Notice2022-26664
Availability of Final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns
Primary source
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Published
December 8, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of the final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Guidelines). The 2022 Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE). The updates provide state, tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns. The 2022 Guidelines finalize the draft guidelines issued on May 25, 2022.
Full Text
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<title>Federal Register, Volume 87 Issue 235 (Thursday, December 8, 2022)</title>
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[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75273-75275]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26664]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0070]
Availability of Final Guidelines for Examining Unusual Patterns
of Cancer and Environmental Concerns
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: General notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) and the
Agency for Toxic Substances and Disease Registry (ATSDR), located
within the Department of Health and Human Services (HHS) announces the
availability of the final Guidelines for Examining Unusual Patterns of
Cancer and Environmental Concerns (2022 Guidelines). The 2022
Guidelines provide updates to the 2013 publication, Investigating
Suspected Cancer Clusters and Responding to Community Concerns:
Guidelines from the CDC and the Council of State and Territorial
Epidemiologists (CSTE). The updates provide state, tribal, local, and
territorial health departments guidance for a
[[Page 75274]]
revised and expanded approach to evaluating concerns about unusual
patterns of cancer in communities, including those associated with
local environmental concerns. The 2022 Guidelines finalize the draft
guidelines issued on May 25, 2022.
DATES: The 2022 Guidelines are available December 8, 2022.
FOR FURTHER INFORMATION CONTACT: Amy Lavery, Centers for Disease
Control and Prevention, National Center for Environmental Health,
Division of Environmental Health Science and Practice, 4770 Buford
Highway NE, Mailstop F-60, Atlanta, GA 30341; Telephone: 770-488-4024;
Email: <a href="/cdn-cgi/l/email-protection#c5868682b0aca1a0a9acaba0b685a6a1a6eba2aab3"><span class="__cf_email__" data-cfemail="17545450627e73727b7e7972645774737439707861">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
CDC/ATSDR is announcing the availability of final Guidelines for
Examining Unusual Patterns of Cancer and Environmental Concerns (2022
Guidelines). The 2022 Guidelines are an update to the 2013 guidelines,
Investigating Suspected Cancer Clusters and Responding to Community
Concerns: Guidelines from CDC and the Council of State and Territorial
Epidemiologists (2013 Guidelines). CDC/ATSDR develops guidance for
state, tribal, local, and territorial (STLT) health departments on how
to respond to cancer cluster concerns. The 2022 Guidelines are a tool
to assist STLT public health agencies in applying a systematic approach
when responding to inquiries about suspected unusual patterns of cancer
in residential or community settings.
In the 2022 Guidelines, CDC/ATSDR has updated and expanded the 2013
Guidelines to provide STLT public health agencies and other interested
parties with access to information about current scientific tools and
approaches to assess and respond to potential unusual patterns of
cancer in communities.
CDC/ATSDR developed the 2022 Guidelines using input from a variety
of sources, including STLT public health agencies, subject matter
experts from academia and non-governmental organizations, an internal
CDC/ATSDR steering committee, public comments received from an
announcement in the Federal Register (84 FR 21786), and focus groups
conducted with community members and organizations that have been
involved with cancer concerns in their communities. CDC/ATSDR also
gathered input from a comprehensive literature review and media scan
and evaluated advances in the field of environmental epidemiology
(e.g., geospatial methods) and community engagement strategies.
On May 25, 2022 CDC/ATSDR published a notice in the Federal
Register announcing the availability of the draft 2022 Guidelines (87
FR 31888). The notice gave the public an opportunity to submit comments
by July 25, 2022. CDC/ATSDR received 46 sets of comments from state
health departments, community members, academicians, clinicians, cancer
registries, non-governmental organizations, and private consultants on
behalf of trade associations (<a href="https://www.regulations.gov/docket/CDC-2022-0070/comments">https://www.regulations.gov/docket/CDC-2022-0070/comments</a>). A summary of the comments received and the
modifications CDC/ATSDR made to the draft 2022 Guidelines after careful
consideration are below:
<bullet> Commenters stated the terms ``cancer cluster'' and
``unusual patterns of cancer'' were used interchangeably throughout the
document without clear definition of both terms.
