As Environmental, Social and Governance (ESG) standards and Environmental Justice (EJ) concepts further extend the reach of federal review and enforcement over corporate policies, attorneys from a wider range of practice areas must become versed in areas of the law that were traditionally considered unique to “environmental law” practice. This Practising Law Institute program, Environmental Regulation in Practice 2022, analyzed current regulations including proposed amendments and...
September 15, 2022
FDA NanoDay Symposium 2022 Will Be Held October 11, 2022
The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics: An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item; A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products; A...
September 15, 2022
Lynn L. Bergeson, “Due diligence in mergers and acquisitions involving chemical products,” Financier Worldwide, October 2022.
The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether ‘neat’ (pure) chemicals, formulations or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media...
September 15, 2022
State Department Will Hold Joint U.S. Stakeholder Meeting on Ad Hoc Open-Ended Working Group to Establish a Science-Policy Panel
The U.S. Department of State (State Department) will hold a joint meeting from 2:00 p.m. to 3:30 p.m. (EDT) on September 22, 2022, to discuss United Nations Environment Assembly (UNEA) Resolution 5/8 and the related upcoming first session of the ad hoc open-ended working group (OEWG) on a science-policy panel (SPP) to contribute further to the sound management of chemicals and waste. In Resolution 5/8, UNEA states that an SPP should be established to contribute further...
On September 2, 2022, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published an advance notice of proposed rulemaking (ANPR) seeking input from stakeholders about how to update its organic regulations on inert ingredients in pesticides used in organic production. 87 Fed. Reg. 54173. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the U.S. Environmental Protection...
September 14, 2022
EUON Publishes Nanopinion on the Transportation of Nanoparticles across the Blood-Brain Barrier
On September 13, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Can the Brain’s Gatekeeper Fight a Nano-Attack?” by Dr. Eugenia (Éva) Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham, who co-authored an article entitled “Biotransformation modulates the penetration of metallic nanomaterials across an artificial blood–brain barrier model.” The researchers set out to explore systematically how...
By Lynn L. Bergeson and Carla N. Hutton On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources...
The Organization for Economic Cooperation and Development (OECD) Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities related to human health and environmental safety. In September 2022, OECD has published two new reports. Advanced Materials: Working Description (No. 104) aims to illustrate the content of the advanced materials playing field and the purpose of the Working Party on Manufactured Nanomaterials’ (WPMN) engagement...
On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...