World Trade Center Health Program; Petition 014-Autoimmune Diseases; Finding of Insufficient Evidence, 11164-11166 [2017-03336]
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Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Proposed Rules
(1) Airbus Service Bulletin A320–53–1308,
dated November 4, 2015 (FR 35.1 LH side).
(2) Airbus Service Bulletin A320–53–1309,
dated November 4, 2015 (FR 35.1 RH side).
(3) Airbus Service Bulletin A320–53–1310,
dated November 4, 2015 (FR 35.2 LH side).
(4) Airbus Service Bulletin A320–53–1311,
dated November 4, 2015 (FR 35.2 RH side).
(5) Airbus Service Bulletin A320–53–1312,
dated November 4, 2015 (FR 35.3 LH side).
(6) Airbus Service Bulletin A320–53–1313,
dated November 4, 2015 (FR 35.3 RH side).
TABLE 1 TO PARAGRAPH (g) OF THIS AD—INSPECTION THRESHOLD
Airplane accumulated total flight cycles at the effective
date of this AD
Compliance time
For airplanes with 18,300 total flight cycles or less ..........
Before exceeding 18,300 total flight cycles, or within 5,300 flight cycles after the effective date of this AD, whichever occurs later.
Before exceeding 23,600 total flight cycles, or within 2,100 flight cycles after the effective date of this AD, whichever occurs later.
For airplanes with more than 18,300 total flight cycles .....
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(h) Corrective Action
If any crack is found during any inspection
required by paragraph (g) of this AD: Before
further flight, repair using a method
approved by the Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA; or the European Aviation
Safety Agency (EASA); or Airbus’s EASA
Design Organization Approval (DOA).
Although the service information specified in
paragraph (g) of this AD specifies to contact
Airbus for repair instructions, and specifies
that action as ‘‘RC’’ (Required for
Compliance), this AD requires repair as
specified in this paragraph. Repair of an
airplane as required by this paragraph does
not constitute terminating action for the
repetitive inspections required by paragraph
(g) of this AD for that airplane, unless
specified otherwise in the repair instructions
approved by the Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA; or EASA; or Airbus’s EASA
DOA.
(i) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the International Branch, send it to ATTN:
Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1405; fax 425–227–1149.
Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using
any approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
the EASA; or Airbus’s EASA DOA. If
approved by the DOA, the approval must
include the DOA-authorized signature.
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(3) Required for Compliance (RC): Except
as required by paragraph (h) of this AD: If
any service information contains procedures
or tests that are identified as RC, those
procedures and tests must be done to comply
with this AD; any procedures or tests that are
not identified as RC are recommended. Those
procedures and tests that are not identified
as RC may be deviated from using accepted
methods in accordance with the operator’s
maintenance or inspection program without
obtaining approval of an AMOC, provided
the procedures and tests identified as RC can
be done and the airplane can be put back in
an airworthy condition. Any substitutions or
changes to procedures or tests identified as
RC require approval of an AMOC.
(j) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2016–0146, dated
July 20, 2016, for related information. This
MCAI may be found in the AD docket on the
Internet at https://www.regulations.gov by
searching for and locating Docket No. FAA–
2016–9571.
(2) For service information identified in
this AD, contact Airworthiness Office—EIAS,
1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61
93 36 96; fax +33 5 61 93 44 51; email
account.airworth-eas@airbus.com; Internet
https://www.airbus.com. You may view this
service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the
availability of this material at the FAA, call
425–227–1221.
Issued in Renton, Washington, on January
11, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2017–03031 Filed 2–17–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program;
Petition 014—Autoimmune Diseases;
Finding of Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
ACTION: Denial of petition for addition of
a health condition.
