On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents. According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance. On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule...
Navigating The Jurisdictional Tightrope Between Biopesticides, Biostimulants, And Related Emerging Technologies, April 29, 2020, 12:00 pm (EDT), Via Webinar: Register for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell, P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant...
March 1, 2020
Lynn L. Bergeson, “TSCA Risk Evaluation Fees: Who Is on the Hook?,” Washington Watch, Spring 2020.
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...
February 28, 2020
Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles
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...
February 28, 2020
EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
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...
February 28, 2020
FDA Issues Final Rule Amending The Definition Of “Biological Product”
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...
February 28, 2020
FDA Upgrades Its Database Of Licensed Biological Products
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...
February 28, 2020
DOE EERE To Host Public Workshops On ESGC Across The Country
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...
February 28, 2020
DOE ORNL Develops Method For Observing Biomaterials’ Nanostructure
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...