Proposed Rule2022-09708
World Trade Center (WTC) Health Program; Addition of Uterine Cancer to the List of WTC-Related Health Conditions
Primary source
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Published
May 10, 2022
Issuing agencies
Health and Human Services Department
Abstract
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program (Program), which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within CDC, provides medical monitoring and treatment to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with the WTC Health Program's regulations, which establish procedures for adding a new condition to the list of health conditions covered by the Program, this proposed rule would add malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List of WTC-Related Health Conditions (List).
Full Text
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<title>Federal Register, Volume 87 Issue 90 (Tuesday, May 10, 2022)</title>
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[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Proposed Rules]
[Pages 27961-27971]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC-2022-0052; NIOSH-347]
RIN 0920-AA82
World Trade Center (WTC) Health Program; Addition of Uterine
Cancer to the List of WTC-Related Health Conditions
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act
of 2010 amended the Public Health Service Act (PHS Act) to establish
the World Trade Center (WTC) Health Program. The WTC Health Program
(Program), which is administered by the Director of the National
Institute for Occupational Safety and Health (NIOSH), within CDC,
provides medical monitoring and treatment to eligible responders to the
September 11, 2001, terrorist attacks in New York City, at the
Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors
of the New York City attacks. In accordance with the WTC Health
Program's regulations, which establish procedures for adding a new
condition to the list of health conditions covered by the Program, this
proposed rule would add malignant neoplasms of corpus uteri and uterus,
part unspecified (uterine cancer) to the List of WTC-Related Health
Conditions (List).
DATES: Comments must be received by June 24, 2022.
ADDRESSES: You may submit comments identified by Docket No. CDC-2022-
0052 and NIOSH-347 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS
C-34, 1090 Tusculum Avenue, Cincinnati, Ohio 45226-1998.
Instructions: All written submissions received in response to this
document must include the agency name and docket number (CDC-2022-0052;
NIOSH-347) for this action. All relevant comments, including any
personal information provided, will be posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Do not submit comments by email. CDC does not
accept comments by email.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst,
National Institute for Occupational Safety and Health, 1090 Tusculum
Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this
is a toll-free number); email <a href="/cdn-cgi/l/email-protection#652b2c2a362d17000216250601064b020a13"><span class="__cf_email__" data-cfemail="eba5a2a4b8a3998e8c98ab888f88c58c849d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. WTC Health Program Statutory Authority
B. Methods Used by the Administrator To Determine Whether To Add
Cancers to the List of WTC-Related Health Conditions
C. History and Scope of Rulemaking
D. Review of Evidence Supporting the Proposed Addition of
Uterine Cancer to the List of WTC-Related Health Conditions
E. Administrator's Decision Regarding Uterine Cancer
IV. Summary of Proposed Rule
V. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
I. Executive Summary
A. Purpose of Regulatory Action
With this rulemaking, the Administrator of the WTC Health Program
(Administrator) and the Secretary of HHS propose the addition of
uterine cancer \1\ to the List. The Administrator received requests
from WTC responders and survivors as well as a September 2020 letter
from five of the WTC Health Program Clinical Centers of Excellence
(CCEs) asking the Administrator to add ``uterine cancer'' to the List.
The Administrator subsequently directed the WTC Health Program's
Science Team to review the available scientific evidence for adding
uterine cancer to the List under existing Program policy and
procedures. A white paper issued by the Program's Science Team in
September 2021 (White Paper) found that the available scientific
evidence provided sufficient support to add uterine cancer to the List
but only for Program members who have a certified WTC-related estrogen-
secreting tumor. The Administrator asked the WTC Health Program
Scientific/Technical Advisory Committee (STAC) for a recommendation on
whether a reasonable basis exists for adding uterine cancer to the
List. Between September and November 2021, the STAC reviewed the White
Paper and other available scientific information, considered public
comment, and deliberated on whether there is a reasonable basis to
recommend the addition of uterine cancer to the List. Ultimately, the
STAC recommended that uterine cancer be added to the List and provided
the Administrator its recommendation and rationale. Upon review, the
Administrator decided that the STAC provided a reasonable basis for its
recommendation to add uterine cancer to the List. Based on the STAC's
recommendation and the scientific literature, including the White
Paper, the Administrator has determined that the available information
provides a sufficient evidentiary basis to propose the addition of
uterine cancer to the List.
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\1\ For the purposes of this action, the WTC Health Program
defines the term ``uterine cancer'' as ICD-10 code C54, including
the following specific malignant neoplasms: Isthmus uteri (C54.0),
endometrium (C54.1), myometrium (C54.2), fundus uteri (C54.3),
overlapping sites of corpus uteri (C54.8), and corpus uteri,
unspecified (C54.9); and ICD-10 code C55, including only a single
sub-category, malignant neoplasm of uterus, part unspecified.
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B. Summary of Major Provisions
This rule proposes the addition of malignant neoplasms of corpus
uteri and uterus, part unspecified (uterine cancer) to the List of WTC-
Related Health Conditions in 42 CFR 88.15(d).
C. Costs and Benefits
The addition of uterine cancer to the List through this rulemaking
is estimated to cost the WTC Health Program from $1,718,691 to
$2,199,808 annually, between 2022 and 2025. All of the costs to the WTC
Health Program are transfers.\2\ Benefits to current and future
[[Page 27962]]
WTC Health Program members are expected to include improved access to
care and better treatment outcomes than members would have in the
absence of Program coverage.
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\2\ Due to the implementation of the Affordable Care Act in
2014, and as required under the authorizing statute for the WTC
Health Program, all current and future Program members are assumed
to have or have access to medical insurance coverage other than
through the WTC Health Program; therefore, all projected treatment
costs to be paid by the WTC Health Program are considered transfers.
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II. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, opinions, recommendations,
and data. Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Comments are invited on any topic related to this proposed
rule. Do not include any information in your comment or supporting
materials that you consider confidential or inappropriate for public
disclosure.
Comments submitted electronically or by mail should be titled
``Docket No. CDC-2022-0052; NIOSH-347'' and should identify the
author(s) and contact information in case clarification is needed.
Written comments can be submitted to the address provided in the
ADDRESSES section, above. All communications received on or before the
closing date for comments will be fully considered by the
Administrator.
Upon publication of this notice of proposed rulemaking, the
Administrator has requested an independent peer review from three
subject-matter experts of the scientific and technical evidence that
comprises the basis of this action.\3\ The peer reviews will be posted,
without attribution, in the rulemaking docket 30 days after the
publication of this proposed rulemaking.
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\3\ See Public Health Service Act, sec. 3312(a)(6)(F).
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To provide interested parties adequate time to review the proposed
rule, supporting scientific literature, and peer reviews, and to submit
written comments to the docket, the Administrator has determined that
good cause exists to extend the 30-day comment period required by the
Program's authorizing statute \4\ to 45 days.
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\4\ See Public Health Service Act, sec. 3312(a)(6)(D)(ii).
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III. Background
In this action, the Administrator and the Secretary of HHS propose
to amend 42 CFR 88.15 to add malignant neoplasms of corpus uteri and
uterus, part unspecified (uterine cancer) \5\ to the List.
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\5\ See supra note 1.
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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 PHS Act \6\ establishing the WTC Health
Program within 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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\6\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the Zadroga Act found in Titles II
and III of Public Law 111-347 do not pertain to the WTC Health
Program and are codified elsewhere.
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All references to the Administrator in this document mean the
Director of NIOSH, within CDC, or his or her designee. Section
3312(a)(6) of the PHS Act requires the Administrator to conduct
rulemaking to propose the addition of a health condition to the List
codified in 42 CFR 88.15.
B. Methods Used by the Administrator To Determine Whether To Add
Cancers to the List of WTC-Related Health Conditions
In accordance with the Program's authorizing statute as well as
regulations in 42 CFR part 88, the Administrator may decide to propose
the addition of a health condition to the List in response to a
petition from an interested party \7\ or at his or her own
discretion.\8\ Under 42 CFR 88.16, the Administrator has established a
process by which health conditions may be considered for addition to
the List in Sec. 88.15. Pursuant to sec. 3312(a)(6)(D) of the PHS Act,
whenever the Administrator determines that a condition should be
proposed for addition to the List, the Administrator is required to
publish a notice of proposed rulemaking and allow interested parties to
comment on the proposed rule.
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\7\ PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.16(a).
\8\ PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.16(b).
