On December 3, 2012, the U.S. Environmental Protection Agency (EPA) continued its use of the Toxic Substances Control Act (TSCA) to regulate products (not just chemicals) in publishing a final rule adding cadmium and cadmium compounds to the TSCA Section 8(d) rule. In so doing, manufacturers and importers of cadmium must submit unpublished health and safety studies to the EPA (including use in materials that have been or are "reasonably likely" to be incorporated into consumer products). This article summarizes the rule and its implications.
In 2010, several petitioners asked EPA and the Consumer Product Safety Commission (CPSC) to address their concern with the presence of cadmium in toy metal jewelry. They requested the CPSC to restrict the use of cadmium to prevent children's exposure to cadmium from such products, and EPA to seek health and safety data and to limit cadmium in toy metal jewelry. Since then, ASTM has issued a voluntary standard addressing CPSC's concerns. The final rule reflects EPA's response to the petitioners' request. TSCA Section 8(d) authorizes EPA to issue rules requiring manufacturers (including importers), processors, or distributors of targeted chemical substances to submit health and safety studies pertinent to such substances.
Under the rule, companies that in the ten years preceding the date a chemical substance is listed either have proposed to manufacture or import or have manufactured or imported the listed substance must submit to EPA a copy of each health and safety study that's in their possession. The same requirement applies to manufacturers or importers that at the time the chemical substance is listed propose to manufacture or import, or are manufacturing or importing the listed chemical substance. The studies must be submitted to EPA by March 4, 2013.
Manufacturers and importers must submit a copy of all unpublished health and safety studies, as well as any studies showing "measurable content of cadmium or cadmium compounds in consumer products."
Why This Rule Is Important
This rule is precedent-setting for several reasons. First, the scope of the rule is vast. "Consumer products" is broadly defined to include items used in and around homes, schools, recreational areas and temporary residences. The rule applies to cadmium at "any measurable level." This sweeps in a huge cross section of consumer products. It does exclude products where cadmium only appears only as an impurity.
Second, "health and safety studies" include any data that "bear on the effects of a chemical substance on health or the environment. . . ." Studies "showing any measurable content of cadmium or cadmium compounds" are reportable.
Third, the requirement applies not just to the chemical, but to the product in which the chemical is embedded regardless of whether there's any potential for the cadmium to be bioavailable or present an exposure risk.
Finally, it's unclear whether the rule imposes a duty to determine whether a product includes cadmium or if cadmium is "reasonably likely to be incorporated" into a consumer product. The rule offers no guidance on what this means or how to assess whether cadmium is "reasonably likely" to be incorporated into a consumer product.
For all these reasons, this rule is troubling. Its issuance raises a raft of procedural concerns beyond the scope of this article. The rule extends TSCA's reach under Section 8(d) well beyond chemicals to products. Because cadmium is found in thousands of consumer products, especially electronics, many entities subject to the rule may be unaware of its application. It's all the more troubling that a rule with so many precedent-setting implications wasn't subject to standard notice and comment rulemaking.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).