World Trade Center Health Program; Petition 011-Autoimmune Diseases; Finding of Insufficient Evidence, 24047-24050 [2016-09527]
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asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
applied to growing crops and raw
agricultural commodities after harvest
under 40 CFR 180.910. The petitioner
believes no analytical method is needed
because it is not required for an
exemption from the requirement of a
tolerance. Contact: RD.
7. PP IN–10890. EPA–HQ–OPP–2016–
0115. Wacker Chemical Corporation,
3301 Sutton Rd., Adrian, ML 49221–
9397 requests to establish an exemption
from the requirement of a tolerance for
siloxanes and silicones, 3bydroxypropyl Me, ethoxylated (CAS
Reg. No. 69430–50–8), when used as an
inert ingredient surfactant, antifoaming
agent) in pesticide formulations applied
to growing crops and raw agricultural
commodities after harvest under 40 CFR
180.910. The petitioner believes no
analytical method is needed because it
is not required for an exemption from
the requirement of a tolerance. Contact:
RD.
8. PP IN–10899. EPA–HQ–OPP–2016–
0118. Celanese Ltd, 222 W Las Colinas
Blvd., Suite 900N, Irving, TX 75039,
requests to establish an exemption from
the requirement of a for residues of 2propenoic acid, 2-methyl-, 2oxiranylmethyl ester, polymer with
ethene, ethenyl acetate,
ethenyltrimethoxysilane and sodium
ethenesulfonate (1:1) with a minimum
number average mole1cular weight (in
amu) of 20,000 (CAS Reg. No. 518057–
54–0) when used as an inert ingredient
in pesticide formulations under 40 CFR
180.960. The petitioner believes no
analytical method is needed because it
is not required for an exemption from
the requirement of a tolerance. Contact:
RD.
9. PP IN–10900. EPA–HQ–OPP–2016–
0149. Celanese Ltd., 222 W Las Colinas
Blvd., Suite 900N, Irving, TX 75039,
requests to establish an exemption from
the requirement of a tolerance for
residues of 2-propenoic acid, butyl
ester, polymer with ethenyl acetate and
sodium ethenesulfonate with a
minimum number average molecular
weight (in amu) of 20,000 (CAS Reg. No.
66573–43–1) when used as an inert
ingredient in pesticide formulations
under 40 CFR 180.960. The petitioner
believes no analytical method is needed
because it is an inert ingredient exempt
from a tolerance. Contact: RD.
Amended Tolerances
1. PP 5F8427. EPA–HQ–OPP–2016–
0067. Geo Logic Corporation, P.O. Box
3091, Tequesta, FL 33409, requests to
amend the tolerances in 40 CFR 180.245
for residues of the bactericide/fungicide
streptomycin by removing tolerances in
or on grapefruit at 0.15 parts per million
(ppm) and grapefruit, dried pulp at 0.40
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ppm. The ion-pair reversed-phase liquid
chromatography with detection by MS/
MS is used to measure and evaluate the
chemical streptomycin. Contact: RD.
2. PP IN–10858. EPA–HQ–OPP–2016–
0121. Drexel Chemical Company, P.O.
Box 13327, Memphis, TN 38113–03227,
requests to amend the tolerance in 40
CFR 180.469 for residues of dichlormid
(CAS Reg. No. 37764–25–3), when used
as an inert ingredient (herbicide safener)
in pesticide formulations to include
tolerances at 0.05 part per million (ppm)
for all commodities for which there are
tolerances for the active ingredients
metolachlor and s-metolachlor (40 CFR
180.368). Gas Chromatography Mass
Spectrometry (GC–MS) with nitrogen
selective thermionic detection is used to
measure and evaluate the chemical
dichlormid. Contact: RD.
Amended Tolerance Exemptions
1. PP 5F8407. EPA–HQ–OPP–2015–
0811. DSM Food Specialties B.V., P.O.
Box 1, 2600 MA Delft, The Netherlands
(c/o Keller and Heckman, LLP 1001 G.
St. NW., Washington, DC 20001),
requests to amend an exemption from
the requirement of a tolerance in 40 CFR
180.1315 for residues of the fungistat
natamycin by adding in or on citrus,
pome, and stone fruit crop groups;
avocado; kiwi; mango; and pomegranate
when applied as a fungistat in
accordance with label directions and
good agricultural practices. The
petitioner believes no analytical method
is needed because the petition is for an
exemption from the requirement of a
tolerance without any numerical
limitation. Further, residues are not
expected on any other crops because
natamycin will only be applied indoors
to these particular crops. Contact: BPPD.