AGENCY:
On September 29, 2016, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition to add autoimmune diseases,
including rheumatoid arthritis, to the
List of WTC-Related Health Conditions
(List). Upon reviewing the information
provided by the petitioner, the
Administrator has determined that
Petition 014 is not substantially
different from Petitions 007, 008, 009,
011, and 013, which also requested the
addition of autoimmune diseases,
including various subtypes. The
Administrator has published responses
to the five previous petitions in the
Federal Register and has determined
that Petition 014 does not provide
additional evidence of a causal
relationship between 9/11 exposures
and autoimmune diseases, including
rheumatoid arthritis. 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 February 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C–46,
Cincinnati, OH 45226; telephone (855)
SUMMARY:
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818–1629 (this is a toll-free number);
email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
rmajette on DSK2TPTVN1PROD with PROPOSALS
A. WTC Health Program Statutory Authority
B. Petition 014
C. Review of Scientific and Medical
Information and Administrator
Determination
D. Administrator’s Final Decision on
Whether To Propose the Addition of
Autoimmune Diseases to the List
E. Approval To Submit Document to the
Office of the Federal Register
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347, as amended by Pub.
L. 114–113), added Title XXXIII to the
Public Health Service (PHS) Act,1
establishing the WTC Health Program
within the Department of Health and
Human Services (HHS). The WTC
Health Program provides medical
monitoring and treatment benefits 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 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
88.15. 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 88.16:
(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
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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Federal Register a determination that
insufficient evidence exists to take
action under (1) through (3) above.
However, in accordance with 42 CFR
88.16(a)(5), the Administrator is
required to consider a new submission
for a previously-evaluated health
condition determined not to qualify for
addition to the List as a valid new
petition only if the submission 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.2
In addition to the regulatory
provisions, the WTC Health Program
has developed policies to guide the
review of submissions and petitions 3
and the analysis of evidence supporting
the potential addition of a non-cancer
health condition to the List.4 In
accordance with the non-cancer health
condition policy, the Administrator
directs the WTC Health 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. A 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 9/11exposed populations; such studies are
considered ‘‘relevant.’’ Relevant studies
identified in the literature search are
further reviewed for their quantity and
quality to provide a basis for deciding
whether to propose adding the health
condition to the List. Where the
available evidence has the potential to
provide a basis for a decision, the
scientific and medical evidence is
further assessed to determine whether a
causal relationship between 9/11
exposures and the health condition is
supported. A health condition may be
added to the List if peer-reviewed,
2 42 CFR 88.16(a)(5) further allows that a
‘‘submission that provides no new medical basis
and is received after the publication of a response
in the Federal Register to a petition requesting the
addition of the same health condition will not be
considered a valid petition and will not be
answered in a Federal Register notice. . . . The
interested party will be informed of the . . .
decision in writing.’’
3 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, https://
www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandling
Procedures14May2014.pdf.
4 See WTC Health Program [2016], Policy and
Procedures for Adding Non-Cancer Conditions to
the List of WTC-Related Health Conditions, May 11,
https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancer_Conditions_Revision_11_May_
2016.pdf.
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published epidemiologic studies
(including direct observational studies
in the case of health conditions such as
injuries) provide substantial support 5
for a causal relationship between 9/11
exposures and the health condition in 9/
11-exposed populations. If the evidence
assessment provides only modest
support 6 for a causal relationship
between 9/11 exposures and the health
condition, the Administrator may then
evaluate additional peer-reviewed,
published epidemiologic studies,
conducted among non-9/11-exposed
populations, evaluating associations
between the health condition of interest
and 9/11 agents.7 If that additional
assessment adds enough support for the
Administrator to determine there is
substantial support 8 for a causal
relationship between a 9/11 agent or
agents and the health condition, the
health condition may be added to the
List.
B. Petition 014
On September 29, 2016, the
Administrator received a petition from a
WTC Health Program member to add
‘‘autoimmune conditions like
Rheumatoid Arthritis’’ to the List,
considered Petition 014.9 This is the
sixth petition to the Administrator
requesting the addition of autoimmune
diseases, including various subtypes, to
the List; each of the first five
autoimmune disease petitions were
denied due to insufficient evidence, as
described in respective Federal Register
notices (FRNs).10 Petition 014 was
5 The substantial evidence standard is met when
the Program assesses all of the available, relevant
information and determines with high confidence
that the evidence supports its findings regarding a
causal association between the 9/11 exposure(s) and
the health condition.
