Notice2023-16844
Notice of Availability: Proposed Supplemental Guidance for CPSC Chronic Hazard Guidelines
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2023
Issuing agencies
Consumer Product Safety Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 163 (Thursday, August 24, 2023)</title>
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[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57947-57948]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>. 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: <a href="/cdn-cgi/l/email-protection#5a392a29397735291a392a2939743d352c"><span class="__cf_email__" data-cfemail="2c4f5c5f4f01435f6c4f5c5f4f024b435a">[email protected]</span></a>.
Docket: For access to the docket to read background documents or
comments received, go to <a href="http://www.regulations.gov">www.regulations.gov</a>, 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: <a href="https://www.cpsc.gov/Newsroom/FOIA/ReportList?month=07&year=2023&nfr_type=commission&title">https://www.cpsc.gov/Newsroom/FOIA/ReportList?month=07&year=2023&nfr_type=commission&title</a>, 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:
<a href="/cdn-cgi/l/email-protection#086d606767636d7a486b787b6b266f677e"><span class="__cf_email__" data-cfemail="d6b3beb9b9bdb3a496b5a6a5b5f8b1b9a0">[email protected]</span></a>.
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: <a href="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">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</a>.
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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
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