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The Program also developed the Policy and Procedures for Adding
Types of Cancer to the List of WTC-Related Health Conditions (Policy
and Procedures) to describe the evaluation of evidence of a causal
association between 9/11 exposures and a type of cancer. Pursuant to
these procedures, a type of cancer may be proposed for addition to the
List if the available evidence meets at least one of the following four
methods: \9\
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\9\ John Howard, Administrator of the WTC Health Program, Policy
and Procedures for Adding Types of Cancer Conditions to the List of
WTC-Related Health Conditions, revised Nov. 18, 2021, <a href="https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Addn_Cancer_11182021-508.pdf">https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Addn_Cancer_11182021-508.pdf</a>.
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Method 1. Epidemiologic Studies of September 11, 2001-Exposed
Populations.
The peer-reviewed, published epidemiologic studies of 9/11-exposed
populations are assessed by applying the following criteria
extrapolated from the Bradford Hill criteria,\10\ as appropriate:
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\10\ See Hill AB [1965], The Environment and Disease:
Association or Causation? Proc R Soc Med 58:295-300.
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a. Strength of the association between a 9/11 exposure and a type
of cancer (including the precision of the risk estimate); \11\
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\11\ Precision of the risk estimate describes the uncertainty
inherent in estimating the strength of association (the effect size)
between exposure and health effect from observational data. It is
often expressed as a confidence interval illustrating a range of
values that contains the true effect size. A narrow confidence
interval indicates a more precise measure of the effect size and a
wider interval indicates greater uncertainty.
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b. Consistency of the findings across multiple studies. If only a
single published epidemiologic study is available for assessment, the
consistency of findings cannot be evaluated, and more emphasis will be
placed on evaluating the strength of the association and the precision
of the risk estimate;
c. Biological gradient, or dose-response relationships between 9/11
exposures and the type of cancer; and
d. Plausibility and coherence with known facts about the biology of
the type of cancer.
Method 2. Established Causal Associations.
A type of cancer may be added to the List if there is well-
established scientific support published in multiple peer-reviewed
epidemiologic studies for a causal association between a condition
already on the List and that cancer.
Method 3. Review of Evaluations of Carcinogenicity in Humans.
A type of cancer may be added to the List under Method 3 only if
both of the following criteria are satisfied:
3A. Published Exposure Assessment Information. A 9/11 agent \12\
included in
[[Page 27963]]
the Inventory of 9/11 Agents \13\ is identified; and
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\12\ 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. WTC Health
Program, Development of the Inventory of 9/11 Agents, published Jul.
17, 2018, <a href="https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf">https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf</a>.
\13\ The Inventory of 9/11 Agents is composed of those agents
identified in Tables 1-4 of the document, Development of the
Inventory of 9/11 Agents. Id.
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3B. Evaluation of Carcinogenicity in Humans from Scientific
Studies. NTP [the National Toxicology Program] has determined that the
9/11 agent is known to be a human carcinogen or is reasonably
anticipated to be a human carcinogen, and the IARC [the World Health
Organization's International Agency for Research on Cancer] has
determined that there is sufficient or limited evidence in humans that
the 9/11 agent causes the type of cancer.
Method 4. Review of Information by the WTC Health Program
Scientific/Technical Advisory Committee (STAC).
A type of cancer may be added to the List if the STAC recommends
the addition and provides a reasonable basis for the
recommendation.\14\ To assist the Administrator in understanding
whether the STAC's recommendation has a reasonable basis, the STAC must
describe in detail the basis for its recommendation and, if applicable,
any evidentiary sources it has used to support its recommendation.
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\14\ The STAC may base its recommendation and reasonable basis
on criteria other than those outlined in Methods 1-3.
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C. History and Scope of Rulemaking
In September 2012, the Administrator published a final rule adding
most types of cancer to the List,\15\ codified at 42 CFR 88.15(d). The
2012 rulemaking added malignant neoplasm of the ovary (ovarian cancer)
to the List pursuant to Method 3, described above; rare cancers were
also added to the List pursuant to Method 4. In a follow-up rulemaking
conducted in February 2014,\16\ the Program clarified the definition of
``rare cancers'' to include any type of cancer that occurs in less than
15 cases per 100,000 persons.\17\ As a result of this rulemaking
other--but not all--types of malignant neoplasms of female genital
organs,\18\ including cervix uteri (invasive cervical cancer) and
uterine sarcomas, were found to meet the revised definition of rare
cancers.\19\ Uterine cancer \20\ was not added to the List because the
scientific evidence available at the time of the 2012 and 2014
rulemakings did not provide sufficient support for its inclusion; nor
did it meet the definition of rare cancer.
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\15\ WTC Health Program final rule, Addition of Certain Types of
Cancer to the List of WTC-Related Health Conditions, 77 FR 56138
(Sept. 12, 2012).
\16\ WTC Health Program interim final rule, Amendments to List
of WTC-Related Health Condition; Cancer; Revision, 79 FR 9100 (Feb.
18, 2014).
\17\ A cancer is considered to be on the List if it meets the
definition of rare cancers in 42 CFR 88.15(d)(24), which is any type
of cancer * that occurs in less than 15 cases per 100,000 persons
per year in the United States.
* Based on 2005-2009 average annual data age-adjusted to the
2000 U.S. population. See Glenn Copeland, Andrew Lake, Rick Firth,
et al. (eds), Cancer in North America: 2005-2009. Volume One:
Combined Cancer Incidence for the United States, Canada and North
America, Springfield, IL: North American Association of Central
Cancer Registries, Inc., June 2012.
See also the Administrator's Policy and Procedures for Rare
Cancers, <a href="https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_RareCancers05052014-508.pdf">https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_RareCancers05052014-508.pdf</a>.
\18\ Although the List does not identify health condition
medical diagnostic codes, the Program uses ICD-10 codes internally
to track certified conditions. Malignant neoplasms of female genital
organs comprise ICD-10 codes C51-C58 and include malignant neoplasms
of the female genital organs: Vulva (C51), vagina (C52), cervix
uteri (C53), corpus uteri (C54), uterus, part unspecified (C55),
ovary (C56), other and unspecified female genital organs (C57), and
placenta (C58). Uterine sarcomas are included in ICD-10 C55. ICD-10
codes C54 and C55 are not currently considered WTC-related health
conditions. World Health Organization (WHO) [1997], International
Classification of Diseases, Tenth Edition.
\19\ See supra note 17.
\20\ See supra note 1.
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Since 2012, the WTC Health Program has received eight submissions
requesting the addition of endometrial or uterine cancer to the List.
Only one of these submissions, Petition 023, received in 2019 and
requesting the addition of ``endometrial cancer,'' \21\ was determined
to be a valid petition.\22\ In response, the Program conducted a
literature search and identified and evaluated seven published, peer-
reviewed, epidemiologic studies about uterine cancer, including
endometrial cancer, in the 9/11-exposed population. Ultimately, in
2019, the Administrator determined that the evidence was insufficient
to support adding uterine cancer, including endometrial cancer, to the
List.\23\
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\21\ The endometrium is the layer of tissue that lines the
uterus. National Cancer Institute, Dictionary of Cancer Terms,
<a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/endometrium">https://www.cancer.gov/publications/dictionaries/cancer-terms/def/endometrium</a>. Endometrial cancer accounts for nearly 90 percent of
uterine cancer cases. See also American Society of Clinical Oncology
[2021], Uterine Cancer: Statistics, <a href="https://www.cancer.net/cancer-types/uterine-cancer/statistics">https://www.cancer.net/cancer-types/uterine-cancer/statistics</a>.
\22\ Interested parties may petition the Administrator to add
health conditions to the List. To be considered a valid petition, a
submission must meet the criteria established in 42 CFR 88.16(a)(1)
and further described in the Policy and Procedures for Handling
Submissions and Petitions to Add a Health Condition to the List of
WTC-Related Health Conditions, <a href="https://www.cdc.gov/wtc/pdfs/policies/WTCHPPPPetitionHandlingProcedures14May2014-508.pdf">https://www.cdc.gov/wtc/pdfs/policies/WTCHPPPPetitionHandlingProcedures14May2014-508.pdf</a>.
\23\ WTC Health Program Federal Register document, Petition 023-
Uterine Cancer, Including Endometrial Cancer; Finding of
Insufficient Evidence, 84 FR 49954 (Sept. 24, 2019).