2. PP 5F8438. EPA–HQ–OPP–2016–
0032. Valent BioSciences Corp., 870
Technology Way, Libertyville, IL 60048,
requests to amend an exemption from
the requirement of a tolerance in 40 CFR
180.1189 for residues of the biochemical
pesticide methyl salicylate by adding in
or on all agricultural commodities. The
petitioner believes no analytical method
is needed because the petitioner has
validated residue methods in both
tomato and pepper. The analytical
method for the assay of methyl
salicylate and salicylic acid is by gas
chromatography with mass-selective
detection. Methyl salicylate will not
result in residues that are of
toxicological concern, as the residue
studies clearly show only natural
background levels of methyl salicylate
and its metabolite (salicylic acid) after
applications, even at time zero. Contact:
BPPD.
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Amended Tolerance Exemption for
Plant Incorporated Product
PP 5F8425. EPA–HQ–OPP–2014–
0457. J.R. Simplot Co., 5369 W. Irving
St., Boise, ID 83706, requests to amend
an exemption from the requirement of a
tolerance in 40 CFR 174.534 for residues
of the plant-incorporated protectant
(PIP) VNT1 protein in or on potato by
converting a currently existing
temporary tolerance exemption to a
permanent tolerance exemption. The
petitioner believes no analytical method
is needed because it is seeking an
exemption from the requirement of a
tolerance. Contact: BPPD.
Authority: 21 U.S.C. 346a.
Dated: April 18, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. 2016–09559 Filed 4–22–16; 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 011—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 January 25, 2016, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 011) to add
‘‘autoimmune disease, lupus, and
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 011 is not substantially
different from Petitions 007, 008, and
009, which also requested the addition
of autoimmune diseases. The
Administrator recently published
responses to Petitions 007, 008, and 009
in the Federal Register and has
determined that Petition 011 does not
provide additional evidence of a causal
relationship between 9/11 exposures
and autoimmune diseases. 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
SUMMARY:
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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 25, 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
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A. WTC Health Program Statutory Authority
B. Approval To Submit Document to the
Office of the Federal Register
C. Petition 011
D. Administrator’s Determination on Petition
011
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Zadroga Act), Public Law 111–347, as
amended by Public Law 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).
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. 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
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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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 April 18, 2016.
C. Petition 011
On January 25, 2016, the
Administrator received a petition from a
responder in the WTC Health Program
to add autoimmune disease, lupus, and
rheumatoid arthritis to the List (Petition
011).2 This is the fourth petition to the
Administrator requesting the addition of
autoimmune diseases to the List; the
first three autoimmune disease
petitions, Petition 007, Petition 008, and
Petition 009, were each denied due to
insufficient evidence as described in
Federal Register notices published on
June 8, 2015,3 July 10, 2015,4 and
October 28, 2015,5 respectively.
The current petition, Petition 011,
presented eight references to support
the request to add ‘‘autoimmune
disease, lupus, and rheumatoid
arthritis’’ to the List. Pursuant to WTC
Health Program policy, the medical
basis for a potential addition to the List
2 See Petition 011. WTC Health Program: Petitions
Received. https://www.cdc.gov/wtc/received.html.
3 80 FR 32333.
4 80 FR 39720.
5 80 FR 73667.
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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.6 Of the references provided,
references 1–5, 7, and an unnumbered
8th reference do not identify peerreviewed, published studies or clinical
case reports about autoimmune disease,
lupus, or rheumatoid arthritis among 9/
11-exposed responders and survivors.
Reference 6 is a study that has already
been evaluated by the Administrator in
consideration of other autoimmune
disease petitions.
In addition to a review of the studies
presented in Petition 011, the WTC
Health Program Associate Director for
Science (ADS) 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. The ADS
previously conducted such a literature
review for autoimmune disorders in
response to Petition 007.7 In reviewing
Petition 011, the ADS conducted an
additional search to update the results
of the previous literature review.8 The
new literature search identified six
studies published in 2015 and 2016.
In accordance with WTC Health
Program policy, the ADS reviewed the
eight references in Petition 011 and the
six studies identified in the literature
review for relevance, and then relevant
studies were further reviewed for
quality, and quantity.9 The ADS review
is discussed below.
