World Trade Center Health Program; Petitions 016 and 017-Parkinson's Disease and Parkinsonism, Including Manganese-Induced Parkinsonism; Finding of Insufficient Evidence, 32312-32315 [2017-14559]
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Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Proposed Rules
6. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (59 FR
22951, November 9, 2000), requires the
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by tribal officials in the development of
regulatory policies that have tribal
implications.’’ This proposed rule does
not have tribal implications, as specified
in EO 13175 because the EPA retains its
authority over Indian Country. Thus, EO
13175 does not apply to this proposed
rule. The EPA specifically solicits
additional comment on this proposed
rule from tribal officials.
7. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
The EPA interprets Executive Order
13045 (62 FR 19885, April 23, 1997) as
applying only to those regulatory
actions that concern health or safety
risks, such that the analysis required
under section 5–501 of the EO has the
potential to influence the regulation.
This action is not subject to EO 13045
because it proposes to approve a state
program.
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8. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This proposed rule is not subject to
Executive Order 13211, ‘‘Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) because it is not a ‘‘significant
regulatory action’’ as defined under EO
12866.
9. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), (Pub. L. 104–
113, 12(d)) (15 U.S.C. 272), directs the
EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus bodies. The
NTTAA directs the EPA to provide
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards. This proposed
rulemaking does not involve technical
standards. Therefore, the EPA is not
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considering the use of any voluntary
consensus standards.
ACTION:
10. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
February 16, 1994) establishes federal
executive policy on environmental
justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States. The
EPA has determined that this proposed
rule will not have disproportionately
high and adverse human health or
environmental effects on minority or
low-income populations. This proposed
rule does not affect the level of
protection provided to human health or
the environment because this rule
proposes to authorize pre-existing State
rules which are equivalent to, and no
less stringent than existing federal
requirements.
SUMMARY:
List of Subjects in 40 CFR Part 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous materials transportation,
Hazardous waste, Indians-lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements.
Authority: This proposed action is issued
under the authority of sections 2002(a), 3006,
and 7004(b) of the Solid Waste Disposal Act,
as amended, 42 U.S.C. 6912(a), 6926, and
6974(b).
Dated: May 31, 2017.
Michelle Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2017–14733 Filed 7–12–17; 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;
Petitions 016 and 017—Parkinson’s
Disease and Parkinsonism, Including
Manganese-Induced Parkinsonism;
Finding of Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
AGENCY:
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Denial of petitions for addition
of health conditions.
On February 22, 2017, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 016) to add
Parkinson’s disease and parkinsonism,
including manganese-induced
parkinsonism, to the List of WTCRelated Health Conditions (List). On
May 10, 2017, the Administrator
received a second petition (Petition 017)
to add the same health conditions to the
List. Upon reviewing the scientific and
medical literature, including
information provided by the two
petitioners, the Administrator has
determined that the available evidence
does not have the potential to provide
a basis for a decision on whether to add
Parkinson’s disease and/or
parkinsonism, including manganeseinduced parkinsonism, to the List. The
Administrator also finds that
insufficient evidence exists to request a
recommendation of the WTC Health
Program Scientific/Technical Advisory
Committee (STAC), to publish a
proposed rule, or to publish a
determination not to publish a proposed
rule.
DATES: The Administrator of the WTC
Health Program is denying these
petitions for the addition of health
conditions as of July 13, 2017.
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. Petition 016 and Petition 017
C. Review of Scientific and Medical
Information and Administrator
Determination
D. Administrator’s Final Decision on
Whether to Propose the Addition of
Parkinson’s Disease and/or
Parkinsonism, Including ManganeseInduced Parkinsonism, to the List
E. Approval to Submit Document to the
Office of the Federal Register
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347, as amended by Pub.
L. 114–113), added Title XXXIII to the
Public Health Service (PHS) Act,1
1 Title XXXIII of the PHS Act is codified at 42
U.S.C. 300mm to 300mm-61. Those portions of the
James Zadroga 9/11 Health and Compensation Act
of 2010 found in Titles II and III of Public Law 111–
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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 designee.
Pursuant to section 3312(a)(6)(B) of
the PHS Act, interested parties may
petition the Administrator to add a
health condition to the List in 42 CFR
88.15 (2017). Within 90 days after
receipt of a petition to add a condition
to the List, the Administrator must take
one of the following four actions
described in section 3312(a)(6)(B) of the
PHS Act and 42 CFR 88.16(a)(2): (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. In
accordance with 42 CFR 88.16(a)(4), the
Administrator may consider more than
one petition simultaneously when the
petitions propose the addition of the
same health condition(s) and the
required Federal Register notices may
respond to more than one petition.
In addition to the regulatory
provisions, the WTC Health Program
has developed policies to guide the
review of submissions and petitions,2 as
well as the analysis of evidence
supporting the potential addition of a
non-cancer health condition to the List.3
347 do not pertain to the WTC Health Program and
are codified elsewhere.
2 See WTC Health Program [2014], Policy and
Procedures for Handling Submissions and Petitions
to Add a Health Condition to the List of WTCRelated Health Conditions, May 14, https://www.
cdc.gov/wtc/pdfs/WTCHPPPPetitionHandling
Procedures14May2014.pdf.
