TSCA

Lynn L. Bergeson, "EPA Revises “Working Approach” Document," Chemical Processing, January 14, 2020.

On December 20, 2019, the U.S. Environmental Protection Agency (EPA) released an updated “Working Approach” document that builds upon its November 2017 version. The EPA states that the updated version, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” explains its approach for making affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA). This article highlights key changes in the document.

Lynn L. Bergeson, "Risk evaluations under TSCA: The state of play," Specialty Chemicals Magazine, December 2019/January 2020.

Among the changes when the Toxic Substances Control Act (TSCA) was amended by the Frank R. Lautenberg Chemical Safety Act for the 21st Century, also known as Lautenberg or ‘new TSCA’, none is more consequential than the requirement that the US Environmental Protection Agency (EPA) conduct risk evaluations for ‘high priority’ chemical substances. We are now three years into new TSCA and this is being done, amid spirited debate and, inevitably, litigation.

Lynn L. Bergeson, "The Growing Influence of Chemical Risk Evaluation on the M&A Market," Financier Worldwide, October 2019.

In 2018, the global M&A market achieved a transaction volume of $4.1 trillion, the third highest year ever for M&A volumes. Divestitures, spin-offs and split-offs are essential to defining corporate identity, a key shareholder imperative. This brisk pace is expected to continue. Whatever the motivation, M&A activity demands razor-sharp due diligence. The premise of this article is that due diligence often underestimates or, worse, ignores the impact implementation of revisions to the Toxic Substances Control Act (TSCA), the US industrial chemical safety law, has on commercial transactions. Implementation of these revisions is now influencing key sectors of the economy, making it essential that TSCA chemical risk evaluations be routinely included in M&A due diligence protocols.

Lynn L. Bergeson, "Chemical Restrictions and TSCA’s Growing Commercial Influence," Environmental Quality Management, Volume 29, Issue 1, Fall 2019.

This past spring, the United States Environmental Protection Agency (EPA) issued a first-ever final rule under Section 6(a) of the Toxic Substances Control Act (TSCA) banning the use of methylene chloride in consumer paint and coating removal products. Although this rule was long in the making, this type of chemical ban of selected products is likely to be seen more routinely in the months and years ahead. This article reflects upon EPA’s broad authority under TSCA Section 6 and explores the reasons why chemical prohibitions, and the commercial complications they inspire, are expected to be the new normal.

Lynn L. Bergeson, "EPA Proposes PBT Chemicals Rule," Chemical Processing, August 27, 2019.

After many years of study, the U.S. Environmental Protection Agency (EPA), industry stakeholders, and the scientific community at large well know that chemicals that are persistent, bioaccumulative, and toxic (PBT) behave differently in the environment and in biological systems than non-PBT chemicals. Congress acknowledged this in updating the Toxic Substances Control Act (TSCA) in 2016 by specifying special provisions under TSCA Section 6(h) for PBT chemicals. In June of this year, the EPA proposed a rule implementing TSCA Section 6(h) review that elicits important insights on how the EPA intends to review such chemicals. The rule is a blueprint for its consideration of PBTs for years to come.

Lynn L. Bergeson, Kathleen M. Roberts, and Richard E. Engler, Ph.D., "Protecting the Value of Health, Safety Studies—Emerging TSCA Issues," Bloomberg Environment Insights, August 22-23, 2019.

Health and safety studies provide invaluable insights into the hazards posed by chemical substances. The cost of generating these studies is also considerable, and access to them should be commensurate with the intellectual property interests they reflect. This article explores two current challenges under the Toxic Substances Control Act (TSCA) and offers practical tips for managing these issues.

Lynn L. Bergeson, "Expert Focus: TSCA and Liability under the False Claims Act – a Potentially Promising Area," Chemical Watch, July 26, 2019.

A federal appellate court recently decided a case brought under the FCA’s reverse false claims provision premised on alleged non-compliance with a TSCA reporting obligation. Kasowitz Benson Torres LLP v. BASF Corp. As discussed in this article, while the court dismissed the case, it did so for fact-specific reasons and creative plaintiff lawyers can be expected to rely upon the FCA in the future to bring actions based on other TSCA provisions.

Lynn L. Bergeson, "EPA Prioritizes Chemicals for Risk Evaluation: Why This Matters," Environmental Quality Management, Volume 28, Issue 4, Summer 2019.

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 40 chemicals for which EPA is initiating the prioritization process for risk evaluation. This article explains why the prioritization process is critically important for product manufacturers to monitor and manage, and how best to do so.

Lynn L. Bergeson, "Protecting Confidential Business Information: An Evolving Challenge," International Chemical Regulatory and Law Review, Volume 2, Issue 2, Summer 2019.

The concept of confidential business information (CBI) is sometimes considered at odds with the concept of the ‘right-to-know.’ When Congress amended the Toxic Substances Control Act (TSCA) in 2016 throughenactment oftheFrankR.LautenbergChemical Safety for the 21st Century Act (Lautenberg), it wasmindful ofthe public’s growing interestin knowing more about the identity of chemicals to which they may be exposed, but equally mindful of a business’ legitimate interest in protecting highly proprietary and commercially sensitive trade secret and other information entitled to protection from disclosure. Congress enacted several significant TSCA modifications in an effort to balance these competing interests, amendmentsthatthe U.S. Environmental Protection Agency (EPA) has been implementing through rulemaking and guidance documents over the past three years. This article discusses key CBI initiatives, and the stakeholder community’s response to them.

Lynn L. Bergeson, "EPA Updates the TSCA Inventory: Impact on chemical importers," Elements, the Magazine of Chemicals Northwest, Spring 2019.

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) released a much anticipated “updated” Toxic Substances Control Act (TSCA) Inventory. The updated TSCA Inventory now lists chemicals that are “active” versus “inactive” in commerce in the U.S. This development has important legal and transactional implications for foreign companies importing chemicals into the U.S. This column explains why.

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