Potentially burdensome regulations governing children’s products take effect in less than two months. The new regulations, issued by the United States Consumer Product Safety Commission (CPSC), apply to children’s products manufactured after February 8, 2013. “Children’s products” are any “consumer product designed or intended primarily for children 12 years of age or younger.” 15 U.S.C. § 2052(a)(2). The new regulations govern manufacturers and importers of those products. 16 C.F.R. § 1107. Because of the likely burden of implementing and complying with the new rules – particularly testing and record-keeping requirements – companies must take steps now to understand how the rules will impact them. Key provisions of the new rules are summarized below.
Third-Party Testing. Beginning on February 8, 2013, covered manufacturers, and any wholesaler or importer that issues the Children's Product Certificate for a product, must submit a sufficient number of samples of a children’s product to an accredited third-party conformity assessment body for testing to support certification and issuance of the Certificate. Id. § 1107.20(a). The covered entity must specify the number of samples to be tested. The covered entity also must submit a sufficient number of samples to a third party assessment body for re-certification of a product when it undergoes a “material change” in design, manufacturing process, or sourcing of components that could affect the product’s ability to comply with applicable safety rules. Id. §§ 1107.2 and 1107.23(a). Should a sample fail certification testing, the covered entity must investigate and remedy the failure and then submit the corrected product for testing. Id. § 1107.20(d). Certified products may bear a label stating “Meets CPSC Safety Requirements.” Id. § 1107.30. To the extent that a wholesaler or importer relies on a manufacturer or supplier for the Children's Product Certificate, those entities must exercise due care to ensure that appropriate testing is undertaken by the manufacturer or supplier.
Ongoing Testing of Children’s Products. Even after a children’s product has been certified, covered entities must use third party conformity assessment bodies to periodically test representative product samples to ensure, with a high degree of assurance, ongoing compliance with all applicable product safety rules. Covered entities can satisfy the periodic testing requirement in several ways, including a “periodic testing plan” involving at least annual tests of representative samples sufficient to provide a high degree of assurance that products manufactured after certification (or since previous periodic testing) are compliant. Id. § 1107.21. Covered entities must carefully document this process, including the procedure used to select representative samples and the basis for inferring compliance from the results of the tested samples. Id. Companies may use component part testing under 16 C.F.R. § 1109 to support the periodic testing requirement.
Avoiding Undue Influence Over Assessment Bodies. Covered entities also are required to implement procedural safeguards against the exercise of undue influence over third party conformity assessment bodies. Id. § 1107.24. These procedures include a written policy statement from the manufacturer, training for all appropriate employees and a signed statement attesting to participation, required reporting to the CPSC of any attempt to hide or exert undue influence over test results, and informing employees of how to confidentially report undue influence to the CPSC. Id.
Required Recordkeeping. The new rules also set forth detailed record keeping requirements, including meticulous documentation of product testing. Covered entities are required to keep the following types of records (electronically or in hardcopy) for each children’s product for five years from the date of production: (1) a copy of the Children’s Product Certificate; (2) records of each third party certification test for each manufacturing site; (3) records of testing plans, actual testing and/or results, as applicable; (4) records of the number of representative samples selected for periodic testing, the procedure used to select them, the testing conducted on those samples, and the basis for inferring compliance from the results of those tested samples; (5) records of descriptions of all “material changes” under § 1107.23; (6) records of the undue influence procedures implemented by the manufacturer, including training materials and employee attestations. Id. § 1107.26(a).