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.

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues -- Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Toxic Substances Control Act (TSCA). The TSCA Inventory lists all chemical substances that may be manufactured or imported into the U.S. for TSCA purposes, and all chemicals in commerce must be on the TSCA Inventory or eligible for exemption. Intergeneric algae are reportable under TSCA, as well as spent biomass byproduct, depending on use. Algae and algal products have similar requirements to demonstrate safety under FFDCA, but this is done mainly through scientific studies as there is no list (or inventory) published by the U.S. Food and Drug Administration (FDA) of approved ingredients. Dr. Engler ended the presentation by emphasizing the need to understand regulatory burdens and seek assistance in preparation, review, and communication with regulators to bring a product to market. For a copy of this presentation, contact Dr. Engler at .(JavaScript must be enabled to view this email address).


 

On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions." This meeting will receive public comments on EPA's algae guidance document, and will inform the development of EPA's "Algae Guidance for The Preparation of TSCA Biotechnology Submissions" document. Approximately 120 people will be able to attend in person, with unlimited access via web connect and teleconference. The meeting is scheduled for October 27, 2016, in Tempe, Arizona, immediately following the Algae Biomass Summit. ABO will post a specific time and location when more information becomes available.


 

On June 14, 2016, DOE's Oak Ridge National Laboratory (ORNL), through UT-Battelle, LLC, published a report determining that bioenergy crops do not impact food security. The report, "Reconciling food security and bioenergy: priorities for action," was put together by experts from ten institutions, including ORNL, the International Food Policy Research Institute, the World Bank, and Imperial College London. The report determined that previous studies finding bioenergy crops to blame for food shortages had underlying assumptions that lead to incorrect conclusions. The authors additionally recommended using flex-crop schemes utilizing crops that may be used as either fuel or food depending on economic and environmental changes.


 

 

On July 11, 2014, the U.S. Department of Energy (DOE) announced that several biobased DOE research projects were recognized by R&D magazine as the most outstanding technology developments with promising commercial potential. According to the DOE notice, projects included in the awards were:


* Lawrence Berkeley National Laboratory, Tissue-Specific Cell-Wall Engineering for Biofuels and Biomaterials. This suite of precision genetic tools is expected to improve crops bred for production of food, biofuels, industrial polymers, and pharmaceuticals. The technology fine-tunes lignin by manipulating chemical signals that govern plant-cell metabolism. This synthetic biology platform can enhance drought-resistance, make cattle forage more nutritious, and even coax plants or fungi to yield high-value drugs and biomaterials.

* Lawrence Berkeley National Laboratory, The Berkeley Lab Multiplex Chemotyping Microarray. This technique performs rapid chemical analyses of prospective biofuel crops and microbial communities by combining high-throughput micro-contact printing technology with high-fidelity vibrational spectroscopy and mass spectrometry. Its ability to identify rapidly the chemical composition and biological function in plant and animal cells is unparalleled.

* Oak Ridge National Laboratory, Super-hydro-tunable HiPAS Membranes. This new class of membrane products can selectively separate molecules in the vapor/gas phase and perform liquid-phase separations that could be especially useful in reducing the price of bio-ethanol, ethanol-gasoline blend fuels, and drop-in fuels from bio-oil processing. The membrane acts as an energy-efficient alternative to the distillation process by using a superhydrophobic or superhydrophillic surface to separate molecules.


More information is available online.
 


 

On September 16, 2013, Cambridge, Massachusetts-based renewable chemicals company, Metabolix, announced the development of Mvera B5010, which is a compostable film grade resin to be used for global compostable bag and film markets. Mvera B5010 meets international industrial standards for compostability and will be featured during K 2013 in Düsseldorf, Germany, October 16-23, 2013. A copy of Metabolix's press release on the announcement is available online.