81 FR 24047 - World Trade Center Health Program; Petition 011-Autoimmune Diseases; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 79 (April 25, 2016)

Page Range		24047-24050
FR Document		2016-09527
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 determination not to publish a proposed rule.
Federal Register, Volume 81 Issue 79 (Monday, April 25, 2016)
[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24047-24050]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09527]


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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.

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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 [email protected].

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).
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the Zadroga Act found in Titles II 
and III of Public Law 111-347 do not pertain to the WTC Health 
Program and are codified elsewhere.
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    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the Director of the National 
Institute for Occupational Safety and Health (NIOSH) or his or her 
designee.
    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested 
parties may petition the Administrator to add a health condition to the 
List in 42 CFR 88.1. 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.
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    \2\ See Petition 011. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ 80 FR 32333.
    \4\ 80 FR 39720.
    \5\ 80 FR 73667.
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    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.
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    \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.
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    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.
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    \7\ See 80 FR 32333 at 32334.
    \8\ Databases searched include: PubMed, Health & Safety Science 
Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and 
NIOSHTIC-2.
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    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.
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    \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. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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    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.
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    \10\ http://www.lupusny.org.
    \11\ http://www.mollysfund.org.
    \12\ http://www.hopkinslupus.org.
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    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.
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    \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.
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    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.
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    \14\ WTC Health Program, Research Meeting Proceedings; June 17-
18, 2014. www.cdc.gov/wtc/proceedings.html.
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    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.
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    \15\ National Institutes of Health, HHS, The Future Directions 
of Lupus Research, Aug. 2007. http://www.niams.nih.gov/About_Us/Mission_and_Purpose/lupus_plan.pdf.
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    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\
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    \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. http://www.cdc.gov/lupus/index.htm.
    \18\ See 80 FR 32333 at 32334.
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    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.
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    \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.
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    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.
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    \20\ See 80 FR 32333 at 32334.
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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.
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    \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. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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    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
Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules 24047

