[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)]
[Proposed Rules]
[Pages 17783-17787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 018--Hypertension; 
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 January 5, 2018, the Administrator of the World Trade 
Center (WTC) Health Program received a petition (Petition 018) to add 
hypertension (high blood pressure) 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 
hypertension 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 April 24, 2018.

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 018
D. Review of Scientific and Medical Information and Administrator 
Determination
E. Administrator's Final Decision on Whether To Propose the Addition 
of Hypertension 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

[[Page 17784]]

Public Health Service (PHS) Act,\1\ establishing the WTC Health Program 
within the Department of Health and Human Services (HHS). The WTC 
Health Program provides medical monitoring and treatment benefits to 
eligible firefighters and related personnel, law enforcement officers, 
and rescue, recovery, and cleanup workers who responded to the 
September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania (responders), and to 
eligible persons who were present in the dust or dust cloud on 
September 11, 2001, or who worked, resided, or attended school, 
childcare, or adult daycare in the New York City disaster area 
(survivors).
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the James Zadroga 9/11 Health and 
Compensation Act of 2010 found in Titles II and III of Public Law 
111-347 do not pertain to the WTC Health Program and are codified 
elsewhere.
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    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the Director of the National 
Institute for Occupational Safety and Health (NIOSH) or his 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 
limitations 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 
agents or hazards reported in a published, peer-reviewed exposure 
assessment study of responders or survivors who were present in the 
New York City disaster area, at the Pentagon site, or at the 
Shanksville, Pennsylvania site, as those locations are defined in 42 
CFR 88.1.
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C. Petition 018

    On January 5, 2018, the Administrator received a petition (Petition 
018) from a WTC responder who worked at Ground Zero, requesting the 
addition of ``hypertension--high blood pressure'' to the List.\8\ The 
petition included one scientific article reviewing the findings of 
peer-reviewed, published epidemiologic studies concerning the 
association of hypertension and cardiovascular disease with post-
traumatic stress disorder (PTSD), by McFarlane [2010].\9\ The McFarlane 
article on its own did not provide a medical basis, but it did provide 
a reference to a peer-reviewed, published study by Gerin et al. [2005] 
\10\ of hypertension in populations that were potentially affected by 
the September 11, 2001, terrorist attacks, in New York City, Washington 
DC, Chicago, and Mississippi, suggesting an association between 9/11 
exposures and the health condition. The inclusion of a reference to 
this study in the submission provides sufficient medical basis for the 
submission to be considered a valid petition.
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    \8\ See Petition 018, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \9\ McFarlane AC [2010], The Long-Term Costs of Traumatic 
Stress: Intertwined Physical and Psychological Consequences, World 
Psychiatry 9:3-10.
    \10\ Gerin W, Chaplin W, Schwartz JE, et al. [2005], Sustained 
Blood Pressure Increase After an Acute Stressor: the Effects of the 
11 September 2001 Attack on the New York City World Trade Center, 
Journal of Hypertension 23(2):279-284.
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D. Review of Scientific and Medical Information and Administrator 
Determination

    In response to Petition 018, and pursuant to the Program policy on 
the addition of non-cancer health conditions to the List,\11\ the 
Program conducted reviews of the scientific literature on 
hypertension.\12\ Through the literature search, the Program

[[Page 17785]]

