Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action

By Richard E. Engler, Ph.D., special to The Digest

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory.

The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Fats and Oils

The most critical barrier that needs to be addressed is the inclusion of source in a substance’s identity. While the Soap and Detergent Association (SDA) nomenclature system strikes a balance between reporting and flexibility, it does not sufficiently cover the nomenclature issues related to many biobased products, as has been discussed in past articles. The SDA system provides industry the ability to choose from among the 35 natural sources of fatty acids that meet the SDA alkyl range criteria and their petroleum equivalents.

Opening the 40-year-old list of organisms eligible to use SDA nomenclature would go a long way towards enabling novel triglyceride sources to enter commerce without triggering new chemical substance notifications throughout the supply chain. Right now, EPA has no mechanism for adding sources without conducting a full rulemaking. A mechanism that enables EPA to add sources to the SDA list as part of the premanufacture notice (PMN) review of a new source would maintain EPA’s ability to ensure new sources do not present unreasonable risk to human health and the environment, as well as lower the barrier to market adoption of these new sources.

Biobased Hydrocarbons

Petroleum streams and similar hydrocarbon products present another problem. Some hydrocarbon substances do not include their source in the identity.

Hydrocarbons, C4-10-unsatd.

(CAS Registry Number 68514-38-5)

These can be made from any source, whether fossil or biomass, without triggering new chemical notification under TSCA, although caution must be used to be sure that the carbon range descriptor is accurate for the potentially new substance. On the other hand, some petroleum streams are identified with the source.

Hydrocarbons, C3-4-rich, petroleum distillates

Definition: A complex combination of hydrocarbons produced by distillation and condensation of crude oil.  It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 through C4.

(CAS Registry Number 68512-91-4)

Substances like these that are “unknown or variable compositions, complex reaction products, and biological” materials (UVCB) are, of course, complex and variable. Their exact composition may depend on variations in the source (e.g., grade of crude oil) and process conditions by which they are made (e.g., temperature). As long as the product fits the definition (other than the source) and characteristics, should the source matter?

Petroleum-equivalent substances may represent less of a supply chain issue for biobased producers compared to triglycerides because many petroleum-equivalents are destined to be fuel rather than feedstock for another substance.  Petroleum-equivalent substances also represent a more challenging problem to fix. There are hundreds of identities listed on the Inventory that include “petroleum” in the name or definition. It would require some effort to determine which are appropriate for a source-agnostic name. Furthermore, updating the nomenclature system for these substances would require coordination with the Chemical Abstracts Service to ensure that the substances can be systematically identified. Affected companies would need to engage with EPA to discuss a path forward. For example, as biobased hydrocarbon streams are developed, they can be reviewed for equivalency and, if appropriate, the petroleum-equivalent identity can be updated to exclude the source as part of the identity, allowing both the incumbent and novel substance to use the same, new identity.

Call to Action

Ideally, the regulated community, including both the producers and their customers, would engage with EPA to seek broad solutions, as a group, rather than individual companies seeking individual solutions. These solutions may require rulemaking and a collective approach could bring the issue to a high enough priority to justify the effort and expense for EPA to undertake rulemaking.

Although specific changes may be too arcane to include in TSCA reform, an updated TSCA could mandate EPA to update the nomenclature systems to allow source-agnostic chemical identities without compromising its ability to protect human health and the environment. The Biobased and Renewable Products Advocacy Group (BRAG), Algal Biomass Organization (ABO), Biotechnology Industry Organization (BIO), and other biofuel and biobased chemical member organizations should approach EPA and Congressional representatives to be sure their concerns are addressed.

Rich Engler is a Senior Policy Advisor with Bergeson & Campbell, P.C. and The Acta Group. Previously, he worked at EPA for 17 years, where he was a staff scientist in the Office of Pollution Prevention and Toxics. At EPA, he reviewed numerous chemicals under TSCA, led the Green Chemistry Program, including the Presidential Green Chemistry Challenge, and worked on many other projects, including the Risk-Screening Environmental Indicators and Trash-Free Waters. 

Prior to joining EPA, Rich taught organic chemistry at the University of San Diego. He holds a Ph.D. in physical organic chemistry from the University of California, San Diego.