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Non-animal Methods for Toxicity Testing

CPSC


Last Updated: December 6, 2007
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  • The U.S. Consumer Product Safety Commission (CPSC) is an independent federal regulatory agency created by Congress in 1972 pursuant to the Consumer Product Safety Act (CPSA). CPSC's mandate is to "protect the public against unreasonable risks of injuries and deaths associated with consumer products."

    About 15,000 types of consumer products are regulated by the CPSC, including items such as children's toys and furniture, mattresses, household appliances, and some chemical components of common household products. The CPSC addresses its mandate to protect the public from hazardous consumer products by developing voluntary and mandatory standards, enforcing mandatory standards, banning and/or recalling unsafe consumer products, and educating consumers about product safety and responding to their inquiries. Another role of the CPSC involves "conducting research on potential product hazards."

     

    Test Regulations & Guidelines

    The activities of the CPSC are directed by statutes and regulations, including the following:

    The CPSC oversees two types of product safety standards: government-mandated and voluntary. The products covered under each type of standard are listed along with other pertinent information and documents on the CPSC website. A mandatory standard does not preclude the existence of voluntary standards also related to a product type. If a product of interest is not listed under the CPSC's mandated or voluntary standards, then it might be under the jurisdiction of another agency.

    The CPSC provides technical support for voluntary standards, but three external standards organizations coordinate and/or develop over 90% of the voluntary safety standards: the American National Standards Institute (ANSI), ASTM International, and Underwriters Laboratories (UL). "These standards are not endorsed by the CPSC; however, failure to meet a voluntary safety standard could lead to a substantial product hazard determination by the Commission and result in a recall" (http://www.cpsc.gov).

    The CPSC Business Site summarizes and links to additional information important for industries developing products regulated by the CPSC.

     

    Alternatives Policies and Actions

    The CPSC issued the following note on animal testing:

    "The FHSA only requires that a product be labeled to reflect the hazards it presents. It does not require anyone to perform animal tests. The Commission policy is, whenever possible, to evaluate product hazards by using alternatives to animal testing. We encourage anyone evaluating products to determine whether they present hazards listed in the FHSA to follow a similar policy. Since the FHSA directs that reliable human experience data take precedence over differing results from animal tests, we first look to records of prior human experience with specific products, if such records exist. Other alternative sources of information we research include literature that records the results of prior animal testing or the results of limited human tests, and expert opinion. We use animal testing only when the other information sources have been exhausted, and, if such testing is necessary, limit those tests to the lowest possible number of animals, taking every possible step to eliminate or reduce the pain or discomfort that can be associated with such tests" (Federal Register Vol. 49, No. 105, 6/30/84).

    The CPSC, as described in its animal testing policy statement, encourages the use of and even prefers the use of human data for the assessment of human toxicity. "Both the FHSA at 2(h)(2) and the supplemental definitions state that available data on human experience that indicate results different from those obtained in animals in the defined dosages or concentrations will always take precedence."

    The CPSC maintains the National Electronic Injury Surveillance System database (NEISS), which contains patient information for every emergency visit to an NEISS hospital that involves an injury from a consumer product. While this database may be useful to the CPSC and to industry for determining the numbers and types of product-related injuries, the human data collected by the NEISS hospitals does not appear to support human hazard identification or classification for chemical-containing products, which could be useful in the development and validation of models EM>

    The CPSC is one of the 15 US federal agencies that are members of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Dr. Marilyn Wind of the CPSC is the acting chair of ICCVAM. CPSC representatives to ICCVAM have participated in its many meetings, panels, and workshops to promote the validation and acceptance of new alternative toxicological test methods. The CPSC, as required by the ICCVAM Authorization Act of 2000 (P.L. 106-545), has reviewed and submitted responses on its acceptance of alternative test methods recommended to US agencies by ICCVAM. For example, in 2003 the CPSC approved the "recommendations of ICCVAM that for the purpose of classification and labeling, the Revised Up-and-Down Procedure (UDP) be used instead of the conventional LD50 test to determine the acute oral toxicity hazard of chemicals...".

    In 2007, the CPSC submitted to ICCVAM/National Toxicology Program Interagency Center for Evaluation of Alternative Toxicological Methods (NICEATM) a nomination entitled Request for Assessment of the Validation of the Local Lymph Node Assay for Classification of Sensitizers. ICCVAM and the European Centre for the Validation of Alternative Methods (ECVAM) had judged the mouse Local Lymph Node Assay (LLNA) to be a validated alternative to the Guinea Pig Maximization Test for hazard identification; the test significantly reduces animal use for this testing application. The CPSC's recent nomination of the LLNA involves its concerns over the proposed uses of the LLNA that have not undergone formal validation, including but not limited to the following: potency determination for classification purposes by the Globally Harmonized System for Classification and Labeling of Chemicals (GHS); the use of nonradioactive chemicals in LLNA protocols; and the use of an LLNA limit test. The CPSC has requested that ICCVAM review the validity of the LLNA for these purposes. The US Food and Drug Administration (FDA) and the US Environmental Protection Agency (EPA) accepted the LLNA assay for use after ICCVAM validated it in 1999. However, the CPSC has not formally accepted the LLNA. ICCVAM is assembling a peer review panel to conduct a review of the LLNA assay as recommended by the CPSC.