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What Are the TSCA Requirements for Components of a Polymeric Coating?

December 15, 2009
Question 

Is the sale of liquid non-TSCA permitted material allowed if the dried film is FDA 175.300 compliant?

Answer 

The answer to your question would depend on how the dried film is used. By way of background, the Toxic Substances Control Act (TSCA) was enacted in 1976 to establish a framework to regulate chemicals, yet avoid overlap in federal agency jurisdiction with respect to end-use applications already subject to regulation under other statutes, such as the Federal Food, Drug, and Cosmetic Act (FFDCA). Thus, several products that are regulated under other federal statutes, are excluded from the term "chemical substance" and, aside from an import certification requirement, are not subject to regulation under TSCA, provided that the product is being used solely for the application regulated by the other federal statute.

Hence, while the FFDCA exemption may exempt food packaging from the requirements of TSCA, it is important to note that this exemption applies only as long as end-uses are limited solely to uses regulated by FDA (e.g., food additives, cosmetics, medical devices). Consequently, to rely on this exemption, you would need to monitor the end-uses of the dried film, and ensure that it is not manufactured for sale into other applications. The regulation of chemical substances under TSCA is fraught with complexities that can easily trip-up the unaware. Please consult with counsel before acting in this area. For more information, see the PackagingLaw.com article, TSCA: Italian Opera or EPA Regulation?