World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence, 60329-60332 [2016-21070]
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Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules
and lead-based paint management
requirements under this part throughout
the 12 months preceding the date the
owner received the environmental
investigation report pursuant to
paragraph (a) of this section; and, in
either case, the owner provided the
HUD field office, within 10 business
days after receiving the notification of
the elevated blood lead level,
documentation that it has conducted the
activities described in this paragraph
(f)(4) of this section.
(g) HUD encourages the designated
party or the owner to evaluate for
sources of lead exposure in units other
than those covered by this subpart, and
to control such sources.
(h) Data collection and record keeping
responsibilities. At least quarterly, the
designated party shall attempt to obtain
from the public health department(s)
with area(s) of jurisdiction similar to
that of the designated party the names
and/or addresses of children of less than
6 years of age with an identified
elevated blood lead level. At least
quarterly, the designated party shall also
report an updated list of the addresses
of units receiving assistance under a
tenant-based rental assistance program
to the same public health department(s),
except that the report(s) to the public
health department(s) is not required if
the health department states that it does
not wish to receive such report. If it
obtains names and addresses of elevated
blood lead level children from the
public health department(s), the
designated party shall match
information on cases of elevated blood
lead levels with the names and
addresses of families receiving tenantbased rental assistance, unless the
public health department performs such
a matching procedure. If a match occurs,
the designated party shall carry out the
requirements of this section.
Dated: August 26, 2016.
Michelle Miller,
Deputy Director, Office of Healthy Homes and
Lead Hazard Control.
[FR Doc. 2016–20955 Filed 8–31–16; 8:45 am]
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BILLING CODE 4210–67–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R01–OAR–2015–0471; A–1–FRL–
9943–04–Region 1]
Air Plan Approval; Connecticut; Open
Burning and Portable Fuel Containers
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Proposed rule.
The Environmental Protection
Agency (EPA) is proposing to approve a
State Implementation Plan (SIP)
revision submitted by the State of
Connecticut on November 19, 2012. We
propose to approve Connecticut’s
request to remove two regulations from
its SIP that regulate ‘‘open burning’’ and
‘‘portable fuel container spillage
control.’’ In place of the open burning
regulation, we propose to approve into
the Connecticut SIP a Connecticut
statute that controls open burning. We
also propose to approve a definition of
‘‘brush,’’ which was included in a
December 15, 2015 SIP submittal by
Connecticut to meet infrastructure
requirements of the Clean Air Act for
the 2012 fine particle (PM2.5) National
Ambient Air Quality Standards
(NAAQS). The requirements in the
Connecticut portable fuel container
regulation have been superseded by
federal portable fuel container
requirements. This action is being taken
in accordance with the Clean Air Act.
DATES: Written comments must be
received on or before October 3, 2016.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R01–
OAR–2015–0471 by one of the following
methods:
1. https://www.regulations.gov: Follow
the online instructions for submitting
comments.
2. Email: arnold.anne@epa.gov.
3. Mail: ‘‘EPA–R01–OAR–2015–
0471,’’ Anne Arnold, U.S.
Environmental Protection Agency, EPA
New England Regional Office, 5 Post
Office Square—Suite 100, (Mail code
OEP05–2), Boston, MA 02109–3912.
4. Hand Delivery or Courier. Deliver
your comments to: Anne Arnold,
Manager, Air Quality Planning Unit,
Office of Ecosystem Protection, U.S.
Environmental Protection Agency, EPA
New England Regional Office, 5 Post
Office Square—Suite 100, (Mail code
OEP05–2), Boston, MA 02109–3912.
Such deliveries are only accepted
during the Regional Office’s normal
hours of operation. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 a.m. to
4:30 p.m., excluding legal holidays.
Please see the direct final rule which
is located in the Rules Section of this
Federal Register for detailed
instructions on how to submit
comments.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Alison C. Simcox, Air Quality Planning
Unit, U.S. Environmental Protection
Agency, EPA New England Regional
Office, 5 Post Office Square—Suite 100,
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60329
(Mail code OEP05–2), Boston, MA
02109–3912, telephone number (617)
918–1684, fax number (617) 918–0684,
email simcox.alison@epa.gov.
