All Published Articles

Lynn L. Bergeson, Charles M. Auer, and Richard E. Engler, Ph.D., "What Lies Ahead for the Next Four Years of TSCA?," Chemical Watch, July 14, 2020.

The Frank R Lautenberg Chemical Safety for the 21st Century Act is four years old. While to some 22 June 2016 seems like yesterday, the past four years have been transformational. The US EPA has worked hard, been timely and done well in thoughtfully implementing the changes. 

Anniversaries tend to inspire reflection on the past, and this year was no exception. The Environmental Law Institute, Bergeson & Campbell and the George Washington University Milken Institute School of Public Health convened for an all-day seminar on TSCA reform, four years after the enactment of Lautenberg. Diverse stakeholders offered their perspectives on TSCA implementation and shared candid reviews on where we are as a TSCA community.

Rather than look back, this article looks forward to the next four years and speculates on some of the many challenging topics the EPA and other TSCA stakeholders are likely to address.

Download a PDF of this article here

Lynn L. Bergeson, "Understand Chemical Data Reporting Changes," Chemical Processing, June 17, 2020.

Section 8 of the Toxic Substances Control Act (TSCA) compels manufacturers (including importers) to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce. The last Chemical Data Reporting (CDR) cycle was in 2016, so TSCA stakeholders have been gearing up for this quadrennial reporting obligation in 2020. This column provides an overview of changes since 2016.

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, "Effectively Managing Supply Chain Communications Under TSCA," Bloomberg Environment Insights, April 28, 2020.

The EPA’s amendments to the Toxic Substances Control Act reporting requirements have increased the need for chemical stakeholders to manage actively supply chain communications. Lynn L. Bergeson, owner and managing partner of Bergeson & Campbell P.C., explores the upsides to be realized through these communications and the perils of failing to seize them. Download a PDF of this article here.

Lynn L. Bergeson, "Chemical Importers are on the Hook for TSCA Risk Evaluation Fees," Elements, the Magazine of Chemicals Northwest, Spring 2020.

Is your company potentially liable for a share of the U.S. Environmental Protection Agency (EPA) $1,350,000 fee for developing a Toxic Substances Control Act (TSCA) risk evaluation? This is a hot topic these days, given EPA’s notice dated January 27, 2020, identifying the “preliminary lists” of manufacturers, including importers, of the 20 chemical substances that EPA has designated as “high-priority” substances for risk evaluation and for which fees will be charged. Stakeholders are required by March 27, 2020, to “self-identify” as manufacturers of a highpriority substance irrespective of whether they are included on the preliminary lists identified by EPA.  

Lynn L. Bergeson and Christopher R. Blunck, "Expert Focus: What Are the Implications of the US EPA’s Expected Final Rule on Persistent, Bioaccumulative and Toxic Chemicals?," Chemical Watch, March 26, 2020.

PBT chemicals have long been recognised to behave differently in the environment and in biological systems from non-PBT substances. The US Congress acknowledged this when amending TSCA in 2016 by crafting special provisions under the Regulation’s Section 6(h) that were uniquely applicable to PBTs. Last July, the EPA proposed a rule that would implement the section, but this caused much controversy and led to comments from, among others, the retail, coatings and aerospace sectors and NGOs. It also raised several novel legal issues relating to TSCA’s interpretation.

 

Nevertheless, the EPA must issue a final rule within 18 months of the proposal, that is to say by December 2020. This article focuses on the novel issues that have arisen and the implications of their resolution on affected stakeholders.

Lynn L. Bergeson, "TSCA Fee Controversy Continues," Chemical Processing, March 20, 2020.

In last month’s column, we reported on the January 27, 2020, notice from the U.S. Environmental Protection Agency (EPA) identifying the preliminary lists of manufacturers, including importers, of the 20 chemical substances the EPA designated as high-priority for risk evaluation and for which fees will be charged. The notice created a firestorm of criticism over the lack of any exemptions from being considered potentially responsible for paying a share of the EPA’s $1,350,000 fee for conducting a risk evaluation of a high-priority chemical. This column updates the status of this fast-changing matter.