applied to growing crops and raw ppm. The ion-pair reversed-phase liquid Amended Tolerance Exemption for
agricultural commodities after harvest chromatography with detection by MS/ Plant Incorporated Product
under 40 CFR 180.910. The petitioner MS is used to measure and evaluate the PP 5F8425. EPA–HQ–OPP–2014–
believes no analytical method is needed chemical streptomycin. Contact: RD. 0457. J.R. Simplot Co., 5369 W. Irving
because it is not required for an 2. PP IN–10858. EPA–HQ–OPP–2016– St., Boise, ID 83706, requests to amend
exemption from the requirement of a 0121. Drexel Chemical Company, P.O. an exemption from the requirement of a
tolerance. Contact: RD. Box 13327, Memphis, TN 38113–03227, tolerance in 40 CFR 174.534 for residues
7. PP IN–10890. EPA–HQ–OPP–2016– requests to amend the tolerance in 40 of the plant-incorporated protectant
0115. Wacker Chemical Corporation, CFR 180.469 for residues of dichlormid (PIP) VNT1 protein in or on potato by
3301 Sutton Rd., Adrian, ML 49221– (CAS Reg. No. 37764–25–3), when used
9397 requests to establish an exemption converting a currently existing
as an inert ingredient (herbicide safener) temporary tolerance exemption to a
from the requirement of a tolerance for in pesticide formulations to include
siloxanes and silicones, 3- permanent tolerance exemption. The
tolerances at 0.05 part per million (ppm) petitioner believes no analytical method
bydroxypropyl Me, ethoxylated (CAS for all commodities for which there are
Reg. No. 69430–50–8), when used as an is needed because it is seeking an
tolerances for the active ingredients exemption from the requirement of a
inert ingredient surfactant, antifoaming metolachlor and s-metolachlor (40 CFR
agent) in pesticide formulations applied tolerance. Contact: BPPD.
180.368). Gas Chromatography Mass
to growing crops and raw agricultural Spectrometry (GC–MS) with nitrogen Authority: 21 U.S.C. 346a.
commodities after harvest under 40 CFR selective thermionic detection is used to Dated: April 18, 2016.
180.910. The petitioner believes no measure and evaluate the chemical Susan Lewis,
analytical method is needed because it dichlormid. Contact: RD. Director, Registration Division, Office of
is not required for an exemption from Pesticide Programs.
the requirement of a tolerance. Contact: Amended Tolerance Exemptions
[FR Doc. 2016–09559 Filed 4–22–16; 8:45 am]
RD. 1. PP 5F8407. EPA–HQ–OPP–2015– BILLING CODE 6560–50–P
8. PP IN–10899. EPA–HQ–OPP–2016–
0811. DSM Food Specialties B.V., P.O.
0118. Celanese Ltd, 222 W Las Colinas
Box 1, 2600 MA Delft, The Netherlands
Blvd., Suite 900N, Irving, TX 75039,
(c/o Keller and Heckman, LLP 1001 G. DEPARTMENT OF HEALTH AND
requests to establish an exemption from
St. NW., Washington, DC 20001), HUMAN SERVICES
the requirement of a for residues of 2-
requests to amend an exemption from
propenoic acid, 2-methyl-, 2-
the requirement of a tolerance in 40 CFR 42 CFR Part 88
oxiranylmethyl ester, polymer with
180.1315 for residues of the fungistat
ethene, ethenyl acetate, [NIOSH Docket 094]
ethenyltrimethoxysilane and sodium natamycin by adding in or on citrus,
ethenesulfonate (1:1) with a minimum pome, and stone fruit crop groups;
avocado; kiwi; mango; and pomegranate World Trade Center Health Program;
number average mole1cular weight (in Petition 011—Autoimmune Diseases;
amu) of 20,000 (CAS Reg. No. 518057– when applied as a fungistat in
accordance with label directions and Finding of Insufficient Evidence
54–0) when used as an inert ingredient
in pesticide formulations under 40 CFR good agricultural practices. The AGENCY: Centers for Disease Control and
180.960. The petitioner believes no petitioner believes no analytical method Prevention, HHS.
analytical method is needed because it is needed because the petition is for an ACTION: Denial of petition for addition of
is not required for an exemption from exemption from the requirement of a a health condition.
the requirement of a tolerance. Contact: tolerance without any numerical
RD. limitation. Further, residues are not SUMMARY: On January 25, 2016, the
9. PP IN–10900. EPA–HQ–OPP–2016– expected on any other crops because Administrator of the World Trade
0149. Celanese Ltd., 222 W Las Colinas natamycin will only be applied indoors Center (WTC) Health Program received
Blvd., Suite 900N, Irving, TX 75039, to these particular crops. Contact: BPPD. a petition (Petition 011) to add
requests to establish an exemption from 2. PP 5F8438. EPA–HQ–OPP–2016– ‘‘autoimmune disease, lupus, and
the requirement of a tolerance for 0032. Valent BioSciences Corp., 870 rheumatoid arthritis’’ to the List of
residues of 2-propenoic acid, butyl Technology Way, Libertyville, IL 60048, WTC-Related Health Conditions (List).
ester, polymer with ethenyl acetate and requests to amend an exemption from Upon reviewing the information
sodium ethenesulfonate with a the requirement of a tolerance in 40 CFR provided by the petitioner, the
minimum number average molecular 180.1189 for residues of the biochemical Administrator has determined that
weight (in amu) of 20,000 (CAS Reg. No. pesticide methyl salicylate by adding in Petition 011 is not substantially
66573–43–1) when used as an inert or on all agricultural commodities. The different from Petitions 007, 008, and
ingredient in pesticide formulations petitioner believes no analytical method 009, which also requested the addition
under 40 CFR 180.960. The petitioner is needed because the petitioner has of autoimmune diseases. The
believes no analytical method is needed validated residue methods in both Administrator recently published
because it is an inert ingredient exempt tomato and pepper. The analytical responses to Petitions 007, 008, and 009
from a tolerance. Contact: RD. method for the assay of methyl in the Federal Register and has
salicylate and salicylic acid is by gas determined that Petition 011 does not
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS

Amended Tolerances chromatography with mass-selective provide additional evidence of a causal
1. PP 5F8427. EPA–HQ–OPP–2016– detection. Methyl salicylate will not relationship between 9/11 exposures
0067. Geo Logic Corporation, P.O. Box result in residues that are of and autoimmune diseases. Accordingly,
3091, Tequesta, FL 33409, requests to toxicological concern, as the residue the Administrator finds that insufficient
amend the tolerances in 40 CFR 180.245 studies clearly show only natural evidence exists to request a
for residues of the bactericide/fungicide background levels of methyl salicylate recommendation of the WTC Health
streptomycin by removing tolerances in and its metabolite (salicylic acid) after Program Scientific/Technical Advisory
or on grapefruit at 0.15 parts per million applications, even at time zero. Contact: Committee (STAC), to publish a
(ppm) and grapefruit, dried pulp at 0.40 BPPD. proposed rule, or to publish a

