The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open
On January 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of EPA’s response to a petition it received from the Biobased and Renewable Products Advocacy Group (BRAG®) under Section 21 of the Toxic Substances Control Act (TSCA). BRAG requested EPA to promulgate a rule pursuant to TSCA Section 8 that would establish a process to amend the list of natural sources of oil and fat in the “Soap and Detergent Association” (SDA) nomenclature system by considering the chemical equivalency of additional natural sources. While EPA denied the TSCA Section 21 petition, EPA left the door open for additional relief in this area and its notice provides useful information regarding options for doing so.
EPA concurred with BRAG that SDA nomenclature is currently limited to the listed sources. In its notice, EPA states, “[t]he petition correctly recognizes the current limitations of certain TSCA Inventory listings (i.e., those listings that incorporate particular assumptions about the natural sources of fats or oils from which the listed substance is derived, because they were named according to the SDA naming convention). Manufacturers of a new chemical substance that clearly falls outside the definitional scope of an existing chemical substance are not allowed to determine that the new chemical substance is nonetheless sufficiently ‘similar’ to the existing chemical substance, and simply deem the new chemical substance to be an existing substance on the basis of that similarity.”
While not providing details as to how it could be accomplished, EPA’s response seems to indicate that there may be opportunities for BRAG to achieve its goal. EPA stated “the petition presumes, without justification, that until a certain preliminary EPA rulemaking has been completed, those same manufacturers lack a meaningful opportunity to request that EPA enlarge the definitional scope of one or more existing chemical substances named according to the SDA naming convention.” “Although the response indicates that the current SDA Nomenclature system is limited to the original 35 sources, it is encouraging that EPA does not see a regulatory barrier to adding additional sources,” stated Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®) and BRAG advisor. Further, “[t]his language appears to support the contention that there may be an opportunity to request EPA to expand the SDA naming convention beyond the current list of 35 plant and animal sources.”
Similarly, Kathleen M. Roberts, Executive Director of BRAG, stated “BRAG is encouraged by the language in Assistant Administrator James J. Jones’ letter to BRAG, in which he highlighted Section 5(h)(4) as a potential mechanism to achieve BRAG’s goal with the Section 21 petition.” Section 5(h)(4) allows EPA to develop a rulemaking for exemption of certain chemical substances if EPA determines that the manufacture, processing, distribution, use, or disposal will not present an unreasonable risk.
Ms. Roberts also stated that “BRAG members are evaluating next steps, including careful consideration of the potential pathways to achieve the ultimate goal of the petition that EPA identified in its response.” As part of its 2016 efforts, BRAG is expanding its membership to include more companies that have already been or may be adversely impacted by EPA’s current naming convention policies, such as companies looking to produce bio-based chemicals from algae or non-traditional plant materials.