July 28, 2022

NASEM Publishes Report on the Importance of Chemical Research to the U.S. Economy

The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by...
July 28, 2022

Lynn L. Bergeson, “How does a recent Supreme Court ruling apply to the EPA’s implementation of TSCA?,” Chemical Watch, July 27, 2022.

Since the US Supreme Court issued its blockbuster ruling in West Virginia v EPA, 597 US _ 2022 WL 2347278 (30 June 2022), many are asking whether the Court’s amplification of the 'major questions doctrine' (MQD) might be used to seek to limit the US EPA’s authority in implementing Congress’s 2016 amendments to TSCA, the Frank R Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). Lynn L Bergeson, managing partner of the law firm Bergeson & Campbell, says there's...
July 28, 2022

EPA Holds Kick-Off Meeting for TSCA New Chemical Engineering Outreach Initiative

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker...
July 28, 2022

EPA Holds Kick-Off Meeting for TSCA New Chemical Engineering Outreach Initiative

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker...
July 26, 2022

EPA Publishes Meeting Minutes and Final Report for April 2022 SACC Meeting on Draft TSCA Systematic Review Protocol

The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft...
July 22, 2022

Lynn L. Bergeson Quoted by Bloomberg Law in Article “Three Lawsuits Aim to Shape EPA’s Use of Chemical Test Orders”

On July 22, 2022, Bloomberg Law quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding three lawsuits that challenge the US Environmental Protection Agency’s (EPA) authority to order chemical manufacturers to generate information on their products. “The Lanxess and Vinyl Institute cases are, to me, a predictable result of a chaotic rollout of EPA Section 4 Test Order efforts,” said Lynn L. Bergeson, managing partner with Bergeson & Campbell...
July 21, 2022

Tips for Working with Foreign Regulators in China — A Conversation with David Cragin, Ph.D.

Download transcript. This week, I sat down with David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director for a large multinational pharmaceutical company, to discuss his experience living and working in China. For many listeners, working with foreign regulators can be particularly challenging for a variety of reasons, including language barriers, cultural differences, and differing regulatory standards. Dave shares his experience working in China and explains his...
July 21, 2022

Draft Revision to Risk Determination for 1-BP Finds 1-BP, as a Whole Chemical Substance, Presents an Unreasonable Risk

On July 20, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 43265. EPA states that the draft revision to the 1-BP risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported...
July 20, 2022

United States Court of Appeals for the Eleventh Circuit Reverses U.S. District Court’s Ruling on Failure to Warn Claim in Glyphosate Case

On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup®, which contains the active ingredient glyphosate,...
July 19, 2022

OECD Publishes Project Report on Chemical Accidents Involving Nanomaterials

The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures — Project Report. Part of OECD’s series on chemical accidents, the document presents the outcome from a project of the OECD Working Party on Chemical Accidents (WPCA) that aimed to investigate safety issues related to the prevention of, preparedness for, and response to...