3 See WTC Health Program [2017], Policy and
Procedures for Adding Non-Cancer Conditions to
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In accordance with the aforementioned
non-cancer health condition addition
policy, the Administrator directs the
WTC Health Program to conduct a
review of the scientific literature to
determine if the available scientific
information has the potential to provide
a basis for a decision on whether to add
the health condition to the List. The
literature review includes a search for
peer-reviewed, published,
epidemiologic studies (including direct
observational studies in the case of
health conditions such as injuries) about
the health condition among 9/11exposed populations. The Program
evaluates the scientific quality
limitations of each peer-reviewed,
published, epidemiologic study of the
health condition identified in the
literature search; the Program then
compiles the scientific results of each
study to assess whether a causal
relationship between 9/11 exposures
and the health condition is supported,
and evaluates whether the results of the
studies are representative of the 9/11exposed population of responders and
survivors. A health condition may be
added to the List if peer-reviewed,
published, epidemiologic studies
provide support that the health
condition is substantially likely 4 to be
causally associated with 9/11 exposures.
If the evaluation of evidence provided
in peer-reviewed, published,
epidemiologic studies of the health
condition in 9/11 populations
demonstrates a high, but not substantial
likelihood of a causal association
between the 9/11 exposures and the
health condition, then the
Administrator may consider additional
highly relevant scientific evidence
regarding exposures to 9/11 agents 5
from sources using non-9/11-exposed
populations. If that additional
assessment establishes that the health
condition is substantially likely to be
causally associated with 9/11 exposures
among 9/11-exposed populations, the
health condition may be added to the
List.
the List of WTC-Related Health Conditions,
February 14, https://www.cdc.gov/wtc/pdfs/
WTCHP_PP_Adding_NonCancers_14_February_
2017.pdf.
4 The ‘‘substantially likely’’ standard is met when
the scientific evidence, taken as a whole,
demonstrates a strong relationship between the 9/
11 exposures and the health condition.
5 9/11 agents are chemical, physical, biological, or
other agents or hazards reported in a published,
peer-reviewed exposure assessment study of
responders or survivors who were present in the
New York City disaster area, at the Pentagon site,
or at the Shanksville, Pennsylvania site, as those
locations are defined in 42 CFR 88.1.
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B. Petition 016 and Petition 017
A valid petition must include
sufficient medical basis for the
association between the September 11,
2001, terrorist attacks and the health
condition to be added; in accordance
with WTC Health Program policy,
reference to a peer-reviewed, published,
epidemiologic study about the health
condition among 9/11-exposed
populations or to clinical case reports of
health conditions in WTC responders or
survivors may demonstrate the required
medical basis.6 Studies linking 9/11
agents to the petitioned health condition
may also provide sufficient medical
basis for a valid petition.
On February 22, 2017, the
Administrator received a petition
(Petition 016) from a WTC responder
who worked at Ground Zero, requesting
the addition of ‘‘young onset Parkinson
Disease’’ 7 and ‘‘Parkinsonia Syndrome’’
to the List. The petition included eight
peer-reviewed, published studies and
reviews of studies of parkinsonism
associated with manganese exposure in
non-9/11-exposed populations and
laboratory animals, and mechanistic
studies of manganese-induced
parkinsonism, discussed below.8 The
Program noted the various terms used to
describe the health condition in the
petition and the references included
with the petition. The general term
‘‘Parkinsonism’’ refers to a category of
neurological diseases exhibiting
disturbance in the dopamine systems of
the basal ganglia, which leads to the
symptoms characterizing the disease:
Tremors, slowness of movement, and
stiffness. Classic (idiopathic)
Parkinson’s disease is the most common
and treatable form of parkinsonism;
non-idiopathic types are considered
atypical and referred to by the more
general term ‘‘parkinsonism.’’ One type
of atypical parkinsonism, manganeseinduced parkinsonism, has been found
to be caused by elevated and prolonged
exposure to manganese.9 The term
‘‘Parkinsonia Syndrome,’’ used by the
petitioner, was likely intended to refer
to ‘‘Parkinsonian syndrome,’’ a lesscommonly used term for atypical
parkinsonism.
The first of the eight peer-reviewed,
published studies provided in Petition
6 See
supra note 2.
diagnosis of young-onset Parkinson’s
disease is the same as typical Parkinson’s disease,
except for the age of the patient.
8 See Petition 016, WTC Health Program: Petitions
Received, https://www.cdc.gov/wtc/received.html.
9 See Kwakye GF, Paoliello MMB, Mukhopadhyay
S, et al. [2015], Manganese-Induced Parkinsonism
and Parkinson’s Disease: Shared and
Distinguishable Features, Int J Environ Res Public
Health 12(7):7519–7540).
7 The
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016, reference 1, ‘‘Manganese-Induced
Parkinsonism Is Not Idiopathic
Parkinson’s Disease: Environmental and
Genetic Evidence’’ by Guilarte et al.
[2015],10 is a review of various peerreviewed and published epidemiologic
and animal studies highlighting the
difference between manganese-induced
parkinsonism and Parkinson’s disease.
