[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57947-57948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16844]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2023-0032]


Notice of Availability: Proposed Supplemental Guidance for CPSC 
Chronic Hazard Guidelines

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Notice of availability and request for comment.

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SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is 
announcing the availability of proposed supplemental guidance for its 
Chronic Hazard Guidelines. The supplements are draft supplemental 
guidance for the use of benchmark dose methodology in risk assessment, 
and draft supplemental guidance for the analysis of uncertainty and 
variability in risk assessment. The Commission requests comments from 
the public on the proposed supplemental guidance.

DATES: Submit comments by October 23, 2023.

ADDRESSES: You can submit comments, identified by Docket No. CPSC-2023-
0032 by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at www.regulations.gov. Follow the instructions for 
submitting comments. Do not submit through this website: confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. CPSC typically does not accept comments submitted by electronic 
mail (email), except as described below.
    Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC 
encourages you to submit electronic comments by using the Federal 
eRulemaking Portal. You may, however, submit comments by mail, hand 
delivery, or courier to: Office of the Secretary, Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 
telephone: (301) 504-7479.
    Instructions: All submissions must include the agency name and 
docket number. CPSC may post all comments without change, including any 
personal identifiers, contact information, or other personal 
information provided to www.regulations.gov. If you wish to submit 
confidential business information, trade secret information, or other 
sensitive or protected information that you do not want to be available 
to the public, you may submit such comments by mail, hand delivery, or 
courier, or you may email them to: [email protected].
    Docket: For access to the docket to read background documents or 
comments received, go to www.regulations.gov, and insert the docket 
number, CPSC-2023-0032 into the ``Search'' box, and follow the prompts. 
The proposed supplemental guidance is available under ``Supporting and 
Related Material.'' It is also available on the Commission's website 
at: https://www.cpsc.gov/Newsroom/FOIA/ReportList?month=07&year=2023𝔫_type=commission&title, and from the 
Commission's Office of the Secretary.

FOR FURTHER INFORMATION CONTACT: Eric Hooker, Directorate for Health 
Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, 
Rockville, MD 20850; telephone: (301) 987-2516; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    In 1992 the Commission issued guidelines for assessing chronic 
hazards under the Federal Hazardous Substances Act (FHSA), including 
carcinogenicity, neurotoxicity, reproductive/developmental toxicity, 
exposure, bioavailability, risk assessment, and acceptable risk.
    Determining whether a product is or contains a hazardous substance 
involves scientific analysis, legal interpretation, and the application 
of policy judgment. The Guidelines are intended to assist firms in 
identifying products that present chronic hazards, to meet their 
labeling obligations under the FHSA and the Labeling of Hazardous Art 
Materials Act (LHAMA). They are not binding on industry or the 
Commission. Indeed, chronic toxicity may be established in various 
ways. The Commission may determine that a product is a hazardous 
substance due to a chronic hazard based on any evidence that is 
relevant and material to such a determination.
    For example, peer-reviewed scientific studies by third parties and 
toxicity assessments from CPSC's peer agencies may be relevant and 
material evidence to establish chronic toxicity and that a substance is 
a ``hazardous substance'' under the FHSA. Likewise, evidence from third 
parties may be useful to determine chronic toxicity. For instance, 
third party studies may indicate that chronic adverse health effects 
are associated with foreseeable levels of consumer exposure, allowing 
the Commission to conclude that the FHSA's criteria for a ``hazardous 
substance'' are satisfied. Other cases, however, may require CPSC to 
undertake original research to fill gaps in knowledge.
    In addition, while the Guidelines describe certain toxic endpoints, 
they do not limit the toxic endpoints the Commission may consider. The 
Commission may consider all forms of personal injury or illness as 
potential toxic endpoints.
    The chronic hazard guidelines, which should be understood as a set 
of best practices, are not mandatory for the Commission or for 
stakeholders. The guidelines describe methods that CPSC staff may use 
to assess chronic hazards under the FHSA. Furthermore, the guidelines 
are intended to be sufficiently flexible to incorporate the latest 
scientific information, such as advances in risk assessment 
methodology. Risk assessors may deviate from the default assumptions 
described in the guidelines, provided that their methods and 
assumptions are

[[Page 57948]]

documented, scientifically defensible, and supported by appropriate 
data as indicated in section VI.A.2 of the preamble of the guidelines. 
However, given that the guidelines represent an available set of best 
practices, risk assessors are encouraged to use the information and 
approaches outlined therein where appropriate.
    In the years since the guidelines were issued, there have been 
numerous advances in the basic science underlying the guidelines, such 
as the use of transgenic animals to elucidate mechanisms of 
carcinogenicity and toxicity. There also have been several changes in 
the practice of risk assessment, including wider acceptance and use of 
risk assessment methods such as the benchmark dose approach and 
probabilistic exposure assessment. Therefore, CPSC is proposing two 
guidance documents to supplement the 1992 guidelines.\1\
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    \1\ The proposed guidance documents are available at: https://www.cpsc.gov/s3fs-public/Federal-Register-Notice-of-Availability-of-Proposed-Supplemental-Guidance-for-CPSC-Chronic-Hazard-Guidelines.pdf?VersionId=dzserzX2mvO8.sO_Q7Thdcb8YufASIsr.
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    The first supplement provides guidance for the application of 
benchmark dose methodology (BMD) to risk assessment. This supplement 
discusses an alternative to the traditional approach described in the 
original guidelines for estimating acceptable daily intakes (ADIs) for 
carcinogenic and other hazards, such as neurotoxicological or 
reproductive/developmental hazards. The second supplement is guidance 
for the analysis of uncertainty and variability, including use of 
probabilistic risk assessment methodology, which is most relevant to 
exposure assessment.
    Like the 1992 guidelines, the proposed supplemental guidance 
documents are not mandatory. Rather, they describe methods that CPSC 
staff and manufacturers may use to evaluate chronic hazards. The 
guidelines are intended to assist manufacturers in complying with the 
requirements of the FHSA and to facilitate the use of reliable risk 
assessment methodologies by both manufacturers and CPSC staff.

B. Request for Comments

    The Commission invites comments on the proposed guidance 
supplementing CPSC's Chronic Hazard Guidelines with respect to the use 
of benchmark dose methodology in risk assessment and analysis of 
uncertainty and variability in risk assessment.
    The CPSC will consider all timely comments before finalizing the 
supplemental guidance. Comments should be submitted by October 23, 
2023. Information on how to submit comments can be found in the 
ADDRESSES section of this notice.
    Authority: 15 U.S.C. 2079(a); 15 U.S.C. 1261; 15 U.S.C. 1277.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2023-16844 Filed 8-23-23; 8:45 am]
BILLING CODE 6355-01-P