SUPPLEMENTARY INFORMATION: In the
Final Rules Section of this Federal
Register, EPA is approving the State’s
SIP submittal as a direct final rule
without prior proposal because the
Agency views this as a noncontroversial
submittal and anticipates no adverse
comments. A detailed rationale for the
approval is set forth in the direct final
rule. If no adverse comments are
received in response to this action rule,
no further activity is contemplated. If
EPA receives adverse comments, the
direct final rule will be withdrawn and
all public comments received will be
addressed in a subsequent final rule
based on this proposed rule. EPA will
not institute a second comment period.
Any parties interested in commenting
on this action should do so at this time.
Please note that if EPA receives adverse
comment on an amendment, paragraph,
or section of this rule and if that
provision may be severed from the
remainder of the rule, EPA may adopt
as final those provisions of the rule that
are not the subject of an adverse
comment.
For additional information, see the
direct final rule which is located in the
Rules Section of this Federal Register.
Dated: February 4, 2016.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2016–21011 Filed 8–31–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program;
Petition 013—Autoimmune Disease;
Finding of Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
ACTION: Denial of petition for addition of
a health condition.
AGENCY:
On April 4, 2016, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 013) to add
‘‘relapsing remitting multiple sclerosis
(autoimmune)’’ to the List of WTCRelated Health Conditions (List). Upon
reviewing the information provided by
the petitioner, the Administrator has
determined that Petition 013 is not
substantially different from Petitions
SUMMARY:
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007, 008, 009, and 011, which also
requested the addition of autoimmune
diseases, including various subtypes.
The Administrator recently published
responses to the four previous petitions
in the Federal Register and has
determined that Petition 013 does not
provide additional evidence of a causal
relationship between 9/11 exposures
and autoimmune diseases, including
multiple sclerosis. Accordingly, the
Administrator 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.
The Administrator of the WTC
Health Program is denying this petition
for the addition of a health condition as
of September 1, 2016.
DATES:
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C–46,
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. Approval To Submit Document to the
Office of the Federal Register
C. Petition 013
D. Administrator’s Determination on Petition
013
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
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 Act (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,
1 Title XXXIII of the PHS Act is codified at 42
U.S.C. 300mm to 300mm-61. Those portions of the
Zadroga Act 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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or adult daycare in the New York City
disaster area (survivors).
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 or her 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
88.1. Within 90 days after receipt of a
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) and 42 CFR 88.17:
(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.
However, in accordance with 42 CFR
88.17(a)(4), the Administrator is
required to consider a new petition for
a previously-evaluated health condition
determined not to qualify for addition to
the List only if the new petition presents
a new medical basis—evidence not
previously reviewed by the
Administrator—for the association
between 9/11 exposures and the
condition to be added.
B. Approval To Submit Document to the
Office of the Federal Register
The Secretary, HHS, or her 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.
Thomas R. Frieden, M.D., M.P.H.,
Director, CDC, and Administrator,
ATSDR, approved this document for
publication on August 24, 2016.
C. Petition 013
On April 4, 2016, the Administrator
received a petition from a responder in
the WTC Health Program to add
‘‘relapsing remitting multiple sclerosis
(autoimmune)’’ to the List (Petition
013).2 Because the petitioner identified
the requested health condition as ‘‘the
2 See Petition 013, WTC Health Program: Petitions
Received, https://www.cdc.gov/wtc/received.html.
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autoimmune disease of multiple
sclerosis’’ in the petition narrative and
used a study of autoimmune diseases
among WTC responders to provide the
medical basis for the petition,3 the
Administrator determined that the
petitioned health condition is
‘‘autoimmune diseases, including
multiple sclerosis.’’
This is the fifth petition to the
Administrator requesting the addition of
autoimmune diseases, including various
subtypes, to the List; each of the first
four autoimmune disease petitions were
denied due to insufficient evidence, as
described in respective Federal Register
notices (FRNs).4 The medical basis for a
potential addition to the List may be
demonstrated by reference to a peerreviewed, 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.5 In
accordance with WTC Health Program
policy, the Science Team reviews
references for relevance, and relevant
studies are further reviewed for quality
and quantity.6 The current petition,
Petition 013, presented five references
to support the request to add ‘‘relapsing
remitting multiple sclerosis
(autoimmune)’’ to the List.
