World Trade Center Health Program; Petition 025-Parkinson's Disease and Parkinsonism, Including Heavy Metal-Induced Parkinsonism; Finding of Insufficient Evidence, 9441-9444 [2020-02991]
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Federal Register / Vol. 85, No. 33 / Wednesday, February 19, 2020 / Proposed Rules
acknowledge review of the security
requirements for the system as set forth
in these regulations, VA’s Rules of
Behavior, and any additional materials
provided by VA.
(c) VBA may, at any time without
notice:
(1) Inspect the computer hardware
and software utilized to obtain access
and their location;
(2) Review the security practices and
training of any attorney, agent, or
representative of a VA-recognized
service organization granted access
under these regulations; and
(3) Monitor the access activities of an
attorney, agent, or representative of a
VA-recognized service organization. By
applying for, and exercising, the access
privileges under § 1.600 through 1.603,
the attorney, agent, or representative of
a VA-recognized service organization
expressly consents to VBA monitoring
access activities at any time for the
purpose of auditing system security.
■ 6. Amend § 1.603 by:
■ a. Revising the section heading
■ b. Revising paragraph (a).
■ c. Revising paragraphs (b)
introductory text and (b)(2).
■ d. Removing paragraph (b)(3).
■ e. Redesignating paragraph (b)(4) as
(b)(3) and revising the newly
redesignated (b)(3).
■ f. Redesignating paragraph (b)(5) as
(b)(4).
■ g. Redesignating paragraph (b)(6) as
(b)(5) and revising the newly
redesignated (b)(5).
■ h. Amend paragraph (c) and by adding
paragraphs (c)(1) through (5).
■ i. Revising paragraph (d).
■ j. Removing paragraph (e).
The revisions read as follows:
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§ 1.603
Revocation and reconsideration.
(a) VA may revoke access of an
attorney, agent, or representative of a
VA-recognized service organization to a
particular claimant’s records because
the individual or organization no longer
represents the claimant, and, therefore,
the claimant’s consent is no longer in
effect.
(b) VA may revoke the access
privileges of an attorney, agent, or
representative of a VA-recognized
service organization either to an
individual claimant’s records or to all
claimants’ records via the VBA IT
systems, if the individual:
(1) * * *
(2) Accesses or attempts to access data
for a purpose other than representation
of an individual claimant;
(3) Accesses or attempts to access data
on a claimant who he, she, or the
service organization does not represent;
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(4) Accesses or attempts to access a
VBA IT system by a method that has not
been approved by VA; or
(5) Modifies or attempts to modify
data in the VBA IT systems without
authorization.
(c) VA will notify the attorney, agent,
or representative of a VA-recognized
service organization of the denial of
access under § 1.601(a)(3) or revocation
of access under paragraph (b) of this
section. If VA denies or revokes access
privileges for a service organization
representative, VA will notify the
service organization(s) through which
the representative is accredited of the
denial or revocation of access.
(1) The denial or revocation of access
by a VBA regional office or center of
jurisdiction is a final decision. The
attorney, agent, or representative of a
VA-recognized service organization may
request reconsideration of a denial or
revocation of access by submitting a
written request to VBA. VBA will
consider the request if it is received by
VBA not later than 30 days after the date
that VA notified the attorney, agent, or
representative of a VA-recognized
service organization of its decision.
(2) The attorney, agent, or
representative of a VA-recognized
service organization may submit
additional information not previously
considered by VA, provided that the
additional information is submitted
with the written request and it is
pertinent to the prohibition of access.
(3) VA will close the record regarding
reconsideration at the end of the 30-day
period described in paragraph (c)(1) of
this section and furnish the request,
including any new information,
submitted by the attorney, agent, or
representative to the Director of the VA
regional office or center with
jurisdiction over the final decision.
(4) VA will reconsider access based
upon a review of the information of
record as of the date of its prior denial
or revocation, with any new information
submitted with the request. The
decision will:
(i) Identify the attorney, agent, or
representative of a VA-recognized
service organization,
(ii) Identify the date of VA’s prior
decision,
(iii) Describe in detail the facts found
as a result of VA’s review of its decision
with any new information submitted
with the reconsideration request, and
(iv) State the reasons for VA’s final
decision, which may affirm, modify, or
overturn its prior decision.
(5) VA will provide written notice of
its final decision on access to:
(i) The attorney, agent, or
representative of a VA-recognized
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9441
service organization requesting
reconsideration, and
(ii) if the conduct that resulted in
denial or revocation of the authority of
an attorney, agent, or representative of
a VA-recognized service organization to
access VBA electronic IT systems merits
potential inquiry into the individual’s
conduct or competence pursuant to
§ 14.633 of this chapter, the VBA
regional office or center of jurisdiction
will immediately inform VA’s Office of
General Counsel in writing of the fact
that it has revoked the individual’s
access privileges and provide the
reasons why.
