Biobased and Renewable Products Advocacy Group,
Keywords: biofuel, biobased, chemical, nomenclaure, TSCA
Summary:As renewable fuel and biobased chemical companies successfully make the leap from research and development to market, they face another set of underappreciated regulatory challenges in order to lawfully commercialize their products. Under the Toxic Substances Control Act (TSCA), all chemical substances, including biofuels and biobased chemicals, must be listed on the TSCA Inventory (or specifically exempted) prior to manufacture or import. U.S. Environmental Protection Agency (EPA) policy requires that listed chemicals be described as precisely as possible and only substances meeting that precise identity can rely on that chemical name. This issue of precise naming for purposes of listing on the TSCA Inventory has and will continue to prove critical for successful commercialization of many biobased chemical products. Many biobased substances are not substances with a single molecular structure, but instead are mixtures that are referred to as “unknown or variable composition, complex reaction products, or biological” (UVCB) materials. Existing EPA policy allows chemical companies to rely on the “Soap and Detergent Association” (SDA) nomenclature system, which is a nomenclature convention for UVCB substances that reduces supply chain complexity and provides some source flexibility. The SDA nomenclature system classifies 35 natural sources of fatty acids, and their synthetic equivalents, into a variety of alkyl group ranges that are based on the constituent chain lengths present in those sources. For example, a chemical producer may identify its product using a SDA alkyl range, when the product is made from any plant oils that meet the criteria for that SDA range. This reduces the burden on chemical manufacturers, allowing them to change oil sources based on price and availability without changing substance identity. The problem for newly developed biobased chemicals is that the existing system limits source flexibility to 35 sources of fats and oils (and their petroleum synthetic equivalents). Since its adoption of the SDA system in 1978, EPA has not attempted to amend the list of 35 sources, most of which are derived from food crops, such as corn or soy. New oils, such as those isolated from non-traditional plants, like camelina and jatropha, derived from algae, or produced by microbes are functionally equivalent to, and may be chemically indistinguishable from, oils listed in the SDA nomenclature system. However, novel sources of chemically equivalent fats and oils are not among the SDA sources, so new oils and their derivatives cannot be named using the SDA system. Without access to the alkyl range names, novel biobased chemical producers and their customers must submit premanufacture notices for triglycerides as well as downstream intermediates and products. This delays commercialization of novel sources and, more importantly, creates a disincentive for customers to switch from traditional oils to these novel sources because the customers must submit new chemical notifications for substances that would be existing chemicals if only they were made from SDA-eligible sources. We will report on the progress of the Biobased and Renewable Products Advocacy Group (BRAG®) engagement with EPA to find a pathway to add sources to the SDA list.