[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39424-39425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12972]



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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2013-0292; FRL-11021-01-ORD]


Public Comment on the Cumulative Risk Assessment Guidelines for 
Planning and Problem Formulation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a 
60-day public comment period on the draft Cumulative Risk Assessment 
(CRA) Guidelines for Planning and Problem Formulation. The CRA 
Guidelines for Planning and Problem Formulation describe steps for the 
planning and problem formulation of CRAs and offer guidelines for when 
cumulative risk assessments could be appropriate. Planning defines both 
the process for conducting the risk assessment and its general scope, 
while problem formulation identifies major factors considered in a 
specific assessment to inform its technical approach. The draft CRA 
Guidelines for Planning and Problem Formulation are not final, and do 
not represent, and should not be construed to represent, Agency policy 
or views.

DATES: The 60-day public comment period begins June 16, 2023 and ends 
August 15, 2023. Comments must be received on or before August 15, 
2023to be considered by EPA.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
ORD-2013-0292, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket 
Center, [insert Program Office Name] Docket, Mail Code 28221T, 1200 
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand Delivery or Courier: EPA Docket Center, WJC West 
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. 
The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m., 
Monday through Friday (except Federal Holidays).
    Instructions: All submissions received must include the Docket ID 
No. for this notice. Comments received may be posted without change to 
https://www.regulations.gov/, including any personal information 
provided. For detailed instructions on sending comments and additional 
information on the public comment process, see the PUBLIC PARTICIPATION 
heading of the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the ORD Docket at the EPA Headquarters Docket Center; 
telephone: 202-566-1752; facsimile: 202-566-9744; or email: 
[email protected]. For technical information on the draft guidelines 
or information on the public comment period, contact Dr. Lawrence 
Martin, via email at: [email protected]; or via phone/voicemail 
at 202-308-5642.

SUPPLEMENTARY INFORMATION: 

I. Public Participation

    Written Comments: Submit your comments, identified by Docket ID No. 
EPA-HQ-ORD-2013-0292, at https://www.regulations.gov (our preferred 
method), or the other methods identified in the ADDRESSES section. Once 
submitted, comments cannot be edited or removed from the docket. The 
EPA may publish any comment received to its public docket. Do not 
submit to EPA's docket at https://www.regulations.gov any information 
you consider to be Confidential Business Information (CBI), Proprietary 
Business Information (PBI), or other information whose disclosure is 
restricted by statute. If you are commenting on specific text in the 
document, please use the page and line number to identify the text to 
which you refer. General recommendations or comments are best tied to a 
specific section in the text that comes closest to addressing the issue 
you are commenting upon. If no such section exists, then a 
recommendation for a new section heading is helpful. Please provide 
citations for any technical information and/or data used to support the 
information you provide. Multimedia submissions (audio, video, etc.) 
must be accompanied by a written comment. The written comment is 
considered the official comment and should include discussion of all 
points you wish to make. The EPA will generally not consider comments 
or comment contents located outside of the primary submission (i.e., on 
the web, cloud, or other file sharing system). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission 
methods; the full EPA public comment policy; information about CBI, 
PBI, or multimedia submissions; and general guidance on making 
effective comments.

II. Background on the CRA Guidelines for Planning and Problem 
Formulation

    The draft CRA Guidelines for Planning and Problem Formulation is 
available at https://www.epa.gov/risk/guidelines-cumulative-risk-assessment-planning-and-problem-formulation and in the public docket at 
http://www.regulations.gov, Docket ID No. EPA-HQ-ORD-2013-0292.
    The CRA Guidelines for Planning and Problem Formulation focus on 
this first phase of a cumulative risk assessment. The document does not 
address other elements of the cumulative risk assessment process, 
including conducting an analysis, risk characterization, risk 
communication, or risk management. Public comments focused on the 
planning and problem formulation phase of a cumulative risk assessment 
would be most useful.
    EPA undertook the development of methods for CRA beginning with the 
1997 Guidance on Cumulative Risk Assessment, Part 1, Planning and 
Scoping. In 2003, EPA published A Framework for Cumulative Risk 
Assessment. EPA continued to advance CRA methods to support 
understanding and reducing risks to people in disproportionately 
impacted communities, in 2008 publishing Concepts, Methods, and Data 
Sources for Cumulative Health Risk Assessment of Multiple Chemicals, 
Exposures and Effects. This draft CRA Guidelines for Planning and 
Problem Formulation build off the 2003 CRA Framework and updates the 
1997 CRA Guidance. The draft CRA Guidelines for Planning and Problem 
Formulation provides methods by which stressors are identified and 
incorporated into problem formulation and a conceptual model. In June 
2021, the draft CRA Guidelines for Planning and Problem Formulation 
received an independent contractor-led external panel peer review. 
Subsequent revision has produced the draft CRA Guidelines for Planning 
and Problem Formulation that is now released for public comment.

III. How will comments be used?

    Public comment received on the draft CRA Guidelines for Planning 
and Problem Formulation will be reviewed and considered to be 
incorporated into or modify text in the final revised draft of the 
Guidelines. The final draft Guidelines will then undergo internal

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EPA review and revision, and then be finalized for publication.

Mary A. Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2023-12972 Filed 6-15-23; 8:45 am]
BILLING CODE 6560-50-P