6 The modest evidence standard is met when the
Program assesses all of the available, relevant
information and determines with moderate
confidence that the evidence supports its findings
regarding a causal association between the 9/11
exposure(s) 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.
8 See supra note 5.
9 See Petition 014, WTC Health Program: Petitions
Received, https://www.cdc.gov/wtc/received.html.
10 ‘‘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); ‘‘World
Trade Center Health Program; Petition 011—
Autoimmune Diseases; Finding of Insufficient
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received prior to recent amendments to
WTC Health Program regulations
regarding petitions for additions to the
List taking effect.11 The Petition was
evaluated pursuant to the regulations
and policies in effect at the time of its
receipt 12 and, therefore, Petition 014
was considered valid. Future such
submissions requesting the addition of
autoimmune diseases to the List and
providing the same peer-reviewed,
published, epidemiologic evidence,
however, may not be considered valid
in accordance with 42 CFR 88.16(a)(5),
as amended.
In accordance with WTC Health
Program policy, 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.13 Petition
014 presented an online news article 14
announcing the online publication of a
study published by Webber et al. [2015],
entitled ‘‘Nested Case-Control Study of
Selected Systemic Autoimmune
Diseases in World Trade Center Rescue/
Recovery Workers.’’ 15 Because Webber
et al. [2015] is a peer-reviewed,
published epidemiologic study of
autoimmune diseases among 9/11exposed responders and survivors, the
petition was considered valid.
Accordingly, the Program conducted a
review of available scientific
information regarding the causal
association between 9/11 exposure and
autoimmune diseases, including
rheumatoid arthritis.
C. Review of Scientific and Medical
Information and Administrator
Determination
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A literature search conducted in
response to Petition 007 16 included all
of the autoimmune conditions in the
Evidence,’’ 81 FR 24047 (April 25, 2016); and
‘‘World Trade Center Health Program; Petition
013—Autoimmune Disease; Finding of Insufficient
Evidence,’’ 81 FR 60329 (Sept. 1, 2016).
11 See ‘‘World Trade Center Health Program;
Amendments to Definitions, Appeals, and Other
Requirements; Final Rule,’’ 81 FR 90926 (Dec. 15,
2016), effective Jan. 17, 2017.
12 See 42 CFR 88.17 (2016); see also 77 FR 24628
(Apr. 25, 2012).
13 See supra note 2.
14 Boynes-Shuck A [2015], Why Rheumatoid
Arthritis Is Plaguing 9/11 First Responders,
Healthline News, https://www.healthline.com/
health-news/why-rheumatoid-arthritis-is-plaguing9-11-first-responders-040415#1.
15 Webber M, Moir W, Zeig-Owens R, et al.
[2015], Nested Case-Control Study of Selected
Systemic Autoimmune Diseases in World Trade
Center Rescue/Recovery Workers, Arthritis
Rheumatol 67(5):1369–1376.
16 80 FR 32333 (June 8, 2015).
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2015 Webber study; the Program
conducted updates of that literature
search in response to Petition 011 and
Petition 013, looking for relevant studies
published since the date of the previous
literature search.17 In reviewing Petition
014, the Program conducted a search 18
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.19 The Program
identified one new reference since the
publication of the Petition 013 FRN in
September 2016, a conference abstract
regarding sarcoidosis in 9/11-exposed
firefighters.20 Upon review, the abstract
was determined not to be relevant
because it is not a published
epidemiologic study in a peer-reviewed
scientific journal.
The literature review did not identify
any newly-published, relevant studies
of autoimmune diseases, including
rheumatoid arthritis, in the 9/11exposed population.21 Therefore, in
accordance with the Program policy
discussed above, the Program was
unable to further evaluate Petition 014.