(d) VA may immediately suspend
access privileges prior to any
determination on the merits of a
revocation where VA determines that
such immediate suspension is necessary
to protect, from a reasonably foreseeable
compromise, the integrity of the system
or confidentiality of the data in VBA IT
systems.
PART 14—LEGAL SERVICES,
GENERAL COUNSEL, AND
MISCELLANEOUS CLAIMS
7. The authority citation for part 14
continues to read as follows:
■
Authority: 5 U.S.C. 301; 28 U.S.C. 2671–
2680; 38 U.S.C. 501(a), 512, 515, 5502, 5901–
5905; 28 CFR part 14, appendix to part 14,
unless otherwise noted.
§ 14.629
[Amended]
8. Amend § 14.629 by removing the
Note.
■
[FR Doc. 2020–03196 Filed 2–18–20; 8:45 am]
BILLING CODE 8320–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program;
Petition 025—Parkinson’s Disease and
Parkinsonism, Including Heavy MetalInduced Parkinsonism; Finding of
Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
ACTION: Denial of petition for addition of
a health condition.
AGENCY:
On October 15, 2019, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 025) to add
‘‘Parkinson’s disease’’ to the List of
SUMMARY:
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WTC-Related Health Conditions (List).
Upon reviewing the scientific and
medical literature, including
information provided by the petitioner,
the Administrator has determined that
there is insufficient evidence available
to support taking further action at this
time regarding Parkinson’s disease and
parkinsonism, including heavy metalinduced parkinsonism. 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 this petition
for the addition of a health condition as
of February 19, 2020.
ADDRESSES: Visit the WTC Health
Program website at https://
www.cdc.gov/wtc/received.html to
review Petition 025.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C–48,
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. Procedures for Evaluating a Petition
C. Petition 025
D. Review of Scientific and Medical
Information and Administrator
Determination
E. Administrator’s Final Decision on Whether
To Propose the Addition of Parkinson’s
Disease and Parkinsonism, Including
Heavy Metal-Induced Parkinsonism, to
the List
F. Approval To Submit Document to the
Office of the Federal Register
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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 and Pub. L. 116–59), added
Title XXXIII to the Public Health
Service (PHS) Act,1 establishing the
WTC Health Program within the
Department of Health and Human
Services (HHS). The WTC Health
Program provides medical monitoring
and treatment benefits for health
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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conditions on the List 2 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). The Program
also provides benefits 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 3 (survivors).
All references to the Administrator of
the WTC Health Program
(Administrator) in this document 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. Within 90 days after receipt of a
valid 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
§ 88.16(a)(2) of the Program regulations:
(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.
More information about the WTC
Health Program, including the List and
the petition process, is available at
www.cdc.gov/wtc/.
B. Procedures for Evaluating a Petition
In addition to the regulatory
provisions, the WTC Health Program
has developed policies to guide the
review of submissions and petitions,4 as
well as the analysis of evidence
supporting the potential addition of a
non-cancer health condition to the List.5
2 The List of WTC-Related Health Conditions is
established in 42 U.S.C. 300mm–22(a)(3)–(4) and
300mm–32(b); additional conditions may be added
through rulemaking and the complete list is
provided in WTC Health Program regulations at 42
CFR 88.15.
3 See 42 U.S.C. 300mm–5(7); 42 CFR 88.1.
4 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, 2014, https://
www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandling
Procedures14May2014.pdf.
5 See WTC Health Program [2017], Policy and
Procedures for Adding Non-Cancer Conditions to
the List of WTC-Related Health Conditions,
February 14, 2017, https://www.cdc.gov/wtc/pdfs/
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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 or hazards 7 to the petitioned
health condition may also provide
sufficient medical basis for a valid
petition.
After the Program has determined that
a petition is valid, the Administrator
must direct the 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.8 The
literature review is a keyword search of
relevant scientific databases intended to
identify peer-reviewed, published,
epidemiologic studies about the health
condition among 9/11-exposed
populations. The Program evaluates the
scientific quality 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 9 to be
causally associated with 9/11 exposures.
If the evaluation of evidence provided
policies/WTCHP_PP_Adding_NonCancers_14_
February_2017-508.pdf.