Lynn L. Bergeson, "The growing spectre of chemical product cancellations, and what to do about it," Financier Worldwide, February 2020.

Effective 1 January 2022, household cleaning, cosmetic and personal care products containing quantities of 1,4-dioxane over specified trivial levels will be prohibited from sale in the state of New York. The law imposing these restrictions, signed by governor Andrew M. Cuomo on 9 December 2019, is intended to protect drinking water supplies from contamination by the chemical. This product ban falls on the heels of the 15 March 2019 final rule issued by the US Environmental Protection Agency (EPA) banning the manufacture, import, processing and distribution, including e-commerce, of methylene chloride for consumer paint and coating removal. The EPA’s determination that the use of methylene chloride in consumer paint and coating removal presents an ‘unreasonable risk’ of injury to health prompted this decision. These commercial bans are not anomalies; they are the new normal. This article explains why, and the reasons corporate leaders, brand managers, investors and others in this commercial space need to understand this trend and plan accordingly.

Lynn L. Bergeson, "Toxic Substances: Are You On The List?," Chemical Processing, February 24, 2020.

The U.S. Environmental Protection Agency (EPA) published on January 27, 2020, a notice identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that the EPA designated as high-priority substances for risk evaluation and for which fees will be charged (85 Fed. Reg. 4661). The list and the EPA’s interpretation of the fee rule caught many off guard. This column explains why.

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 and Richard E. Engler, Ph.D., "Chemical Innovation and New TSCA: The Good, the Bad, and the Evolving," International Chemical Regulatory and Law Review, Volume 2, Issue 4, Winter 2019.

New chemical innovation is not as celebrated as innovation in electronics, materials, software, or other sectors, but it is every bit as important. Many believe, as do we, that new chemical innovation is essential to achieving sustainable development. For this reason, a close look at the 2016 amendments to the Toxic Substances Control Act (TSCA) and the U.S. Environmental Protection Agency’s (EPA) implementation of them offers valuable insights into whether the new U.S. industrial chemical management law and EPA policy initiatives implementing it are aligned with this goal. This article discusses EPA’s implementation of the TSCA amendments as they relate to new chemical innovation and highlights EPA policy positions and institutional practices that EPA should reconsider to alignmore closely with the goal of more sustainable new chemical technologies.

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, "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, "Chemical Compliance: Court Nullifies New York Disclosure Program," Chemical Processing, September 18, 2019.

In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program. The program is an example of the newest trend in state “information disclosure” programs intended to force product manufacturers to disclose the ingredients in products sold to consumers. This article discusses the program and explains why the court rescinded it.

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.

J. Brian Xu, Jane S. Vergnes, and Carla N. Hutton, "China Drafts Changes to Chemical Registration Rules," Bloomberg Environment Insights, July 29, 2019.

Manufacturers and importers should weigh in on China’s planned changes to registration requirements for new chemical substances, write Brian Xu and Jane Vergnes of The Acta Group, and Carla Hutton of Bergeson & Campbell.

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, "USDA Enhances Biobased Procurement Program," Chemical Processing, July 16, 2019.

The U.S. Department of Agriculture (USDA) published a final rule on July 5, 2019, amending its “Guidelines for Designating Biobased Products for Federal Procurement” to include 30 more product categories for biobased products that may receive procurement preference by federal agencies and their contractors. These 30 product categories contain finished products made, in large part, from intermediate ingredients designated for federal procurement preference. This article explains why Chemical Processing readers should note this important development.

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.

Zameer Qureshi, "EU REACH: how’s life after the Registration deadlines?," Elements, the Magazine of Chemicals Northwest,, Spring 2019.

The registration deadlines for pre-registered “phase-in” chemical substances under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation presented for the chemicals industry a wide range of demanding tasks requiring substantial expertise from scientists, consultants, lawyers, and others. The transitional phase of REACH ended on 31 May 2018, and companies of all shapes and sizes are now engaged in a wide range of ongoing compliance activities. This column addresses certain important REACH-related activities being undertaken by numerous entitites in the ongoing post-deadline era, and provides comments on their significance. 

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 through enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), it was mindful of the public’s growing interest in 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, amendments that the 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.

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