D. Administrator’s Final Decision on
Whether To Propose the Addition of
Autoimmune Diseases to the List
Finding no newly-published, relevant
studies with regard to Petition 014, the
Administrator has accordingly
determined that insufficient evidence is
available to take further action at this
time, including either proposing the
addition of autoimmune diseases,
17 See 81 FR 24047 (April 25, 2016) and 81 FR
60329 (Sept. 1, 2016), respectively.
18 Databases searched include: CINAHL, Embase,
NIOSHTIC–2, ProQuest Health and Safety Science
Abstracts, PubMed, Scopus, Toxicology Abstracts,
and TOXLINE.
19 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).
20 Hena K, Yip J, Jaber N, et al. [2016], Clinical
Characteristics of Sarcoidosis in World Trade
Center (WTC) Exposed Fire Department of the City
of New York (FDNY) Firefighters, Chest
150(4S):514A.
21 Two relevant studies identified in previous
FRNs, Webber et al. [2015] and Webber M, Moir W,
Crowson C, et al. [2016], 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, were reviewed in the
Petition 011 and Petition 013 FRNs and found not
to have the potential to provide a basis for a
decision on whether to propose adding
autoimmune diseases to the List. These studies are
not further discussed in this notice; discussions of
the Administrator’s findings with regard to these
studies may be found in previous notices for
Petition 011, 81 FR 24047 (April 25, 2016) and
Petition 013, 81 FR 60329 (Sept. 1, 2016).
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including rheumatoid arthritis, 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 014 request to add autoimmune
diseases, including rheumatoid arthritis,
to the List of WTC-Related Health
Conditions is denied.
E. Approval To Submit Document to the
Office of the Federal Register
The Secretary, HHS, or her/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.
Anne Schuchat, M.D., Acting Director,
CDC, and Acting Administrator,
ATSDR, approved this document for
publication on February 9, 2017.
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. 2017–03336 Filed 2–17–17; 8:45 am]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 161103999–7146–01]
RIN 0648–BG43
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Coastal
Migratory Pelagic Resources in the
Gulf of Mexico and Atlantic Region;
Framework Amendment 4
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
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Agencies
[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Proposed Rules]
[Pages 11164-11166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03336]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 014--Autoimmune
Diseases; Finding of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Denial of petition for addition of a health condition.
-----------------------------------------------------------------------
SUMMARY: On September 29, 2016, the Administrator of the World Trade
Center (WTC) Health Program received a petition to add autoimmune
diseases, including rheumatoid arthritis, to the List of WTC-Related
Health Conditions (List). Upon reviewing the information provided by
the petitioner, the Administrator has determined that Petition 014 is
not substantially different from Petitions 007, 008, 009, 011, and 013,
which also requested the addition of autoimmune diseases, including
various subtypes. The Administrator has published responses to the five
previous petitions in the Federal Register and has determined that
Petition 014 does not provide additional evidence of a causal
relationship between 9/11 exposures and autoimmune diseases, including
rheumatoid arthritis. 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 February 21,
2017.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855)
[[Page 11165]]
818-1629 (this is a toll-free number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Petition 014
C. Review of Scientific and Medical Information and Administrator
Determination
D. Administrator's Final Decision on Whether To Propose the Addition
of Autoimmune Diseases to the List
E. Approval To Submit Document to the Office of the Federal Register
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title
XXXIII to the Public Health Service (PHS) Act,\1\ establishing the WTC
Health Program within the Department of Health and Human Services
(HHS). The WTC Health Program provides medical monitoring and treatment
benefits 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 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 88.15. 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
88.16: (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 88.16(a)(5), the Administrator is required to
consider a new submission for a previously-evaluated health condition
determined not to qualify for addition to the List as a valid new
petition only if the submission 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.\2\
---------------------------------------------------------------------------
\2\ 42 CFR 88.16(a)(5) further allows that a ``submission that
provides no new medical basis and is received after the publication
of a response in the Federal Register to a petition requesting the
addition of the same health condition will not be considered a valid
petition and will not be answered in a Federal Register notice. . .