Petition references 1, 2, and 3 are the
Web sites of the S.L.E. Lupus
Foundation,10 Molly’s Fund Fighting
Lupus,11 and the Johns Hopkins Lupus
Center,12 respectively. The referenced
Web pages discuss the development of
lupus in general terms, but do not
reference 9/11 exposure-related
causation specifically. The Johns
Hopkins Web page includes references
to book chapters about lupus, none of
6 See John Howard, Administrator, 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.
7 See 80 FR 32333 at 32334.
8 Databases searched include: PubMed, Health &
Safety Science Abstracts, Toxicology Abstracts,
Toxline, Scopus, Embase, and NIOSHTIC–2.
9 See John Howard, Administrator of the WTC
Health Program, Policy and Procedures for Adding
Non-Cancer Conditions to the List of WTC-Related
Health Conditions, Oct. 21, 2014. https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
10 https://www.lupusny.org.
11 https://www.mollysfund.org.
12 https://www.hopkinslupus.org.
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which associate the disease with 9/11
exposure. These references are not
considered relevant under the policy for
adding non-cancers to the List because
they are not published, peer-reviewed
epidemiologic studies of autoimmune
disease, lupus, and/or rheumatoid
arthritis in 9/11-exposed populations
and, therefore, they were not further
reviewed.
Petition reference 4 is the Fire
Department of New York (FDNY) EMS
Retirees Association’s Web page on
WTC Monitoring and Treatment
Centers, which mentions lupus and
rheumatoid arthritis and is relevant to
the 9/11 population, but does not
identify a published, peer-reviewed
epidemiologic study or clinical case
report. This reference is not considered
relevant under the policy for adding
non-cancers to the List because it is not
a published, peer-reviewed
epidemiologic study of autoimmune
disease, lupus, and/or rheumatoid
arthritis in 9/11-exposed populations
and, therefore, it was not further
reviewed.
Petition reference 5 is a 2011 Medical
News Today Web page that summarizes
a study by Zeig-Owens, et al., ‘‘Early
Assessment of Cancer Outcomes in New
York City Firefighters after the 9/11
Attacks: An Observational Cohort
Study,’’ apparently for the premise that
9/11 exposures could also trigger
chronic inflammation through
autoimmune disease.13 Although the
Zeig-Owens study is a published, peerreviewed epidemiologic study relevant
to the 9/11 population, it does not
include any discussion of the basis for
a causal association between the
September 11, 2001, terrorist attacks
and autoimmune disease, lupus, and/or
rheumatoid arthritis. Thus, this
reference is not considered relevant
under the policy for adding non-cancers
to the List because it is not a published,
peer-reviewed epidemiologic study of
autoimmune disease, lupus, and/or
rheumatoid arthritis in 9/11-exposed
populations and, therefore, it was not
further reviewed.
Petition reference 7 is an abstract for
a NIOSH-funded study titled,
‘‘Autoimmune Disease among WTCHR
[WTC Health Registry] Registrants:
Survey Design and Preliminary
Response Rates.’’ 14 Because the study is
on-going and not yet published, it is not
13 Rachel Zeig-Owens, Mayris Webber, Charles
Hall, et al., Early Assessment of Cancer Outcomes
in New York City Firefighters after the 9/11 Attacks:
An Observational Cohort Study, The Lancet
2011;378(9794):898–905 at 904.
14 WTC Health Program, Research Meeting
Proceedings; June 17–18, 2014. www.cdc.gov/wtc/
proceedings.html.
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considered relevant under the policy for
adding non-cancers to the List because
it is not a published, peer-reviewed
epidemiologic study of autoimmune
disease, lupus, and/or rheumatoid
arthritis in 9/11-exposed populations
and, therefore, it was not further
reviewed.
Petition reference 8 (unnumbered in
the petition) is two excerpts from an
HHS publication entitled, ‘‘The Future
Directions of Lupus Research.’’ 15
Neither the topic of the first excerpt,
concerning environmental factors
leading to the development of lupus,
nor the second, concerning the role of
crystalline silica in the development of
lupus, addresses this disease among
9/11-exposed populations. Similar to
the references discussed above, this
reference is not considered relevant
under the policy for adding non-cancers
to the List because it is not a published,
peer-reviewed epidemiologic study of
autoimmune disease, lupus, and/or
rheumatoid arthritis in 9/11-exposed
populations and, therefore, it was not
further reviewed.