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which associate the disease with 9/11 considered relevant under the policy for information did not have the potential
exposure. These references are not adding non-cancers to the List because to form the basis for a decision on
considered relevant under the policy for it is not a published, peer-reviewed whether to propose adding autoimmune
adding non-cancers to the List because epidemiologic study of autoimmune diseases to the List of WTC-Related
they are not published, peer-reviewed disease, lupus, and/or rheumatoid Health Conditions for Petition 007.18
epidemiologic studies of autoimmune arthritis in 9/11-exposed populations The ADS identified six references in
disease, lupus, and/or rheumatoid and, therefore, it was not further the literature review performed
arthritis in 9/11-exposed populations reviewed. pursuant to the policy for adding non-
and, therefore, they were not further Petition reference 8 (unnumbered in cancer health conditions to the List.
reviewed. the petition) is two excerpts from an Four were found to be not relevant
Petition reference 4 is the Fire HHS publication entitled, ‘‘The Future because they were not epidemiologic
Department of New York (FDNY) EMS Directions of Lupus Research.’’ 15 studies, therefore they were not further
Retirees Association’s Web page on Neither the topic of the first excerpt, assessed. One study was the 2015
WTC Monitoring and Treatment concerning environmental factors Webber et al. study reviewed by the
Centers, which mentions lupus and leading to the development of lupus, Administrator in consideration of
rheumatoid arthritis and is relevant to nor the second, concerning the role of Petition 007, discussed above.
the 9/11 population, but does not crystalline silica in the development of The final study identified in the
identify a published, peer-reviewed lupus, addresses this disease among literature review was a 2016
epidemiologic study or clinical case 9/11-exposed populations. Similar to epidemiologic study by Webber et al.19
report. This reference is not considered the references discussed above, this The 2016 Webber study is a follow-up
relevant under the policy for adding reference is not considered relevant to the 2015 Webber study, which looked
non-cancers to the List because it is not under the policy for adding non-cancers at the association between 9/11-related
a published, peer-reviewed to the List because it is not a published, exposures and systemic autoimmune
epidemiologic study of autoimmune peer-reviewed epidemiologic study of diseases. The 2016 Webber study looked
disease, lupus, and/or rheumatoid autoimmune disease, lupus, and/or at the same cohort of FDNY rescue/
arthritis in 9/11-exposed populations rheumatoid arthritis in 9/11-exposed
recovery workers included in the 2015
and, therefore, it was not further populations and, therefore, it was not
study to estimate the incidence of
reviewed. further reviewed.
The remaining petition reference, systemic autoimmune diseases from
Petition reference 5 is a 2011 Medical
reference 6, is a 2015 study by Webber September 12, 2001, through September
News Today Web page that summarizes
et al., titled ‘‘Nested Case-Control Study 11, 2014, in the cohort of FDNY rescue/
a study by Zeig-Owens, et al., ‘‘Early
of Selected Systemic Autoimmune recovery workers. The authors also
Assessment of Cancer Outcomes in New
Diseases in World Trade Center Rescue/ compared the FDNY incidence rates to
York City Firefighters after the 9/11
Recovery Workers.’’ 16 The 2015 Webber rates from demographically similar men
Attacks: An Observational Cohort
study assessed whether 9/11-related included in the Rochester Epidemiology
Study,’’ apparently for the premise that
exposure was associated with new-onset Project (REP) and to other published
9/11 exposures could also trigger
systemic autoimmune disease rates, in order to measure observed
chronic inflammation through
(including rheumatoid arthritis and FDNY cases against the number of cases
autoimmune disease.13 Although the
systemic lupus erythematosus, or expected. Because this study was found
Zeig-Owens study is a published, peer-
SLE 17) using a nested case-control study relevant, it was further reviewed and
reviewed epidemiologic study relevant
of male 9/11-exposed Fire Department evaluated for quantity and quality to
to the 9/11 population, it does not
of New York (FDNY) rescue/recovery provide a sufficient basis for deciding
include any discussion of the basis for
workers. In reviewing the 2015 Webber whether to propose an addition to the
a causal association between the
study in consideration of Petition 007, List.
September 11, 2001, terrorist attacks
and autoimmune disease, lupus, and/or the ADS found that the study was In the 2016 study, Webber et al.
rheumatoid arthritis. Thus, this relevant and conducted further review confirmed cases of systemic
reference is not considered relevant for quantity and quality of evidence in autoimmune diseases in the FDNY
under the policy for adding non-cancers the study. Ultimately, the ADS found cohort either through medical records
to the List because it is not a published, that the study lacked information on review using the American College of
peer-reviewed epidemiologic study of other important confounders that could Rheumatology criteria or based on self-
autoimmune disease, lupus, and/or explain associations between 9/11- reports deemed ‘‘probable’’ by two
rheumatoid arthritis in 9/11-exposed related exposures and systemic board certified rheumatologists. The
populations and, therefore, it was not autoimmune diseases; in addition, there study identified 97 cases of systemic
further reviewed. were limitations regarding the sample autoimmune diseases among the FDNY
Petition reference 7 is an abstract for size, methods used to quantify cohort (63 medical record-confirmed
a NIOSH-funded study titled, exposure, and generalizability. Taken cases and 34 probable self-report cases).
‘‘Autoimmune Disease among WTCHR together, these limitations led the ADS The authors next calculated incidence
[WTC Health Registry] Registrants: to conclude that the available for each specific autoimmune disease
Survey Design and Preliminary identified in the study among the FDNY
15 National Institutes of Health, HHS, The Future cohort, and also calculated the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS

Response Rates.’’ 14 Because the study is
Directions of Lupus Research, Aug. 2007. http:// incidence for all systemic autoimmune
on-going and not yet published, it is not www.niams.nih.gov/About_Us/Mission_and_
Purpose/lupus_plan.pdf.
diseases combined.
13 Rachel Zeig-Owens, Mayris Webber, Charles 16 Mayris Webber, William Moir, Rachel Zeig-

Hall, et al., Early Assessment of Cancer Outcomes Owens, et al., Nested Case-Control Study of 18 See80 FR 32333 at 32334.
in New York City Firefighters after the 9/11 Attacks: Selected Systemic Autoimmune Diseases in World 19 Mayris Webber, William Moir, Cynthia
An Observational Cohort Study, The Lancet Trade Center Rescue/Recovery Workers, Journal of Crowson, et al., Post-September 11, 2001, Incidence
2011;378(9794):898–905 at 904. Arthritis & Rheumatology 2015;67(5):1369–1376. of Systemic Autoimmune Diseases in World Trade
14 WTC Health Program, Research Meeting 17 Systematic lupus erythematosus is the most Center-Exposed Firefighters and Emergency
Proceedings; June 17–18, 2014. www.cdc.gov/wtc/ common type of lupus. See CDC: Lupus. http:// Medical Service Workers, Mayo Clin Proc
proceedings.html. www.cdc.gov/lupus/index.htm. 2016;91(1):23–32.

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24050 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules