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On September 11, 2020, the Administrator received a submission from
five of the Program's CCEs, requesting the addition of uterine cancer
to the List. Although the Program determined that the submission was
not a valid petition, the Administrator thought that it raised
important questions about the potential association between endocrine
disrupting chemicals (EDCs) and hormone-related tumors such as
endometrial cancer. The CCEs noted that the WTC Health Program's
scientific literature evaluation conducted for Petition 023 did not
include consideration of the relationship between EDCs and uterine
cancer, despite some EDCs being included in the Inventory of 9/11
Agents.\24\ The CCEs argued that research that has emerged since 2012
suggests EDCs may have a role in the development of estrogen-related
diseases such as endometrial cancer. Moreover, the CCEs noted the low
numbers of female \25\ WTC responders in the occupational studies of
the health effects of 9/11 exposure and expressed concern that this may
lead to gaps in the research.
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\24\ Inventory of 9/11 Agents means those 9/11 agents identified
as being present at a 9/11 site and included in Tables 1-4 of the
WTC Health Program publication, Development of the Inventory of 9/11
Agents, Jul. 17, 2018, <a href="https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf">https://wwwn.cdc.gov/ResearchGateway/Content/pdfs/Development_of_the_Inventory_of_9-11_Agents_20180717.pdf</a>. EDCs
in the Inventory of 9/11 Agents include persistent organic
pollutants and other industrial substances such as cadmium, dioxins,
perfluoroalkyl and poly fluoroalkyl substances (PFAS), phthalates,
polybrominated diphenyl ethers (PBDE), and polychlorinated biphenyls
(PCB). None of these 9/11 agents have been found by NTP or IARC to
be known to cause or reasonably anticipated to cause uterine cancer.
\25\ Although this rulemaking refers to uterine cancer in
females, the WTC Health Program recognizes that some individuals who
identify as male may also be at risk for uterine cancer.
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The Administrator determined that a more thorough evaluation of the
scientific information regarding uterine cancer available since 2012
was needed and asked the WTC Health Program Science Team (Science Team)
to conduct a review of the available scientific evidence to determine
whether it might now support adding uterine cancer to the List. The
Science Team conducted a literature review and issued a White Paper
(discussed below) documenting its findings in September 2021. The White
Paper describes the
[[Page 27964]]
Science Team's conclusion that insufficient evidence exists to support
a decision to add uterine cancer to the List under Methods 1 or 3 of
the Policy and Procedures described above; evidence considered under
Method 2 supports adding uterine cancer to the List, but only for those
Program members who have a certified WTC-related estrogen-secreting
tumor.
Pursuant to Method 4 of the Policy and Procedures, the
Administrator exercised his discretion to request a recommendation from
the STAC \26\ regarding whether the available evidence provides a
reasonable basis exists for adding uterine cancer to the List. The
Administrator convened the STAC on September 28-29, 2021, and gave the
Committee the following charge:
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\26\ See PHS Act, sec. 3312(a)(6)(A).
As you are aware, the WTC Health Program currently covers all
major types of cancer, except for uterine cancer. I welcome the
Committee's evaluation and recommendation on whether there is a
reasonable scientific basis to support adding uterine cancer to the
List of WTC-Related Health Conditions.\27\
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\27\ Administrator's Charge to the World Trade Center Health
Program Scientific/Technical Advisory Committee, <a href="https://www.cdc.gov/wtc/pdfs/stac/STAC_AdmCharge_Revised20210928-P.pdf">https://www.cdc.gov/wtc/pdfs/stac/STAC_AdmCharge_Revised20210928-P.pdf</a>.
At the September 2021 meeting, the Science Team presented the White
Paper describing the available scientific evidence for an association
between uterine cancer and 9/11 exposures. The STAC heard public
comment and deliberated on the evidence presented in the White Paper.
The Committee ultimately decided to create a workgroup to ``write a
report describing the committee's conclusion, scientific rationale, and
supporting evidence for adding uterine cancer as a WTC-related health
condition.'' \28\ At a follow-up meeting on November 18, 2021, the
workgroup presented their draft report to the Committee. Following
deliberation, the 12 STAC members present \29\ voted unanimously to
approve the report and recommend that the Administrator add uterine
cancer to the List. Both the White Paper and the STAC recommendation
are discussed below.
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\28\ World Trade Center Health Program Scientific/Technical
Advisory Committee, Executive Summary of Meeting, September 28-29,
2021, <a href="https://www.cdc.gov/wtc/pdfs/stac/WTCHP_STACmeetingMinutes_20210928-29.pdf">https://www.cdc.gov/wtc/pdfs/stac/WTCHP_STACmeetingMinutes_20210928-29.pdf</a>.
\29\ Per STAC bylaws, a quorum consists of a majority of the
committee's membership. Based on the membership at the time of the
meeting, the required number of members for a quorum was nine. Four
members were unable to attend the November 18, 2021, meeting,
however 12 members were in attendance and quorum was maintained
throughout the meeting.
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D. Review of Evidence Supporting the Proposed Addition of Uterine
Cancer to the List
1. WTC Health Program Science Team Review
As discussed above, the Administrator asked the Science Team to
assess the scientific evidence currently available to determine whether
a basis exists under the Policy and Procedures for proposing the
addition of uterine cancer to the List. The Science Team reported its
findings in the White Paper entitled, Scientific Considerations for
Potential Addition of Uterine Cancer to the List of Covered Conditions
by the World Trade Center Health Program (Revised): Preliminary
Assessment for the World Trade Center Health Program Scientific/
Technical Advisory Committee.\30\ The White Paper describes the scope
of the Science Team's query as well as the literature search and
inclusion criteria, and summarizes the studies identified that describe
the available evidence on causal relationships between 9/11 exposures
and uterine cancer.
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\30\ WTC Health Program [2021], Scientific Considerations for
Potential Addition of Uterine Cancer to the List of Covered
Conditions by the World Trade Center Health Program (Revised):
Preliminary Assessment for the World Trade Center Health Program
Scientific/Technical Advisory Committee. The Science Team's White
Paper is available in the docket for this rulemaking and on the WTC
Health Program website, at <a href="https://www.cdc.gov/wtc/pdfs/stac/ScientificConsiderationsUterineCancer_STAC_20210928.pdf">https://www.cdc.gov/wtc/pdfs/stac/ScientificConsiderationsUterineCancer_STAC_20210928.pdf</a>.
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Pursuant to Method 1, the Science Team conducted a literature
search in April 2021. As described in the White Paper, the Science Team
identified and summarized nine studies: Six which were previously
evaluated in the Petition 023 Federal Register document,\31\ one that
recapitulated the results of two of those previously evaluated studies,
and two additional studies published since the Petition 023 literature
search and evaluation were conducted. Ultimately, five studies were
found to be relevant for further evaluation, including some of the
earlier studies which have been recently updated by their authors.\32\
With regard to Method 1, the Science Team concluded:
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\31\ A seventh study was evaluated in the Petition 023 review
but was not considered in the Science Team's evaluation for reasons
described in the White Paper, id. at 8.
\32\ See full discussion of the Science Team's literature review
and findings regarding Method 1 in the White Paper, id. at 8-17.
Five relevant peer-reviewed, published, epidemiologic studies
were identified and reviewed. The studies do not provide consistent
evidence of elevated uterine cancer incidence or mortality among WTC
responders and survivors. The studies also do not report a dose-
response relationship between 9/11 exposures and uterine cancer and
the study designs may be susceptible to selection bias. As a result,
collectively, these studies do not demonstrate a potential to
provide a basis for a decision on whether to add uterine cancer to
the List.\33\
---------------------------------------------------------------------------
\33\ Id. at 6-7.
Pursuant to Method 2, the Science Team explored whether a causal
association exists between uterine cancer and a health condition
already on the List. The Science Team found that uterine cancer may be
medically associated with estrogen-secreting tumors, which are
considered rare cancers in the Program. Studies reviewed by the Science
Team demonstrate support for a causal association between granulosa
cell tumors of the ovary (the most common type of estrogen-secreting
tumor) and uterine cancer.\34\ With regard to Method 2, the Science
Team concluded:
---------------------------------------------------------------------------
\34\ See full discussion of the Science Team's review of the
scientific literature and findings regarding Method 2 in the White
Paper, supra note 30, at 17-18.
