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Is your company potentially liable for a share of the U.S. Environmental Protection Agency (EPA) $1,350,000 fee for developing a Toxic Substances Control Act (TSCA) risk evaluation?  It may well be.  This is a hot topic these days, given EPA’s Federal Register notice published on January 27, 2020, identifying the “preliminary lists” of manufacturers, including importers, of the 20 chemical substances that EPA has designated as “high-priority” substances for risk evaluation...

The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced on February 27, 2020, that it plans to begin its audit of the EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018.  According to the Project Notification, the audit objectives are to determine whether: The financial statements are fairly presented in all material respects in accordance with...

The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical...

On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of its final rule on procedures for review of confidential business information (CBI) claims made under the Toxic Substances Control Act (TSCA). The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and...

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 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, the full...

By Lynn L. Bergeson On February 21, 2020, U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE), announced that it will hold a series of workshops to receive input on the approaches and activities for its new initiative, the Energy Storage Grand Challenge (ESGC). Launched in January 2020 by DOE Secretary Dan Brouillette, ESGC was created to accelerate the development, commercialization, and utilization of next-generation energy storage technologies. With...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 19, 2020, the University of Oulu, Finland, announced that scientists from its Research Unit of Sustainable Chemistry have developed a new synthetic bioplastic that provides protection from ultraviolet (UV) radiation. In addition to its UV-light blocking capacity, the transparent bioplastic made from a biomass-based copolymer with bisfuran structure, the new bioplastic also has airtightness capabilities three to four times higher than...