In the wake of multiple recalls of children’s toys, jewelry and other household articles, and under pressure from environmental advocacy groups to exercise its

regulatory authorities under the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) announced a final rule that will require certain manufacturers and importers of consumer products containing lead or lead compounds that are intended for use by children to report certain unpublished health and safety data to EPA. See 73 Fed.Reg. 5109 (Jan. 29, 2008).

The requirements apply to manufacturers and importers across a wide range of industries, including: costume

jewelry and novelty manufacturing; doll and stuffed toy manufacturing, game; toy and children’s vehicle

manufacturing; fastener, button, needle and pin manufacturing; toy and hobby goods and supplies merchant

wholesalers; discount department stores; and warehouse clubs and supercenters. The rule excludes children’s

jewelry, which currently is the subject of rulemaking by the Consumer Product Safety Commission (CPSC). The final rule is effective February 28, 2008, and affected companies must submit the required information between February 28, 2008 and April 28, 2008.

EPA promulgated this new rule pursuant to section 8(d) of TSCA. The rule specifically requires submission of health and safety studies relating to the lead content of consumer products intended for use by children, not including children’s metal jewelry. It also requires studies assessing exposure to lead from such products. EPA is particularly interested in toxicity data that would show a “substantial risk of injury to health or the environment.” All unpublished health and safety studies relating either to the lead content of those products or

exposure assessments (including bioavailability studies) are therefore required to be submitted by companies subject to the regulation.