September 5, 2019
The U.S. Congress originally enacted the Toxic Substances Control Act (TSCA) in 1976 and significantly amended it in 2016. However, many misunderstandings or myths persist regarding several critical provisions; including TSCA jurisdictional coverage, TSCA Inventory status, and notification obligations.
This article – the first in a three-part series – answers several jurisdictional questions: When and how does TSCA apply?
Q: Are cosmetics or pesticides regulated under TSCA?
TSCA was originally enacted to fill gaps in existing chemical regulatory programs, without creating overlapping authorities. As a result, entire categories of chemical substances were excluded from regulation under TSCA because they were already subject to regulation under existing programs.
For instance, substances manufactured, processed or distributed in commerce solely for use in the production of foods, food additives, drugs, cosmetics or devices are subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and are not subject to TSCA. To illustrate with examples:
- Products intended for cleansing the human body are regulated as cosmetics under the FFDCA.
- Detergents not intended for cleansing the human body are regulated by the Environmental Protection Agency (EPA) under TSCA.
Similarly, pesticides are regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and are not regulated under TSCA, unless the substances also have non-pesticidal uses. In short, the intended uses of a chemical substance will determine whether it is regulated under TSCA and/or one or more other chemical regulatory programs.
Q: Are formulators subject to TSCA?
Formulators make products, such as cleaners and paints, by physically blending chemical raw materials that they purchase from other sources of supply. Some formulators mistakenly believe that they are not subject to TSCA because they neither manufacture chemicals, by carrying out chemical reactions, nor import chemicals directly from foreign sources of supply.
It is true that certain requirements, such as the premanufacture notification (PMN) requirements for new chemicals under TSCA Section 5, apply only to manufacturers and importers. However, numerous other requirements under TSCA also apply to processors; and, formulators are processors. Therefore, formulators are subject to TSCA.
Q: Chemical substances listed on the TSCA Inventory are not subject to any regulatory requirements under TSCA. True or False?
False. Chemical substances listed on the TSCA Inventory are considered to be existing chemicals for purposes of regulation under TSCA. Existing chemicals are not subject to the PMN requirements for new chemicals under TSCA Section 5. However, they are subject to numerous other requirements under TSCA’s existing chemicals program.
Stay tuned for our second article in this series: TSCA: Myth or Fact Part 2: Nuances of TSCA Inventory Status.
Other articles in this series:
- TSCA: Myth or Fact Part 2: Nuances of TSCA Inventory Status
- TSCA: Myth or Fact Part 3: What You Need To Know About New Chemical Notification Obligations
NOTE: This article is for general information purposes only and is not intended to convey legal or other professional advice.
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