Petition 013 references 1, 2, and 4 are
links to the same newspaper article
announcing the online publication of a
study published in 2015.7 Petition 013
3 Id.
4 ‘‘World Trade Center Health Program; Petition
007—Autoimmune Diseases; Finding of Insufficient
Evidence,’’ 80 FR 32333 (June 8, 2015); ‘‘World
Trade Center Health Program; Petition 008—
Autoimmune Diseases; Finding of Insufficient
Evidence,’’ 80 FR 39720 (July 10, 2015); ‘‘World
Trade Center Health Program; Petition 009—
Autoimmune Diseases; Finding of Insufficient
Evidence,’’ 80 FR 65980 (Oct. 28, 2015); and
‘‘World Trade Center Health Program; Petition
011—Autoimmune Diseases; Finding of Insufficient
Evidence,’’ 81 FR 24047 (April 25, 2016).
5 See John Howard, Administrator of the WTC
Health Program, 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/WTCHPPPPetitionHandlingProcedures14May
2014.pdf.
6 Information is determined to be relevant if it is
presented in peer-reviewed, published,
epidemiologic studies of the health condition in 9/
11-exposed populations. John Howard,
Administrator of the WTC Health Program, Policy
and Procedures for Adding Non-Cancer Conditions
to the List of WTC-Related Health Conditions, May
11, 2016, https://www.cdc.gov/wtc/pdfs/WTCHP_PP
_Adding_NonCancer_Conditions_Revision_11_
May_2016.pdf.
7 The article, by Amy Norton, is published in
reference 1, New Health Worry for 9/11 Recovery
Workers, HealthDay, March 19, 2015, in
www.cbsnews.com/news/ground-zero-workers-atrisk-of-autoimmune-diseases; reference 2, ‘Ground
Zero’ Workers at Risk of Autoimmune Diseases:
Study, HealthDay, March 19, 2015, in https://
www.medicinenet.com/script/main/
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reference 3 is a different newspaper
article announcing the online
publication of the same study.8 These
four references identify a 2015 study by
Webber et al., a peer-reviewed,
published epidemiologic study of
autoimmune diseases among 9/11exposed responders and survivors, titled
‘‘Nested Case-Control Study of Selected
Systemic Autoimmune Diseases in
World Trade Center Rescue/Recovery
Workers.’’ 9 The 2015 Webber et al.
study has already been evaluated by the
Administrator in consideration of the
other four autoimmune disease
petitions, and is discussed below.
The fifth reference provided in
Petition 013 does not specifically
identify a peer-reviewed, published
epidemiologic study of the health
condition among 9/11-exposed
populations, nor is it a clinical case
report of the health condition in WTC
responders or survivors. Petition 013
reference 5 is a link to the proceedings
of a research meeting conducted by the
WTC Health Program in 2014.10 Two
abstracts found in the proceedings
address the topic of autoimmune
disease among the 9/11 population—
‘‘Autoimmune Disease among WTCHR
[World Trade Center Health Registry]
Registrants: Survey Design and
Preliminary Response Rates,’’ and
‘‘Post-9/11 Incidence of Systemic
Autoimmune Diseases in the FDNY
Cohort.’’ The former abstract references
an unpublished study; because
unpublished studies do not meet the
Program’s standard for relevance, it was
not further considered. The latter
abstract describes a study that resulted
in the 2015 Webber et al. publication
discussed in this action and reviewed in
full in the April 2016 FRN for Petition
011.
As discussed in the April 2016 FRN
finding of insufficient evidence for
Petition 011, the 2015 Webber et al.
study looked at the association between
art.asp?articlekey=187534; and reference 4, ‘Ground
Zero’ Workers at Risk of Autoimmune Diseases:
Study, HealthDay, March 19, 2015, https://
consumer.healthday.com/senior-citizeninformation-31/misc-arthritis-news-41/ground-zeroworkers-at-risk-of-autoimmune-diseases-study697581.html. The study announced in the Norton
article is the 2015 study by Webber et al., cited infra
note 9.
8 Nancy Walsh, Autoimmunity Rising in 9/11
Workers, MedPage Today, March 19, 2015, https://
www.medpagetoday.com/Rheumatology/General
Rheumatology/50548.
9 Mayris Webber, William Moir, Rachel ZeigOwens, et al., Nested Case-Control Study of
Selected Systemic Autoimmune Diseases in World
Trade Center Rescue/Recovery Workers, Arthritis
Rheumatol 2015;67(5):1369–1376.
10 WTC Health Program, Research Meeting
Proceedings, June 17–18, 2014, www.cdc.gov/wtc/
proceedings.html.