A thorough review of the scientific literature found that
estrogen-secreting tumors are associated with endometrial cancer,
but that these estrogen-secreting tumors are rare. Because estrogen-
secreting tumors fall under the category of ``rare cancers'' in the
List, uterine cancer [may be considered a medically associated
condition and thus] . . . added to the List only for members who
have a certified estrogen-secreting tumor.\35\
---------------------------------------------------------------------------
\35\ Id. at 7.
Pursuant to Method 3, the Science Team considered the evaluations
of carcinogenicity published by NTP and IARC of those EDCs that are 9/
11 agents identified in the Inventory of 9/11 Agents. With regard to
---------------------------------------------------------------------------
Method 3, the Science Team concluded:
Four EDCs listed in the Inventory of 9/11 Agents are considered
carcinogenic to humans by NTP or IARC: (1) 2,3,7,8-
tetrachlorodibenzodioxin (TCDD); (2) 2,3,4,7,8-
pentachlorodibenzofuran; (3) polychlorinated biphenyls (PCB); and
(4) cadmium. None of these agents is considered to have sufficient
or even limited evidence of uterine carcinogenicity [based on IARC's
Monographs]. Further review of epidemiologic studies published after
. . . [IARC's Monographs] did not identify additional evidence of
carcinogenicity to the uterus.\36\
---------------------------------------------------------------------------
\36\ Id. at 7.
In addition, since Method 4 allows a cancer to be proposed for
addition to the List if the STAC provides a reasonable basis, the
Science Team presented
[[Page 27965]]
supplementary evidence that was reviewed but found not to be applicable
to Methods 1, 2, or 3 for the STAC's consideration. First, the Science
Team described the commonalities between the mechanisms of development
for uterine cancer and other types of cancer, including ``estrogen, an
abnormal mismatch repair (MMR) system, genetic abnormalities, and
aberrant methylation of DNA and microRNA.'' \37\ Next, the Science Team
presented evidence from studies in non-9/11-exposed populations that
demonstrate associations between uterine cancer and the 9/11 agents
TCDD, PCBs, cadmium, and asbestos (known EDCs). Additionally, the
Science Team noted that most studies of EDC exposure are conducted
among occupational cohorts, including few or no women. Finally, the
Science Team presented evidence that some EDCs in the Inventory of 9/11
Agents, including 2,3,7,8-tetrachlorodibenzodioxin and PCBs, are
considered by NTP and IARC to be known or probable human carcinogens
associated with types of cancer other than uterine cancer (e.g.,
melanoma, breast cancer, lymphoma, and leukemia), supporting the
inference that some EDC 9/11 agents may also be linked to uterine
cancer.
---------------------------------------------------------------------------
\37\ Id. at 27.
---------------------------------------------------------------------------
2. WTC Health Program Scientific/Technical Advisory Committee Review
After being presented with the White Paper at the September 28-29,
2021, STAC meeting, the Committee created a workgroup to ``write a
report describing the committee's conclusion, scientific rationale, and
supporting evidence for adding uterine cancer as a WTC-related health
condition.'' \38\ Following the deliberation of the full committee at
the November 18, 2021, meeting, the STAC voted to recommend that
uterine cancer be added to the List. The Chair of the STAC sent a
letter with the Committee's formal recommendation and rationale to the
Administrator, which he received on November 29, 2021.\39\
---------------------------------------------------------------------------
\38\ WTC Health Program STAC, Executive Summary of Meeting,
September 28-29, 2021, <a href="https://www.cdc.gov/wtc/stac_meeting.html">https://www.cdc.gov/wtc/stac_meeting.html</a>, at
2.
\39\ Letter from Dr. Elizabeth Ward, Chair of the STAC, to the
Administrator, regarding the STAC's resolution on the addition of
uterine cancer to the List of WTCHP Covered Conditions, received
November 29, 2021. The letter from Dr. Ward, including the STAC's
recommendation is available in the docket for this rulemaking and on
the WTC Health Program website, at <a href="https://www.cdc.gov/wtc/pdfs/stac/STAC.Recommendation.Received.29.November.2021.pdf">https://www.cdc.gov/wtc/pdfs/stac/STAC.Recommendation.Received.29.November.2021.pdf</a>.
---------------------------------------------------------------------------
The STAC recommendation is grounded in evidence and principles
first developed by the STAC in its 2012 recommendation to the
Administrator concerning the addition of cancers to the List.\40\ The
2021 STAC recommendation quotes the 2012 STAC recommendation, which
described those principles as including an understanding that
``exposures resulting from the collapse of the World Trade Center were
unlike any other exposures in intensity and variety in history. . . .
Compounding the uniqueness of the exposures is the absence of any data
on air contaminant levels or the composition of the dust and fumes in
the first four days after the attack, and the presence of multiple and
complex exposures.'' \41\ Further, the STAC found in 2012 that ``both
responder populations and area residents and workers had potential for
significant exposures to toxic and carcinogenic components of WTC dust
and smoke.'' \42\
---------------------------------------------------------------------------
\40\ Letter from Dr. Elizabeth Ward, Chair of the STAC, to the
Administrator, regarding the STAC's resolution on the addition of
cancer to the List of WTC-Related Health Conditions, received Apr.
2, 2012, <a href="https://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-040212-Letter.pdf">https://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-040212-Letter.pdf</a>.
\41\ Supra note 39, at 6.
\42\ Id. at 7.
---------------------------------------------------------------------------
The STAC also revisited the arguments presented in the 2012 STAC
recommendation for the addition of all cancer types, adding that:
. . . we believe that the arguments for adding all cancers can apply
to the question of whether to include all types of uterine cancer.
Other than uterine cancer, all cancer types now are covered as WTC-
related conditions. Mechanisms for carcinogenesis resulting from
endogenous and exogenous exposures are similar for most cancer
types. It is therefore highly implausible that uterine cancer would
be the only cancer not related to WTC exposures.\43\
---------------------------------------------------------------------------
\43\ Id. at 2.
In fact, in reviewing the literature, the STAC found that uterine
cancer ``shares many of the same genetic mechanisms with cancers
already included in [the] List of WTC-Related Health Conditions.'' \44\
Because exposure to endogenous and exogenous estrogen is strongly
associated with both endometrial \45\ and breast cancer, the STAC found
exposure to EDCs in WTC dust to be ``particularly relevant.'' Noting
that the 2012 STAC recommendation did not review evidence supporting an
association between EDCs and cancer types, the November 2021
recommendation summarized the STAC's understanding of exposures to EDCs
and their possible association with uterine cancer.\46\
---------------------------------------------------------------------------
\44\ Id.
\45\ In footnote 1 of its recommendation, the STAC clarifies
that ``endometrial'' and ``uterine'' cancer are used synonymously
and that most of the literature reviewed by the STAC relates
specifically to endometrial cancer. The STAC recommendations pertain
to all types of uterine cancer, including endometrial cancer.
\46\ See supra note 39, at Attachment 1.
---------------------------------------------------------------------------
The STAC acknowledged that ``[s]tudying the potential health
effects of exposure to EDCs is inherently challenging and much remains
unknown despite decade[s] of research,'' and quoted a recent review
which described EDCs' multiple mechanisms of action, acting
``simultaneously at the level of the receptor, hormone synthesis, and
hormone degradation.'' \47\
---------------------------------------------------------------------------
\47\ Id. at 8.
---------------------------------------------------------------------------
The STAC noted that the Inventory of 9/11 Agents includes certain
9/11 agents which are recognized as EDCs. Specifically, the STAC noted
that elevated levels of polychlorinated dibenzo-para-dioxins and
polychlorinated dibenzofurans (PCDD/F) were found on window surfaces
from locations in lower Manhattan and Brooklyn six weeks after
September 11, 2001. Other EDCs were found in WTC dust and smoke samples
and in runoff samples from Rector Street on September 14 and 20, 2001.
Two biomonitoring studies demonstrated significantly elevated levels of
EDCs in 9/11-exposed cohorts: A study of perfluorochemicals in plasma
from WTC responders working near Ground Zero between September 11 and
December 23, 2001 found levels of perfluorooctanoic acid (PFOA) and
perfluorohexanesulfonate (PFHxS) twice as high as in the U.S. general
population; and a study comparing 9/11-exposed adolescents to non-9/11-
exposed adolescents found that PCDD/F levels were statistically
significantly higher among the 9/11-exposed cohort.\48\ The STAC found
that PBDEs, high levels of which were found in WTC dust, in particular
have been shown to ``interfere with estrogen- . . . mediated
processes'' and that ``some toxicologic studies provide indirect
evidence'' for an association between PBDE exposures and uterine
cancer.\49\
---------------------------------------------------------------------------
\48\ See full discussion of the STAC's review of the scientific
literature and findings in Attachment 1, sec. 2 of the STAC
recommendation, supra note 39.
