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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...

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...

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...

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,...

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...

The U.S. Environmental Protection Agency (EPA) issued a final rule on July 18, 2022, updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 42651. The final rule updates the regulations to identify five per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA)...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. 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...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused...

The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles. The request notes that titanium dioxide is authorized...