The remaining petition reference,
reference 6, is a 2015 study by Webber
et al., titled ‘‘Nested Case-Control Study
of Selected Systemic Autoimmune
Diseases in World Trade Center Rescue/
Recovery Workers.’’ 16 The 2015 Webber
study assessed whether 9/11-related
exposure was associated with new-onset
systemic autoimmune disease
(including rheumatoid arthritis and
systemic lupus erythematosus, or
SLE 17) using a nested case-control study
of male 9/11-exposed Fire Department
of New York (FDNY) rescue/recovery
workers. In reviewing the 2015 Webber
study in consideration of Petition 007,
the ADS found that the study was
relevant and conducted further review
for quantity and quality of evidence in
the study. Ultimately, the ADS found
that the study lacked information on
other important confounders that could
explain associations between 9/11related exposures and systemic
autoimmune diseases; in addition, there
were limitations regarding the sample
size, methods used to quantify
exposure, and generalizability. Taken
together, these limitations led the ADS
to conclude that the available
15 National Institutes of Health, HHS, The Future
Directions of Lupus Research, Aug. 2007. https://
www.niams.nih.gov/About_Us/Mission_and_
Purpose/lupus_plan.pdf.
16 Mayris Webber, William Moir, Rachel ZeigOwens, et al., Nested Case-Control Study of
Selected Systemic Autoimmune Diseases in World
Trade Center Rescue/Recovery Workers, Journal of
Arthritis & Rheumatology 2015;67(5):1369–1376.
17 Systematic lupus erythematosus is the most
common type of lupus. See CDC: Lupus. https://
www.cdc.gov/lupus/index.htm.
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information did not 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 for Petition 007.18
The ADS identified six references in
the literature review performed
pursuant to the policy for adding noncancer health conditions to the List.
Four were found to be not relevant
because they were not epidemiologic
studies, therefore they were not further
assessed. One study was the 2015
Webber et al. study reviewed by the
Administrator in consideration of
Petition 007, discussed above.
The final study identified in the
literature review was a 2016
epidemiologic study by Webber et al.19
The 2016 Webber study is a follow-up
to the 2015 Webber study, which looked
at the association between 9/11-related
exposures and systemic autoimmune
diseases. The 2016 Webber study looked
at the same cohort of FDNY rescue/
recovery workers included in the 2015
study to estimate the incidence of
systemic autoimmune diseases from
September 12, 2001, through September
11, 2014, in the cohort of FDNY rescue/
recovery workers. The authors also
compared the FDNY incidence rates to
rates from demographically similar men
included in the Rochester Epidemiology
Project (REP) and to other published
rates, in order to measure observed
FDNY cases against the number of cases
expected. Because this study was found
relevant, it was further reviewed and
evaluated for quantity and quality to
provide a sufficient basis for deciding
whether to propose an addition to the
List.
In the 2016 study, Webber et al.
confirmed cases of systemic
autoimmune diseases in the FDNY
cohort either through medical records
review using the American College of
Rheumatology criteria or based on selfreports deemed ‘‘probable’’ by two
board certified rheumatologists. The
study identified 97 cases of systemic
autoimmune diseases among the FDNY
cohort (63 medical record-confirmed
cases and 34 probable self-report cases).
The authors next calculated incidence
for each specific autoimmune disease
identified in the study among the FDNY
cohort, and also calculated the
incidence for all systemic autoimmune
diseases combined.
18 See
80 FR 32333 at 32334.
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.
19 Mayris
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The 2016 Webber study then looked
to the REP comparison group to provide
age- and sex-specific incidence rates
during a similar time period as reviewed
for the FDNY cases. Incidence rates for
the REP comparison group were only
available, however, for a limited subset
of five autoimmune conditions:
Rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis, SLE, and
scleroderma. By applying the REP
incidence rates to the FDNY cohort, the
study authors were able to generate agespecific expected numbers of cases for
the FDNY cohort. The observed
incidence rates in the FDNY cohort
were then compared with the expected
numbers of cases for the FDNY cohort
derived from the REP rates.
Standardized ratios, which are the ratios
of the observed number of cases in the
FDNY cohort to the expected number of
cases (based on the REP rates) were then
calculated. Overall, FDNY rates for the
five types of autoimmune disease
compared were not significantly
different from expected rates (SIR, 0.97;
95% CI, 0.77–1.21). Only SLE had a
standardized incidence ratio that was
statistically significantly greater among
the entire FDNY cohort. Other ratios
were either reduced or not statistically
significant.