Reference 2, ‘‘Manganese-Induced
Parkinsonism and Parkinson’s Disease:
Shared and Distinguishable Features’’
by Kwakye et al. [2015],11 is also a
review of peer-reviewed and published
epidemiologic, animal, and mechanistic
studies comparing characteristics of
manganese-induced parkinsonism and
Parkinson’s disease. Reference 3,
‘‘Inducible Nitric Oxide Synthase Gene
Methylation and Parkinsonism in
Manganese-Exposed Welders’’ by
Searles et al. [2015],12 is an
epidemiologic study examining gene
methylation of inducible nitric oxide
synthase, an enzyme involved in
inflammation, among manganeseexposed welders. Reference 4, ‘‘aSynuclein Protects Against Manganese
Neurotoxic Insult During the Early
Stages of Exposure in a Dopaminergic
Cell Model of Parkinson’s Disease’’ by
Harischandra et al. [2015],13 is an ex
vivo laboratory study in rat cell lines
exploring the effects of a-synuclein, a
protein found in the brain, on
manganese-induced dopaminergic
neurotoxicity. Reference 5, ‘‘SLC30A10
is a Cell Surface-Localized Manganese
Efflux Transporter, and ParkinsonismCausing Mutations Block its
Intracellular Trafficking and Efflux
Activity’’ by Leyva-Illades et al.
[2014],14 is a mechanistic and functional
cell culture study looking at the role of
interactions between genetic and
environmental factors in the
development of parkinsonism.
Reference 6, ‘‘Correlation Between the
Biochemical Pathways Altered by
Mutated Parkinson-Related Genes and
10 Guilarte TR, Gonzales KK [2015], ManganeseInduced Parkinsonism is Not Idiopathic Parkinson’s
Disease: Environmental and Genetic Evidence,
Toxicol Sci 146(2):204–212.
11 Supra note 9.
12 Searles Nielsen S, Checkoway H, Criswell SR,
et al. [2015], Inducible Nitric Oxide Synthase Gene
Methylation and Parkinsonism in ManganeseExposed Welders, Parkinsonism. Relat Disord
21(4):355–60.
13 Harischandra DS, Jin H, Anantharam V, et al.
[2015], a-Synuclein Protects Against Manganese
Neurotoxic Insult During the Early Stages of
Exposure in a Dopaminergic Cell Model of
Parkinson’s Disease, Toxicol Sci 143(2):454–468.
14 Leyva-Illades D, Chen P, Zogzas CE, et al.
[2014], SLC30A10 Is a Cell Surface-Localized
Manganese Efflux Transporter, and ParkinsonismCausing Mutations Block Its Intracellular
Trafficking and Efflux Activity, J Neurosci
34(42):14079–14095.
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Chronic Exposure to Manganese’’ by
Roth [2014],15 is a review of peerreviewed, published studies describing
genes involved in the development of
parkinsonism and illustrating how the
proposed mechanism of each gene may
relate to the onset and severity of
manganese toxicity. Reference 7,
‘‘Manganese-Induced Atypical
Parkinsonism is Associated with
Altered Basal Ganglia Activity and
Changes in Tissue Levels of
Monoamines in the Rat’’ by Bouabid et
al. [2014],16 is a study on changes to
motor and non-motor functions and
behavior, similar to those observed in
parkinsonism, in manganese-exposed
rats. Finally, reference 8,
‘‘Neurofunctional Dopaminergic
Impairment in Elderly After Lifetime
Exposure to Manganese’’ by Lucchini et
al. [2014],17 is an epidemiologic study
of the effects of manganese exposure
due to emissions from nearby ferroalloy
plants on the neurocognitive and motor
functions of elderly study participants.
The eight references offered as
medical basis for Petition 016 suggested
a potential association between
exposure to the 9/11 agent manganese
and manganese-induced parkinsonism
and Parkinson’s disease and established
a sufficient medical basis to consider
the submission a valid petition for
manganese-induced parkinsonism.
Although the petitioner requested the
addition of ‘‘young onset Parkinson
Disease’’ and ‘‘Parkinsonia Syndrome,’’
the medical basis provided by the
petitioner primarily included studies
concerning manganese-induced
parkinsonism; therefore, the
Administrator determined that the
petitioner requested the addition of both
Parkinson’s disease and parkinsonism,
including manganese-induced
parkinsonism.
On May 10, 2017, the Administrator
received a petition from a WTC survivor
(Petition 017), requesting the addition of
‘‘Parkinson’s Disease’’ to the List. The
petition referenced five peer-reviewed,
published, epidemiologic studies of
heavy metal exposure, including
manganese, and Parkinson’s disease or
15 Roth, JA [2014], Correlation Between the
Biochemical Pathways Altered by Mutated
Parkinson-Related Genes and Chronic Exposure to
Manganese, Neurotoxicology Sep;44:314–325.
16 Bouabid S, Delaville C, De Deurwaerdere P, et
`
al. [2014], Manganese-Induced Atypical
Parkinsonism Is Associated With Altered Basal
Ganglia Activity and Changes in Tissue Levels of
Monoamines in the Rat, PLoS ONE 9(6):e98952.