. The interested party will be informed of the . . . decision in
writing.''
---------------------------------------------------------------------------
In addition to the regulatory provisions, the WTC Health Program
has developed policies to guide the review of submissions and petitions
\3\ and the analysis of evidence supporting the potential addition of a
non-cancer health condition to the List.\4\ In accordance with the non-
cancer health condition policy, the Administrator directs the WTC
Health 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. A 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; such studies are considered
``relevant.'' Relevant studies identified in the literature search are
further reviewed for their quantity and quality to provide a basis for
deciding whether to propose adding the health condition to the List.
Where the available evidence has the potential to provide a basis for a
decision, the scientific and medical evidence is further assessed to
determine whether a causal relationship between 9/11 exposures and the
health condition is supported. A health condition may be added to the
List if peer-reviewed, published epidemiologic studies (including
direct observational studies in the case of health conditions such as
injuries) provide substantial support \5\ for a causal relationship
between 9/11 exposures and the health condition in 9/11-exposed
populations. If the evidence assessment provides only modest support
\6\ for a causal relationship between 9/11 exposures and the health
condition, the Administrator may then evaluate additional peer-
reviewed, published epidemiologic studies, conducted among non-9/11-
exposed populations, evaluating associations between the health
condition of interest and 9/11 agents.\7\ If that additional assessment
adds enough support for the Administrator to determine there is
substantial support \8\ for a causal relationship between a 9/11 agent
or agents and the health condition, the health condition may be added
to the List.
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\3\ 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, https://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
\4\ See WTC Health Program [2016], Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, May 11, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
\5\ The substantial evidence standard is met when the Program
assesses all of the available, relevant information and determines
with high confidence that the evidence supports its findings
regarding a causal association between the 9/11 exposure(s) and the
health condition.
\6\ The modest evidence standard is met when the Program
assesses all of the available, relevant information and determines
with moderate confidence that the evidence supports its findings
regarding a causal association between the 9/11 exposure(s) 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.
\8\ See supra note 5.
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B. Petition 014
On September 29, 2016, the Administrator received a petition from a
WTC Health Program member to add ``autoimmune conditions like
Rheumatoid Arthritis'' to the List, considered Petition 014.\9\ This is
the sixth petition to the Administrator requesting the addition of
autoimmune diseases, including various subtypes, to the List; each of
the first five autoimmune disease petitions were denied due to
insufficient evidence, as described in respective Federal Register
notices (FRNs).\10\ Petition 014 was
[[Page 11166]]
received prior to recent amendments to WTC Health Program regulations
regarding petitions for additions to the List taking effect.\11\ The
Petition was evaluated pursuant to the regulations and policies in
effect at the time of its receipt \12\ and, therefore, Petition 014 was
considered valid. Future such submissions requesting the addition of
autoimmune diseases to the List and providing the same peer-reviewed,
published, epidemiologic evidence, however, may not be considered valid
in accordance with 42 CFR 88.16(a)(5), as amended.
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\9\ See Petition 014, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
\10\ ``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); ``World Trade Center Health Program; Petition 011--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 81 FR 24047
(April 25, 2016); and ``World Trade Center Health Program; Petition
013--Autoimmune Disease; Finding of Insufficient Evidence,'' 81 FR
60329 (Sept. 1, 2016).
\11\ See ``World Trade Center Health Program; Amendments to
Definitions, Appeals, and Other Requirements; Final Rule,'' 81 FR
90926 (Dec. 15, 2016), effective Jan. 17, 2017.
\12\ See 42 CFR 88.17 (2016); see also 77 FR 24628 (Apr. 25,
2012).