Limitations similar to those found in
the 2015 Webber study, discussed
above, were seen in the 2016 Webber
study, including the lack of information
on potential confounders such as family
history of autoimmune disease and both
work-related and recreational non-9/11related exposures, and poor
generalizability to other 9/11-exposed
groups. The 2016 Webber study did not
include new or additional information
or controls that would avoid or mitigate
the limitations found in the 2015 study.
Consistent with the assessment of
Petition 007,20 the ADS disagreed with
the method for measuring chronic
exposure with a duration variable that
did not differentiate between those with
one day versus many days of exposure
in a given month. Furthermore, the lack
of information about occupational
history and other potential confounders
among the REP cohort calls into
question the applicability and
comparability of the rates used in the
2016 Webber study.
D. Administrator’s Determination on
Petition 011
The Administrator has established a
policy for evaluating whether to propose
the addition of non-cancer health
conditions to the List of WTC-Related
20 See
80 FR 32333 at 32334.
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Health Conditions.21 Petition 011
requested the addition of autoimmune
diseases which were previously
reviewed by the Administrator for
Petition 007, and neither the references
included in the petition nor the studies
found in the literature review conducted
by the ADS presented evidence of a
causal association between 9/11
exposures and autoimmune diseases,
lupus, and/or rheumatoid arthritis. The
Administrator initially reviewed the
findings presented in the 2015 Webber
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 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 study
was also presented as evidence to
support Petition 008 regarding
autoimmune disorders, specifically
encephalitis of the brain, as well as
Petition 009 regarding the autoimmune
disorder multiple sclerosis.
In reviewing the 2016 Webber study
for potential support for Petition 011,
the ADS concluded that similar
inadequacies existed for the 2016 study
as those seen in the 2015 Webber study.
Taken together, the two Webber studies,
while meeting the relevance threshold
of being published, peer-reviewed
epidemiologic studies of autoimmune
disease, including lupus and
rheumatoid arthritis, 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.
Accordingly, with regard to Petition
011, the Administrator has determined
that insufficient evidence exists to take
further action at this time, including
either proposing the addition of
autoimmune diseases to the List
21 John Howard, Administrator of the WTC Health
Program, Policy and Procedures for Adding NonCancer Conditions to the List of WTC-Related
Health Conditions, Oct. 21, 2014. https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
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(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 011 to add
autoimmune disease, lupus, and
rheumatoid arthritis 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 7 in the petition) and
any other studies that address
autoimmune diseases among 9/11exposed populations.
Dated: April 20, 2016.
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. 2016–09527 Filed 4–22–16; 8:45 am]
BILLING CODE 4163–18–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 76
[MB Docket No. 16–126; DA 16–407]
Petition for Declaratory Ruling Filed by
National Cable & Telecommunications
Association and American Cable
Association
Federal Communications
Commission.
ACTION: Petition for declaratory ruling;
request for comments.
AGENCY:
This document seeks
comment on a petition for declaratory
ruling filed by the National Cable &
Telecommunications Association and
American Cable Association seeking a
declaratory ruling clarifying the
‘‘written information’’ requirement of
section 76.1602(b) of the Commission’s
rules. Specifically, NCTA and ACA
‘‘seek a ruling that electronic
dissemination by email to subscribers
for whom a cable operator has a
confirmed email address, by the
provision of appropriately-noticed links
to Web sites, or by other electronic
measures reasonably calculated to reach
SUMMARY:
E:\FR\FM\25APP1.SGM
25APP1
]]>Agencies
[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24047-24050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09527]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 011--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 January 25, 2016, the Administrator of the World Trade
Center (WTC) Health Program received a petition (Petition 011) to add
``autoimmune disease, lupus, and 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 011 is not substantially different from Petitions 007, 008,
and 009, which also requested the addition of autoimmune diseases. The
Administrator recently published responses to Petitions 007, 008, and
009 in the Federal Register and has determined that Petition 011 does
not provide additional evidence of a causal relationship between 9/11
exposures and autoimmune diseases. 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
[[Page 24048]]
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 25, 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 011
D. Administrator's Determination on Petition 011
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Zadroga Act), Public Law 111-347, as amended by Public Law 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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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. 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 April 18, 2016.