17 Lucchini RG, Guazzetti S, Zoni S, et al. [2014],
Neurofunctional Dopaminergic Impairment in
Elderly After Lifetime Exposure to Manganese,
Neurotoxicology 0:309–17.
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parkinsonism in non-9/11-exposed
populations.18
The first of the five peer-reviewed,
published, epidemiologic studies
provided in Petition 017, reference 1,
‘‘Increased Risk of Parkinsonism
Associated With Welding Exposure’’ by
Racette et al. [2012],19 examined the
prevalence and clinical characteristics
of parkinsonism among workers
exposed to welding fumes. Reference 2,
‘‘Inducible Nitric Oxide Synthase Gene
Methylation and Parkinsonism in
Manganese-Exposed Welders’’ by
Searles et al. [2015],20 was also cited as
reference 3 in Petition 016, as discussed
above. Reference 3, ‘‘Multiple Risk
Factors for Parkinson’s Disease’’ by
Gorell et al. [2004],21 evaluated the
contribution of various occupational,
lifestyle, and genetic risk factors,
including manganese exposure, to the
development of Parkinson’s disease.
Reference 4, ‘‘Occupational Exposure to
Manganese, Copper, Lead, Iron, Mercury
and Zinc and the Risk of Parkinson’s
Disease’’ by Gorell et al. [1999],22
assessed the association between a
variety of heavy metals and Parkinson’s
disease. Finally, reference 5, ‘‘WholeBody Lifetime Occupational Lead
Exposure and Risk of Parkinson’s
Disease’’ by Coon et al. [2006],23
evaluated the role of chronic lead
exposure among individuals with
Parkinson’s disease.
These five studies suggested a
potential association between exposure
to known 9/11 agents and Parkinson’s
disease and parkinsonism, including
manganese-induced parkinsonism, and
thus provided a sufficient medical basis
to consider the submission a valid
petition. Because the medical basis
provided by the petitioner included
studies concerning both Parkinson’s
disease and manganese-induced
parkinsonism, the Administrator
determined that the petitioner requested
the addition of both Parkinson’s disease
and manganese-induced parkinsonism.
Since the Administrator determined
that the scope of both Petition 016 and
18 See Petition 017, WTC Health Program:
Petitions Received, https://www.cdc.gov/wtc/
received.html.
19 Racette BA, et al. [2012], Increased Risk of
Parkinsonism Associated With Welding Exposure,
Neurotoxicology 33(5):1356–1361.
20 Supra note 12.
21 Gorell JM, et al. [2004], Multiple Risk Factors
for Parkinson’s Disease, J Neurol Sci 217(2):169–
174.
22 Gorell JM, et al. [1999], Occupational Exposure
to Manganese, Copper, Lead, Iron, Mercury and
Zinc and the Risk of Parkinson’s Disease,
Neurotoxicology 20(2–3):239–247.
23 Coon S, Stark A, Peterson E, et al. [2006],
Whole-Body Lifetime Occupational Lead Exposure
and Risk of Parkinson’s Disease, Environ Health
Perspect Dec;114(12):1872–6.
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32315
Petition 017 include requests for the
addition of Parkinson’s disease and
parkinsonism, including manganeseinduced parkinsonism, the
Administrator decided to exercise his
discretion, as permitted by 42 CFR
88.16(a)(4), to combine consideration of
the petitions and issue a single Federal
Register notice.
Parkinson’s disease or parkinsonism,
including manganese-induced
parkinsonism, in 9/11 populations were
identified, the Program was unable to
conduct an evaluation of scientific
evidence to determine the likelihood of
a causal association between 9/11
exposures and the petitioned health
conditions.
3312(a)(6)(B)(i) and 42 CFR
88.16(a)(2)(i)) is unwarranted.
For the reasons discussed above, the
Petition 016 and Petition 017 requests to
add Parkinson’s disease and/or
parkinsonism, including manganeseinduced parkinsonism, to the List of
WTC-Related Health Conditions are
denied.
C. Review of Scientific and Medical
Information and Administrator
Determination
In response to Petition 016 and
Petition 017, and pursuant to the
Program policy on the addition of noncancer health conditions to the List,24
the Program conducted reviews of the
scientific literature on Parkinson’s
disease and parkinsonism, including
manganese-induced parkinsonism.25
Neither the references provided in the
petitions nor the literature search
conducted by the Program identified
any peer-reviewed, published,
epidemiologic studies of either
Parkinson’s disease or parkinsonism,
including manganese-induced
parkinsonism, in 9/11-exposed
populations. Since no peer-reviewed,
published, epidemiologic studies of
D. Administrator’s Final Decision on
Whether To Propose the Addition of
Parkinson’s Disease and/or ManganeseInduced Parkinsonism to the List
E. Approval To Submit Document to the
Office of the Federal Register
24 Supra
note 3.
searched include: Embase,
NIOSHTIC–2, ProQuest Health & Safety, PsycINFO,
PubMed, Scopus, Toxicology Abstracts, and
TOXLINE.