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9/11-related exposures and systemic
autoimmune diseases. It was found to be
a published, peer-reviewed
epidemiologic study of autoimmune
diseases in the 9/11 population, and
therefore deemed relevant. However, the
study was found to exhibit substantial
limitations, and it was ultimately
concluded not to have the potential to
form the basis for a decision on whether
to propose adding autoimmune diseases
to the List of WTC-Related Health
Conditions.11
In addition to a review of the studies
presented in Petition 013, the WTC
Health Program Science Team
conducted 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 condition to the List.
A previously conducted literature
review for autoimmune diseases in
response to Petition 007 12 included all
of the autoimmune conditions in the
2015 Webber et al. study.13 In reviewing
Petition 013, the Science Team
conducted a search to update the results
of the previous literature review for all
of the types of autoimmune diseases
identified in the 2015 Webber et al.
study, and also conducted a separate
search for published, peer-reviewed
studies of multiple sclerosis in 9/11
populations.14
The Science Team identified five
additional references to review for
relevance. Of the five additional
references, only one study, published in
2016 by Webber et al.,15 was found to
be a relevant, published, peer-reviewed
study of autoimmune diseases in 9/11exposed populations. No published,
peer-reviewed epidemiologic studies of
multiple sclerosis in 9/11-exposed
populations were identified in the
literature search.
The 2016 Webber et al. study is a
follow-up to the 2015 Webber et al.
study discussed above. The 2016
Webber et al. study looked at the same
cohort of FDNY rescue/recovery
11 81
FR 24047 at 24049.
80 FR 32333 at 32334.
13 Rheumatoid arthritis; spondyloarthritis;
inflammatory myositis (polymyositis and
dermatomyositis); systemic lupus erythematosus;
systemic sclerosis (scleroderma); Sjogren’s
syndrome; antiphospholipid syndrome;
granulomatosis with polyangiitis (Wegener’s); and
eosinophilic granulomatosis with polyangiitis
(Churg-Strauss).
14 Databases searched include: CINAHL, Embase,
NIOSHTIC–2, PsycINFO, PubMed, Scopus,
Toxicology Abstracts, and TOXLINE.
15 Mayris Webber, William Moir, Cynthia
Crowson, et al., Post-September 11, 2001, Incidence
of Systemic Autoimmune Diseases in World Trade
Center-Exposed Firefighters and Emergency
Medical Service Workers, Mayo Clin Proc
2016;91(1):23–32.
12 See
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60331
workers included in the 2015 study to
estimate the incidence of systemic
autoimmune diseases in the cohort of
FDNY rescue/recovery workers and to
compare the FDNY incidence rates to
demographically similar men and other
published rates. This additional
reference, the 2016 Webber et al. study,
was also identified as relevant in the
literature search for Petition 011. As a
result, it was further reviewed in the
April 2016 FRN for Petition 011 and,
along with the 2015 Webber et al. study,
evaluated for quantity and quality to
provide a sufficient basis for deciding
whether to propose an addition to the
List. Significant limitations, discussed
in the April 2016 FRN for Petition 011,
led the WTC Health Program to
conclude that the 2015 Webber et al.,
and the 2016 Webber et al. study
together do not have the potential to
provide a basis for a decision on
whether to propose adding autoimmune
diseases to the List.
All of the references and potential
medical bases presented in Petition 013
were previously identified and assessed
in Petition 011; as discussed above,
these medical bases had significant
limitations that prevented them from
having the potential to provide a basis
to propose adding autoimmune diseases
to the List. The Science Team did not
find any information during their
review of Petition 013 which would
alter the assessment of the previously
reviewed studies. Moreover, none of the
studies identified, including the 2015
and 2016 Webber et al. studies, include
multiple sclerosis. Thus, no evidence
was found specific to multiple sclerosis
which would have the potential to form
the basis for a decision on whether to
propose adding multiple sclerosis to the
List.
D. Administrator’s Determination on
Petition 013
The Administrator has established a
policy for evaluating whether to propose
the addition of non-cancer health
conditions to the List of WTC-Related
Health Conditions.16 Petition 013
requested the addition of ‘‘relapsing
remitting multiple sclerosis
(autoimmune)’’ to the List. The
Administrator previously reviewed the
category of ‘‘autoimmune diseases,’’
which includes multiple sclerosis, for
Petitions 007, 008, 009, and 011. Neither
the references included in Petition 013
nor the studies found in the literature
review conducted by the Science Team
presented evidence of a causal
association between 9/11 exposures and
16 Supra
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Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules
autoimmune diseases, including
multiple sclerosis.