C. Petition 011
On January 25, 2016, the Administrator received a petition from a
responder in the WTC Health Program to add autoimmune disease, lupus,
and rheumatoid arthritis to the List (Petition 011).\2\ This is the
fourth petition to the Administrator requesting the addition of
autoimmune diseases to the List; the first three autoimmune disease
petitions, Petition 007, Petition 008, and Petition 009, were each
denied due to insufficient evidence as described in Federal Register
notices published on June 8, 2015,\3\ July 10, 2015,\4\ and October 28,
2015,\5\ respectively.
---------------------------------------------------------------------------
\2\ See Petition 011. WTC Health Program: Petitions Received.
https://www.cdc.gov/wtc/received.html.
\3\ 80 FR 32333.
\4\ 80 FR 39720.
\5\ 80 FR 73667.
---------------------------------------------------------------------------
The current petition, Petition 011, presented eight references to
support the request to add ``autoimmune disease, lupus, and rheumatoid
arthritis'' to the List. Pursuant to 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.\6\ Of the
references provided, references 1-5, 7, and an unnumbered 8th reference
do not identify peer-reviewed, published studies or clinical case
reports about autoimmune disease, lupus, or rheumatoid arthritis among
9/11-exposed responders and survivors. Reference 6 is a study that has
already been evaluated by the Administrator in consideration of other
autoimmune disease petitions.
---------------------------------------------------------------------------
\6\ See John Howard, Administrator, 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.
---------------------------------------------------------------------------
In addition to a review of the studies presented in Petition 011,
the WTC Health Program Associate Director for Science (ADS) 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. The ADS
previously conducted such a literature review for autoimmune disorders
in response to Petition 007.\7\ In reviewing Petition 011, the ADS
conducted an additional search to update the results of the previous
literature review.\8\ The new literature search identified six studies
published in 2015 and 2016.
---------------------------------------------------------------------------
\7\ See 80 FR 32333 at 32334.
\8\ Databases searched include: PubMed, Health & Safety Science
Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and
NIOSHTIC-2.
---------------------------------------------------------------------------
In accordance with WTC Health Program policy, the ADS reviewed the
eight references in Petition 011 and the six studies identified in the
literature review for relevance, and then relevant studies were further
reviewed for quality, and quantity.\9\ The ADS review is discussed
below.
---------------------------------------------------------------------------
\9\ See John Howard, Administrator of the WTC Health Program,
Policy and Procedures for Adding Non-Cancer Conditions to the List
of WTC-Related Health Conditions, Oct. 21, 2014. https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
---------------------------------------------------------------------------
Petition references 1, 2, and 3 are the Web sites of the S.L.E.
Lupus Foundation,\10\ Molly's Fund Fighting Lupus,\11\ and the Johns
Hopkins Lupus Center,\12\ respectively. The referenced Web pages
discuss the development of lupus in general terms, but do not reference
9/11 exposure-related causation specifically. The Johns Hopkins Web
page includes references to book chapters about lupus, none of
[[Page 24049]]
which associate the disease with 9/11 exposure. These references are
not considered relevant under the policy for adding non-cancers to the
List because they are not published, peer-reviewed epidemiologic
studies of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/
11-exposed populations and, therefore, they were not further reviewed.
---------------------------------------------------------------------------
\10\ https://www.lupusny.org.
\11\ https://www.mollysfund.org.
\12\ https://www.hopkinslupus.org.
---------------------------------------------------------------------------
Petition reference 4 is the Fire Department of New York (FDNY) EMS
Retirees Association's Web page on WTC Monitoring and Treatment
Centers, which mentions lupus and rheumatoid arthritis and is relevant
to the 9/11 population, but does not identify a published, peer-
reviewed epidemiologic study or clinical case report. This reference is
not considered relevant under the policy for adding non-cancers to the
List because it is not a published, peer-reviewed epidemiologic study
of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-
exposed populations and, therefore, it was not further reviewed.
Petition reference 5 is a 2011 Medical News Today Web page that
summarizes a study by Zeig-Owens, et al., ``Early Assessment of Cancer
Outcomes in New York City Firefighters after the 9/11 Attacks: An
Observational Cohort Study,'' apparently for the premise that 9/11
exposures could also trigger chronic inflammation through autoimmune
disease.\13\ Although the Zeig-Owens study is a published, peer-
reviewed epidemiologic study relevant to the 9/11 population, it does
not include any discussion of the basis for a causal association
between the September 11, 2001, terrorist attacks and autoimmune
disease, lupus, and/or rheumatoid arthritis. Thus, this reference is
not considered relevant under the policy for adding non-cancers to the
List because it is not a published, peer-reviewed epidemiologic study
of autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-
exposed populations and, therefore, it was not further reviewed.