6 See supra note 4.
7 9/11 agents are chemical, physical, biological, or
other hazards reported in a published, peerreviewed exposure assessment study of responders,
recovery workers, or survivors who were present in
the New York City disaster area, or at the Pentagon
site, or the Shanksville, Pennsylvania site, as those
locations are defined in 42 CFR 88.1, as well as
those hazards not identified in a published, peerreviewed exposure assessment study, but which are
reasonably assumed to have been present at any of
the three sites. See WTC Health Program [2018],
Development of the Inventory of 9/11 Agents, July
17, 2018, https://wwwn.cdc.gov/ResearchGateway/
Content/pdfs/Development_of_the_Inventory_of_911_Agents_20180717.pdf.
8 See supra note 5.
9 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.
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Federal Register / Vol. 85, No. 33 / Wednesday, February 19, 2020 / Proposed Rules
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 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.
More information about the WTC
Health Program, including the List and
the petition process, is available at
www.cdc.gov/wtc/.
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C. Petition 025
On October 15, 2019, the
Administrator received a petition
(Petition 025) requesting the addition of
‘‘Parkinson’s disease’’ to the List.10 The
Program has determined that the scope
of the Petition 025 review should
include not only ‘‘Parkinson’s disease’’
but also ‘‘parkinsonism, including
heavy metal-induced parkinsonism,’’ 11
because the references provided in the
petition address the association between
copper, iron, and manganese and the
health condition, as described below.
The petition’s validity was
established by references to four web
articles 12 which, in turn, referenced six
10 See Petition 025, WTC Health Program:
Petitions Received, https://www.cdc.gov/wtc/
received.html.
11 ‘‘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.’’
World Trade Center Health Program; Petitions 016
and 017—Parkinson’s Disease and Parkinsonism,
Including Manganese-Induced Parkinsonism;
Finding of Insufficient Evidence, 82 FR 32312 at
32313, July 13, 2017.
12 Adams C. [2018], Parkinson’s Disease Linked to
Exposure to Heavy Metals, https://
www.realnatural.org/parkinsons-disease-linked-toexposure-to-heavy-metals/; The Parkinson’s Plan
[2018], Heavy Metals, Neurotoxins, and Parkinson’s
Disease, https://www.theparkinsonsplan.com/blog/
heavy-metals-and-parkinsons-disease/; Iowa State
University News Service [2019], Researchers
Explore Link Between Metal Exposure and
Parkinson’s Symptoms, https://
www.news.iastate.edu/news/2019/03/12/
manganeseparkinsons; Wilson L [2019],
Parkinson’s Disease, https://drlwilson.com/Articles/
PARKINSON.htm.>
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peer-reviewed, published epidemiologic
studies and literature reviews
identifying a positive association
between 9/11 agents and Parkinson’s
disease and/or parkinsonism (although
none of the studies were conducted in
the 9/11-exposed population). A quote
provided in the petition is attributed to
a seventh peer-reviewed, published
epidemiologic study. Because the web
articles reference scientific sources
identifying a positive association
between 9/11 agents and the petitioned
condition, the petition provides the
necessary medical basis to require the
Administrator to conduct an evaluation
of the petition. The referenced studies
and literature reviews each individually
establishing a medical basis are as
follows:
D Heavy Metals and the Etiology of
Parkinson’s Disease and Other
Movement Disorders, by Montgomery
[1994],13 is a peer-reviewed, published
literature review discussing the role of
heavy metals (iron and manganese) in
Parkinson’s disease and speculating on
possible mechanisms of pathogenesis.
D *Metals, Oxidative Stress and
Neurodegenerative Disorders, by Jomova
et al. [2010],14 is a peer-reviewed,
published review article discussing the
role of iron, copper, and zinc in the
oxidative stress-related etiology of
Parkinson’s disease (the theory that
heavy metals cause oxidative stress,
which in turn leads to the
neurodegeneration that characterizes
Parkinson’s disease).
D *Metal Emissions and Urban
Incident Parkinson Disease: A
Community Health Study of Medicare
Beneficiaries by Using Geographic
Information Systems, by Willis et al.
[2010],15 is a peer-reviewed, published
epidemiologic study demonstrating
increased Parkinson’s disease incidence
in urban counties with high levels of
environmental copper or manganese.
D *Association of Parkinson’s Disease
with Altered Serum Levels of Lead and
Transition Metals among South Indian
Subjects, by Kumudini et al. [2014],16 is
13 Montgomery EB [1994], Heavy Metals and the
Etiology of Parkinson’s Disease and Other
Movement Disorders, Toxicology 97(1), https://
doi.org/10.1016/0300-483X(94)02962-T.