identified 21 references to review for relevance; \13\ of those 
identified references, three were found to be relevant peer-reviewed, 
published, epidemiologic studies of hypertension in 9/11-exposed 
populations: Simeon et al. [2008],\14\ Trasande et al. [2013],\15\ and 
Kim et al. [2018].\16\ At this stage of the evaluation process, the 
Gerin et al. [2005] study was more carefully reviewed. The study 
population in Gerin et al. [2005] included participants residing in New 
York City and Washington DC who might have been exposed to reports of 
the September 11, 2001, terrorist attacks, in ``newspapers, radio and 
television broadcasts, magazine articles, and web-based discussions, 
literally every day from the time they occurred. . . .'' \17\ None of 
the participants were reported to have been first responders, 
volunteers, or survivors of the terrorist attacks, or to have been 
directly exposed to 9/11 agents. Accordingly, the Administrator 
determined that Gerin et al. [2005] is not an epidemiologic study of 
hypertension in the 9/11-exposed populations and does not meet the 
threshold for relevance established in the Program policy; therefore, 
the study is not further reviewed below.
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    \11\ Supra note 3.
    \12\ Databases searched include: NIOSHTIC-2, ProQuest Health & 
Safety, PubMed, Scopus, Toxicology Abstracts/TOXLINE, and Medline.
    \13\ The 21 studies included a study by Jordan et al. [2011], 
which the Program evaluated and determined not to be relevant to an 
evaluation of hypertension among the 9/11 population. The study's 
authors evaluated cardiovascular disease hospitalizations among WTC 
Health Registry members; however, hypertension was grouped with 
other cardiovascular conditions and, therefore, the effect of 9/11 
exposures on hypertension hospitalizations could not be ascertained. 
Jordan HT, Brackbill RM, Cone JE, et al. [2011], Mortality among 
survivors of the Sept 11, 2001, World Trade Center disaster: results 
from the World Trade Center Health Registry cohort, Lancet 
378(9794):879-887.
    \14\ Simeon D, Yehuda R, Knutelska M, et al. [2008], 
Dissociation versus posttraumatic stress: cortisol and physiological 
correlates in adults highly exposed to the World Trade Center attack 
on 9/11, Psychiatry Research 161(3):325-329.
    \15\ Trasande L, Fiorino EK, Attina T, et al. [2013], 
Associations of World Trade Center exposures with pulmonary and 
cardiometabolic outcomes among children seeking care for health 
concerns, The Science of the Total Environment 444:320-326.
    \16\ Kim H, Kriebel D, Liu B, et al. [2018], Standardized 
morbidity ratios of four chronic health conditions among World Trade 
Center responders: Comparison to the National Health Interview 
Survey, American Journal of Industrial Medicine (accepted for 
publication).
    \17\ Supra note 10, at 283.
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    Simeon et al. [2008]. The cross-sectional study \18\ by Simeon et 
al. [2008] was designed to ``investigate perturbations in the major 
stress response systems . . . after the 9/11 attack, with a specific 
focus of dissecting unique correlates of posttraumatic stress versus 
dissociative symptomatology.'' The authors' primary hypothesis was that 
dissociation and posttraumatic stress show different associations to 
cortisol and psychophysiological measures (dexamethasone suppression, 
psychosocial stress reactivity, and physiological stress reactivity). 
Blood pressure and heart rate were also measured to allow comparisons 
between physiologic measures of dissociation and posttraumatic stress 
in exposed and unexposed study participants. Participants included 21 
New York City residents considered ``highly exposed to 9/11,'' as well 
as 10 New York City residents who did not have significant 9/11 
exposure or a diagnosis of posttraumatic stress disorder (PTSD), who 
served as the control group. Exposed participants reported being inside 
a tower, being in very close proximity to Ground Zero, losing a close 
loved-one, or participating in rescue and recovery efforts. Mean 
resting systolic blood pressure, mean resting diastolic blood pressure, 
mean peak Trier Social Stress Test (TSST) systolic blood pressure, and 
mean peak TSST diastolic blood pressure \19\ did not differ 
significantly between the exposed and unexposed groups, even among 
seven of the 21 exposed participants who met criteria for a diagnosis 
of PTSD.
