[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Notices]
[Page 18772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06825]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2021-0006]


Notice of Availability: Final 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, ``Final 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.''

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: 
<a href="/cdn-cgi/l/email-protection#e18b868e93858e8fa1dd80c189938487dc" http: cpsc.gov">cpsc.gov</a>">jgordon@cpsc.gov</a>.

SUPPLEMENTARY INFORMATION: 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 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 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, on March 31, 2021, the Commission 
published a Notice of Availability in the Federal Register and 
requested comments on ``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'' 86 FR 16704. CPSC received five 
comments that are addressed in the staff's briefing package on the 
final guidance. The staff's briefing package is available on CPSC's 
website at NAM Final Guidance BVS (cpsc.gov).
    The CPSC has finalized its guidance for industry and test method 
developers.\2\ The final guidance informs the public of staff's 
informational requirements and process for evaluating NAMs and IATAs. 
The final guidance does not prescribe a specific form of validation and 
explains that validation can be accomplished via several different 
processes. A method's reliability includes reproducibility, 
repeatability, and robustness. In addition to the performance and 
applicability of the NAM/IATA, good scientific, technical, and quality 
practices will ensure that the overall process is more efficient and 
effective and leads to increased confidence in the proposed method. The 
final guidance also includes an optional NAM nomination form that can 
be used to organize information about a NAM or IATA for evaluation by 
CPSC staff. 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.
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    \2\ The Commission voted 4-0 to approve this notice.
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    The final guidance will be available at: https://www.regulations.gov under docket number, CPSC-2021-0006, under 
``Supporting and Related Material,'' and on the Commission's website 
at: https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Recommended-Procedures-Regarding-the-CPSCs-Policy-on-Animal-Testing.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-06825 Filed 3-30-22; 8:45 am]
BILLING CODE 6355-01-P


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