The Administrator initially reviewed
the findings presented in the 2015
Webber et al. study in response to
Petition 007, which also requested the
addition of autoimmune diseases,
including rheumatoid arthritis and
connective tissue diseases. In that
review, due to limitations in the 2015
Webber et al. study, the Administrator
determined that insufficient evidence
existed to take any of the following
actions: Propose the addition of
autoimmune diseases to the List
(pursuant to PHS Act, sec.
3312(a)(6)(B)(ii) and 42 CFR
88.17(a)(2)(ii)); publish 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
88.17(a)(2)(iii)); or request a
recommendation from the STAC
(pursuant to PHS Act, sec.
3312(a)(6)(B)(i) and 42 CFR
88.17(a)(2)(i)). The 2015 Webber et al.
study was also presented as evidence to
support the Petition 008 request for
autoimmune disorders, specifically
encephalitis of the brain, the Petition
009 request for autoimmune disorders,
including multiple sclerosis, as well as
the Petition 011 request for autoimmune
disorders, including lupus and
rheumatoid arthritis. The 2016 Webber
et al. study was also presented as
evidence to support Petition 011. As
concluded in the April 2016 FRN for
Petition 011, the two Webber et al.
studies, taken together, while meeting
the relevance threshold of being
published, peer-reviewed epidemiologic
studies of autoimmune diseases in 9/11exposed populations, were found to
exhibit significant limitations and were
thus insufficient to provide a potential
basis for a decision on whether to
propose adding the requested health
conditions to the List.17
Finding no additional relevant studies
with regard to Petition 013, the
Administrator has accordingly
determined that insufficient evidence
exists to take further action at this time,
including either proposing the addition
of autoimmune diseases, including
multiple sclerosis, to the List (pursuant
to PHS Act, sec. 3312(a)(6)(B)(ii) and 42
CFR 88.17(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 88.17(a)(2)(iii)). The Administrator
has also determined that requesting a
recommendation from the STAC
(pursuant to PHS Act, sec.
17 81
FR 24047 at 24050.
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3312(a)(6)(B)(i) and 42 CFR
88.17(a)(2)(i)) is unwarranted.
For the reasons discussed above, the
request made in Petition 013 to add
‘‘relapsing remitting multiple sclerosis
(autoimmune)’’ to the List of WTCRelated Health Conditions is denied.
The Administrator will continue to
monitor the scientific literature for
publication of the results of the ongoing
WTC Health Registry study discussed
above (reference 5 in the petition) and
any other studies that address
autoimmune diseases among 9/11exposed populations.
John 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. 2016–21070 Filed 8–31–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 577
[Docket No. NHTSA–2016–0001]
RIN 2127–AL66
Update Means of Providing Recall
Notification
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
NHTSA proposes to amend
the means of recall notification to
owners and purchasers required under
the Safety Act to be in an electronic
manner, in addition to first class mail,
in accordance with Section 30130 of the
Moving Ahead for Progress in the 21st
Century Act (MAP–21) and Section
24104 of the Fixing America’s Surface
Transportation Act (FAST Act).
Through this proposed rule, NHTSA
also seeks to improve the efficacy of
recalls by requiring manufacturers to
send additional notifications of defects
or noncompliance with applicable
Federal Motor Vehicle Safety Standards
(FMVSS) if a second notification by the
manufacturer does not result in an
adequate number of motor vehicles or
replacement equipment being returned
for remedy.
DATES: Comments must be received on
or before October 31, 2016. In
compliance with the Paperwork
Reduction Act, NHTSA is also seeking
SUMMARY:
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comment on amendments to an
information collection. See the
Paperwork Reduction Act section under
Rulemaking Analyses and Notices
below. Please submit all comments
relating to the information collection
requirements to NHTSA and to the
Office of Management and Budget
(OMB) at the address listed in the
ADDRESSES section on or before October
31, 2016. Comments to OMB are most
useful if submitted within 30 days of
publication.
You may submit comments
by any of the following methods:
• Internet: Go to https://
www.regulations.gov and follow the
online instructions for submitting
comments.
• Mail: Docket Management Facility,
M–30, U.S. Department of
Transportation, 1200 New Jersey
Avenue SE., West Building, Room W12–
140, Washington, DC 20590.
• Hand Delivery or Courier: U.S.