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In accordance with WTC Health Program policy, 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.\13\ Petition 014 presented
an online news article \14\ announcing the online publication of a
study published by Webber et al. [2015], entitled ``Nested Case-Control
Study of Selected Systemic Autoimmune Diseases in World Trade Center
Rescue/Recovery Workers.'' \15\ Because Webber et al. [2015] is a peer-
reviewed, published epidemiologic study of autoimmune diseases among 9/
11-exposed responders and survivors, the petition was considered valid.
Accordingly, the Program conducted a review of available scientific
information regarding the causal association between 9/11 exposure and
autoimmune diseases, including rheumatoid arthritis.
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\13\ See supra note 2.
\14\ Boynes-Shuck A [2015], Why Rheumatoid Arthritis Is Plaguing
9/11 First Responders, Healthline News, https://www.healthline.com/health-news/why-rheumatoid-arthritis-is-plaguing-9-11-first-responders-040415#1.
\15\ Webber M, Moir W, Zeig-Owens R, et al. [2015], Nested Case-
Control Study of Selected Systemic Autoimmune Diseases in World
Trade Center Rescue/Recovery Workers, Arthritis Rheumatol
67(5):1369-1376.
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C. Review of Scientific and Medical Information and Administrator
Determination
A literature search conducted in response to Petition 007 \16\
included all of the autoimmune conditions in the 2015 Webber study; the
Program conducted updates of that literature search in response to
Petition 011 and Petition 013, looking for relevant studies published
since the date of the previous literature search.\17\ In reviewing
Petition 014, the Program conducted a search \18\ 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.\19\ The Program
identified one new reference since the publication of the Petition 013
FRN in September 2016, a conference abstract regarding sarcoidosis in
9/11-exposed firefighters.\20\ Upon review, the abstract was determined
not to be relevant because it is not a published epidemiologic study in
a peer-reviewed scientific journal.
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\16\ 80 FR 32333 (June 8, 2015).
\17\ See 81 FR 24047 (April 25, 2016) and 81 FR 60329 (Sept. 1,
2016), respectively.
\18\ Databases searched include: CINAHL, Embase, NIOSHTIC-2,
ProQuest Health and Safety Science Abstracts, PubMed, Scopus,
Toxicology Abstracts, and TOXLINE.
\19\ 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).
\20\ Hena K, Yip J, Jaber N, et al. [2016], Clinical
Characteristics of Sarcoidosis in World Trade Center (WTC) Exposed
Fire Department of the City of New York (FDNY) Firefighters, Chest
150(4S):514A.
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The literature review did not identify any newly-published,
relevant studies of autoimmune diseases, including rheumatoid
arthritis, in the 9/11-exposed population.\21\ Therefore, in accordance
with the Program policy discussed above, the Program was unable to
further evaluate Petition 014.
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\21\ Two relevant studies identified in previous FRNs, Webber et
al. [2015] and Webber M, Moir W, Crowson C, et al. [2016], 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, were reviewed in
the Petition 011 and Petition 013 FRNs and found not to have the
potential to provide a basis for a decision on whether to propose
adding autoimmune diseases to the List. These studies are not
further discussed in this notice; discussions of the Administrator's
findings with regard to these studies may be found in previous
notices for Petition 011, 81 FR 24047 (April 25, 2016) and Petition
013, 81 FR 60329 (Sept. 1, 2016).
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D. Administrator's Final Decision on Whether To Propose the Addition of
Autoimmune Diseases to the List
Finding no newly-published, relevant studies with regard to
Petition 014, the Administrator has accordingly determined that
insufficient evidence is available to take further action at this time,
including either proposing the addition of autoimmune diseases,
including rheumatoid arthritis, 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 014 request to add
autoimmune diseases, including rheumatoid arthritis, to the List of
WTC-Related Health Conditions is denied.
E. Approval To Submit Document to the Office of the Federal Register
The Secretary, HHS, or her/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. Anne
Schuchat, M.D., Acting Director, CDC, and Acting Administrator, ATSDR,
approved this document for publication on February 9, 2017.
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. 2017-03336 Filed 2-17-17; 8:45 am]
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