18772 Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Notices 

1https://www.cpsc.gov/Business— 

Manufacturing/Testing-Certification/ 

Recommended-Procedures-Regarding-the-CPSCsPolicy-on-Animal-Testing/. 

2The Commission voted 4–0 to approve this 

notice. 

Estimated Average Burden Hours per 

Respondent: 1,148.5 hours. 

Estimated Total Annual Burden 

Hours: 122,889.5 hours. 

Frequency of Collection: As 

applicable. 

There are no capital costs or operating 

and maintenance costs associated with 

this collection. 

(Authority: 44 U.S.C. 3501 et seq.) 

Dated: March 25, 2022. 

Robert Sidman, 

Deputy Secretary of the Commission. 

[FR Doc. 2022–06751 Filed 3–30–22; 8:45 am] 

BILLING CODE 6351–01–P 

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. 

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: jgordon@cpsc.gov. 

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 nonanimal 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 CPSCaccepted 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). 

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. 

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/TestingCertification/RecommendedProcedures-Regarding-the-CPSCsPolicy-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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