14 Jomova K, Vondrakova D, Lawson M, Valko M
[2010], Metals, Oxidative Stress and
Neurodegenerative Disorders, Mol Cell Biochem
345(1–2), 91–104.
15 Willis AW, Evanoff BA, Lian M, Galarza A,
Wegrzyn A, Schootman M, Racette BA [2010], Metal
Emissions and Urban Incident Parkinson Disease: A
Community Health Study of Medicare Beneficiaries
by Using Geographic Information Systems, Am J
Epidemiol 172(12):1357–1363.
16 Kumudini N, Uma A, Devi YP, Naushad SM,
Mridula R, Borgohain R, Kutala VK [2014],
Association of Parkinson’s Disease with Altered
Serum Levels of Lead and Transition Metals among
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9443
a peer-reviewed, published
epidemiologic (case-control) study
demonstrating the positive association
of Parkinson’s disease with plasma
levels of iron and copper in urban and
rural populations in India. The authors
speculate that increased iron levels
induce oxidative stress which leads to
Parkinson’s disease.
D *A Revised Picture of the Cu (II)¥
a-Synuclein Complex: The Role of NTerminal Acetylation, by Moriarty et al.
[2014],17 is a peer-reviewed, published
in vitro study suggesting new avenues of
investigation into copper-mediated
neurodegeneration in Parkinson’s
disease pathology.
D *Inflammasomes: An Emerging
Mechanism Translating Environmental
Toxicant Exposure into
Neuroinflammation in Parkinson’s
Disease, by Anderson et al. [2018],18 is
a peer-reviewed, published literature
review positing that exposure to heavy
metals, which are known to cause
cellular stress, may do so by triggering
intracellular inflammasomes (cytosolic
assemblies of proteins) which in turn
lead to neurodegeneration and
Parkinson’s disease.
D *Manganese Promotes the
Aggregation and Prion-Like Cell-to-Cell
Exosomal Transmission of a-Synuclein,
by Harischandra et al. [2019],19 is a
peer-reviewed, published experimental
study demonstrating in cell cultures and
animal models that manganese exposure
promotes the pathological propagation
of a-synuclein (a neuronal protein
found in the brain) leading to
Parkinson’s disease through
neuroinflammation and
neurodegeneration.
These seven studies suggest a
potential association between exposure
to 9/11 agents (specifically copper, iron,
and manganese) and Parkinson’s disease
and parkinsonism, including heavy
metal-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 parkinsonism
South Indian Subjects, Indian J Biochem Biophys
51(2):121–126.
17 Moriarty GM, Minetti CA, Remeta DP, Baum J
[2014], A Revised Picture of the Cu (II)—aSynuclein Complex: The Role of N-Terminal
Acetylation, Biochemistry 53(17), 2815–2817.
18 Anderson FL, Coffey MM, Berwin BL, Havrda
MC [2018], Inflammasomes: An Emerging
Mechanism Translating Environmental Toxicant
Exposure into Neuroinflammation in Parkinson’s
Disease, Toxicol Sci 166(1), 3–15.
19 Harischandra DS, Rokad D, Neal ML, Ghaisas
S, Manne S, Sarkar S, Panicker N, Zenitsky G, Jin
H, Lewis M, Huang X, Anantharam V, Kanthasamy
A, Kanthasamy AG [2019], Manganese Promotes the
Aggregation and Prion-Like Cell-to-Cell Exosomal
Transmission of a-Synuclein, Sci Signal 12(572).
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induced by copper, iron, and
manganese, the Administrator
determined that the petitioner requested
the addition of both Parkinson’s disease
and parkinsonism, including heavy
metal-induced parkinsonism.
D. Review of Scientific and Medical
Information and Administrator
Determination
In response to Petition 025, and
pursuant to the Program policy on the
addition of non-cancer health
conditions to the List, the Program
conducted a review of the scientific
literature on Parkinson’s disease and
parkinsonism, including heavy metalinduced parkinsonism, to identify peerreviewed, published, epidemiologic
studies of the health condition in the 9/
11-exposed population.20
Neither the references provided in the
petitions, including those described
above, nor the literature search
conducted by the Program identified
any peer-reviewed, published,
epidemiologic studies of either
Parkinson’s disease or parkinsonism,
including heavy metal-induced
parkinsonism, in 9/11-exposed
populations. Pursuant to the WTC
Health Program’s policy on the
evaluation of petitions,21 since no peerreviewed, published, epidemiologic
studies of Parkinson’s disease or
parkinsonism, including heavy metalinduced 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.
