Federal/EPA Regulatory Policy

Lynn L. Bergeson, "EPA Expands TRI Reporting Rules," Chemical Processing, May 17, 2021.

The U.S. Environmental Protection Agency (EPA) announced on April 29, 2021, that it will be “taking important steps under the Toxics Release Inventory (TRI) to advance environmental justice, improve transparency, and increase access to environmental information.” The EPA plans to expand the scope of TRI reporting requirements to cover additional chemicals and facilities, including those not currently reporting ethylene oxide (EtO) releases. The agency also announced enhancements to its TRI reporting tools, but this article will focus on the chemical expansion effort and why it is significant.

Lynn L. Bergeson, "The TSCA under the Biden administration: what to expect," Environmental Law & Management, Volume 31, Issue 6, 2019.

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will be busy in 2021. Implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) will continue to dominate the Office of Pollution Prevention and Toxics (OPPT). In 2021, the EPA will need to complete outstanding risk evaluators of the 'first 10' chemicals and begin developing proposals for the section 6 risk management rules necessitated by the risk evaluations' conclusions. Given the tight statutory deadline for issuing proposed risk management rules, the complexity of the issues and the novelty of applying the new regulatory authorities, risk management decisions will likely present daunting challenges to the EPA as it sorts through the many legal and evolving policy issues at play. The EPA also now has four manufacture-requested risk evaluations that will parallel the 'next 20' chemicals for review. The change in administration makes the next four years especially 'unpredictable', not a word the business community welcomes.

Lynn L. Bergeson, "EPA Eyes Stricter Phosphogypsum Rule," Chemical Processing, April 21, 2021.

In early April, a Florida pond that sits atop phosphogypsum tailings sprung a leak. State authorities scrambled to keep the pond from collapsing and flooding the surrounding area with millions of gallons of contaminated water. This situation likely wasn’t top of mind on February 8, 2021, when a group of environmental protection advocates prepared and submitted to the U.S. Environmental Protection Agency (EPA) a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition seeks to reverse the EPA’s 1991 “Bevill” regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The timing of the Florida near-catastrophe could not be more ironic.

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.

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