U.S.-A company is importing a medical device covered under Section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (and thus exempt from TSCA). Company A imports the medical device in a package that contains PFAS, and the packaging is removed before use. Is the company required to report under the TSCA 8(a)(7) rule?

Possibly. TSCA § 3(2)(B)(vi) excludes from the definition of “chemical substance” “any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.” 15 U.S.C.§2602(2)(B)(vi) (emphases added).

Under the relevant FFDCA definitions, substances intended for use as a component of a food,  food additive, drug, cosmetic, or device are encompassed within the meaning of such terms. However, chemical substances in packaging materials could meet the definition of “chemical Substance” under TSCA even if the packaging material is later used to hold medical devices. The determination of whether a substance is excluded from the definition of “chemical substance” under TSCA because it falls under the FFDCA’s definition is product-specific and is made on a case by-case basis in a fact-specific inquiry. The company may consider reaching out to the Food and Drug Administration to confirm whether the medical device packaging falls under the jurisdiction of Section 201 of the FFDCA.

Attachment

Toxic Substances Control Act (2016 Amendment)