All Published Articles

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, "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 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, "Chemical Compliance: Get Ready for South Korean Deadline," Chemical Processing, May 17, 2019.

Global chemical substance notification deadlines continue to populate the regulatory horizon. For companies active in worldwide markets, it’s crucial to review and meet all important notification and registration deadlines in each country. This article focuses on South Korea’s policy and explains why it’s essential to meet these deadlines.

Lynn L. Bergeson, "The Rise of Ingredient Disclosure: The California and New York Experience," Environmental Quality Management, Volume 28, Issue 3, Spring 2019.

In the recent past, two important states—California and New York—have launched extensive and precedent‐setting ingredient disclosure laws regarding cleaning products with the clear goal of prompting the deselection of certain chemical substances and forcing product reformulation. Industry prefers to refer to this trend as “ingredient communication,” a goal we can all agree is desirable. By whatever name, these state measures will have a significant impact on ingredient disclosure trends across product lines, likely well beyond their stated application to cleaning products. These state laws are summarized in this article, followed by a discussion of their similarities, key differences, and their implications.

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.

Lynn L. Bergeson, "Regulatory Opportunities and Challenges in Commercialising Biobased Chemicals," International Chemical Regulatory and Law Review, Volume 2, Issue 1, Spring 2019.

The 21st Century has witnessed intense renewed interest in commercialising new biobased chemicals, defined generally to include chemicals that are derived fromplants and otherrenewablematerials. The Toxic Substances Control Act (TSCA) is the U.S. law thatregulatesindustrial chemicalsubstances,including biobased chemicals, used in applications other than food, drugs, cosmetics, and pesticides, or uses that are regulated by other federal authorities. TSCA wassignificantly amended in 2016, and stakeholders need now more than ever to understand how TSCA applies to biobased chemicals to appreciate the implications of new TSCA on their commercial operations. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

Lynn L. Bergeson, "GAO Evaluates EPA Performance," Chemical Processing, March 18, 2019.

The U.S. Government Accountability Office (GAO) released on March 6, 2019, a report titled “High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas.” This column discusses the report and its implications on chemical management policy.

Cheryl B. Cleveland, Carrie R. Fleming, Jason E. Johnston, Angela S. Klemens, and Bruce M. Young, "Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations," Journal of Agricultural and Food Chemistry, March 14, 2019.

The International Estimated Short-Term Intake IESTI equations are used during the establishment of Codex Maximum Residue Limits. A recent proposal to revise the equations sparked international debate regarding selection of residue inputs and the appropriate level of consumer protection. The 49th Codex Committee on Pesticide Residues meeting recommended benchmarking the IESTI equations against distributions of actual exposures. Using publicly available data and models, this work compares dietary exposures for strawberries, tomatoes, and apples at five levels of refinement to place these equations into context relative to real-world exposures. Case studies were based on availability of robust USDA PDP monitoring data, which is uniquely suited to refine dietary exposures for a population. Benchmarking dietary exposure involves several decision points. Alternate methodology choices are not expected to impact the large margins observed between the probabilistic estimates and the IESTI equations or to change the overall conclusion that existing IESTI equations are conservative and health-protective.

Lynn L. Bergeson and Karin F. Baron, "Expert Focus: A Glimpse at US OSHA’s Updated Hazard Communication Standard," Chemical Watch, March 11, 2019.

The Hazard Communication Standard (HCS) is, by its very nature, perennially a work in progress. The US is committed to global harmonisation in classifying chemical hazards, and the US Department of Labor’s Occupational Safety and Health Administration (Osha) 2012 incorporation of the Globally Harmonized System (GHS) of classification and labelling of chemicals into the Hazard Communication Standard (HCS) was a big step forward in achieving global harmonisation. The road is long, however, and the administration recognises much work remains to be done. This article reports on Osha's efforts to continue the harmonisation process.

Lynn L. Bergeson, "Changing of the Guard," Specialty Chemicals Magazine, March 2019.

The 2018 US mid-term elections have redefined the political winds in Washington, DC. What these currents mean for domestic chemical policy, and its impact on global chemical policy initiatives, is unclear. 

Lynn L, Bergeson, "FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials," Nanotechnology Now, February 22, 2019.

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.

Lynn L. Bergeson, "New York Disclosure Program Hits A Snag," Chemical Processing, February 18, 2019.

On January 9, 2019, the New York Department of Environmental Conservation (NYDEC) announced it was delaying its enforcement of the New York Household Cleansing Product Information Disclosure Program (NYDP) to October 2, 2019. NYDEC’s announcement was published in the Environmental Notice Bulletin. This article explains the significance of this development.

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