[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Notices]
[Pages 16704-16705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06567]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2021-0006]


Title: Notice of Availability: Proposed Guidance on Alternative 
Test Methods and Integrated Testing Approaches

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Notice of availability.

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SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is 
announcing the availability of a document titled, ``Proposed Guidance 
for Industry and Test Method Developers: CPSC Staff Evaluation of 
Alternative Test Methods and Integrated Testing Approaches and Data 
Generated from Such Methods to Support FHSA Labeling Requirements.'' 
The Commission requests comments on the proposed guidance.

DATES: Submit comments by June 14, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2021-
0006, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov. The CPSC encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Mail/hand delivery/courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer 
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, 
MD 20814; telephone: (301) 504-7479; email: [email protected].
    Instructions: All submissions must include the agency name and 
docket number for this notice. CPSC may post all comments received 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: https://www.regulations.gov. Do not submit electronically: Confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. If you wish to submit such information, please submit it 
according to the instructions for written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2021-0006, into the ``Search'' box, and follow the 
prompts. The proposed guidance is available under ``Supporting and 
Related Material.'' It is also available on the Commission's website 
at: https://cpsc.gov/s3fs-public/NOA-Proposed-Guidance-on-Alternative-Test-Methods-and-Integrated-Testing-Approaches.pdf?NDYVpNRIAMpOPJDPzlt770dvxnvPJHh6 and from the 
Commission's Division of the Secretariat.

FOR FURTHER INFORMATION CONTACT: John Gordon, Toxicologist, Directorate 
for Health Sciences, U.S. Consumer Product Safety Commission, 5 
Research Place, Rockville, MD 20850; telephone: 301-987-2025; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1275, 
requires that hazardous substances bear certain cautionary statements 
on their labels. Manufacturers may perform toxicological tests to 
determine whether such products require cautionary labeling addressing 
the hazard. Although animals are still used in toxicological testing, 
most governmental agencies support reduced use of animals in testing, 
by promoting the acceptance of data from alternative test methods.
    In 1997, the National Institute of Environmental Health Sciences 
(NIEHS), the National Toxicology Program (NTP), and 13 federal agencies 
(including CPSC) joined to form the Interagency Coordinating Committee 
for the Validation of Alternative Methods (ICCVAM). ICCVAM sponsors 
scientific review of non-animal tests (known as New Approach 
Methodologies or NAMs) that may reduce, refine, or replace animal tests 
in evaluating potential hazards. Reviews from ICCVAM and other federal 
agencies can provide a basis for regulatory agencies, such as CPSC, to 
consider non-animal testing alternatives for use in regulatory decision 
making. In the past, CPSC staff relied upon ICCVAM's validation of new 
alternative testing methods, as reliable test methods to determine 
compliance with the labeling requirements of the FHSA. However, ICCVAM 
no longer formally validates test methods.
    In 2012, CPSC issued a policy on non-animal or alternative testing 
methods to support labeling requirements under the FHSA, as codified 
under 16 CFR 1500.232 (Animal Testing Policy). CPSC's website lists 
current CPSC-accepted alternative test methods and their conditions of 
use.\1\ Since 2012, new advancements in toxicological testing, and, in 
particular, with NAMs, have occurred. NAMs include in vitro (in test 
tube), in chemico (all chemical test, no biological material), or in 
silico (computer models) methods and approaches used to test for 
toxicological effects in place of animal testing. In some cases, NAMs 
are combined with other NAMs or existing in vivo (animal) data to form 
an ``integrated approach to testing and assessment'' (IATAs).
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    \1\ https://www.cpsc.gov/Business-Manufacturing/Testing-Certification/Recommended-Procedures-Regarding-the-CPSCs-Policy-on-Animal-Testing/.
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    The Commission reaffirms its policy to find alternatives to 
traditional animal testing that replace animals, reduce the number of 
animals tested, and decrease the pain and suffering in animals 
associated with testing household products. As such, the Commission 
strongly encourages all agency stakeholders to submit for evaluation by 
CPSC staff any scientifically validated alternative test methods that 
do not require animal testing for determining compliance with the 
labeling requirements under the FHSA.
    Because ICCVAM no longer formally validates test methods, to assist 
stakeholders, including the public, manufacturers, test method 
developers, and test laboratories, in determining what test methods are 
deemed reliable for determining compliance with the labeling 
requirements under the FHSA,

[[Page 16705]]

CPSC staff drafted proposed guidance clarifying staff's informational 
requirements and process for evaluating NAMs and IATAs. As described in 
the proposed guidance, the types of information CPSC staff would use to 
evaluate NAMs or IATAs submitted to CPSC would include (but not be 
limited to): Concordance and reproducibility data; false positive and 
false negative rates; applicability domain; test endpoint; validation 
studies; or any other pertinent information needed to make a 
determination. The proposed guidance also includes an optional NAM 
nomination form, which can be used to organize information about a NAM 
or IATA for CPSC staff evaluation. Such non-animal alternative test 
methods, if accepted by CPSC, would be considered reliable test methods 
for determining compliance with the labeling requirements under the 
FHSA. Additionally, CPSC would continue to list CPSC-accepted 
alternative test methods on CPSC's website.
    The proposed guidance is not a rule and does not establish legal 
requirements. The proposed guidance is intended to inform stakeholders 
about what information CPSC staff uses to evaluate NAMs or IATAs for 
FHSA labeling determinations. The proposed guidance also informs 
stakeholders of CPSC staff's process for evaluating that information. 
Depending on the complexity of specific NAMs or IATAs, the information 
discussed in the guidance may or may not apply; and in some instances, 
staff may need additional information not specifically described in the 
guidance document to make an evaluation. The proposed guidance is 
available at: https://www.regulations.gov under docket number, CPSC-
2021-0006, under ``Supporting and Related Material'', on the 
Commission's website at: https://cpsc.gov/s3fs-public/NOA-Proposed-Guidance-on-Alternative-Test-Methods-and-Integrated-Testing-Approaches.pdf?NDYVpNRIAMpOPJDPzlt770dvxnvPJHh6, and from the CPSC's 
Division of the Secretariat, as provided in the ADDRESSES section of 
this notice.

B. Request for Comments

    The Commission invites comments on the ``Proposed Guidance for 
Industry and Test Method Developers: CPSC Staff Evaluation of 
Alternative Test Methods and Integrated Testing Approaches and Data 
Generated from Such Methods to Support FHSA Labeling Requirements.'' 
The CPSC will consider all timely comments before finalizing the 
guidance. Comments should be submitted by June 14, 2021. Information on 
how to submit comments can be found in the ADDRESSES section of this 
notice.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2021-06567 Filed 3-30-21; 8:45 am]
BILLING CODE 6355-01-P