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    \18\ An observational study that analyzes data from a population 
or sub-set of a population at a specific point in time.
    \19\ Blood pressure was measured at rest (averaged over four 
hourly time points) and at its peak during TSST. The study did not 
provide any information about equipment used or guidelines followed 
to measure blood pressure.
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    The Program found several limitations with the Simeon et al. [2008] 
study. First, the study inadequately adjusted for confounding; because 
the authors did not provide enough information about the control group, 
the Program was unable to determine whether adjustments had been made 
for all potential confounders. Second, the study inadequately addressed 
recruitment bias; the exposed study participants were recruited by 
newspaper advertisement, which primarily captures those individuals who 
subscribe to or purchase the newspaper and thus may not be 
representative of the entire 9/11-exposed population. Third, the study 
incompletely considered all aspects of exposure; the authors described 
the experimental and control groups only as ``highly exposed'' and no 
``significant exposure,'' respectively, rather than seeking to 
quantitatively or qualitatively characterize the different types of 
exposure experienced by participants, as well as the intensity and 
duration of their exposures, and the resulting impacts on health 
outcomes. Finally, the study insufficiently addressed the inadequacies 
of the referent population; the study employs a small sample size and 
thus lacks adequate power to evaluate the association between 9/11 
exposure and hypertension.
    Trasande et al. [2013]. The second study, by Trasande et al. 
[2013], is also a cross-sectional study. It was designed to examine the 
impact of clinically-reported exposures on the health of children who 
were exposed to the terrorist attack in New York City. Study 
participants included 148 patients who were 18 years of age or younger 
on September 11, 2001, enrolled in the WTC Environmental Health Center 
(the health program for 9/11 survivors that predated the WTC Health 
Program). The authors compared blood pressure data from the study 
population \20\ with that of children 6 to 19 years of age, reported in 
CDC's National Health and Nutrition Examination Survey (NHANES) 2001-
2006. The authors developed exposure categories for dust cloud exposure 
and presence/absence at their home residence one day during September 
11-18, 2001, but none were used in the evaluation of an association 
with prehypertension or hypertension. The study found that 45.5 percent 
of children in the study population were prehypertensive and 10.6 
percent were hypertensive, compared with the NHANES data, in which 6.9 
percent were prehypertensive and 2.4 percent were hypertensive; \21\ 
prehypertension among the study group was positively associated with 
older age (+9.5% odds/year older, p = 0.024).
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    \20\ Blood pressure was measured using a Philips SureSigns VS3 
oscillometric sphygmomanometer with appropriate cuff size for arm 
length, following American Heart Association guidelines in Urbina E, 
Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, et al. 
[2008], Ambulatory blood pressure monitoring in children and 
adolescents: recommendations for standard assessment: a scientific 
statement from the American Heart Association Atherosclerosis, 
Hypertension, and Obesity in Youth Committee of the council on 
cardiovascular disease in the young and the council for high blood 
pressure research, Hypertension 52:433-51. The guidelines referenced 
by the study authors are for ambulatory blood pressure monitoring, 
not single clinic measurements as were conducted during the study.
    \21\ The study authors categorized blood pressure (BP) outcomes 
as follows: present/absent prehypertension (BP >=90th percentile for 
age/height Z-score/gender or systolic BP >=120 mm Hg or diastolic BP 
>=80 mm Hg) and present/absent hypertension (BP >=95th percentile 
for age/height Z-score/gender or systolic BP >=140 mm Hg or 
diastolic BP >=90 mm Hg).
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    Although the results of Trasande et al. [2013] suggest possible 
cardiovascular effects, the Program found several major limitations 
with the study. First, the study inadequately adjusted for possible 
confounders; although the authors