Department of Transportation, 1200
New Jersey Avenue SE., West Building,
Room W12–140, Washington, DC 20590
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Monday through Friday, except Federal
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[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Proposed Rules]
[Pages 60329-60332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21070]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 013--Autoimmune
Disease; 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 April 4, 2016, the Administrator of the World Trade Center
(WTC) Health Program received a petition (Petition 013) to add
``relapsing remitting multiple sclerosis (autoimmune)'' to the List of
WTC-Related Health Conditions (List). Upon reviewing the information
provided by the petitioner, the Administrator has determined that
Petition 013 is not substantially different from Petitions
[[Page 60330]]
007, 008, 009, and 011, which also requested the addition of autoimmune
diseases, including various subtypes. The Administrator recently
published responses to the four previous petitions in the Federal
Register and has determined that Petition 013 does not provide
additional evidence of a causal relationship between 9/11 exposures and
autoimmune diseases, including multiple sclerosis. Accordingly, the
Administrator 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 September 1,
2016.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-46, 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. Approval To Submit Document to the Office of the Federal Register
C. Petition 013
D. Administrator's Determination on Petition 013
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 Act (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 Zadroga Act 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 or her
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 88.1. Within 90 days after receipt of a 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) and 42 CFR
88.17: (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. However, in
accordance with 42 CFR 88.17(a)(4), the Administrator is required to
consider a new petition for a previously-evaluated health condition
determined not to qualify for addition to the List only if the new
petition presents a new medical basis--evidence not previously reviewed
by the Administrator--for the association between 9/11 exposures and
the condition to be added.
B. Approval To Submit Document to the Office of the Federal Register
The Secretary, HHS, or her 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. Thomas
R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR,
approved this document for publication on August 24, 2016.
C. Petition 013
On April 4, 2016, the Administrator received a petition from a
responder in the WTC Health Program to add ``relapsing remitting
multiple sclerosis (autoimmune)'' to the List (Petition 013).\2\
Because the petitioner identified the requested health condition as
``the autoimmune disease of multiple sclerosis'' in the petition
narrative and used a study of autoimmune diseases among WTC responders
to provide the medical basis for the petition,\3\ the Administrator
determined that the petitioned health condition is ``autoimmune
diseases, including multiple sclerosis.''
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\2\ See Petition 013, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
\3\ Id.
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This is the fifth petition to the Administrator requesting the
addition of autoimmune diseases, including various subtypes, to the
List; each of the first four autoimmune disease petitions were denied
due to insufficient evidence, as described in respective Federal
Register notices (FRNs).\4\ The medical basis for a potential addition
to the List may be demonstrated by 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.\5\ In accordance with WTC Health Program
policy, the Science Team reviews references for relevance, and relevant
studies are further reviewed for quality and quantity.\6\ The current
petition, Petition 013, presented five references to support the
request to add ``relapsing remitting multiple sclerosis (autoimmune)''
to the List.
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\4\ ``World Trade Center Health Program; Petition 007--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 32333
(June 8, 2015); ``World Trade Center Health Program; Petition 008--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 39720
(July 10, 2015); ``World Trade Center Health Program; Petition 009--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 65980
(Oct. 28, 2015); and ``World Trade Center Health Program; Petition
011--Autoimmune Diseases; Finding of Insufficient Evidence,'' 81 FR
24047 (April 25, 2016).
\5\ See John Howard, Administrator of the WTC Health Program,
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.
\6\ Information is determined to be relevant if it is presented
in peer-reviewed, published, epidemiologic studies of the health
condition in 9/11-exposed populations. John Howard, Administrator of
the WTC Health Program, Policy and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related Health Conditions, May 11,
2016, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
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Petition 013 references 1, 2, and 4 are links to the same newspaper
article announcing the online publication of a study published in
2015.\7\ Petition 013
[[Page 60331]]
reference 3 is a different newspaper article announcing the online
publication of the same study.\8\ These four references identify a 2015
study by Webber et al., a peer-reviewed, published epidemiologic study
of autoimmune diseases among 9/11-exposed responders and survivors,
titled ``Nested Case-Control Study of Selected Systemic Autoimmune
Diseases in World Trade Center Rescue/Recovery Workers.'' \9\ The 2015
Webber et al. study has already been evaluated by the Administrator in
consideration of the other four autoimmune disease petitions, and is
discussed below.