\49\ Id. at 10.
---------------------------------------------------------------------------
The STAC found that EDC exposure-related imbalances in sex steroid
hormones are a ``plausible mechanism'' for the development of uterine
cancer among WTC responders and survivors. Hormone-related cancers
thought to be caused by EDC exposure include thyroid cancer, breast
cancer, testicular and prostate cancers, and all female reproductive
organ cancers, all of which are included on the List with the exception
of uterine cancer.
[[Page 27966]]
The STAC also commented on the likely inability of existing and
future epidemiologic studies in the 9/11-exposed responder population--
the most studied 9/11-exposure cohort--to accurately capture uterine
cancer incidence because of the small number of female responders.
Moreover, the STAC noted that studies of carcinogens reviewed by IARC
and other authoritative bodies typically represent industrial cohorts,
which often include few or no females, making finding an association
between a 9/11 agent and uterine cancer highly unlikely and thus
potentially foreclosing Method 3 as a basis for adding uterine cancer
to the List.
Finally, the STAC considered public comment as well as the strong
support of the WTC Health Program CCEs for the addition of uterine
cancer to the List, noting that many Program members and advocates feel
the exclusion of uterine cancer from the List is ``illogical and unfair
and may cause tangible harm.'' The STAC cited a recent study \50\
supporting the argument that WTC responders and survivors diagnosed
with uterine cancer will experience better cancer survival if uterine
cancer is covered by the Program due to treatment coverage and high-
quality care.
---------------------------------------------------------------------------
\50\ See full discussion of the STAC's review of the scientific
literature and findings in Attachment 1, sec. 2 of the STAC
recommendation, supra note 39.
---------------------------------------------------------------------------
After reviewing the available evidence and hearing comment from
both the public and the WTC Health Program's CCEs, the STAC concluded
that:
In view of the strong rationale for adding all types of uterine
cancer to the list of WTC-related cancers and the potential benefits
to affected WTC responders, WTC survivors, and providers caring for
these patients, we recommend that all types of uterine cancer be
added to the list of WTC-related cancers and urge the Administrator
to make all feasible efforts to do so as quickly as policies and
procedures allow.\51\
---------------------------------------------------------------------------
\51\ Id. at 5.
E. Administrator's Decision Regarding Uterine Cancer
After reviewing the available body of scientific evidence
describing the causal relationship between 9/11 exposures and uterine
cancer, including certain 9/11 agents which are known EDCs, as well as
evaluating the STAC's comprehensive rationale and recommendation, the
Administrator concludes that the totality of available information
provides a sufficient evidentiary basis to propose adding uterine
cancer \52\ to the List.
---------------------------------------------------------------------------
\52\ ICD-10 codes C54 and C55. See supra note 1.
---------------------------------------------------------------------------
In accordance with the Program's Policy and Procedures, the
Administrator evaluated the available information under the four
methods developed for determining whether to add a type of cancer to
the List. First, he assessed whether there was sufficient evidence in
peer-reviewed, published, epidemiologic studies of 9/11-exposed
populations to support adding uterine cancer to the List under Method
1. The Administrator concurs with the Science Team's evaluation of the
literature pursuant to Method 1 and finds that the available literature
does not provide sufficient support for the addition of uterine cancer
to the List under Method 1.
Next, he looked at Method 2 which permits an addition to the List
if multiple peer-reviewed epidemiologic studies establish a causal
association between a condition already on the List and that cancer.
The Administrator agrees with the Science Team's finding that there is
evidence of a causal association between estrogen-secreting tumors,
which are considered rare cancers in the Program, and uterine cancer.
Thus, the Administrator finds that uterine cancer may be proposed for
addition to the List pursuant to Method 2, but such an addition would
be limited to only those Program members who have a certified WTC-
related estrogen-secreting tumor.
The Administrator also examined NTP and IARC evaluations of
carcinogenicity under Method 3, which permits an addition to the List
if NTP has determined that a specific 9/11 agent is known to be a human
carcinogen or is reasonably anticipated to be a human carcinogen, and
IARC has determined that there is sufficient or limited evidence in
humans that the 9/11 agent causes the type of cancer. The Administrator
reviewed the NTP and IARC evaluations of those EDCs that are on the
Inventory on 9/11 Agents (i.e., TCDD, 2,3,4,7,8-
pentachlorodibenzofuran, PCB, and cadmium) and concurs with the Science
Team's finding that there is insufficient support for the addition of
uterine cancer pursuant to Method 3.
Finally, the Administrator reviewed the recommendation of the STAC
to determine if uterine cancer could be added to the List pursuant to
Method 4, which permits an addition where the STAC recommends such an
addition and provides a reasonable basis for the recommendation. The
Administrator finds that the STAC's recommendation provides a
reasonable basis for the addition of uterine cancer under Method 4 and
this recommendation is further supported by the supplemental
information presented by the Science Team in the White Paper.
Specifically, the Administrator agrees with the STAC's finding that
mechanisms of initiation and progression of uterine cancer are similar
to those for several other cancers on the List.\53\ In particular, the
evidence showing similar gene mutations and abnormal mismatch repair
proteins among many cancers, including uterine cancer, strongly
supports shared etiology and pathogenesis between uterine cancer and
other cancer types on the List. For example, gene mutations found in
low-grade, endometrioid endometrial cancer (which accounts for 80
percent of all endometrial cancers) include those in PTEN (phosphatase
and tensin homolog deleted on chromosome 10), CTNNB1 ([beta]-catenin),
and K-RAS. PTEN inactivation is similarly found in malignant melanoma,
brain tumors, and ovarian, thyroid, breast, and prostate cancers, while
CTNNB1 and K-RAS mutations are found in a variety of human cancers.
High-grade endometrial cancers are associated with mutations in
oncogene ERBB2 (HER-2/neu) and tumor suppressor gene TP53. ERBB2 gene
mutations are also found in breast and ovarian cancers; likewise, TP53
is frequently mutated in a variety of human cancers, including high-
grade serous ovarian and basal-like breast cancers.\54\ Finally,
studies have shown that several microRNAs (miRNAs), including miR-152
which plays a role as a tumor suppressor, can be epigenetically
silenced by hyper-methylation of their respective DNA locus in
endometrial cancer.\55\ Aberrant methylation of miR-152 has also been
reported for other cancers, including acute lymphoblastic leukemia,
gastrointestinal cancer, and cholangiocarcinoma. Recent pan-cancer
molecular studies \56\ have found shared
[[Page 27967]]
molecular features among invasive breast carcinoma and several
gynecologic tumors, such as high-grade serous ovarian
cystadenocarcinoma, uterine corpus endometrial carcinoma, cervical
squamous cell carcinoma and endocervical adenocarcinoma, and uterine
carcinosarcoma.\57\ The Administrator agrees with the STAC's finding
that the shared etiology and pathogenesis described in the scientific
literature suggest it would be unlikely that uterine cancer would be
the only cancer type not related to 9/11 exposures.
---------------------------------------------------------------------------
\53\ Banno K, Yanokura M, Iida M, Masuda K, Aoki D [2014],
Carcinogenic Mechanisms of Endometrial Cancer: Involvement of
Genetics and Epigenetics, J Obstet Gynaecol Res 40(8):1957-1967;
Urick ME and Bell DW [2019], Clinical Actionability of Molecular
Targets in Endometrial Cancer, Nat Rev Cancer 19, 510-521.
\54\ Levine DA and the Cancer Genome Atlas Research Network
[2013], Integrated Genomic Characterization of Endometrial
Carcinoma, Nature 497(7447):67-73.
\55\ Favier A, Rocher G, Larsen AK, Delangle R, Uzan C, Sabbah
M, Castela M, Duval A, Mehats C, Canlorbe G [2021], MicroRNA as
Epigenetic Modifiers in Endometrial Cancer: A Systematic Review,
Cancers (Basel) 6;13(5):1137.