[cir] Response: CDC/ATSDR provided a clear definition of both
terms.
<bullet> Commenters noted that it was unclear whether every
proactive evaluation must result in the criteria assessment. Commenters
questioned how the criteria assessment differs from the response from
an incoming inquiry.
[cir] Response: CDC/ATSDR added language to clarify the response to
both proactive monitoring and incoming inquiries and provided examples
on how to respond to unusual patterns of cancer identified in the
proactive monitoring. CDC/ATSDR refined the flow chart in Figure 1,
which provides a summary of the enhanced process for evaluating
patterns of cancer routinely and evaluating community inquiries about
unusual patterns of cancer and environmental concerns. CDC/ATSDR also
clarified the discussion on proactive evaluation and routine monitoring
of cancer data, including clarifying the need for collaboration with
other health agency programs to determine the need for further
evaluation through the criteria assessment.
<bullet> Commenters noted that the discussion of challenges and
limitations was important to mention early in the guidelines document,
rather than in later sections of the document.
[cir] Response: CDC/ATSDR added information on limitations and
challenges related to implementation of the recommendations provided
within the guidelines early in the document and then reinforced these
limitations later in the document.
<bullet> Several comments were focused on clarifying phases and the
intent of various criteria, as well as the need for examples to enhance
clarity.
[cir] Response: CDC/ATSDR made editorial changes to improve clarity
and provided examples when possible, such as including examples of
specific partners within a public health agency to engage on unusual
patterns of cancer.
CDC/ATSDR endeavored to improve clarity with respect to certain
components of the criteria. For example, CDC/ATSDR changed step 8 of
the criteria from ``Is there known biologic plausibility of the
cancer(s) of concern with suspected environmental contaminants in terms
of disease etiology?'' to ``Is there a plausible pathway of exposure
between the suspected environmental contaminants and the cancer(s) of
concern in terms of disease etiology?'' This change allowed for a
clearer depiction of the intent of step 8 of the criteria.
<bullet> Some commenters raised the issue of how frequent and
regular routine monitoring of cancer may place additional burdens on
public health agency resources.
[cir] Response: 50% of states reported through the STLT survey that
they already conduct routine monitoring of cancer incidence data.
However, CDC/ATSDR acknowledged, within the 2022 Guidelines, that
resource limitations may impact the frequency with which routine
monitoring can be carried out. CDC's National Environmental Public
Health Tracking Program (<a href="https://www.cdc.gov/nceh/tracking/default.htm">https://www.cdc.gov/nceh/tracking/default.htm</a>)
worked with state cancer registries and tracking partners to make
three- and five-year rates more readily available, to reduce the burden
on states with respect to monitoring.
<bullet> Commenters suggested that providing more references would
be helpful.
[cir] Response: CDC/ATSDR added additional references throughout
the 2022 Guidelines.
<bullet> Commenters noted that more guidance and instructions are
needed on the use of the Cancer Inquiry intake form.
[cir] Response: CDC/ATSDR is developing an instructions document
for STLT public health agencies to use as a supplement to the Cancer
Inquiry intake form.
<bullet> Commenters noted that more details and resources were
needed on use of the standardized incidence ration, such as specific
minimum thresholds.
[cir] Response: CDC/ATSDR is developing additional education and
resource tools and will post on the National Center for Environmental
Health's Health Studies website once available.
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For more information about the process of updating the 2022
Guidelines, please visit <a href="https://www.cdc.gov/nceh/cancer-environment/index.html">https://www.cdc.gov/nceh/cancer-environment/index.html</a>.
Availability of the Final 2022 Guideline: The Final 2022 Guidelines
can be found in the Supporting & Related Materials tab of this docket
found on the Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
identified by Docket No. CDC-2022-0070.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-26664 Filed 12-7-22; 8:45 am]
BILLING CODE 4163-18-P
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