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E. Administrator’s Final Decision on
Whether To Propose the Addition of
Parkinson’s Disease and Parkinsonism,
Including Heavy Metal-Induced
Parkinsonism, to the List
Pursuant to PHS Act, sec.
3312(a)(6)(B)(iv) and 42 CFR
88.16(a)(2)(iv), the Administrator has
20 Databases searched include: CINAHL, Embase,
NIOSHTIC–2, ProQuest Health & Safety, PsycINFO,
PubMed, Scopus, Toxicology Abstracts, TOXLINE,
and the WTCHP Research Compendium Endnote
Database. Keywords/phrases used to conduct the
search include: World Trade Center; WTC;
September 11; parkinsonian disorders; parkinson*;
manganism; supranuclear palsy, progressive;
progressive supranuclear palsy; multiple system
atrophy; multiple system atrophy; Lewy body
disease; dementia with Lewy bodies; corticobasal
degeneration; hypokinesia; bradykinesia; tremor;
tremors; slow movement; stiffness; muscle rigidity;
rigidity; masked face; micrographia; monotonous
speech; loss of postural reflex; cock-walk gait;
asymmetric dystonia; levodopa; basal ganglia; and
basal ganglia nuclei. The literature search was
conducted in English-language journals on
December 27, 2019.
21 See supra note 5.
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determined that insufficient evidence is
available to take further action at this
time, including proposing the addition
of Parkinson’s disease and
parkinsonism, including heavy metalinduced 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 025 request to add Parkinson’s
disease and parkinsonism, including
heavy metal-induced parkinsonism, to
the List of WTC-Related Health
Conditions is denied.
F. 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.
Robert Redfield M.D., Director, CDC,
and Administrator, ATSDR, approved
this document for publication on
February 3, 2020.
John J. 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. 2020–02991 Filed 2–18–20; 8:45 am]
BILLING CODE 4163–18–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[WC Docket No. 12–375; DA 20–127; FRS
16478]
Wireline Competition Bureau Seeks To
Refresh the Record on Ancillary
Service Charges Related to Inmate
Calling Services
Federal Communications
Commission.
ACTION: Proposed rule; solicitation of
comments.
AGENCY:
PO 00000
Frm 00046
Fmt 4702
Sfmt 4702
In this document, the
Wireline Competition Bureau (Bureau)
seeks to refresh the record on ancillary
service charges imposed in connection
with inmate calling services (ICS) in
response to a remand from the United
States Court of Appeals for the District
of Columbia Circuit.
DATES: Comments are due March 20,
2020. Reply Comments are due April 6,
2020.
ADDRESSES: Federal Communications
Commission, 445 12th Street SW,
Washington, DC 20554
FOR FURTHER INFORMATION CONTACT:
Minsoo Kim, Wireline Competition
Bureau, Pricing Policy Division, via
phone at 202–418–1739 or via email at
Minsoo.Kim@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Public Notice that the
Federal Communications Commission’s
Wireline Competition Bureau released
on February 4, 2020. A full-text version
of the Public Notice is available at the
following internet address: https://
docs.fcc.gov/public/attachments/DA-20127A1.pdf.
In this document, the Wireline
Competition Bureau (Bureau) seeks to
refresh the record on ancillary service
charges imposed in connection with
inmate calling services (ICS). In the
2015 ICS Order, the Commission
adopted rules limiting the ancillary
services for which ICS providers could
assess fees and capping the permissible
charges for these ancillary services.
In Global Tel*Link v. FCC, the United
States Court of Appeals for the District
of Columbia Circuit affirmed the
Commission’s plenary authority to cap
ancillary service charges for interstate
ICS, but held that, based on the record
before the Court, the Commission lacked
authority to regulate ancillary service
charges for intrastate ICS. Because the
Court could not ‘‘discern from the
record whether ancillary fees can be
segregated between interstate and
intrastate calls,’’ the Court remanded the
issue to the Commission for further
consideration. The Bureau seeks to
refresh the record on ancillary service
charges in response to the D.C. Circuit’s
remand.
The 2015 ICS Order did not address
whether any particular ancillary service
charge could be segregated between
interstate and intrastate calls given the
Commission’s imposition of identical
rate caps for interstate and intrastate
calls alike. The Bureau now seeks
specific comment on whether each
permitted ICS ancillary service charge
may be segregated between interstate
and intrastate calls and, if so, how. The
Bureau asks commenters to explain in
SUMMARY:
E:\FR\FM\19FEP1.SGM
19FEP1
]]>Agencies
[Federal Register Volume 85, Number 33 (Wednesday, February 19, 2020)]
[Proposed Rules]
[Pages 9441-9444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02991]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 025--Parkinson's
Disease and Parkinsonism, Including Heavy Metal-Induced Parkinsonism;
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 October 15, 2019, the Administrator of the World Trade
Center (WTC) Health Program received a petition (Petition 025) to add
``Parkinson's disease'' to the List of
[[Page 9442]]
WTC-Related Health Conditions (List). Upon reviewing the scientific and
medical literature, including information provided by the petitioner,
the Administrator has determined that there is insufficient evidence
available to support taking further action at this time regarding
Parkinson's disease and parkinsonism, including heavy metal-induced
parkinsonism. 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 this
petition for the addition of a health condition as of February 19,
2020.