\56\ Pan-cancer molecular studies examine the similarities and
differences among the genomic and cellular alterations found across
diverse tumor types. Weinstein JN, Collisson EA, Mills GB, Mills
Shaw KR, Ozenberger BA, Ellrott K, Shmulevich I, Sander C, Stuart JM
[2013]. The Cancer Genome Atlas Pan-Cancer analysis project, Nature
Genetics. 45 (10): 1113-1120.
\57\ Berger AC et al. [2018], A Comprehensive Pan-Cancer
Molecular Study of Gynecologic and Breast Cancers, Cancer Cell
33(4):690-705.
---------------------------------------------------------------------------
The Administrator also finds that an association between exposure
to EDCs in WTC dust and uterine cancer risk is plausible. EDCs can
mimic endogenous hormones and interfere with endogenous hormone
homeostasis, which may lead to a variety of adverse health outcomes,
including cancer (e.g., estrogen imbalances are a key risk factor for
uterine cancer). There is extensive evidence from human studies of an
etiologic role of estrogens in cancer. However, finding a causal
association between an EDC 9/11 agent and uterine cancer is highly
unlikely given the potentially long latency between exposure and
disease. Moreover, the low number of women included in epidemiologic
studies examining EDC carcinogenic risks in occupational cohorts
increases the difficulty in finding conclusive evidence of a causal
association with uterine cancer. Given the growing body of scientific
evidence suggesting that exposure to EDCs may be a risk factor for
female reproductive organ cancers (e.g., breast, ovarian, and
endometrial cancers), it is reasonable to assume that exposure to EDCs
in WTC dust may contribute to uterine cancer risk.
Finally, the Administrator recognizes that the disproportionally
low representation of women in the most studied cohorts of exposed
responders makes it epidemiologically unlikely that a definitive
association between 9/11 exposures and the occurrence of uterine cancer
will be identified during the lifetime of even the most highly exposed
Program members.
The Administrator has determined that the available scientific
evidence and rationale provided by the STAC in its recommendation,
supported by the supplemental information presented by the Science Team
in the White Paper, offers a plausible rationale for an association
between uterine cancer and EDCs in the Inventory of 9/11 Agents.
Moreover, the cohorts relevant to understanding uterine cancer in the
9/11-exposed population are too small to allow a definitive decision
about whether uterine cancer is causally associated with 9/11 exposure.
For these reasons, the Administrator finds that a reasonable basis has
been provided by the STAC under Method 4 and, accordingly, proposes to
add uterine cancer to the List of WTC-Related Health Conditions.
IV. Summary of Proposed Rule
For the reasons discussed above, the Administrator proposes to
amend 42 CFR 88.15 by adding a new paragraph (d)(15) to include
malignant neoplasms of corpus uteri and uterus, part unspecified \58\
on the List of WTC-Related Health Conditions. The existing paragraph
(d)(15)--malignant neoplasm of the ovary--and the remainder of the
cancer types identified in existing paragraphs (d)(16) through (24)--
rare cancers--are renumbered paragraphs (d)(16) through (25),
accordingly. Adding uterine cancer to the List would allow the WTC
Health Program to offer treatment services to members whose uterine
cancers are certified as WTC-related.
---------------------------------------------------------------------------
\58\ See supra note 1.
---------------------------------------------------------------------------
V. Required Regulatory Analyses
A. Executive Order 12866 (Regulatory Planning and Review) and Executive
Order 13563 (Improving Regulation and Regulatory Review)
Executive Orders (E.O.) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility.
This proposed rule has been determined not to be a significant
regulatory action under sec. 3(f) of E.O. 12866, and therefore has not
been reviewed by the Office of Management and Budget (OMB). The
addition of uterine cancer proposed by this rulemaking is estimated to
cost the WTC Health Program between $1,718,691 and $2,199,808 per annum
for 2022-2025.\59\ All costs to the WTC Health Program will be
transfers due to the implementation of provisions of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) in 2014 and as
required under the authorizing statute for the WTC Health Program.\60\
The rule would not interfere with state, local, or tribal governments
in the exercise of their governmental functions.
---------------------------------------------------------------------------
\59\ As discussed in this section, NIOSH estimated lower and
upper bound estimates to reflect the uncertainty in the Agency's
ability to predict the expected number of cancer cases in three
years after this rulemaking. The low bound reflects the general U.S.
population cancer rate and uses undiscounted costs for 2022 and
costs for 2023-2025 discounted at the 7% discount rate. The upper
bound reflects the U.S. population cancer rate + 21%, based on a
study by Li et al. [2021], infra note 69, and uses undiscounted
rates for 2022 and costs for 2023-2025 discounted at the 3% discount
rate. Although, if added to the List, uterine cancer would be
considered a covered condition for the duration of the WTC Health
Program (currently authorized through FY 2090), the dates 2022-2025
were chosen in order to provide a snapshot of uterine cancer costs
in the coming years.
\60\ Because sec. 3331(c)(3) of the PHS Act requires WTC Health
Program members to maintain minimum essential insurance coverage all
treatment costs to be paid by the WTC Health Program are considered
transfers.
---------------------------------------------------------------------------
Population Estimates
The WTC Health Program has, as of September 30, 2021, enrolled
approximately 82,000 WTC responders and approximately 32,000 survivors,
or approximately 114,000 individuals in total. Of that total
population, approximately 60,000 individuals were participants in
previous WTC medical programs and were enrolled as ``Legacy'' members
in the WTC Health Program established by Title XXXIII of the PHS Act.
For the purpose of calculating a baseline estimate of cancer prevalence
only, the Administrator assumed that a steady rate of enrollment would
continue, based on the trend in enrollees through September 2021.
According to WTC Health Program data, 12 percent of the current
responder members (approximately 10,000 individuals) and 50 percent of
survivor members (approximately 16,000 individuals) are female.\61\ The
Administrator acknowledges that some uterine cancer cases in this
population may not have been caused by 9/11 exposures. The
certification of individual cancer diagnoses will be conducted on a
case-by-case basis, as required by the Zadroga Act. For the purpose of
this economic analysis, however, the Administrator assumes that all
diagnosed uterine cancers will be certified for treatment by the WTC
Health Program. Finally, because there are no existing data on cancer
rates related to 9/11 exposures at either the Pentagon or in
Shanksville, Pennsylvania, the Administrator has
[[Page 27968]]
used only data from studies of individuals who were responders or
survivors in the New York City disaster area.
---------------------------------------------------------------------------
\61\ See supra note 25.
---------------------------------------------------------------------------
Cost of Uterine Cancer Treatment
The Administrator estimated the treatment costs associated with
covering uterine cancer in this rulemaking. The costs of treatment are
divided into three treatment phases: The first year of treatment
following diagnosis; the intervening years or continuing treatment
after the first year; and treatment during the last year of life. The
first-year costs of cancer treatment are higher due to the initial need
for aggressive medical care (e.g., radiation or chemotherapy) and
surgical care. The costs during the last year of life are often
dominated by increased hospitalization costs.\62\ Therefore, three
different treatment phase costs were used to provide a best estimate of
treatment costs in conjunction with expected incidence and long-term
survival rates for uterine cancer. Average treatment costs for uterine
cancer are in Table A, below.
---------------------------------------------------------------------------
\62\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M,
Meekins A, Brown ML [2008], Cost of Care for Elderly Cancer Patients
in the United States, J Natl Cancer Inst 100(9):630-41.
Table A--Average Costs of Treatment for Uterine Cancer, 2021$
------------------------------------------------------------------------
------------------------------------------------------------------------
Stage of treatment:
Initial (first 12 months after diagnosis).................. $39,638
Continuing (annual)........................................ 2,066
Last year of life (last 12 months of life)................. 118,058
------------------------------------------------------------------------
These cost figures were based on a study of cancer patients from
the Surveillance, Epidemiology, and End Results (SEER) program
maintained by the National Cancer Institute and using Medicare
files.\63\ The average costs of treatment described above are given in
2021 prices adjusted using the Medical Consumer Price Index for all
urban consumers.\64\
---------------------------------------------------------------------------
\63\ Surveillance, Epidemiology, and End Results (SEER) Program
(<a href="http://www.seer.cancer.gov">www.seer.cancer.gov</a>) SEER*Stat Database: Incidence--SEER 9 Regs
Research Data, Nov 2020 Sub (1975-2018), National Cancer Institute,
DCCPS, Surveillance Research Program, Surveillance Systems Branch,
released Apr. 2021, based on the Nov. 2020 submission. Although
patients who are Medicare members are age 65 and older, cancer
treatment costs are not expected to vary with age.
