Federal/EPA Regulatory Policy

Lynn L. Bergeson, "The importance of regulatory diligence in funding," Financier Worldwide, April 2021.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses.

Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.

Lynn L. Bergeson, "What Might EHS Expect from the Biden EPA?," EHS Daily Advisor, March 10, 2021.

As a new administration arrives in Washington, D.C., few things are certain except that 2021 is sure to be an eventful year.​

While underlying partisan jockeying and prospects for bipartisan cooperation will greatly affect what may happen in the more limited context of chemical regulation, the Biden administration has already laid out priorities on the environment that will surely influence the U.S. Environmental Protection Agency’s (EPA) positions on climate change, the role of science, and regulation in general.

Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D., "Why the US EPA can, and should, evaluate the risk-reducing role a new chemical may play if allowed on the market," Chemical Watch, February 22, 2021.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

Lynn L. Bergeson, "Pandemic Spurs Enforcement Revisions," Chemical Processing, October 26, 2020.

The White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) issued memorandum M-20-31 on August 31, 2020, on the implementation of Section 6 of Executive Order (EO) 13924, “Executive Order on Regulatory Relief to Support Economic Recovery.” This article explains the guidance, why it may prove useful to know about its content, and how to leverage the guidance successfully in future enforcement actions and adjudications.

Lynn L. Bergeson, "EPA Axes Temporary Enforcement Lull," Chemical Processing, July 22, 2020.

The U.S. Environmental Protection Agency (EPA) issued in March a temporary enforcement policy relaxing certain compliance obligations because of the COVID-19 pandemic. On June 29, the agency announced an “addendum on termination” that aims to end the policy on August 31, 2020. This column discusses the termination memorandum.

Lynn L. Bergeson, "Compliance: Talk To Your Supply Chain," Chemical Processing, May 13, 2020.

Much attention now focuses on COVID-19 and subsequent supply chain disruptions; here, we tackle supply chain communications and ways to optimize them. The Toxic Substances Control Act (TSCA) requires such communications, as do evolving best business practices. Managing supply chain communications effectively, and strategically optimizing the commercial interactions and exchanges of information they elicit are essential business practices.

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, "EPA Issues New Accidental Release Rule," Chemical Processing, December 20, 2019.

On November 20, 2019, the U.S. Environmental Protection Agency (EPA) signed off on final changes to the risk management program (RMP) rule, most recently amended in January 2017. The regulations were promulgated under Section 112(r) of the Clean Air Act (CAA) when the law was amended in 1990. This section is intended to prevent or minimize the consequences of accidental chemical releases. A need to prevent or minimize the catastrophic consequences of accidental chemical release is a point few would argue. How best to “prevent or minimize,” however, has evoked exhausting debate and legal wrangling. This column summarizes key changes in the reissued final rule.

Lynn L. Bergeson, "SEC Proposes Changes To Reporting Rules," Chemical Processing, October 16, 2019.

Publicly traded companies must disclose certain legal proceedings and risk factors in registration statements and in annual and quarterly reports. These disclosures significantly help investors in assessing the financial integrity of a publicly traded company; formulating a disclosure precisely is critical to compliance, while at the same time accurately capturing the nature and extent of the potential risks. This article summarizes this Securities and Exchange Commission (SEC) proposed rule, which is intended to modernize the Regulation S-K obligations, particularly as they relate to environmental disclosures, and discusses the unique challenges these reporting obligations impose on the chemical industry.

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.

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