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Environmental Edge
December 3, 2021

EPA: We (Also) Can't Regulate Chemicals in Cosmetics Under TSCA

Environmental Edge: Climate Change & Regulatory Insights

Citizens groups, environmental groups, and even concerned individuals continue to try to use the Toxic Substances Control Act to compel EPA to take actions to regulate certain chemicals. 

We previously discussed EPA's recent denial of a petition under TSCA Section 21 requesting that EPA regulate chemicals in cigarettes. The decision there was based on rather straightforward legal principles: although EPA has broad authorities under TSCA, the agency may only exercise that authority to regulate "chemical substances." Given that Congress excluded tobacco and tobacco products from the statutory definition of "chemical substances," EPA has no TSCA-based authority to regulate cigarettes; it followed that EPA must deny the petition. The individual who submitted the cigarette petition submitted another Section 21 petition, but this time focusing on cosmetics. The petitioner asked EPA to determine "that the chemical mixtures contained within cosmetics present an unreasonable risk of injury to public health and the environment; and order by rule that the manufacturing producers of cosmetics eliminate the hazardous chemicals used in mixtures."

Just as with the cigarette petition, EPA's primary rationale for denial of the cosmetics petition was straightforward: TSCA section 3(2)(B), which defines "chemical substance," excludes "any food, food additive, drug, cosmetic, or device when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device." Accordingly, under TSCA, "cosmetics" are not a "chemical substance" when manufactured, processed, or distributed in commerce solely for use as a cosmetic and the EPA cannot therefore issue a rule pursuant to TSCA section 6(a) to impose requirements on the manufacturers of cosmetics. Simply stated, the petition requested actions that were outside EPA's jurisdiction under TSCA, and the petition therefore had to be denied.

What is notable about the denial are the multiple rationales present in the EPA's explanation of the disposition of the petition. As mentioned, the principal reason for denial was simple enough: lack of statutory authority over cosmetics. The specific ask in the petition was for EPA to mandate that manufacturers eliminate hazardous chemicals in cosmetics. Yet, EPA apparently felt compelled to use its denial notice to simultaneously explore whether there were facts presented by the petitioner establishing that cosmetics disposal - a subject that was merely mentioned in the petition - presented an unreasonable risk to human health or the environment, thereby demonstrating the necessity to initiate action pursuant to Section 21 (an action for which no specific request was made in the petition). This intellectual exercise did flesh out a nuance that was not addressed in the cigarette petition, and one we highlighted in our discussion of that petition: what substantiation must be presented in a Section 21 petition to allow EPA to go forward with a Section 6 risk management rulemaking. EPA's statement on this point was clear: a petition for a TSCA section 6(a) rulemaking must set forth facts which would enable EPA to conclude that there is an unreasonable risk for which a TSCA section 6(a) risk management rule is warranted. Perhaps EPA wanted to stress this point and therefore took an opportunity to do.

With this most recent response, EPA is up to date on responding to all known pending Section 21 petitions it has received. Now that this EPA has set some key parameters for what is required to sustain a Section 21 petition for a risk management rulemaking, it remains to be seen whether the process will indeed be more successfully used for that purpose.

© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.