\64\ Bureau of Labor Statistics, Consumer Price Index, <a href="https://fred.stlouisfed.org">https://fred.stlouisfed.org</a>. Accessed on Apr. 28, 2021.
---------------------------------------------------------------------------
Incident Cases of Cancer
The Administrator estimated the expected number of cases of cancer
that would be observed in a cohort of responders and survivors followed
for cancer incidence after September 11, 2001, using U.S. population
cancer rates. Demographic characteristics of the cohort were assigned
since the actual data are not available for individuals in the
responder and survivor populations who have not yet enrolled in the WTC
Health Program. Sex and age (at the time of exposure) distributions for
responders and survivors were assumed to be the same as current members
in the WTC Health Program. Because uterine cancer occurs only in
females,\65\ all calculations only consider female WTC Health Program
members.
---------------------------------------------------------------------------
\65\ See supra note 25.
---------------------------------------------------------------------------
The Administrator assumed race and ethnic origin distributions for
responders and survivors, respectively, according to distributions in
the WTC Health Registry cohort: \66\ 57 percent non-Hispanic white, 15
percent non-Hispanic black, 21 percent Hispanic, and 8 percent other
race/ethnicity for responders; 50 percent non-Hispanic white, 17
percent non-Hispanic black, 15 percent Hispanic, and 18 percent other
race/ethnicity for survivors. Registry follow-up for cancer morbidity
for each person began on January 1, 2002, or age 15 years, whichever
was later. Age 15 was considered because the cancer incidence rate file
did not include rates for persons less than 15 years of age. Follow-up
ended on December 31, 2016, or the estimated last year of life,
whichever was earlier. The estimated last year of life was used since
not all persons would be expected to remain alive at the end of 2016.
The estimated last year of life was based on U.S. gender, race, age,
and year-specific death rates from CDC WONDER.\67\ A life-table
analysis program, LTAS.NET, was used to estimate the expected number of
incident cancers for uterine cancer.\68\ The Administrator calculated
cancer incidence rates using data through 2018 from the SEER Program
and estimated rates for 2002-2025.\69\ The Program applied the
resulting gender, race, age, and year-specific cancer incidence rates
to the estimated person-years at risk to estimate the expected number
of cancer cases for uterine cancer starting from year 2002, the first
full year following the September 11, 2001, terrorist attacks, to 2025.
---------------------------------------------------------------------------
\66\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L,
Stellman SD [2011], Mortality Among Survivors of the Sept 11, 2001,
Word Trade Center Disaster: Results from the World Trade Center
Health Registry Cohort, Lancet 378:879-887. Note: percentages may
not sum to 100 percent due to rounding.
\67\ Centers for Disease Control and Prevention, National Center
for Health Statistics, Compressed Mortality File 1999-2016 on CDC
WONDER Online Database, released June 2017. Data are from the
Compressed Mortality File 1999-2016 Series 20 No. 2U, 2016, as
compiled from data provided by the 57 vital statistics jurisdictions
through the Vital Statistics Cooperative Program. <a href="http://wonder.cdc.gov/cmf-icd10.html">http://wonder.cdc.gov/cmf-icd10.html</a>. Accessed May 29, 2021.
\68\ Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM,
Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011],
Update of the NIOSH Life Table Analysis System: A Person-Years
Analysis program for the Windows Computing Environment, Am J Ind Med
54:915-924.
\69\ See supra note 62.
---------------------------------------------------------------------------
Prevalence of Cancer
To determine the potential number of persons in the responder and
survivor populations with cancer, the Administrator used the number of
incident uterine cancer cases described above for each year starting
with 2002 and estimated the prevalence of uterine cancer using survival
rate statistics for each incident cancer group through 2025.\70\ Using
the incident cases and survival rate statistics, the Administrator
estimated the prevalence (number of persons living with cancer) of
cases during the 23-year period (2002-2025) since September 11, 2001.
For the purposes of illustrating an upper bound incidence rate and
prevalence estimate, the Administrator assumed that the rate of cancer
in the WTC Health Program exceeds the general U.S. population rate by
21 percent due to 9/11 exposures. The peer-reviewed literature supports
the use of a 21 percent excess risk of cancer in the 9/11-exposed
population over the U.S. population cancer rate; a 2021 study by Li et
al.\71\ reported an adjusted hazard ratio of 1.21 (95 percent CI: 1.12,
1.31) for all cancer sites and used a within-cohort comparison less
affected by healthy worker selection bias. The resulting Table B
summarizes those results for each year from 2022 through 2025, the
number of new cases occurring in that year (incidence), the number of
persons surviving up to 23 years beyond their first diagnosis
(prevalence), and the number of individuals who might be expected to
die from their cancer in that year.\72\
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\70\ Id.
\71\ Li J, Yung J, Qiao B, Takemoto E, Goldfarb DG, Zeig-Owens
R, Cone JE, Brackbill RM, Farfel MR, Kahn AR, Schymura MJ, Shapiro
MZ, Dasaro CR, Todd AC, Kristjansson D, Prezant DJ, Boffetta P, Hall
CB [2021], Cancer Incidence in World Trade Center Rescue and
Recovery Workers: 14 Years of Follow-Up, J Natl Cancer Inst <a href="https://doi.org/10.1093/jnci/djab165">https://doi.org/10.1093/jnci/djab165</a>.
\72\ The 23-year survival limit is imposed based on the analytic
time horizon.
[[Page 27969]]
Table B--Estimated Incidence and Prevalence of Uterine Cancer
[2022-2025]
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 2025
----------------------------------------------------------------------------------------------------------------
Responders (based on ~10,000 female members)
----------------------------------------------------------------------------------------------------------------
New cases....................................... 6.69 6.92 7.14 7.27
Live cases from previous years.................. 29.46 30.78 32.09 33.33
Deaths.......................................... 5.09 5.37 5.61 5.90
---------------------------------------------------------------
Total cases................................. 36.15 37.70 39.23 40.60
----------------------------------------------------------------------------------------------------------------
Survivors (based on ~16,000 female members)
----------------------------------------------------------------------------------------------------------------
New cases....................................... 10.91 10.91 10.91 10.91
Live cases from previous years.................. 53.70 54.72 55.49 56.17
Deaths.......................................... 9.60 9.90 10.17 10.31
---------------------------------------------------------------
Total cases................................. 64.61 65.63 66.40 67.08
----------------------------------------------------------------------------------------------------------------
Total (based on ~26,000 female WTC responder and survivor members)
----------------------------------------------------------------------------------------------------------------
New cases....................................... 17.6 17.83 18.05 18.18
Live cases from previous years.................. 83.16 85.50 87.58 89.50
Deaths.......................................... 14.69 15.27 15.78 16.21
---------------------------------------------------------------
Total cases................................. 100.76 103.33 105.63 107.68
----------------------------------------------------------------------------------------------------------------
Cost Computation
To compute the costs for uterine cancer, the Administrator assumes
that the individuals diagnosed with uterine cancer will be certified by
the WTC Health Program for treatment and monitoring services. The
treatment costs for the first year of treatment (Table A, year
adjusted) were applied to the predicted newly incident (Year 1) cases
for each year. Likewise, the costs of treatment for the last year of
life were applied in each year to the number of people predicted to die
from their cancer in that year. The costs of continuing treatment from
Table A were applied to the number of prevalent cases who had survived
their cancers beyond their year of diagnosis, for each year of survival
(Year 2-23).
The estimated treatment costs for responders and survivors were re-
computed under the following two assumptions: (1) The rate of cancer in
the WTC Health Program is equal to the rate of cancer observed in the
general U.S. population; and (2) the rate of cancer in the WTC Health
Program exceeds the general U.S. population rate by 21 percent, as
discussed above. Costs for future years are discounted at both 7
percent and 3 percent to reflect net present value.\73\
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\73\ See OMB Circular A-94, Guidelines and Discount Rates for
Benefit-Cost Analysis of Federal Programs. <a href="https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A94/a094.pdf">https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A94/a094.pdf</a>.
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The sum of the annual costs in the table for the years 2022 through
2025 represents the estimated treatment costs to the WTC Health Program
for coverage of uterine cancer for the 12 percent of approximately
82,000 WTC responders who are female and the 50 percent of
approximately 32,000 WTC survivors who are female.