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25 Databases
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Because no peer-reviewed, published,
epidemiologic studies of Parkinson’s
disease or parkinsonism, including
manganese-induced parkinsonism, in 9/
11 populations were identified, the
Administrator has determined that
insufficient evidence is available to take
further action at this time, including
either proposing the addition of
Parkinson’s disease or parkinsonism,
including manganese-induced
parkinsonism, to the List (pursuant to
PHS Act, sec. 3312(a)(6)(B)(ii) and 42
CFR 88.16(a)(2)(ii)) or publishing a
determination not to publish a proposed
rule in the Federal Register (pursuant to
PHS Act, sec. 3312(a)(6)(B)(iii) and 42
CFR 88.16(a)(2)(iii)). The Administrator
has also determined that requesting a
recommendation from the STAC
(pursuant to PHS Act, sec.
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The Secretary, HHS, or his designee,
the Director, Centers for Disease Control
and Prevention (CDC) and
Administrator, Agency for Toxic
Substances and Disease Registry
(ATSDR), authorized the undersigned,
the Administrator of the WTC Health
Program, to sign and submit the
document to the Office of the Federal
Register for publication as an official
document of the WTC Health Program.
Anne Schuchat, M.D., Acting Director,
CDC, and Acting Administrator,
ATSDR, approved this document for
publication on July 6, 2017.
John Howard,
Administrator, World Trade Center Health
Program and Director, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention, Department
of Health and Human Services.
[FR Doc. 2017–14559 Filed 7–12–17; 8:45 am]
BILLING CODE 4163–18–P
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Agencies
[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Proposed Rules]
[Pages 32312-32315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14559]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petitions 016 and 017--
Parkinson's Disease and Parkinsonism, Including Manganese-Induced
Parkinsonism; Finding of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Denial of petitions for addition of health conditions.
-----------------------------------------------------------------------
SUMMARY: On February 22, 2017, the Administrator of the World Trade
Center (WTC) Health Program received a petition (Petition 016) to add
Parkinson's disease and parkinsonism, including manganese-induced
parkinsonism, to the List of WTC-Related Health Conditions (List). On
May 10, 2017, the Administrator received a second petition (Petition
017) to add the same health conditions to the List. Upon reviewing the
scientific and medical literature, including information provided by
the two petitioners, the Administrator has determined that the
available evidence does not have the potential to provide a basis for a
decision on whether to add Parkinson's disease and/or parkinsonism,
including manganese-induced parkinsonism, to the List. The
Administrator also finds that insufficient evidence exists to request a
recommendation of the WTC Health Program Scientific/Technical Advisory
Committee (STAC), to publish a proposed rule, or to publish a
determination not to publish a proposed rule.
DATES: The Administrator of the WTC Health Program is denying these
petitions for the addition of health conditions as of July 13, 2017.
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. Petition 016 and Petition 017
C. Review of Scientific and Medical Information and Administrator
Determination
D. Administrator's Final Decision on Whether to Propose the Addition
of Parkinson's Disease and/or Parkinsonism, Including Manganese-
Induced Parkinsonism, to the List
E. Approval to Submit Document to the Office of the Federal Register
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title
XXXIII to the Public Health Service (PHS) Act,\1\
[[Page 32313]]
establishing the WTC Health Program within the Department of Health and
Human Services (HHS). The WTC Health Program provides medical
monitoring and treatment benefits to eligible firefighters and related
personnel, law enforcement officers, and rescue, recovery, and cleanup
workers who responded to the September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in Shanksville, Pennsylvania
(responders), and to eligible persons who were present in the dust or
dust cloud on September 11, 2001, or who worked, resided, or attended
school, childcare, or adult daycare in the New York City disaster area
(survivors).
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\1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the James Zadroga 9/11 Health and
Compensation Act of 2010 found in Titles II and III of Public Law
111-347 do not pertain to the WTC Health Program and are codified
elsewhere.
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All references to the Administrator of the WTC Health Program
(Administrator) in this notice mean the Director of the National
Institute for Occupational Safety and Health (NIOSH) or his designee.
Pursuant to section 3312(a)(6)(B) of the PHS Act, interested
parties may petition the Administrator to add a health condition to the
List in 42 CFR 88.15 (2017). Within 90 days after receipt of a petition
to add a condition to the List, the Administrator must take one of the
following four actions described in section 3312(a)(6)(B) of the PHS
Act and 42 CFR 88.16(a)(2): (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. In accordance with 42 CFR 88.16(a)(4), the
Administrator may consider more than one petition simultaneously when
the petitions propose the addition of the same health condition(s) and
the required Federal Register notices may respond to more than one
petition.