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\7\ The article, by Amy Norton, is published in reference 1, New
Health Worry for 9/11 Recovery Workers, HealthDay, March 19, 2015,
in www.cbsnews.com/news/ground-zero-workers-at-risk-of-autoimmune-diseases; reference 2, `Ground Zero' Workers at Risk of Autoimmune
Diseases: Study, HealthDay, March 19, 2015, in https://www.medicinenet.com/script/main/art.asp?articlekey=187534; and
reference 4, `Ground Zero' Workers at Risk of Autoimmune Diseases:
Study, HealthDay, March 19, 2015, https://consumer.healthday.com/senior-citizen-information-31/misc-arthritis-news-41/ground-zero-workers-at-risk-of-autoimmune-diseases-study-697581.html. The study
announced in the Norton article is the 2015 study by Webber et al.,
cited infra note 9.
\8\ Nancy Walsh, Autoimmunity Rising in 9/11 Workers, MedPage
Today, March 19, 2015, https://www.medpagetoday.com/Rheumatology/GeneralRheumatology/50548.
\9\ Mayris Webber, William Moir, Rachel Zeig-Owens, et al.,
Nested Case-Control Study of Selected Systemic Autoimmune Diseases
in World Trade Center Rescue/Recovery Workers, Arthritis Rheumatol
2015;67(5):1369-1376.
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The fifth reference provided in Petition 013 does not specifically
identify a peer-reviewed, published epidemiologic study of the health
condition among 9/11-exposed populations, nor is it a clinical case
report of the health condition in WTC responders or survivors. Petition
013 reference 5 is a link to the proceedings of a research meeting
conducted by the WTC Health Program in 2014.\10\ Two abstracts found in
the proceedings address the topic of autoimmune disease among the 9/11
population--``Autoimmune Disease among WTCHR [World Trade Center Health
Registry] Registrants: Survey Design and Preliminary Response Rates,''
and ``Post-9/11 Incidence of Systemic Autoimmune Diseases in the FDNY
Cohort.'' The former abstract references an unpublished study; because
unpublished studies do not meet the Program's standard for relevance,
it was not further considered. The latter abstract describes a study
that resulted in the 2015 Webber et al. publication discussed in this
action and reviewed in full in the April 2016 FRN for Petition 011.
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\10\ WTC Health Program, Research Meeting Proceedings, June 17-
18, 2014, www.cdc.gov/wtc/proceedings.html.
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As discussed in the April 2016 FRN finding of insufficient evidence
for Petition 011, the 2015 Webber et al. study looked at the
association between 9/11-related exposures and systemic autoimmune
diseases. It was found to be a published, peer-reviewed epidemiologic
study of autoimmune diseases in the 9/11 population, and therefore
deemed relevant. However, the study was found to exhibit substantial
limitations, and it was ultimately concluded not to have the potential
to form the basis for a decision on whether to propose adding
autoimmune diseases to the List of WTC-Related Health Conditions.\11\
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\11\ 81 FR 24047 at 24049.
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In addition to a review of the studies presented in Petition 013,
the WTC Health Program Science Team conducted 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 condition to the List. A previously conducted
literature review for autoimmune diseases in response to Petition 007
\12\ included all of the autoimmune conditions in the 2015 Webber et
al. study.\13\ In reviewing Petition 013, the Science Team conducted a
search to update the results of the previous literature review for all
of the types of autoimmune diseases identified in the 2015 Webber et
al. study, and also conducted a separate search for published, peer-
reviewed studies of multiple sclerosis in 9/11 populations.\14\
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\12\ See 80 FR 32333 at 32334.
\13\ Rheumatoid arthritis; spondyloarthritis; inflammatory
myositis (polymyositis and dermatomyositis); systemic lupus
erythematosus; systemic sclerosis (scleroderma); Sjogren's syndrome;
antiphospholipid syndrome; granulomatosis with polyangiitis
(Wegener's); and eosinophilic granulomatosis with polyangiitis
(Churg-Strauss).
\14\ Databases searched include: CINAHL, Embase, NIOSHTIC-2,
PsycINFO, PubMed, Scopus, Toxicology Abstracts, and TOXLINE.
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The Science Team identified five additional references to review
for relevance. Of the five additional references, only one study,
published in 2016 by Webber et al.,\15\ was found to be a relevant,
published, peer-reviewed study of autoimmune diseases in 9/11-exposed
populations. No published, peer-reviewed epidemiologic studies of
multiple sclerosis in 9/11-exposed populations were identified in the
literature search.
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\15\ Mayris Webber, William Moir, Cynthia Crowson, et al., Post-
September 11, 2001, Incidence of Systemic Autoimmune Diseases in
World Trade Center-Exposed Firefighters and Emergency Medical
Service Workers, Mayo Clin Proc 2016;91(1):23-32.
