by Richard E. Engler, Ph.D. (Bergeson & Campbell, P.C. and The Acta Group) When I meet people from bioeconomy companies, I ask them about their products’ status under the Toxic Substances Control Act (TSCA). The most common answers I receive are: “TSCA doesn’t apply because our product is not toxic,” “TSCA doesn’t apply because our product is naturally occurring,” and “We are compliant with TSCA because we’re making something that’s already in commerce.” This usually leads to a more in-depth discussion of how TSCA works and its idiosyncrasies with respect to biobased products. I do not ask this to be accusatory, rather I want to be sure that companies understand their obligations so that they do not run afoul of the law. TSCA penalties can add up quickly (maximum $37,500 per violation per day) and can threaten nascent companies if they are not diligent.
Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions.
TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.
TSCA requires that a company must ensure that any chemical substance it intends to manufacture (or import) is listed on the TSCA Chemical Substance Inventory (the Inventory) or be subject to an exemption before commercial production occurs. If a substance is not listed on the Inventory, the manufacturer must submit a premanufacture notice (PMN) to EPA 90 days prior to producing or importing that substance.
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Triglyceride oils provide an instructive example of how the source is included in the substance identity.
Corn oil is listed on the Inventory as:
Corn oil.
Definition: Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Zea mays).
(CAS registry number 8001-30-7).
It is a distinct substance from other vegetable oils, such as:
Soybean oil.
Definition: Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida).
(CAS registry number is 8001-22-7).
The definitions of these two oils are the same, except for the source names — Zea mays and Soja hispida. Even though the two oils are often used interchangeably because they have very similar fatty acid profiles, the different sources mean that these are two different substances under TSCA. A manufacturer of one could not rely on the identity of the other for TSCA purposes. Furthermore, the source-based name may also extend into a downstream product. For example, a fatty acid methyl ester (FAME) biodiesel made by the transesterification of corn oil with methanol would be:
Fatty acids, corn-oil, Me esters
(CAS registry number 515152-40-6),
while the soy FAME would be:
Soybean oil, Me ester
(CAS registry number 67784-80-9).
These two identities are distinct and a biodiesel producer would have to be sure that the corresponding FAMEs were listed on the TSCA Inventory before making biodiesel from either corn or soybean oil. The same is true for novel sources of triglycerides, such as algae, genetically modified microorganisms, or other non-traditional oil sources, even if they are otherwise identical to existing triglycerides listed on the Inventory. The source is included in the name, so each distinct source leads to a distinct chemical identity for products.
This can lead to a headache for TSCA reporting for your customers.
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Mixed biobased hydrocarbon streams from pyrolysis or reforming may be identical to petroleum refinery streams that are listed on the Inventory, but if those petroleum streams include “petroleum,” “crude oil,” or other similar terms in either the name or the definition, manufacturers of the biobased equivalent cannot use the petroleum-based names for TSCA purposes. READ MORE