Summary of Costs
Because HHS lacks data to account for recoupment from workers'
compensation insurance or primary payment by either private health
insurance or Medicare/Medicaid payments, the estimates offered here are
reflective of estimated WTC Health Program costs only and assume the
Program is the primary payer. This analysis offers an assumption about
the number of individuals who might enroll in the WTC Health Program
and estimates the impact of both a low rate of cancer (U.S. population
average rate) and an increased rate (21 percent greater than the U.S.
population average) on the number of cases and the resulting estimated
treatment costs to the WTC Health Program. This analysis does not
include administrative costs associated with certifying additional WTC-
related uterine cancers that might result from this action.
Since the implementation of provisions of the Affordable Care Act
on January 1, 2014, all members and future members are assumed to have
or have access to medical insurance coverage other than through the WTC
Health Program.\74\ Therefore, all treatment costs to be paid by the
WTC Health Program from 2022 through 2025 are considered transfers.
---------------------------------------------------------------------------
\74\ Sec. 3331(c)(3) of the PHS Act requires WTC Health Program
members to maintain minimum essential insurance coverage.
Table C--Medical Treatment Cost for Uterine Cancer Cases During 2022-2025, 2021$
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
2022 costs, undiscounted, 2021$ 2023-2025 2023-2025
costs,* 7% costs, 3%
discount rate discount rate
---------------------------------------------------------------------------
Cancer rate
Cancer rate
---------------------------------------------------------------------------
U.S. average U.S. average + 21% U.S. average U.S. average + 21%
----------------------------------------------------------------------------------------------------------------
Responders.......................... $749,741 $907,187 $2,145,844 $2,801,474
[[Page 27970]]
Survivors........................... 1,067,098 1,291,189 2,912,084 3,799,381
---------------------------------------------------------------------------
Total........................... 1,816,839 2,198,376 5,057,928 6,600,855
----------------------------------------------------------------------------------------------------------------
* Since this table summarizes the lowest and highest cost estimates for treatment of uterine cancer, values
representing 2023-2025 costs at the 7% discount rate and at the increased cancer rate and 2023-2025 costs at
the 3% discount rate and at the U.S. population average rate were not included.
The Administrator found the cost estimate range by adding the low
2023-2025 estimate in Table C (7 percent discount rate, U.S. cancer
rate average) and the low estimate for 2022 (U.S. cancer rate average)
and dividing the sum by four to find the annual low-cost estimate
(i.e., $1,718,691). The same calculation was done for the annual high-
cost estimates, adding the higher numbers in Table C (3 percent
discount rate, U.S. cancer rate average +21 percent) to the high
estimate for 2022 (U.S. cancer rate average +21 percent) and dividing
the sum by four (i.e., $2,199,808).
Examination of Benefits (Health Impact)
This section qualitatively describes the potential benefits of this
rulemaking to add uterine cancer to the List of WTC-Related Health
Conditions in terms of the expected improvements in the health and
health-related quality of life of potential uterine cancer patients
treated through the WTC Health Program, compared to not conducting the
rulemaking.
The Administrator does not have information on the health of the
population that may have experienced 9/11 exposures and is not
currently enrolled in the WTC Health Program. In addition, the
Administrator has only limited information about health insurance and
healthcare services for uterine cancers potentially caused by 9/11
exposures and suffered by any population of responders and survivors,
including responders and survivors currently enrolled in the WTC Health
Program and responders and survivors not enrolled in the Program. For
the purposes of this analysis, the Administrator assumes that all
unenrolled responders and survivors are now covered by health insurance
due to access provided by the Affordable Care Act and may be receiving
treatment outside the WTC Health Program.
Although the Administrator cannot quantify the benefits associated
with the WTC Health Program, members with uterine cancer are expected
to experience better treatment outcomes as Program members than non-
members. A recent study found that ``WTC-exposed responder cancer
patients enrolled in the MMTP [WTC Medical Monitoring and Treatment
Program, a predecessor to the WTC Health Program] had higher survival
rates compared with those not enrolled in the MMTP.'' \75\ Moreover,
under other insurance plans, patients would have deductibles and
copays, which impact access to care and, particularly, its
timeliness.\76\ WTC Health Program members have first-dollar coverage
and hence are likely to seek care sooner, when indicated, resulting in
improved treatment outcomes.
---------------------------------------------------------------------------
\75\ Goldfarb DG, Zeig-Owens R, Kristjansson D, Li J, Brackbill
RM, Farfel MR, Cone JE, Kahn AR, Qiao B, Schymura MJ, Webber MP,
Dasaro CR, Lucchini RG, Todd AC, Prezant DJ, Hall CB, Boffetta P
[2021], Cancer Survival among World Trade Center Rescue and Recovery
Workers: A Collaborative Cohort Study, Am J Ind Med 64(10):815-826.
\76\ Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-
Degnan D, Landon BE [2008], Cancer Screening before and after
Switching to a High-Deductible Health Plan, Ann Intern Med
148(9):647-655.
---------------------------------------------------------------------------
Finally, during public meetings, Program members have expressed
that the lack of social and clinical support, and lack of recognition
that their diagnosed uterine cancer is a WTC-related health condition,
have had a significant negative impact on their morale and quality of
life.
Limitations
The analysis presented here was limited by the dearth of verifiable
data on the uterine cancer status of responders and survivors who have
yet to apply for enrollment in the WTC Health Program. Because of the
limited data, the Administrator was not able to estimate benefits in
terms of averted healthcare costs; nor was the Administrator able to
estimate administrative costs, or indirect costs, such as averted
absenteeism, short- and long-term disability, and productivity losses
averted due to premature mortality.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities, including small businesses, small
governmental units, and small not-for-profit organizations. The
Administrator certifies that this proposed rule has ``no significant
economic impact upon a substantial number of small entities'' within
the meaning of the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on, and to obtain OMB approval of,
any regulation that requires 10 or more people to report information to
the agency or to keep certain records. The Administrator has determined
that this rulemaking does not contain any new information collection
requirements or recordkeeping requirements; thus, the PRA does not
apply to this rulemaking. Data collection and recordkeeping
requirements for the WTC Health Program are approved by OMB under
``World Trade Center Health Program Enrollment, Appeals &
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2021,
currently under OMB review).
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq., HHS will report
the promulgation of this rule to Congress prior to its effective date.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531
et seq., directs agencies to assess the effects of Federal regulatory
actions on state, local, and tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this proposed rule does not include any
Federal mandate that may result in increased annual expenditures in
excess of $100 million in 1995 dollars by state, local, or tribal
governments in the aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice)
This proposed rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. This rule has
[[Page 27971]]
been reviewed carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Administrator has reviewed this proposed rule in accordance
with Executive Order 13132 regarding federalism and has determined that
it does not have ``Federalism implications.'' The rule does not ``have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, the Administrator has
evaluated the environmental health and safety effects of this proposed
rule on children. The Administrator has determined that the rule would
have no environmental health and safety effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, the Administrator has
evaluated the effects of this proposed rule on energy supply,
distribution, or use, and has determined that the rule will not have a
significant adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), Executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. The Administrator has attempted to
use plain language in promulgating the proposed rule consistent with
the Federal Plain Writing Act guidelines and requests public comment on
this effort.
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal procedures, Cancer, Healthcare,
Mental health conditions, Musculoskeletal disorders, Respiratory and
pulmonary diseases.
For the reasons discussed in the preamble, the Administrator and
HHS Secretary propose to amend 42 CFR part 88 as follows:
PART 88--WORLD TRADE CENTER HEALTH PROGRAM
0
1. The authority citation for part 88 is revised to read as follows:
Authority: 42 U.S.C. 300mm to 300mm-61.
0
2. Amend Sec. 88.15 as follows:
0
a. Redesignate paragraphs (d)(15) through (24) as paragraphs (d)(16)
through (25).
0
b. Add new paragraph (d)(15).
0
c. In newly redesignated paragraph (d)(24), remove ``Childhood
cancers:'' and add ``Childhood cancers:'' in its place.
0
d. In newly redesignated paragraph (d)(25), remove ``Rare cancers:''
and add ``Rare cancers:'' in its place.
The addition reads as follows:
Sec. 88.15 List of WTC-Related Health Conditions.
* * * * *
(d) * * *
(15) Malignant neoplasms of corpus uteri and uterus, part
unspecified.
* * * * *
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.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-09708 Filed 5-9-22; 8:45 am]
BILLING CODE 4163-18-P
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