ADDRESSES: Visit the WTC Health Program website at https://www.cdc.gov/wtc/received.html to review Petition 025.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-48, 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. Procedures for Evaluating a Petition
C. Petition 025
D. Review of Scientific and Medical Information and Administrator
Determination
E. Administrator's Final Decision on Whether To Propose the Addition
of Parkinson's Disease and Parkinsonism, Including Heavy Metal-
Induced Parkinsonism, to the List
F. 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 and Pub. L. 116-
59), added Title XXXIII to the Public Health Service (PHS) Act,\1\
establishing the WTC Health Program within the Department of Health and
Human Services (HHS). The WTC Health Program provides medical
monitoring and treatment benefits for health conditions on the List \2\
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). The Program
also provides benefits 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 \3\ (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.
\2\ The List of WTC-Related Health Conditions is established in
42 U.S.C. 300mm-22(a)(3)-(4) and 300mm-32(b); additional conditions
may be added through rulemaking and the complete list is provided in
WTC Health Program regulations at 42 CFR 88.15.
\3\ See 42 U.S.C. 300mm-5(7); 42 CFR 88.1.
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All references to the Administrator of the WTC Health Program
(Administrator) in this document 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. Within 90 days after receipt of a valid 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 Sec. 88.16(a)(2) of the Program regulations: (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.
More information about the WTC Health Program, including the List
and the petition process, is available at www.cdc.gov/wtc/.
B. Procedures for Evaluating a Petition
In addition to the regulatory provisions, the WTC Health Program
has developed policies to guide the review of submissions and
petitions,\4\ as well as the analysis of evidence supporting the
potential addition of a non-cancer health condition to the List.\5\
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\4\ 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, 2014, https://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
\5\ See WTC Health Program [2017], Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, February 14, 2017, https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancers_14_February_2017-508.pdf.
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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 or hazards \7\ to the petitioned health condition
may also provide sufficient medical basis for a valid petition.
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\6\ See supra note 4.
\7\ 9/11 agents are chemical, physical, biological, or other
hazards reported in a published, peer-reviewed exposure assessment
study of responders, recovery workers, or survivors who were present
in the New York City disaster area, or at the Pentagon site, or the
Shanksville, Pennsylvania site, as those locations are defined in 42
CFR 88.1, as well as those hazards not identified in a published,
peer-reviewed exposure assessment study, but which are reasonably
assumed to have been present at any of the three sites. See WTC
Health Program [2018], Development of the Inventory of 9/11 Agents,
July 17, 2018, https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf.
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After the Program has determined that a petition is valid, the
Administrator must direct the 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.\8\ The literature
review is a keyword search of relevant scientific databases intended to
identify peer-reviewed, published, epidemiologic studies about the
health condition among 9/11-exposed populations. The Program evaluates
the scientific quality 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 \9\ to be causally associated
with 9/11 exposures. If the evaluation of evidence provided
[[Page 9443]]
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 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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\8\ See supra note 5.
\9\ 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.
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More information about the WTC Health Program, including the List
and the petition process, is available at www.cdc.gov/wtc/.
C. Petition 025
On October 15, 2019, the Administrator received a petition
(Petition 025) requesting the addition of ``Parkinson's disease'' to
the List.\10\ The Program has determined that the scope of the Petition
025 review should include not only ``Parkinson's disease'' but also
``parkinsonism, including heavy metal-induced parkinsonism,'' \11\
because the references provided in the petition address the association
between copper, iron, and manganese and the health condition, as
described below.
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\10\ See Petition 025, WTC Health Program: Petitions Received,
https://www.cdc.gov/wtc/received.html.
\11\ ``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.'' World Trade Center Health Program; Petitions 016 and
017--Parkinson's Disease and Parkinsonism, Including Manganese-
Induced Parkinsonism; Finding of Insufficient Evidence, 82 FR 32312
at 32313, July 13, 2017.