The 2016 Webber study then looked Health Conditions.21 Petition 011 (pursuant to PHS Act, sec.
to the REP comparison group to provide requested the addition of autoimmune 3312(a)(6)(B)(ii) and 42 CFR
age- and sex-specific incidence rates diseases which were previously 88.17(a)(2)(ii)) or publishing a
during a similar time period as reviewed reviewed by the Administrator for determination not to publish a proposed
for the FDNY cases. Incidence rates for Petition 007, and neither the references rule in the Federal Register (pursuant to
the REP comparison group were only included in the petition nor the studies PHS Act, sec. 3312(a)(6)(B)(iii) and 42
available, however, for a limited subset found in the literature review conducted CFR 88.17(a)(2)(iii)). The Administrator
of five autoimmune conditions: by the ADS presented evidence of a has also determined that requesting a
Rheumatoid arthritis, psoriatic arthritis, causal association between 9/11 recommendation from the STAC
ankylosing spondylitis, SLE, and exposures and autoimmune diseases, (pursuant to PHS Act, sec.
scleroderma. By applying the REP lupus, and/or rheumatoid arthritis. The 3312(a)(6)(B)(i) and 42 CFR
incidence rates to the FDNY cohort, the Administrator initially reviewed the 88.17(a)(2)(i)) is unwarranted.
study authors were able to generate age- findings presented in the 2015 Webber For the reasons discussed above, the
specific expected numbers of cases for study in response to Petition 007, which request made in Petition 011 to add
the FDNY cohort. The observed also requested the addition of autoimmune disease, lupus, and
incidence rates in the FDNY cohort autoimmune diseases, including rheumatoid arthritis to the List of WTC-
were then compared with the expected rheumatoid arthritis and connective Related Health Conditions is denied.
numbers of cases for the FDNY cohort tissue diseases. In that review, due to The Administrator will continue to
derived from the REP rates. limitations in the 2015 Webber study, monitor the scientific literature for
Standardized ratios, which are the ratios the Administrator determined that publication of the results of the ongoing
of the observed number of cases in the insufficient evidence existed to take any WTC Health Registry study discussed
FDNY cohort to the expected number of of the following actions: propose the above (reference 7 in the petition) and
cases (based on the REP rates) were then addition of autoimmune diseases to the any other studies that address
calculated. Overall, FDNY rates for the List (pursuant to PHS Act, sec. autoimmune diseases among 9/11-
five types of autoimmune disease 3312(a)(6)(B)(ii) and 42 CFR exposed populations.
compared were not significantly 88.17(a)(2)(ii)); publish a determination
Dated: April 20, 2016.
different from expected rates (SIR, 0.97; not to publish a proposed rule in the
Federal Register (pursuant to PHS Act, John Howard,
95% CI, 0.77–1.21). Only SLE had a
sec. 3312(a)(6)(B)(iii) and 42 CFR Administrator, World Trade Center Health
standardized incidence ratio that was Program and Director, National Institute for
statistically significantly greater among 88.17(a)(2)(iii)); or request a
Occupational Safety and Health, Centers for
the entire FDNY cohort. Other ratios recommendation from the STAC
Disease Control and Prevention, Department
were either reduced or not statistically (pursuant to PHS Act, sec. of Health and Human Services.
significant. 3312(a)(6)(B)(i) and 42 CFR
[FR Doc. 2016–09527 Filed 4–22–16; 8:45 am]
Limitations similar to those found in 88.17(a)(2)(i)). The 2015 Webber study
BILLING CODE 4163–18–P
the 2015 Webber study, discussed was also presented as evidence to
above, were seen in the 2016 Webber support Petition 008 regarding
autoimmune disorders, specifically
study, including the lack of information FEDERAL COMMUNICATIONS
encephalitis of the brain, as well as
on potential confounders such as family COMMISSION
Petition 009 regarding the autoimmune
history of autoimmune disease and both
disorder multiple sclerosis.
work-related and recreational non-9/11- In reviewing the 2016 Webber study 47 CFR Part 76
related exposures, and poor for potential support for Petition 011,
generalizability to other 9/11-exposed [MB Docket No. 16–126; DA 16–407]
the ADS concluded that similar
groups. The 2016 Webber study did not inadequacies existed for the 2016 study
include new or additional information Petition for Declaratory Ruling Filed by
as those seen in the 2015 Webber study. National Cable & Telecommunications
or controls that would avoid or mitigate Taken together, the two Webber studies,
the limitations found in the 2015 study. Association and American Cable
while meeting the relevance threshold Association
Consistent with the assessment of of being published, peer-reviewed
Petition 007,20 the ADS disagreed with epidemiologic studies of autoimmune AGENCY: Federal Communications
the method for measuring chronic disease, including lupus and Commission.
exposure with a duration variable that rheumatoid arthritis, in 9/11-exposed ACTION: Petition for declaratory ruling;
did not differentiate between those with populations, were found to exhibit request for comments.
one day versus many days of exposure significant limitations and were thus
in a given month. Furthermore, the lack insufficient to provide a potential basis SUMMARY: This document seeks
of information about occupational for a decision on whether to propose comment on a petition for declaratory
history and other potential confounders adding the requested health conditions ruling filed by the National Cable &
among the REP cohort calls into to the List. Telecommunications Association and
question the applicability and Accordingly, with regard to Petition American Cable Association seeking a
comparability of the rates used in the 011, the Administrator has determined declaratory ruling clarifying the
2016 Webber study. that insufficient evidence exists to take ‘‘written information’’ requirement of
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS

D. Administrator’s Determination on further action at this time, including section 76.1602(b) of the Commission’s
Petition 011 either proposing the addition of rules. Specifically, NCTA and ACA
autoimmune diseases to the List ‘‘seek a ruling that electronic
The Administrator has established a dissemination by email to subscribers
policy for evaluating whether to propose 21 John Howard, Administrator of the WTC Health for whom a cable operator has a
the addition of non-cancer health Program, Policy and Procedures for Adding Non- confirmed email address, by the
conditions to the List of WTC-Related Cancer Conditions to the List of WTC-Related
Health Conditions, Oct. 21, 2014. http://
provision of appropriately-noticed links
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_ to Web sites, or by other electronic
20 See 80 FR 32333 at 32334. NonCancers_21_Oct_2014.pdf. measures reasonably calculated to reach

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Document Created: 2016-04-23 01:38:52
Document Modified: 2016-04-23 01:38:52
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Denial of petition for addition of a health condition.
Dates		The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of April 25, 2016.
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 [email protected]
FR Citation		81 FR 24047