EPA denies TSCA petition on cigarettes
The Toxic Substances Control Act (TSCA) section 6(a) authorizes EPA to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, and/or disposal presents an unreasonable risk of injury to health or the environment. If unreasonable risk to health or the environment is determined, then EPA must, by law, issue regulations to the extent necessary to that the chemical substance so that it no longer presents that level of risk.
Petition on chemical mixtures in cigarettes
In August, EPA received a TSCA petition asking the agency to:
- Determine ‘‘that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment,”
- 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,’’
- “Develop material techniques of biodegradation to counter or reduce’’ environmental risk from current disposal methods of cigarettes (cigarette butts), and
- Take “any other prudent methods of toxic mixture substance control [EPA] may see due and fit.”
EPA denies petition
After careful consideration, EPA has denied this TSCA petition, as announced in the October 29th Federal Register. EPA evaluated the information presented in the petition and considered that information in the context of the applicable authorities and requirements of TSCA sections 6, 21, and 26.
The agency explains that TSCA section 3(2)(B) excludes from the definition of “chemical substance” “any mixture” and “tobacco or any tobacco product.” Because the EPA determined a cigarette (including a cigarette butt) to be a tobacco product, such products are not chemical substances and cannot be subject to a rule issued under TSCA section 6(a).
Because the agency also determined that a combination of chemicals with tobacco is not a mixture as defined by TSCA section 3(10), such a combination cannot be subject to a rule issued under TSCA section 6(a).
EPA adds that it cannot compel a manufacturer to alter existing or develop new product designs (such as to reduce cigarette butt disposal to the environment). Moreover, the agency has authority to regulate disposal for commercial purposes, but it has no authority to regulate ordinary consumer disposal methods.
FDA regulates cigarettes
Section 901(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) makes clear that Food and Drug Administration (FDA) has authority over “all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.”