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...
Category: General
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...
September 9, 2022
EPA Webinars Will Kick off Public Engagement and Outreach on Risk Management under TSCA
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2020, a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final Toxic Substances Control Act (TSCA) chemical risk evaluations. After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust...
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of...
September 8, 2022
TSCA Fundamentals, September 1, 2, 7, and 8, 2022, via webinar
Implementation of the amended Toxic Substances Control Act (TSCA) is very much a work in progress, and the US EPA’s regulatory actions require continuous monitoring. Staying on top of these changes is critically important, and training on current regulatory requirements is vital. During this "TSCA Fundamentals" training course, Richard E. Engler, Ph.D., Director of Chemistry with Bergeson & Campbell, P.C. (B&C®), provided in-depth training on the very latest TSCA...
On September 6, 2022, the U.S. Environmental Protection Agency proposed to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 87 Fed. Reg. 54415. According to EPA, “[s]uch a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘forever’...
September 7, 2022
Regulatory Summit Europe 2022, September 26-27, 2022, Brussels, Belgium and via webinar
Chemical Watch's Regulatory Summit Europe brought together regulators, experts from industry and service providers to share their perspectives and understanding of European and global regulatory challenges. Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) presented "Updates on TSCA" on September 27.
ASTM has announced that a new subcommittee will develop standards on per- and polyfluoroalkyl substances (PFAS) that are present in consumer products. ASTM describes PFAS as “a group of chemicals that are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease and water.” The new subcommittee (F15.81) will operate under the jurisdiction of ASTM’s consumer products committee (F15). According to ASTM, the new subcommittee “will develop standards...
September 4, 2022
EPA Selects Recipients of Nearly $12 Million in P2 Grants Funded by the Bipartisan Infrastructure Law
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2022, that it selected 39 recipients that will receive nearly $12 million in pollution prevention (P2) grants made possible by President Joseph Biden’s Bipartisan Infrastructure Law’s $100 million program investment. According to EPA, the grants will allow states and Tribes to provide businesses with technical assistance to help them develop and adopt P2 practices to prevent or reduce pollution before it is even...
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...
September 1, 2022
Do We Need An Animal Protection Agency? — A Conversation with Prof. Delcianna J. Winders
WEBINAR -- Registration Opens For “Environmental, Social, And Governance Issues: A Business Imperative,” October 11, 2022, 12:00 p.m. - 1:00 p.m. (EDT): Environmental, Social, and Governance (ESG) performance is more than an aspiration, and realizing it in real time is not easy. A well-designed ESG strategy can achieve meaningful improvements in corporate performance and provide real value to stakeholders through specific commitments to corporate responsibility. Any such approach,...
As reported in our March 14, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. EPA has since submitted the ICR to the Office of Management and Budget (OMB) for review and approval. EPA published a notice on August 30, 2022, allowing for an...
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include: Variability and Relevance of Traditional Toxicity Tests;...
August 23, 2022
EPA New Chemicals Program Will Discontinue Use of Exposure Modeling Thresholds When Assessing Health and Environmental Risks
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According...
August 22, 2022
Lynn L. Bergeson, “EPA Holds Webinar on PFAS Strategic Roadmap: Research Tools and Resources,” Finishing & Coating, August 22, 2022.
The U.S. Environmental Protection Agency held a webinar on August 17, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar provided a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key per- and polyfluoroalkyl substances (PFAS) research needs for environmental decision-making.