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 mission is defined as “Protecting the public against unreasonable risks of injury from consumer products through education, safety standards activities, regulation, and enforcement.”
The five strategic goals of the CPSC listed below are described in detail in CPSC’s 2011-2016 Strategic Plan:
Five Commissioners, appointed by the President, oversee the CPSC with one designated as the Chairperson. The Chairperson oversees six offices, with the Office of Executive Director being further divided into four offices involved in operations support and four offices involved in safety operations. The main CPSC office is located in Bethesda, Maryland, and the CPSC National Product Testing and Evaluation Center is located in Rockville, Maryland.
The CPSC website provides good access to their reports and activities and explains specific activities related to product safety, injury prevention, and hazard identification. 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.
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 (products such as automobiles, drugs, and pesticides).
The CPSC provides limited 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). “CPSC staff considers these standards to be a safety floor from which to design your product…[and manufacturers] are encouraged to consider how consumers may use or even misuse [a] product in ways that were not intended but may still be foreseeable from the CPSC’s perspective.”
The CPSC Business Site summarizes and links to additional information important for industries developing products regulated by the CPSC.
The CPSC also maintains the National Electronic Injury Surveillance System (NEISS), a large database of patient information for every emergency visit to a NEISS hospital that involves an injury from a consumer product. All types of product injuries seen in these emergency departments are documented according to a product code(s) so that product-related injuries nationwide can be estimated from the data.
The activities of the CPSC are directed by statutes and regulations. CPSC’s Regulations are specified in the Code of Federal Regulations (CFR), Title 16, Chapter II.
In 2008, the Consumer Product Safety Improvement Act (CPSIA) authorized new regulations and testing for children’s and some other products by amending several CPSC statutes, including the CPSA. These changes allowed creation of SaferProducts.gov, a publicly-searchable database on consumer-reported product problems.
The CPSC is charged with administering the following laws related to consumer product safety:
The Federal Hazardous Substances Act, which “requires precautionary labeling on the immediate container of hazardous household products,” is the CPSC law most likely to result in regulations specifying toxicity testing. “To require labeling, a product must first be toxic, corrosive, flammable or combustible, an irritant, or a strong sensitizer, or it must generate pressure through decomposition, heat, or other means. Second, the product must have the potential to cause substantial personal injury or substantial illness during or as a result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.”
The Summary of guidelines for determining chronic toxicity (§ 1500.135) covers approaches for assessing chronic hazards such as carcinogenicity, neurotoxicity, and reproductive and developmental toxicity. Data to support labeling claims for these toxicity endpoints are generated by conducting animal testing, which requires the use of many animals (typically rodents) per test substance and endpoint. This section of the FHSA also makes the following statement regarding the use of animal alternative test methods: “All default assumptions contained in the guidelines on hazard and risk determination are subject to replacement when alternatives which are supported by appropriate data become available.”
Other relevant sections of FHSA, including testing toxic substances (§ 1500.40), eye irritants (§ 1500.42), and dermal irritants (§ 1500.41), indicate that guidelines for testing include tests that do not require animals as provided in the CPSC’s animal testing policy (16 CFR 1500.232). Additionally, § 1500.4, Human experience with hazardous substances, indicates that reliable human data takes precedence over differing animal data.
Part of the CPSC Statement on animal testing policy (§1500.232), as updated in 2012, states that
Neither the FHSA nor the Commission’s regulations requires animal testing. Reliable human experience always takes precedence over results from animal data. In the cases where animal tests are conducted, the Commission prefers test methods that reduce stress and suffering in test animals and that use fewer animals while maintaining scientific integrity. To this end, the Commission reviews recommendations on alternative test methods developed by the scientific and regulatory communities. Current descriptions of test method recommendations approved by or known to the Commission can be accessed via the Internet at: http://www.cpsc.gov/Business–Manufacturing/Testing-Certification/Recommended-Procedures-Regarding-the-CPSCs-Policy-on-Animal-Testing [an updated link]. The Commission strongly supports the use of scientifically sound alternatives to animal testing.
The Commission’s animal testing page, “Recommended procedures regarding the CPSC’s policy on animal testing” (November 26, 2012), clearly articulates the agency’s policy on accepting animal alternative test methods, as well as explaining exactly which alternative methods it has/will consider accepting. The CPSC animal testing page is accessible only through “search” or by using this direct link.
The CPSC is one of 15 US federal agencies whose members comprise the Interagency Coordinating Committee on the Validation of Alternative Methods (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. Dr. Marilyn Wind also served as the ICCVAM Chair from 2004-2010. 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.
In 2007, the CPSC submitted a nomination to ICCVAM entitled Request for Assessment of the Validation of the Local Lymph Node Assay [LLNA] for Classification of Sensitizers. ICCVAM and the European Centre for the Validation of Alternative Methods (ECVAM) had judged the mouse LLNA to be a validated alternative to the Guinea Pig Maximization Test for hazard identification in 1999; the test significantly reduces animal use for this testing application. The CPSC’s nomination of the LLNA involved its concerns over the proposed uses of the LLNA that had not undergone formal validation. Although the CPSC did not accept the original LLNA test method, following the additional assessments they did accept the several newer versions and modifications of the LLNA in 2010 and 2011.