---------------------------------------------------------------------------
\13\ Rachel Zeig-Owens, Mayris Webber, Charles Hall, et al.,
Early Assessment of Cancer Outcomes in New York City Firefighters
after the 9/11 Attacks: An Observational Cohort Study, The Lancet
2011;378(9794):898-905 at 904.
---------------------------------------------------------------------------
Petition reference 7 is an abstract for a NIOSH-funded study
titled, ``Autoimmune Disease among WTCHR [WTC Health Registry]
Registrants: Survey Design and Preliminary Response Rates.'' \14\
Because the study is on-going and not yet published, it is not
considered relevant under the policy for adding non-cancers to the List
because it is not a published, peer-reviewed epidemiologic study of
autoimmune disease, lupus, and/or rheumatoid arthritis in 9/11-exposed
populations and, therefore, it was not further reviewed.
---------------------------------------------------------------------------
\14\ WTC Health Program, Research Meeting Proceedings; June 17-
18, 2014. www.cdc.gov/wtc/proceedings.html.
---------------------------------------------------------------------------
Petition reference 8 (unnumbered in the petition) is two excerpts
from an HHS publication entitled, ``The Future Directions of Lupus
Research.'' \15\ Neither the topic of the first excerpt, concerning
environmental factors leading to the development of lupus, nor the
second, concerning the role of crystalline silica in the development of
lupus, addresses this disease among 9/11-exposed populations. Similar
to the references discussed above, this reference is not considered
relevant under the policy for adding non-cancers to the List because it
is not a published, peer-reviewed epidemiologic study of autoimmune
disease, lupus, and/or rheumatoid arthritis in 9/11-exposed populations
and, therefore, it was not further reviewed.
---------------------------------------------------------------------------
\15\ National Institutes of Health, HHS, The Future Directions
of Lupus Research, Aug. 2007. https://www.niams.nih.gov/About_Us/Mission_and_Purpose/lupus_plan.pdf.
---------------------------------------------------------------------------
The remaining petition reference, reference 6, is a 2015 study by
Webber et al., titled ``Nested Case-Control Study of Selected Systemic
Autoimmune Diseases in World Trade Center Rescue/Recovery Workers.''
\16\ The 2015 Webber study assessed whether 9/11-related exposure was
associated with new-onset systemic autoimmune disease (including
rheumatoid arthritis and systemic lupus erythematosus, or SLE \17\)
using a nested case-control study of male 9/11-exposed Fire Department
of New York (FDNY) rescue/recovery workers. In reviewing the 2015
Webber study in consideration of Petition 007, the ADS found that the
study was relevant and conducted further review for quantity and
quality of evidence in the study. Ultimately, the ADS found that the
study lacked information on other important confounders that could
explain associations between 9/11-related exposures and systemic
autoimmune diseases; in addition, there were limitations regarding the
sample size, methods used to quantify exposure, and generalizability.
Taken together, these limitations led the ADS to conclude that the
available information did not 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 for Petition 007.\18\
---------------------------------------------------------------------------
\16\ 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, Journal of Arthritis
& Rheumatology 2015;67(5):1369-1376.
\17\ Systematic lupus erythematosus is the most common type of
lupus. See CDC: Lupus. https://www.cdc.gov/lupus/index.htm.
\18\ See 80 FR 32333 at 32334.
---------------------------------------------------------------------------
The ADS identified six references in the literature review
performed pursuant to the policy for adding non-cancer health
conditions to the List. Four were found to be not relevant because they
were not epidemiologic studies, therefore they were not further
assessed. One study was the 2015 Webber et al. study reviewed by the
Administrator in consideration of Petition 007, discussed above.
The final study identified in the literature review was a 2016
epidemiologic study by Webber et al.\19\ The 2016 Webber study is a
follow-up to the 2015 Webber study, which looked at the association
between 9/11-related exposures and systemic autoimmune diseases. The
2016 Webber study looked at the same cohort of FDNY rescue/recovery
workers included in the 2015 study to estimate the incidence of
systemic autoimmune diseases from September 12, 2001, through September
11, 2014, in the cohort of FDNY rescue/recovery workers. The authors
also compared the FDNY incidence rates to rates from demographically
similar men included in the Rochester Epidemiology Project (REP) and to
other published rates, in order to measure observed FDNY cases against
the number of cases expected. Because this study was found relevant, it
was further reviewed and evaluated for quantity and quality to provide
a sufficient basis for deciding whether to propose an addition to the
List.