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The 2016 Webber et al. study is a follow-up to the 2015 Webber et
al. study discussed above. The 2016 Webber et al. study looked at the
same cohort of FDNY rescue/recovery workers included in the 2015 study
to estimate the incidence of systemic autoimmune diseases in the cohort
of FDNY rescue/recovery workers and to compare the FDNY incidence rates
to demographically similar men and other published rates. This
additional reference, the 2016 Webber et al. study, was also identified
as relevant in the literature search for Petition 011. As a result, it
was further reviewed in the April 2016 FRN for Petition 011 and, along
with the 2015 Webber et al. study, evaluated for quantity and quality
to provide a sufficient basis for deciding whether to propose an
addition to the List. Significant limitations, discussed in the April
2016 FRN for Petition 011, led the WTC Health Program to conclude that
the 2015 Webber et al., and the 2016 Webber et al. study together do
not have the potential to provide a basis for a decision on whether to
propose adding autoimmune diseases to the List.
All of the references and potential medical bases presented in
Petition 013 were previously identified and assessed in Petition 011;
as discussed above, these medical bases had significant limitations
that prevented them from having the potential to provide a basis to
propose adding autoimmune diseases to the List. The Science Team did
not find any information during their review of Petition 013 which
would alter the assessment of the previously reviewed studies.
Moreover, none of the studies identified, including the 2015 and 2016
Webber et al. studies, include multiple sclerosis. Thus, no evidence
was found specific to multiple sclerosis which would have the potential
to form the basis for a decision on whether to propose adding multiple
sclerosis to the List.
D. Administrator's Determination on Petition 013
The Administrator has established a policy for evaluating whether
to propose the addition of non-cancer health conditions to the List of
WTC-Related Health Conditions.\16\ Petition 013 requested the addition
of ``relapsing remitting multiple sclerosis (autoimmune)'' to the List.
The Administrator previously reviewed the category of ``autoimmune
diseases,'' which includes multiple sclerosis, for Petitions 007, 008,
009, and 011. Neither the references included in Petition 013 nor the
studies found in the literature review conducted by the Science Team
presented evidence of a causal association between 9/11 exposures and
[[Page 60332]]
autoimmune diseases, including multiple sclerosis.
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\16\ Supra note 6.
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The Administrator initially reviewed the findings presented in the
2015 Webber et al. study in response to Petition 007, which also
requested the addition of autoimmune diseases, including rheumatoid
arthritis and connective tissue diseases. In that review, due to
limitations in the 2015 Webber et al. study, the Administrator
determined that insufficient evidence existed to take any of the
following actions: Propose the addition of autoimmune diseases to the
List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR
88.17(a)(2)(ii)); publish 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 88.17(a)(2)(iii)); or request a
recommendation from the STAC (pursuant to PHS Act, sec.
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)). The 2015 Webber et al.
study was also presented as evidence to support the Petition 008
request for autoimmune disorders, specifically encephalitis of the
brain, the Petition 009 request for autoimmune disorders, including
multiple sclerosis, as well as the Petition 011 request for autoimmune
disorders, including lupus and rheumatoid arthritis. The 2016 Webber et
al. study was also presented as evidence to support Petition 011. As
concluded in the April 2016 FRN for Petition 011, the two Webber et al.
studies, taken together, while meeting the relevance threshold of being
published, peer-reviewed epidemiologic studies of autoimmune diseases
in 9/11-exposed populations, were found to exhibit significant
limitations and were thus insufficient to provide a potential basis for
a decision on whether to propose adding the requested health conditions
to the List.\17\
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\17\ 81 FR 24047 at 24050.
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Finding no additional relevant studies with regard to Petition 013,
the Administrator has accordingly determined that insufficient evidence
exists to take further action at this time, including either proposing
the addition of autoimmune diseases, including multiple sclerosis, to
the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR
88.17(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 88.17(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 88.17(a)(2)(i))
is unwarranted.
For the reasons discussed above, the request made in Petition 013
to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the
List of WTC-Related Health Conditions is denied.
The Administrator will continue to monitor the scientific
literature for publication of the results of the ongoing WTC Health
Registry study discussed above (reference 5 in the petition) and any
other studies that address autoimmune diseases among 9/11-exposed
populations.
John 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. 2016-21070 Filed 8-31-16; 8:45 am]
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