July 6, 2023
EuropaBio Offers Recommendations on Biomanufacturing
By Lynn L. Bergeson and Carla N. Hutton On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted its inaugural Biomanufacturing Policy Summit in Brussels, “marking the first major milestone from its newly established Biomanufacturing Platform.” The Summit captured priorities of 80 industry leaders,...
July 5, 2023
OECD Working Party on the Harmonization of Regulatory Oversight in Biotechnology Met in April 2023
By Lynn L. Bergeson and Carla N. Hutton The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...
On June 22, 2023, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2,6-dibromophenol], also known as “tetrabromobisphenol A” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing risk evaluations under the Toxic Substances Control Act. 88 Fed. Reg. 40728. EPA states that the proposed significant new uses are manufacture (including...
July 3, 2023
Lynn L. Bergeson, “Expanding PFAS liability in the US,” Financier Worldwide, July 2023.
Few words inspire the panic that ‘polyfluoroalkyl substance (PFAS)’ does. Companies producing, processing, distributing and using (whether knowingly or not) these substances must be aware of expanding legal liability and take steps now to minimise risk. This article outlines key US per- and PFAS developments, the legal and commercial implications of these developments, and measures stakeholders should consider taking to limit liability....
The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA states that the webinar will be useful for anyone looking...
The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. Following the mandate from the EC, the scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered to be safe in light of the exposure identified and in light of the classification of titanium dioxide...
July 3, 2023
OSTP Announces New Action Plan to Bolster, Expand, and Diversify the Biotechnology and Biomanufactur
By Lynn L. Bergeson and Carla N. Hutton On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new...
June 30, 2023
Biden Administration Announces Funding for Homegrown Biofuels under Inflation Reduction Act
By Lynn L. Bergeson and Carla N. Hutton The U.S. Department of Agriculture announced on June 26, 2023, that it plans to invest up to $500 million from President Biden’s Inflation Reduction Act to increase the availability of domestic biofuels and “give Americans additional cleaner fuel options at the pump.” USDA notes that in December 2022, it made available $50 million in Inflation Reduction Act funding to expand the use and availability of higher-blend...
June 29, 2023
TSCA Reform – Seven Years Later, June 29, 2023 8:00 a.m. – 5:30 p.m. (EDT), via webinar
Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented the seventh annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform — Seven Years Later.” This complimentary virtual conference featured speakers from the U.S. Environmental Protection Agency (EPA) and non-governmental and industry stakeholders, providing updates on a host of topics, including the...