In addition to the regulatory provisions, the WTC Health Program
has developed policies to guide the review of submissions and
petitions,\2\ as well as the analysis of evidence supporting the
potential addition of a non-cancer health condition to the List.\3\ In
accordance with the aforementioned non-cancer health condition addition
policy, the Administrator directs the WTC Health Program to conduct a
review of the scientific literature to determine if the available
scientific information has the potential to provide a basis for a
decision on whether to add the health condition to the List. The
literature review includes a search for peer-reviewed, published,
epidemiologic studies (including direct observational studies in the
case of health conditions such as injuries) about the health condition
among 9/11-exposed populations. The Program evaluates the scientific
quality limitations of each peer-reviewed, published, epidemiologic
study of the health condition identified in the literature search; the
Program then compiles the scientific results of each study to assess
whether a causal relationship between 9/11 exposures and the health
condition is supported, and evaluates whether the results of the
studies are representative of the 9/11-exposed population of responders
and survivors. A health condition may be added to the List if peer-
reviewed, published, epidemiologic studies provide support that the
health condition is substantially likely \4\ to be causally associated
with 9/11 exposures. If the evaluation of evidence provided in peer-
reviewed, published, epidemiologic studies of the health condition in
9/11 populations demonstrates a high, but not substantial likelihood of
a causal association between the 9/11 exposures and the health
condition, then the Administrator may consider additional highly
relevant scientific evidence regarding exposures to 9/11 agents \5\
from sources using non-9/11-exposed populations. If that additional
assessment establishes that the health condition is substantially
likely to be causally associated with 9/11 exposures among 9/11-exposed
populations, the health condition may be added to the List.
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\2\ See WTC Health Program [2014], Policy and Procedures for
Handling Submissions and Petitions to Add a Health Condition to the
List of WTC-Related Health Conditions, May 14, https://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
\3\ See WTC Health Program [2017], Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, February 14, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_14_February_2017.pdf.
\4\ The ``substantially likely'' standard is met when the
scientific evidence, taken as a whole, demonstrates a strong
relationship between the 9/11 exposures and the health condition.
\5\ 9/11 agents are chemical, physical, biological, or other
agents or hazards reported in a published, peer-reviewed exposure
assessment study of responders or survivors who were present in the
New York City disaster area, at the Pentagon site, or at the
Shanksville, Pennsylvania site, as those locations are defined in 42
CFR 88.1.
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B. Petition 016 and Petition 017
A valid petition must include sufficient medical basis for the
association between the September 11, 2001, terrorist attacks and the
health condition to be added; in accordance with WTC Health Program
policy, reference to a peer-reviewed, published, epidemiologic study
about the health condition among 9/11-exposed populations or to
clinical case reports of health conditions in WTC responders or
survivors may demonstrate the required medical basis.\6\ Studies
linking 9/11 agents to the petitioned health condition may also provide
sufficient medical basis for a valid petition.
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\6\ See supra note 2.
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On February 22, 2017, the Administrator received a petition
(Petition 016) from a WTC responder who worked at Ground Zero,
requesting the addition of ``young onset Parkinson Disease'' \7\ and
``Parkinsonia Syndrome'' to the List. The petition included eight peer-
reviewed, published studies and reviews of studies of parkinsonism
associated with manganese exposure in non-9/11-exposed populations and
laboratory animals, and mechanistic studies of manganese-induced
parkinsonism, discussed below.\8\ The Program noted the various terms
used to describe the health condition in the petition and the
references included with the petition. The general term
``Parkinsonism'' refers to a category of neurological diseases
exhibiting disturbance in the dopamine systems of the basal ganglia,
which leads to the symptoms characterizing the disease: Tremors,
slowness of movement, and stiffness. Classic (idiopathic) Parkinson's
disease is the most common and treatable form of parkinsonism; non-
idiopathic types are considered atypical and referred to by the more
general term ``parkinsonism.'' One type of atypical parkinsonism,
manganese-induced parkinsonism, has been found to be caused by elevated
and prolonged exposure to manganese.\9\ The term ``Parkinsonia
Syndrome,'' used by the petitioner, was likely intended to refer to
``Parkinsonian syndrome,'' a less-commonly used term for atypical
parkinsonism.
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\7\ The diagnosis of young-onset Parkinson's disease is the same
as typical Parkinson's disease, except for the age of the patient.
\8\ See Petition 016, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
\9\ See Kwakye GF, Paoliello MMB, Mukhopadhyay S, et al. [2015],
Manganese-Induced Parkinsonism and Parkinson's Disease: Shared and
Distinguishable Features, Int J Environ Res Public Health
12(7):7519-7540).
---------------------------------------------------------------------------
The first of the eight peer-reviewed, published studies provided in
Petition
[[Page 32314]]
016, reference 1, ``Manganese-Induced Parkinsonism Is Not Idiopathic
Parkinson's Disease: Environmental and Genetic Evidence'' by Guilarte
et al. [2015],\10\ is a review of various peer-reviewed and published
epidemiologic and animal studies highlighting the difference between
manganese-induced parkinsonism and Parkinson's disease. Reference 2,
``Manganese-Induced Parkinsonism and Parkinson's Disease: Shared and
Distinguishable Features'' by Kwakye et al. [2015],\11\ is also a
review of peer-reviewed and published epidemiologic, animal, and
mechanistic studies comparing characteristics of manganese-induced
parkinsonism and Parkinson's disease. Reference 3, ``Inducible Nitric
Oxide Synthase Gene Methylation and Parkinsonism in Manganese-Exposed
Welders'' by Searles et al. [2015],\12\ is an epidemiologic study
examining gene methylation of inducible nitric oxide synthase, an
enzyme involved in inflammation, among manganese-exposed welders.
