TSCA Petition to Regulate Cigarettes Goes Up in Smoke

Recent Ask to EPA: Use TSCA to Regulate Chemicals in Cigarettes

Section 21 of the Toxic Substances Control Act (TSCA) establishes a process whereby any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of: rules to require chemical testing, to impose regulatory controls on chemicals, or to require the reporting or submission of information; and certain administrative orders. The petitioner generally must make the case why it is necessary for EPA to initiate the requested action. Under Section 21, once the petition is received, EPA has 90 days to either grant or deny it. If granted, the EPA must then commence the requested regulatory action. If denied, EPA must publish the reason for denial in the Federal Register and such denial can be challenged in federal District Court.

In July 2021, an individual petitioned EPA under TSCA Section 21 to take several actions. The petitioner asked EPA to determine “that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment.” The petitioner also asked EPA to issue a rule or order to “eliminate the hazardous chemicals used in a mixture with tobacco, including and not limited to the toxic substance inclusions resulting from tobacco growing or handling techniques,” and to “develop material techniques of biodegradation to counter or reduce” environmental risk from current cigarette disposal methods. Lastly, the petitioner requested “any other prudent methods of toxic mixture substance control [EPA] may see due and fit.” The petition did not focus on any specific chemical, but rather cited to general allegations of negative impact to human health and the environment from cigarettes and cigarette butts.

The Answer: We Can’t

On October 29, EPA published its response in the Federal Register. The underlying legal basis for EPA’s decision was rather simple and straightforward: TSCA gives the EPA authority to regulate chemical substances. TSCA section 3(2)(B), which defines “chemical substance,” explicitly excludes “tobacco or any tobacco product” from the definition. EPA cited to the Federal Food Drug and Cosmetic Act for definition of “tobacco product,” and that would include cigarettes and cigarette butts. Having concluded that cigarettes and cigarette butts are tobacco products, and tobacco products are not “chemical substances,” it followed that EPA has no TSCA-granted authority to regulate cigarettes and cigarette butts. Accordingly, EPA is not able to issue any rule under TSCA concerning cigarettes, and the action sought in the petition is beyond EPA authority. Hence, the petition was formally denied.

Is There More to the Answer Than Meets the Eye?

Despite the decision’s simplicity, it is nonetheless noteworthy as it is the first decision on a Section 21 petition under the Biden Administration that implicates risk management rulemakings under TSCA Section 6. In responses to Section 21 petitions requesting Section 6 risk management rulemaking issuing from the Trump administration’s EPA, the Agency made rather clear pronouncements regarding the “burden of proof” requirements for such petitions: In a petition, EPA would expect the same data and analysis to be cited or submitted that would be used for an EPA-conducted TSCA risk evaluation that would precede a section 6(a) rulemaking under the 2016 amendments to TSCA. Those facts would need to be sufficiently clear and robust for EPA to be able to conclude, within 90 days of receiving a petition, that the chemical (s) in question present(s) an unreasonable risk of injury to health or the environment and that a TSCA section 6(a) rule is the appropriate response to the petition. (See TSCA Section 21 Petition To Prohibit the Use of Hydrofluoric Acid at Oil Refineries; Reasons for Agency Response ).

In contrast, in its response to the tobacco petition, the Biden EPA made no such pronouncements. In fact, EPA appeared to move in the opposite direction. EPA explicitly stated that “(n)otwithstanding that the burden is on the petitioner to present ‘‘the facts which it is claimed establish that it is necessary’’ for EPA to initiate the rule or issue the order sought, EPA nonetheless also considered relevant information that was reasonably available to the Agency during the 90- day petition review period.” EPA implies it went beyond the information contained in the petition during its review. Nevertheless, the basis for EPA’s decision was solely that cigarettes are not a product that can be regulated under TSCA. The decision also made no mention as to whether the information provided by a petitioner must meet EPA’s own Section 6 risk evaluation standards, and if the information submitted in the instant case indeed met those standards.

The absence of any elaboration on the Section 6 review standard may be simply attributable to the fact that EPA had a straightforward reason for denying the petition: no statutory authority over cigarettes. There has been a rise in litigation in recent years following TSCA section 21 petition denials. However, the articulation of the intent to “do things differently” than the last administration by current leadership at EPA, and the agency’s statement in their analysis that EPA went beyond the facts presented in the petition, give reason to pay careful attention to how this EPA will handle future Section 21 petitions for Section 6 Risk management rules.

© 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.