110:703-714.
\30\ Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R,
Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K,
Murray CJL, Forouzanfar MH [2016], Global Burden of Stroke and Risk
Factors in 188 Countries, During 1990-2013: A Systematic Analysis
for the Global Burden of Disease Study 2013, Lancet Neurol
15(9):913-924; B[eacute]jot Y, Reis J, Giroud M, Feigin V [2018], A
Review of Epidemiological Research on Stroke and Dementia and
Exposure to Air Pollution, Int J Stroke 13(7):687-695.
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Evaluation of Representativeness of Studies
Finally, the three studies were reviewed to determine whether both
the WTC responder and survivor cohorts studied are representative of
the entire 9/11-exposed population, and whether the results can be
extrapolated. The cohort studied by Brackbill et al. consisted of
survivors enrolled in the WTC Health Registry; the population studied
by Yu et al. included responders and survivors enrolled in the WTC
Health Registry; the population studied by Remch et al. only included
non-firefighter responders who were members of the WTC-Heart cohort
within the WTC Health Program. Although Brackbill et al. and Yu et al.
consisted of Registry members, the former only included 8,418 adult
survivors of collapsed buildings and buildings with major or moderate
damage, while the latter included 42,527 survivors and responders of
the WTC attack.\31\ According to an assessment of the WTC Health
Registry by Kim et al. [2018],\32\ although enrollment was voluntary,
extensive outreach efforts show that selection bias is unlikely for
this cohort. The cohort studied by Remch et al. is nested within the
WTC Health Program and appears to be representative of the population
served by the clinics where recruitment took place. As a result, the
Program determined that the results of the three evaluated studies can
be extrapolated to the entire 9/11-exposed population.
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\31\ For more information on the WTC Health Registry cohort and
recruitment methods, see: Farfel M, DiGrande L, Brackbill R, Prann
A, Cone J, Friedman S, Walker DJ, Pezeshki G, Thomas P, Galea S,
Williamson D, Frieden TR, Thorpe L [2008], An Overview of 9/11
Experiences and Respiratory and Mental Health Conditions among World
Trade Center Health Registry Enrollees, J Urban Health 85(6):880-
909.
\32\ Kim H, Baidwan NK, Kriebel D, Cifuentes M, Baron S [2018],
Asthma among World Trade Center First Responders: A Qualitative
Synthesis and Bias Assessment, Int J Environ Res Public Health
15(6):1053.
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Summary of Evaluation
Although the studies described and evaluated above provide evidence
that suggests a possible association between 9/11 exposure and stroke,
the evidence is insufficient to conclude that stroke is either
substantially likely \33\ or highly likely \34\ to be causally
associated with 9/11 exposures among 9/11-exposed populations. The
evidence provided by the three studies is insufficient to support an
addition to the List for several reasons. Most importantly, the results
of the three studies lacked consistency: Two studies found a positive
association between 9/11 exposure and stroke (Brackbill et al. and Yu
et al.), and one did not (Remch et al.). The two studies that found a
positive association between 9/11 exposure and stroke relied on self-
reported stroke, which may be prone to recall bias and the
imperfections of human memory. In contrast, Remch et al. confirmed the
presence of stroke using medical records and SPARCS data, but failed to
find an association between 9/11 exposure and stroke. Another
limitation common to all three studies was the lack of differentiation
between hemorrhagic and ischemic stroke; these two variants have
different pathophysiology and causes, and therefore it is not clear if
the reported incidence of stroke refers to one or both types of stroke.
Finally, the absence of an exposure-response analysis in all of the
studies means that the biological gradient is not adequately assessed.
In conclusion, when all three studies are considered together, their
limitations and lack of consistent findings do not provide adequate
evidence to propose the addition of stroke to the List. Without
significant positive findings from studies with sufficient sample size,
objective confirmation of stroke, and an assessment of exposure-
response, the available evidence does not demonstrate that stroke is
either substantially likely or highly likely to be causally associated
with 9/11 exposures among 9/11-exposed populations.
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\33\ See supra note 3 at sec. III.B.1.c.(1).
\34\ See supra note 3 at sec. III.B.1.c.(2).
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E. Administrator's Final Decision on Whether To Propose the Addition of
Stroke 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 stroke 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 020 request to add
stroke 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
[[Page 5977]]
this document for publication on February 14, 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. 2019-02941 Filed 2-22-19; 8:45 am]
BILLING CODE 4163-18-P
