Thomas C. Berger of Keller & Heckman overviews some of the key pitfalls of enforcement of the Toxic Substances Control Act
REGULATION & COMPLIANCE
TSCA: A trap for the unwary
Thomas C. Berger of Keller & Heckman overviews some of the key pitfalls of enforcement of the Toxic Substances Control Act
Companies that conduct business in the US, including some that may not traditionally regard themselves as‘ chemical’ companies, would be well advised to be mindful of the requirements of and penalties for noncompliance with the general chemical regulatory law in the US: the Toxic Substances Control Act( TSCA).
TSCA and its implementing regulations create a comprehensive scheme that govern the manufacture, import, processing, distribution, use and export of‘ chemical substances’. Non-compliance can result in multimillion dollar penalties, regardless of the absence of fault or any measurable harm to human health or the environment. Even if a company can avoid its monetary penalties, TSCA can create financially catastrophic business shutdown situations.
Successfully navigating TSCA’ s regulatory and penalty schemes requires awareness of their requirements, as well as careful planning and strategic actions. Voluntary compliance, self-auditing and self-disclosure play key roles, and, if properly approached and managed, can substantially mitigate the severity of TSCA enforcement.
Scope of TSCA
TSCA was enacted in 1976 and was significantly amended by the Frank R. Lautenberg Chemical Safety Act( LCSA) in 2016. It is administered by the US Environmental Protection Agency( EPA). TSCA provides for the testing(§ 4), new chemical premanufacture or pre-import notification(§ 5), existing chemical regulation(§ 6, § 7) and reporting(§§ 8, 12, 13) of nonexempt chemical substances.
Among the common misconceptions regarding TSCA is that it regulates only‘ toxic’ substances. In fact, it regulates all‘ chemical substances,’ which term is broadly defined to include organic substances, inorganic chemicals, polymers, consumer products, microorganisms and, with some exceptions, substances derived from nature.
TSCA has a reduced reporting‘ low volume exemption’( 40 CFR § 723.50), but low production volume substances and substances present at low concentrations in mixtures are otherwise fully subject to it. There exist many exemptions, varying by requirement, but generally these are narrowly construed.
Central to TSCA is the requirement that to properly travel through US commerce a non-exempt chemical must appear on a list of chemicals known as the TSCA Chemical Substance Inventory.( Indeed, since the 2016 amendments, such chemicals must appear on the‘ active’ portion of the Inventory, which is the case for only about half of those currently listed.) The Inventory has both non-confidential( or public) and confidential portions, and currently contains over 86,000 chemicals.
Inspection & liability
Section 11 of TSCA gives the EPA broad general authority to inspect US facilities at which chemical substances are manufactured, imported, processed, stored or held before or after their distribution in commerce.
The agency is required to provide written, but not advance, notice of a pending on-site inspection. Normally, it provides such notice two to three
MAY / JUN 2025