A December 3 announcement from the US Environmental Protection Agency (EPA) indicates the Agency’s continued willingness to play a role in regulating consumer products on the basis of chemical content. EPA has released a final Toxic Substances Control Act (TSCA) rule that will require manufacturers of cadmium or cadmium compounds and those who import cadmium or cadmium compounds, including products (i.e. “articles”) that contain those substances, to report certain unpublished health and safety studies to EPA when the substances have been or are reasonably likely to be incorporated into consumer products.
This rule is likely to be of importance not only to companies in the chemicals industry, but also to the makers and importers of consumer products (including toys and electronics) that might contain cadmium and cadmium compounds. EPA has identified the following types of industries as potentially implicated by the rule (though this list is not exhaustive):
- Manufacturers of basic inorganic chemicals
- Manufacturers (including importers) of inorganic dyes and pigments
- Manufacturers of basic organic chemical products
- Establishments engaged in primary production or refining of nonferrous metals (except copper and aluminum)
- Wholesalers of toy and hobby goods
- Discount department stores
- Warehouse clubs and supercenters
Companies affected by the rule will have to report certain types of existing studies related to cadmium and cadmium compounds, but not undertake new studies to meet the rule’s requirements. Types of studies that must be reported include those on the following topics:
- Human health effects, including studies related to mutagenicity, carcinogenicity, teratogenicity, and pharmacology of the chemical substance in question;
- Ecological and environmental effects, including those related to invertebrates, fish, other animal, plants, and ecosystems;
- Human and environmental exposure, including studies relating to workplace exposure, chemical degradation, biomagnification, and chemical and physical properties of the chemical substance in question; and
- Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
Perhaps more ominously for importers of consumer use products (and at some later date processors and even retail distributors), the Agency interprets the definition of health and safety studies to include studies showing “measurable content of cadmium or cadmium compounds in consumer products.”
For more detailed information about the EPA rule and its implications, click here.