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The petition's validity was established by references to four web
articles \12\ which, in turn, referenced six peer-reviewed, published
epidemiologic studies and literature reviews identifying a positive
association between 9/11 agents and Parkinson's disease and/or
parkinsonism (although none of the studies were conducted in the 9/11-
exposed population). A quote provided in the petition is attributed to
a seventh peer-reviewed, published epidemiologic study. Because the web
articles reference scientific sources identifying a positive
association between 9/11 agents and the petitioned condition, the
petition provides the necessary medical basis to require the
Administrator to conduct an evaluation of the petition. The referenced
studies and literature reviews each individually establishing a medical
basis are as follows:
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\12\ Adams C. [2018], Parkinson's Disease Linked to Exposure to
Heavy Metals, https://www.realnatural.org/parkinsons-disease-linked-to-exposure-to-heavy-metals/; The Parkinson's Plan [2018], Heavy
Metals, Neurotoxins, and Parkinson's Disease, https://www.theparkinsonsplan.com/blog/heavy-metals-and-parkinsons-disease/;
Iowa State University News Service [2019], Researchers Explore Link
Between Metal Exposure and Parkinson's Symptoms, https://www.news.iastate.edu/news/2019/03/12/manganeseparkinsons; Wilson L
[2019], Parkinson's Disease, https://drlwilson.com/Articles/PARKINSON.htm.>
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[ssquf] Heavy Metals and the Etiology of Parkinson's Disease and
Other Movement Disorders, by Montgomery [1994],\13\ is a peer-reviewed,
published literature review discussing the role of heavy metals (iron
and manganese) in Parkinson's disease and speculating on possible
mechanisms of pathogenesis.
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\13\ Montgomery EB [1994], Heavy Metals and the Etiology of
Parkinson's Disease and Other Movement Disorders, Toxicology 97(1),
https://doi.org/10.1016/0300-483X(94)02962-T.
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[ssquf] *Metals, Oxidative Stress and Neurodegenerative Disorders,
by Jomova et al. [2010],\14\ is a peer-reviewed, published review
article discussing the role of iron, copper, and zinc in the oxidative
stress-related etiology of Parkinson's disease (the theory that heavy
metals cause oxidative stress, which in turn leads to the
neurodegeneration that characterizes Parkinson's disease).
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\14\ Jomova K, Vondrakova D, Lawson M, Valko M [2010], Metals,
Oxidative Stress and Neurodegenerative Disorders, Mol Cell Biochem
345(1-2), 91-104.
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[ssquf] *Metal Emissions and Urban Incident Parkinson Disease: A
Community Health Study of Medicare Beneficiaries by Using Geographic
Information Systems, by Willis et al. [2010],\15\ is a peer-reviewed,
published epidemiologic study demonstrating increased Parkinson's
disease incidence in urban counties with high levels of environmental
copper or manganese.
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\15\ Willis AW, Evanoff BA, Lian M, Galarza A, Wegrzyn A,
Schootman M, Racette BA [2010], Metal Emissions and Urban Incident
Parkinson Disease: A Community Health Study of Medicare
Beneficiaries by Using Geographic Information Systems, Am J
Epidemiol 172(12):1357-1363.
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[ssquf] *Association of Parkinson's Disease with Altered Serum
Levels of Lead and Transition Metals among South Indian Subjects, by
Kumudini et al. [2014],\16\ is a peer-reviewed, published epidemiologic
(case-control) study demonstrating the positive association of
Parkinson's disease with plasma levels of iron and copper in urban and
rural populations in India. The authors speculate that increased iron
levels induce oxidative stress which leads to Parkinson's disease.
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\16\ Kumudini N, Uma A, Devi YP, Naushad SM, Mridula R,
Borgohain R, Kutala VK [2014], Association of Parkinson's Disease
with Altered Serum Levels of Lead and Transition Metals among South
Indian Subjects, Indian J Biochem Biophys 51(2):121-126.
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[ssquf] *A Revised Picture of the Cu (II)- [alpha]-Synuclein
Complex: The Role of N-Terminal Acetylation, by Moriarty et al.
[2014],\17\ is a peer-reviewed, published in vitro study suggesting new
avenues of investigation into copper-mediated neurodegeneration in
Parkinson's disease pathology.
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\17\ Moriarty GM, Minetti CA, Remeta DP, Baum J [2014], A
Revised Picture of the Cu (II)--[alpha]-Synuclein Complex: The Role
of N-Terminal Acetylation, Biochemistry 53(17), 2815-2817.