---------------------------------------------------------------------------
\19\ 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.
---------------------------------------------------------------------------
In the 2016 study, Webber et al. confirmed cases of systemic
autoimmune diseases in the FDNY cohort either through medical records
review using the American College of Rheumatology criteria or based on
self-reports deemed ``probable'' by two board certified
rheumatologists. The study identified 97 cases of systemic autoimmune
diseases among the FDNY cohort (63 medical record-confirmed cases and
34 probable self-report cases). The authors next calculated incidence
for each specific autoimmune disease identified in the study among the
FDNY cohort, and also calculated the incidence for all systemic
autoimmune diseases combined.
[[Page 24050]]
The 2016 Webber study then looked to the REP comparison group to
provide age- and sex-specific incidence rates during a similar time
period as reviewed for the FDNY cases. Incidence rates for the REP
comparison group were only available, however, for a limited subset of
five autoimmune conditions: Rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis, SLE, and scleroderma. By applying the REP
incidence rates to the FDNY cohort, the study authors were able to
generate age-specific expected numbers of cases for the FDNY cohort.
The observed incidence rates in the FDNY cohort were then compared with
the expected numbers of cases for the FDNY cohort derived from the REP
rates. Standardized ratios, which are the ratios of the observed number
of cases in the FDNY cohort to the expected number of cases (based on
the REP rates) were then calculated. Overall, FDNY rates for the five
types of autoimmune disease compared were not significantly different
from expected rates (SIR, 0.97; 95% CI, 0.77-1.21). Only SLE had a
standardized incidence ratio that was statistically significantly
greater among the entire FDNY cohort. Other ratios were either reduced
or not statistically significant.
Limitations similar to those found in the 2015 Webber study,
discussed above, were seen in the 2016 Webber study, including the lack
of information on potential confounders such as family history of
autoimmune disease and both work-related and recreational non-9/11-
related exposures, and poor generalizability to other 9/11-exposed
groups. The 2016 Webber study did not include new or additional
information or controls that would avoid or mitigate the limitations
found in the 2015 study. Consistent with the assessment of Petition
007,\20\ the ADS disagreed with the method for measuring chronic
exposure with a duration variable that did not differentiate between
those with one day versus many days of exposure in a given month.
Furthermore, the lack of information about occupational history and
other potential confounders among the REP cohort calls into question
the applicability and comparability of the rates used in the 2016
Webber study.
---------------------------------------------------------------------------
\20\ See 80 FR 32333 at 32334.
---------------------------------------------------------------------------
D. Administrator's Determination on Petition 011
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.\21\ Petition 011 requested the addition
of autoimmune diseases which were previously reviewed by the
Administrator for Petition 007, and neither the references included in
the petition nor the studies found in the literature review conducted
by the ADS presented evidence of a causal association between 9/11
exposures and autoimmune diseases, lupus, and/or rheumatoid arthritis.
The Administrator initially reviewed the findings presented in the 2015
Webber 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 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 study was
also presented as evidence to support Petition 008 regarding autoimmune
disorders, specifically encephalitis of the brain, as well as Petition
009 regarding the autoimmune disorder multiple sclerosis.
---------------------------------------------------------------------------
\21\ John Howard, Administrator of the WTC Health Program,
Policy and Procedures for Adding Non-Cancer Conditions to the List
of WTC-Related Health Conditions, Oct. 21, 2014. https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
---------------------------------------------------------------------------
In reviewing the 2016 Webber study for potential support for
Petition 011, the ADS concluded that similar inadequacies existed for
the 2016 study as those seen in the 2015 Webber study. Taken together,
the two Webber studies, while meeting the relevance threshold of being
published, peer-reviewed epidemiologic studies of autoimmune disease,
including lupus and rheumatoid arthritis, 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.
Accordingly, with regard to Petition 011, the Administrator has
determined that insufficient evidence exists to take further action at
this time, including either proposing 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)) 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 011
to add autoimmune disease, lupus, and rheumatoid arthritis 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 7 in the petition) and any
other studies that address autoimmune diseases among 9/11-exposed
populations.
Dated: April 20, 2016.
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. 2016-09527 Filed 4-22-16; 8:45 am]
BILLING CODE 4163-18-P
