By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On May 12, 2020, a bill was introduced in the U.S. House of Representatives, which would make emergency supplemental appropriations for the fiscal year ending on September 30, 2020. Titled the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), this bill addresses various issues, many of which have been worsened by the COVID-19 pandemic. Some of these issues include provisions of revenue, health, retirement,...
By Lynn L. Bergeson On May 11, 2020, a total of 70 Mayors from various cities in the United States submitted a letter to Andrew Wheeler, U.S. Environmental Protection Agency (EPA) Administrator, criticizing the decision not to uphold the Renewable Fuel Standard (RFS) and not to reject proposed waivers under Section 211(o)(7) of the Clean Air Act. The Mayors state that this decision on waivers is already causing damage to the economy and will continue...
May 14, 2020
EPA Will Hold Webinar on CDR Requirements on May 19
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements. The 2020 CDR submission period is from June 1, 2020, to November 30, 2020. The webinar will include information about the revised reporting requirements, including: The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will...
May 13, 2020
EPA’s Updated Small Manufacturer Definition Will Apply to CDR Reporting Period Beginning June 1
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the...
May 8, 2020
Register Now For The “TSCA Reform — Four Years Later,” Virtual Symposium, Wednesday, June 24, 2020,
By Lynn L. Bergeson B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform — Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers...
May 8, 2020
Richard E. Engler, Ph.D., Presents “TSCA New Chemicals” During GlobalChem Webinar Series, May 13, 20
By Lynn L. Bergeson The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy...
By Lynn L. Bergeson On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a...
By Lynn L. Bergeson On April 28, 2020, U.S. Representative Abby Finkenauer (D-IA) introduced the Clean Fuels Deployment Act of 2020, which would fund installation and conversion of fuel pump infrastructure to deliver higher blends of biofuel. Co-sponsored by Representatives Angie Craig (D-MN), Don Bacon (R-NE), and Roger Marshall (R-KS), this bipartisan bill creates a clean fuels grant program with $600 million over a six-year period to help biofuel retailers. The plan is to assist...
By Lynn L. Bergeson On April 24, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it intends to issue a funding opportunity to: Stimulate technology innovation; Enable manufacturing of cutting-edge products in the United States; and Improve energy productivity of manufacturing. On behalf of the Advance Manufacturing Office (AMO), this potential funding opportunity aims to advance the Trump...