On Tuesday, June 18, 2013, at the BIO World Congress, BRAG sponsored a workshop entitled 'Commercializing Renewable Chemicals and TSCA: Getting To Yes,' which highlighted the potential pitfalls awaiting biobased and renewable chemicals on their way to EPA approval, pitfalls that are often unanticipated, resulting in delays, expense, and even termination on the road to commercialization. Lynn L. Bergeson of Bergeson & Campbell, P.C. opened the workshop with an overview of the current challenge of trying to fit these new chemicals into the existing regulatory framework created by a 37-year-old law -- TSCA. Ms. Bergeson highlighted the deep well of resources available to BRAG members, from former EPA directors, to Ph.D. organic chemists, to toxicologists, to lawyers who have worked with EPA regulation for decades, commenting that 'we know the granularity of this space' and can help the biobased community navigate it.
Ms. Bergeson then turned the workshop over to Kathleen M. Roberts of B&C Consortia Management, L.L.C., and Executive Director of BRAG, who took participants through a lively and informative presentation of the journey a biobased product will face in EPA's current system of regulation. She pointed out that even if the end product is chemically identical to an existing (usually petroleum-based) chemical, if the byproducts or impurities are different, it can be designated a new chemical and subject to increased scrutiny. She called attention to the importance of the Pollution Prevention (P2) page, and gave examples of information that should be shared with EPA using the P2 page. Ms. Roberts also revealed that renewables are drawing a disproportionate levy of Significant New Use Rules (SNUR). Ms. Roberts' presentation is available online.