[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75273-75275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected].

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 (https://www.regulations.gov/docket/CDC-2022-0070/comments). A summary of the comments received and the 
modifications CDC/ATSDR made to the draft 2022 Guidelines after careful 
consideration are below:
     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.
     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.
     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.
     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.
     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 (https://www.cdc.gov/nceh/tracking/default.htm) 
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.
     Commenters suggested that providing more references would 
be helpful.
    [cir] Response: CDC/ATSDR added additional references throughout 
the 2022 Guidelines.
     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.
     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 https://www.cdc.gov/nceh/cancer-environment/index.html.
    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: https://www.regulations.gov, 
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]
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