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The U.S. Environmental Protection Agency (EPA) announced on June 16, 2023, a 60-day public comment period on the draft Guidelines for Cumulative Risk Assessment Planning and Problem Formulation (draft CRA Guidelines). 88 Fed. Reg. 39424. According to EPA, the draft CRA Guidelines describe steps for the planning and problem formulation of CRAs and offer guidelines for when CRAs could be appropriate. Planning defines both the process for conducting the risk assessment and its...

The Organization for Economic Cooperation and Development (OECD) announced on July 4, 2023, that it published a number of new, updated, and corrected Test Guidelines (TG), including the following for nanomaterials: TG No. 126: Determination of the Hydrophobicity Index of Nanomaterials through an Affinity Measurement: This new TG describes a method to determine the hydrophobicity index (Hy) of nanomaterials, through an affinity measurement. OECD states that hydrophobicity is defined as...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants: InnerPlant modified two soybean plants and one tomato plant to...

On June 16, 2023, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a new report providing an overview of new approach methods (NAM) in human health risk assessment of chemicals and calling on the U.S. Environmental Protection Agency (EPA) to develop a framework for evaluating and building trust in NAMs. NASEM states that some pollutants, such as lead, benzene, and ozone, are well studied, enabling EPA to characterize their hazards and risks to...

August 1, 202311:00 a.m. - 12:00 p.m. (EDT) REGISTER NOW International compliance in today’s evolving regulatory arena presents challenges to organizations. Supply chain networks must evolve to support operations with ever-changing regulations and requirements that materially impact commercial operations. Keeping abreast of permissible practices in countries of commercial interest is an essential product stewardship practice. Promoting strategic alliances within supply chain networks,...

On June 29, 2023, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and where...

Switzerland’s Federal Office of Public Health (FOPH) has updated its precautionary matrix for synthetic nanomaterials, which is a method for assessing the nano-specific health and environmental risks of nanoproducts. According to FOPH, the precautionary matrix enables the structured assessment of the “nano-specific need for precautions” when handling synthetic nanomaterials. The precautionary matrix is designed “to help industry and trade comply with their due diligence and their...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) hosted its 2023 Project Peer Review on April 3-7, 2023. During the event, more than 280 projects in BETO’s research, development, and demonstration portfolios presented their progress and accomplishments to the public and were reviewed by more than 50 external subject-matter experts from industry, academia, and federal agencies. The 2023 Project Peer Review...

On July 7, 2023, Earthjustice, on behalf of its clients, announced that it notified the U.S. Environmental Protection Agency (EPA) of its intent to sue for missing the statutory deadlines under the Toxic Substances Control Act (TSCA) for EPA to evaluate the risks to public health posed by 22 toxic chemicals. Earthjustice states that until EPA completes the overdue risk evaluations, “some of the most dangerous and widely used chemicals on the market will remain unregulated under [TSCA].”...

By Lynn L. Bergeson and Carla N. Hutton   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...