B&C® Biobased and Sustainable Chemicals Blog

By Lynn L. Bergeson On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases,...

By Lynn L. Bergeson On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined...

By Lynn L. Bergeson On February 17, 2020, researchers from the University of Massachusetts Amherst (UMass Amherst) announced that one of its laboratories has developed a device using a natural protein to create electricity from moisture in the air. Electrical engineer Jun Yao and microbiologist Derek Lovley have created what they call “Air-Gen,” which consists of an air-powered generator with electrically conductive protein nanowires produced by the microbe Geobacter. The Air-gen...

By Lynn L. Bergeson The EPA Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices. EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental footprint and helping to protect...

By Lynn L. Bergeson On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released its review plan for certain confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Aiming to provide clarity for affected stakeholders and efficiently fulfill CBI requirements under TSCA, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. The final rule is a follow-on to the...

By Lynn L. Bergeson The European Commission (EC) will host a webinar on biobased products developed from fast pyrolysis oil, where four companies will present their work. A technology that can convert a wide range of biomass into clean and uniform bio-oil that is easy to transport and store, fast pyrolysis has mostly focused, thus far, on the use of pyrolysis oil for energy purposes. According to EC, the Horizon 2020 project called Bio4Products, however,...

By Lynn L. Bergeson On February 10, 2020, the Governor of Wyoming, Mark Gordon, delivered his 2020 State of the State Address, which included a request to lawmakers of a $25 million investment to establish the Energy Commercialization Program. The program is designed to provide a coordinated approach to support research on technologies that advance zero or net-negative carbon uses for coal and other fossil fuels. Gordon stated: “Wyoming will always advocate for our industries,...

By Lynn L. Bergeson Federal enforcement of chemical product laws is alive and well, despite a broadly held misconception to the contrary. We have seen over the past 18 months or so an uptick in federal enforcement under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Bergeson & Campbell, P.C. (B&C®) writes to alert stakeholders of this fact. B&C believes that this trend will continue in 2020. Check...

By Lynn L. Bergeson On February 11, 2020, U.S. Senator Tom Udall (D-NM), U.S. Representative Alan Lowenthal (D-CA), U.S. Senator Jeff Merkley (D-OR), and U.S. Representative Katherine Clark (D-MA) introduced a bill that would phase out unnecessary single-use plastic products: Break Free From Plastic Pollution Act of 2020. The legislation would also hold corporations accountable for wasteful products, reform the broken waste and recycling collection system, and reduce wasteful packaging....

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and...