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[ssquf] *Inflammasomes: An Emerging Mechanism Translating
Environmental Toxicant Exposure into Neuroinflammation in Parkinson's
Disease, by Anderson et al. [2018],\18\ is a peer-reviewed, published
literature review positing that exposure to heavy metals, which are
known to cause cellular stress, may do so by triggering intracellular
inflammasomes (cytosolic assemblies of proteins) which in turn lead to
neurodegeneration and Parkinson's disease.
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\18\ Anderson FL, Coffey MM, Berwin BL, Havrda MC [2018],
Inflammasomes: An Emerging Mechanism Translating Environmental
Toxicant Exposure into Neuroinflammation in Parkinson's Disease,
Toxicol Sci 166(1), 3-15.
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[ssquf] *Manganese Promotes the Aggregation and Prion-Like Cell-to-
Cell Exosomal Transmission of [alpha]-Synuclein, by Harischandra et al.
[2019],\19\ is a peer-reviewed, published experimental study
demonstrating in cell cultures and animal models that manganese
exposure promotes the pathological propagation of [alpha]-synuclein (a
neuronal protein found in the brain) leading to Parkinson's disease
through neuroinflammation and neurodegeneration.
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\19\ Harischandra DS, Rokad D, Neal ML, Ghaisas S, Manne S,
Sarkar S, Panicker N, Zenitsky G, Jin H, Lewis M, Huang X,
Anantharam V, Kanthasamy A, Kanthasamy AG [2019], Manganese Promotes
the Aggregation and Prion-Like Cell-to-Cell Exosomal Transmission of
[alpha]-Synuclein, Sci Signal 12(572).
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These seven studies suggest a potential association between
exposure to 9/11 agents (specifically copper, iron, and manganese) and
Parkinson's disease and parkinsonism, including heavy metal-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 parkinsonism
[[Page 9444]]
induced by copper, iron, and manganese, the Administrator determined
that the petitioner requested the addition of both Parkinson's disease
and parkinsonism, including heavy metal-induced parkinsonism.
D. Review of Scientific and Medical Information and Administrator
Determination
In response to Petition 025, and pursuant to the Program policy on
the addition of non-cancer health conditions to the List, the Program
conducted a review of the scientific literature on Parkinson's disease
and parkinsonism, including heavy metal-induced parkinsonism, to
identify peer-reviewed, published, epidemiologic studies of the health
condition in the 9/11-exposed population.\20\
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\20\ Databases searched include: CINAHL, Embase, NIOSHTIC-2,
ProQuest Health & Safety, PsycINFO, PubMed, Scopus, Toxicology
Abstracts, TOXLINE, and the WTCHP Research Compendium Endnote
Database. Keywords/phrases used to conduct the search include: World
Trade Center; WTC; September 11; parkinsonian disorders; parkinson*;
manganism; supranuclear palsy, progressive; progressive supranuclear
palsy; multiple system atrophy; multiple system atrophy; Lewy body
disease; dementia with Lewy bodies; corticobasal degeneration;
hypokinesia; bradykinesia; tremor; tremors; slow movement;
stiffness; muscle rigidity; rigidity; masked face; micrographia;
monotonous speech; loss of postural reflex; cock-walk gait;
asymmetric dystonia; levodopa; basal ganglia; and basal ganglia
nuclei. The literature search was conducted in English-language
journals on December 27, 2019.
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Neither the references provided in the petitions, including those
described above, nor the literature search conducted by the Program
identified any peer-reviewed, published, epidemiologic studies of
either Parkinson's disease or parkinsonism, including heavy metal-
induced parkinsonism, in 9/11-exposed populations. Pursuant to the WTC
Health Program's policy on the evaluation of petitions,\21\ since no
peer-reviewed, published, epidemiologic studies of Parkinson's disease
or parkinsonism, including heavy metal-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.
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\21\ See supra note 5.
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E. Administrator's Final Decision on Whether To Propose the Addition of
Parkinson's Disease and Parkinsonism, Including Heavy Metal-Induced
Parkinsonism, to the List
Pursuant to PHS Act, sec. 3312(a)(6)(B)(iv) and 42 CFR
88.16(a)(2)(iv), the Administrator has determined that insufficient
evidence is available to take further action at this time, including
proposing the addition of Parkinson's disease and parkinsonism,
including heavy metal-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 025 request to add
Parkinson's disease and parkinsonism, including heavy metal-induced
parkinsonism, to the List of WTC-Related Health Conditions is denied.
F. 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. Robert
Redfield M.D., Director, CDC, and Administrator, ATSDR, approved this
document for publication on February 3, 2020.
John J. 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. 2020-02991 Filed 2-18-20; 8:45 am]
BILLING CODE 4163-18-P