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identify that an important confounder is living in an urban setting 
where the types and concentrations of particulates are different than 
in other settings, no adjustments were made to account for the setting, 
limiting the value of the comparing the urban study population's blood 
pressure data with NHANES data, which includes data from suburban and 
rural populations likely exposed to different types and concentrations 
of particulates. Second, the study inadequately addressed recruitment 
bias; the authors selected participants from among those who presented 
to the WTC Environmental Health Center, and were <=18 years old on 
September 11, 2001 and thus may have been sicker than the general 
population of survivors. Third, the study incompletely considered all 
aspects of exposure; 9/11 exposure among participants with hypertension 
was not considered or evaluated. Finally, the study insufficiently 
addressed the inadequacies of the referent population; the study does 
not describe whether the NHANES sample has a comparable ethnic 
composition and residential setting to that of the study group. 
Although the study did find a relatively high frequency of 
cardiometabolic risks, including elevated blood pressure, the authors 
did not evaluate the association between 9/11 exposure and 
hypertension.
    Kim et al. [2018]. The third study, a prospective cohort study \22\ 
by Kim et al. [2018], was designed to compare the lifetime prevalence 
of hypertension, asthma, diabetes, and cancer among WTC responders 
currently enrolled in the WTC Health Program, with a referent group 
from the National Health Interview Survey (NHIS). Hypertension \23\ 
among WTC responders was self-reported, as was exposure to WTC dust and 
other stressors. After comparing annual standardized morbidity ratios 
for hypertension prevalence, the authors found that hypertension 
prevalence was statistically significantly increased among male WTC 
responders between 2007 and 2009, peaking at 1.17 (95% CI 1.13-1.22) in 
2008, but decreased among male WTC responders in 2010, which was the 
last year studied. Hypertension prevalence was never elevated among 
women. The authors ultimately concluded that the slightly higher 
prevalence of hypertension in men in the study group may be associated 
with WTC-related PTSD and that further analysis and follow-up of WTC 
responders is warranted.
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    \22\ A study that follows a cohort of similar individuals over 
time to determine how risk factors affect health outcomes.
    \23\ Responders who participated in the Kim et al. [2018], study 
were asked: ``Has a doctor ever told you that you had high blood 
pressure?'' The Program assumes the authors define hypertension as 
having responded ``yes'' to this questions, although this level of 
detail was not provided by the authors. Participants of the NHIS 
study were asked: ``Have you ever been told by a doctor or health 
professional that you have hypertension, also called high blood 
pressure?'' Kim et al. [2018] provides no further information 
provided regarding the study's definition of ``high blood pressure'' 
or ``hypertension.''
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    The Program identified several limitations with the Kim et al. 
[2018] study. First, the study inadequately adjusted for confounders; 
the standardized morbidity ratios were age-adjusted, but not adjusted 
for other confounders. Second, the study did not adequately adjust for 
recruitment bias; the authors acknowledge that selection bias is likely 
because sicker WTC responders may have been more likely to enroll in 
the WTC Health Program and attend follow-up examinations more 
frequently. Third, the study incompletely considered all aspects of 
exposure; the authors described the WTC responder and referent groups 
only as ``exposed'' and ``unexposed,'' respectively. Fourth, the study 
incompletely addressed the inadequacies of the referent population; the 
NHIS data, while representative of the U.S. population, is likely not 
comparable to the WTC responder cohort. Finally, outcome data in the 
study was incomplete; the authors used self-reported hypertension 
rather than conducting blood pressure measurements in study 
participants, and used different questions to define hypertension in 
the WTC responder group compared with the referent group.
    Together, all three studies were assessed to determine whether a 
causal relationship between 9/11 exposures and hypertension is 
supported. The 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 findings, biological 
gradient, and plausibility and coherence. Only one of the three studies 
demonstrated a statistically significant increase in hypertension among 
WTC responders (Kim et al. [2018]); one study found no statistically 
significant differences in blood pressure between exposed and unexposed 
participants (Simeon et al. [2008]); and one study used an inadequate 
comparison group and this faulty study design feature precluded an 
evaluation of the association between 9/11 exposures and the risk of 
hypertension (Trasande et al. [2013]). Only one of the three studies 
demonstrated a precise risk estimate (Kim et al. [2018]); risk 
estimates were not calculated in the other two studies. The studies did 
not share a single definition of hypertension, and, ultimately, their 
findings were not consistent, as only Kim et al. [2018] showed a 
statistically significant increase in hypertension among WTC 
responders. The biological gradient and dose response were not 
evaluated in any of the studies. Although none of the studies evaluated 
a causal association between hypertension and WTC dust, the Program 
finds it plausible and coherent that 9/11 exposures may increase blood 
pressure, possibly through one or more of the following mechanisms: (1) 
Systemic oxidative stress/inflammation, (2) elevated endothelin levels 
or activity, or (3) altered autonomic nervous system balance,\24\ and 
this is consistent with the results presented by Trasande et al. [2013] 
and Kim et al. [2018].
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    \24\ See Brook RD, Urch B, Dvonch JT, et al. [2009], Insights 
into the mechanisms and mediators of the effects of air pollution 
exposure on blood pressure and vascular function in healthy humans, 
Hypertension 54(3):659-667.
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    Finally, the three studies were reviewed to determine whether the 
studies represent both the WTC responder and survivor populations or a 
subgroup of those populations, or whether the results can be 
extrapolated to the entire 9/11-exposed population. The Program found 
that only one study demonstrated that the results could be extrapolated 
to the population of WTC responders (Kim et al. [2018]); another study 
was conducted among a potentially non-representative and small sample 
of WTC survivors (Simeon et al. [2008]), and the final study did not 
describe a sampling procedure to allow an assessment of 
representativeness (Trasande et al. [2013]).
    The studies described and evaluated above had limitations and 
lacked consistency among their results. Neither the one study that 
showed a statistically significant increase in hypertension among WTC 
responders, Kim et al. [2018], nor all three studies, taken together, 
were able to demonstrate that hypertension is substantially likely to 
be causally associated with 9/11 exposures among 9/11-exposed 
populations.

E. Administrator's Final Decision on Whether To Propose the Addition of 
Hypertension to the List

    The Administrator has determined that insufficient evidence is 
available to take further action at this time, including proposing the 
addition of hypertension 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

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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 018 request to add 
hypertension to the List of WTC-Related Health Conditions is denied.
    The WTC Health Program may consider hypertension to be a condition 
medically associated with a certified WTC-related health condition in 
individual cases. Program members who think their hypertension is a 
progression or side effect of treatment of a certified WTC-related 
health condition should ask their WTC Health Program medical provider 
whether their hypertension might be considered a medically associated 
health condition.

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 April 18, 2018.

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. 2018-08456 Filed 4-23-18; 8:45 am]
BILLING CODE 4163-18-P