Reference 4, ``[alpha]-Synuclein Protects Against Manganese Neurotoxic
Insult During the Early Stages of Exposure in a Dopaminergic Cell Model
of Parkinson's Disease'' by Harischandra et al. [2015],\13\ is an ex
vivo laboratory study in rat cell lines exploring the effects of
[alpha]-synuclein, a protein found in the brain, on manganese-induced
dopaminergic neurotoxicity. Reference 5, ``SLC30A10 is a Cell Surface-
Localized Manganese Efflux Transporter, and Parkinsonism-Causing
Mutations Block its Intracellular Trafficking and Efflux Activity'' by
Leyva-Illades et al. [2014],\14\ is a mechanistic and functional cell
culture study looking at the role of interactions between genetic and
environmental factors in the development of parkinsonism. Reference 6,
``Correlation Between the Biochemical Pathways Altered by Mutated
Parkinson-Related Genes and Chronic Exposure to Manganese'' by Roth
[2014],\15\ is a review of peer-reviewed, published studies describing
genes involved in the development of parkinsonism and illustrating how
the proposed mechanism of each gene may relate to the onset and
severity of manganese toxicity. Reference 7, ``Manganese-Induced
Atypical Parkinsonism is Associated with Altered Basal Ganglia Activity
and Changes in Tissue Levels of Monoamines in the Rat'' by Bouabid et
al. [2014],\16\ is a study on changes to motor and non-motor functions
and behavior, similar to those observed in parkinsonism, in manganese-
exposed rats. Finally, reference 8, ``Neurofunctional Dopaminergic
Impairment in Elderly After Lifetime Exposure to Manganese'' by
Lucchini et al. [2014],\17\ is an epidemiologic study of the effects of
manganese exposure due to emissions from nearby ferroalloy plants on
the neurocognitive and motor functions of elderly study participants.
---------------------------------------------------------------------------
\10\ Guilarte TR, Gonzales KK [2015], Manganese-Induced
Parkinsonism is Not Idiopathic Parkinson's Disease: Environmental
and Genetic Evidence, Toxicol Sci 146(2):204-212.
\11\ Supra note 9.
\12\ Searles Nielsen S, Checkoway H, Criswell SR, et al. [2015],
Inducible Nitric Oxide Synthase Gene Methylation and Parkinsonism in
Manganese-Exposed Welders, Parkinsonism. Relat Disord 21(4):355-60.
\13\ Harischandra DS, Jin H, Anantharam V, et al. [2015],
[alpha]-Synuclein Protects Against Manganese Neurotoxic Insult
During the Early Stages of Exposure in a Dopaminergic Cell Model of
Parkinson's Disease, Toxicol Sci 143(2):454-468.
\14\ Leyva-Illades D, Chen P, Zogzas CE, et al. [2014], SLC30A10
Is a Cell Surface-Localized Manganese Efflux Transporter, and
Parkinsonism-Causing Mutations Block Its Intracellular Trafficking
and Efflux Activity, J Neurosci 34(42):14079-14095.
\15\ Roth, JA [2014], Correlation Between the Biochemical
Pathways Altered by Mutated Parkinson-Related Genes and Chronic
Exposure to Manganese, Neurotoxicology Sep;44:314-325.
\16\ Bouabid S, Delaville C, De Deurwaerd[egrave]re P, et al.
[2014], Manganese-Induced Atypical Parkinsonism Is Associated With
Altered Basal Ganglia Activity and Changes in Tissue Levels of
Monoamines in the Rat, PLoS ONE 9(6):e98952.
\17\ Lucchini RG, Guazzetti S, Zoni S, et al. [2014],
Neurofunctional Dopaminergic Impairment in Elderly After Lifetime
Exposure to Manganese, Neurotoxicology 0:309-17.
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The eight references offered as medical basis for Petition 016
suggested a potential association between exposure to the 9/11 agent
manganese and manganese-induced parkinsonism and Parkinson's disease
and established a sufficient medical basis to consider the submission a
valid petition for manganese-induced parkinsonism. Although the
petitioner requested the addition of ``young onset Parkinson Disease''
and ``Parkinsonia Syndrome,'' the medical basis provided by the
petitioner primarily included studies concerning manganese-induced
parkinsonism; therefore, the Administrator determined that the
petitioner requested the addition of both Parkinson's disease and
parkinsonism, including manganese-induced parkinsonism.
On May 10, 2017, the Administrator received a petition from a WTC
survivor (Petition 017), requesting the addition of ``Parkinson's
Disease'' to the List. The petition referenced five peer-reviewed,
published, epidemiologic studies of heavy metal exposure, including
manganese, and Parkinson's disease or parkinsonism in non-9/11-exposed
populations.\18\
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\18\ See Petition 017, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
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The first of the five peer-reviewed, published, epidemiologic
studies provided in Petition 017, reference 1, ``Increased Risk of
Parkinsonism Associated With Welding Exposure'' by Racette et al.
[2012],\19\ examined the prevalence and clinical characteristics of
parkinsonism among workers exposed to welding fumes. Reference 2,
``Inducible Nitric Oxide Synthase Gene Methylation and Parkinsonism in
Manganese-Exposed Welders'' by Searles et al. [2015],\20\ was also
cited as reference 3 in Petition 016, as discussed above. Reference 3,
``Multiple Risk Factors for Parkinson's Disease'' by Gorell et al.
