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U.S. Consumer Product Safety Commission Amends Regulations on Animal Testing Methods

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Announcement distributed December 10, 2012

A rule published by the U.S. Consumer Product Safety Commission (CPSC) codifies the statement of policy on animal testing that provides guidance for manufacturers of products subject to the Federal Hazardous Substances Act (FHSA) regarding replacement, reduction, and refinement of animals. Codification of this policy is intended to make CPSC's animal testing policy and test methods recommended by ICCVAM and accepted by CPSC more transparent and accessible to interested parties.

The rule was published December 10, 2012, in the Federal Register (77 FR 73286). The rule includes comments received on the proposal and CPSC responses to the comments. The rule also includes the relevant amendments made to the text of 16 CFR part 1500. The statement of policy is effective January 9, 2013.

View Federal Register notice View PDF - View notice as webpage

In a related notice, the CPSC announced amendments to its regulations on the CPSC's animal testing methods under the FHSA. The announcement, also published in today's Federal Register (77 FR 73290) includes comments received on the proposed rule and CPSC responses to the comments. The rule also includes revisions to animal testing regulations and explanations of the rationale for the revisions. The rule takes effect January 9, 2013.

View Federal Register notice View PDF - View notice as webpage

The FHSA (15 U.S.C. 1261-1278) requires appropriate cautionary labeling to alert consumers to the potential hazards that certain hazardous household products may present. These include products that are toxic, corrosive, irritants, flammable, combustible, or strong sensitizers. The changes to the FHSA announced today clarify the criteria used for classification of substances as "highly toxic," "toxic," "corrosive," "irritant," "primary irritant," and "eye irritant." The changes emphasize that the use of in vitro and other alternative test methods, including a weight-of-evidence approach, and prior human experience are recommended over in vivo animal tests wherever possible. Furthermore, the CPSC reiterates its preference for reliable human experience over animal test data.

CPSC has also established a page on its website Exiting the ICCVAM website regarding ICCVAM recommendations and new developments in test methods that avoid or further reduce or refine animal testing.

According to the ICCVAM Authorization Act, ICCVAM member agencies should promote and encourage the development and use of alternatives to animal test methods for regulatory purposes. Since the establishment of ICCVAM, the CPSC has approved, where applicable, recommendations made by ICCVAM to reduce and refine animal testing applicable to test methods under the FHSA. A table summarizing U.S. and international regulatory acceptance of alternative test methods, which includes methods recommended by ICCVAM applicable to testing under the FHSA, is available on the ICCVAM website.

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