[2004],\21\ evaluated the contribution of various occupational,
lifestyle, and genetic risk factors, including manganese exposure, to
the development of Parkinson's disease. Reference 4, ``Occupational
Exposure to Manganese, Copper, Lead, Iron, Mercury and Zinc and the
Risk of Parkinson's Disease'' by Gorell et al. [1999],\22\ assessed the
association between a variety of heavy metals and Parkinson's disease.
Finally, reference 5, ``Whole-Body Lifetime Occupational Lead Exposure
and Risk of Parkinson's Disease'' by Coon et al. [2006],\23\ evaluated
the role of chronic lead exposure among individuals with Parkinson's
disease.
---------------------------------------------------------------------------
\19\ Racette BA, et al. [2012], Increased Risk of Parkinsonism
Associated With Welding Exposure, Neurotoxicology 33(5):1356-1361.
\20\ Supra note 12.
\21\ Gorell JM, et al. [2004], Multiple Risk Factors for
Parkinson's Disease, J Neurol Sci 217(2):169-174.
\22\ Gorell JM, et al. [1999], Occupational Exposure to
Manganese, Copper, Lead, Iron, Mercury and Zinc and the Risk of
Parkinson's Disease, Neurotoxicology 20(2-3):239-247.
\23\ Coon S, Stark A, Peterson E, et al. [2006], Whole-Body
Lifetime Occupational Lead Exposure and Risk of Parkinson's Disease,
Environ Health Perspect Dec;114(12):1872-6.
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These five studies suggested a potential association between
exposure to known 9/11 agents and Parkinson's disease and parkinsonism,
including manganese-induced parkinsonism, and thus provided a
sufficient medical basis to consider the submission a valid petition.
Because the medical basis provided by the petitioner included studies
concerning both Parkinson's disease and manganese-induced parkinsonism,
the Administrator determined that the petitioner requested the addition
of both Parkinson's disease and manganese-induced parkinsonism.
Since the Administrator determined that the scope of both Petition
016 and
[[Page 32315]]
Petition 017 include requests for the addition of Parkinson's disease
and parkinsonism, including manganese-induced parkinsonism, the
Administrator decided to exercise his discretion, as permitted by 42
CFR 88.16(a)(4), to combine consideration of the petitions and issue a
single Federal Register notice.
C. Review of Scientific and Medical Information and Administrator
Determination
In response to Petition 016 and Petition 017, and pursuant to the
Program policy on the addition of non-cancer health conditions to the
List,\24\ the Program conducted reviews of the scientific literature on
Parkinson's disease and parkinsonism, including manganese-induced
parkinsonism.\25\
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\24\ Supra note 3.
\25\ Databases searched include: Embase, NIOSHTIC-2, ProQuest
Health & Safety, PsycINFO, PubMed, Scopus, Toxicology Abstracts, and
TOXLINE.
---------------------------------------------------------------------------
Neither the references provided in the petitions nor the literature
search conducted by the Program identified any peer-reviewed,
published, epidemiologic studies of either Parkinson's disease or
parkinsonism, including manganese-induced parkinsonism, in 9/11-exposed
populations. Since no peer-reviewed, published, epidemiologic studies
of Parkinson's disease or parkinsonism, including manganese-induced
parkinsonism, in 9/11 populations were identified, the Program was
unable to conduct an evaluation of scientific evidence to determine the
likelihood of a causal association between 9/11 exposures and the
petitioned health conditions.
D. Administrator's Final Decision on Whether To Propose the Addition of
Parkinson's Disease and/or Manganese-Induced Parkinsonism to the List
Because no peer-reviewed, published, epidemiologic studies of
Parkinson's disease or parkinsonism, including manganese-induced
parkinsonism, in 9/11 populations were identified, the Administrator
has determined that insufficient evidence is available to take further
action at this time, including either proposing the addition of
Parkinson's disease or parkinsonism, including manganese-induced
parkinsonism, to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii)
and 42 CFR 88.16(a)(2)(ii)) or publishing a determination not to
publish a proposed rule in the Federal Register (pursuant to PHS Act,
sec. 3312(a)(6)(B)(iii) and 42 CFR 88.16(a)(2)(iii)). The Administrator
has also determined that requesting a recommendation from the STAC
(pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.16(a)(2)(i))
is unwarranted.
For the reasons discussed above, the Petition 016 and Petition 017
requests to add Parkinson's disease and/or parkinsonism, including
manganese-induced parkinsonism, to the List of WTC-Related Health
Conditions are denied.
E. Approval To Submit Document to the Office of the Federal Register
The Secretary, HHS, or his designee, the Director, Centers for
Disease Control and Prevention (CDC) and Administrator, Agency for
Toxic Substances and Disease Registry (ATSDR), authorized the
undersigned, the Administrator of the WTC Health Program, to sign and
submit the document to the Office of the Federal Register for
publication as an official document of the WTC Health Program. Anne
Schuchat, M.D., Acting Director, CDC, and Acting Administrator, ATSDR,
approved this document for publication on July 6, 2017.
John Howard,
Administrator, World Trade Center Health Program and Director, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2017-14559 Filed 7-12-17; 8:45 am]
BILLING CODE 4163-18-P