All Published Articles

Lynn L. Bergeson, "Extended producer responsibility for packaging: and so it begins in the US," Financier Worldwide, October 2021.

On 13 July 2021, Maine became the first state in the US to enact extended producer responsibility (EPR) legislation for packaging. Quickly thereafter, on 6 August, Oregon became the second state to enact a similar EPR law applicable to packaging. Other states are poised to enact similar legislation, following trends more mature in the European Union (EU) and elsewhere around the world.

Lynn L. Bergeson, "EPA Goes Back To The Drawing Board On Toxic Substances," Chemical Processing, September 15, 2021.

The implementation of the Toxic Substances Control Act (TSCA) provisions relating to regulating persistent, bioaccumulative and toxic (PBT) chemicals has been anything but smooth. On September 3, 2021, the Environmental Protection Agency (EPA) announced it intends to initiate new PBT rulemaking and anticipates proposing new rules for five PBT chemicals subject to final risk management rules under TSCA Section 6(h). Additionally, and happily, the agency extended the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)). The action was imperative as EPA’s earlier-issued “No Action Assurance” (NAA) lapsed on September 4, 2021. This article provides key points related to this complicated area of TSCA regulation.

Lynn L. Bergeson, "Is FDA Food Safety Revision in Our Future?," Chemical Processing, August 24, 2021.

Food safety comes in many forms. Years ago, Congress passed the Food Quality Protection Act, amending the nation’s pesticide law to ensure a safer, more reliable, food supply. Consumer groups have urged Congress for years to modernize the nation’s food chemical law, the Federal Food, Drug, and Cosmetic Act (FFDCA), to address often-stated concerns with chemicals in food. Thus far, those concerns remain largely unaddressed by any legislative effort. Things may be changing. On July 26, 2021, Representative Jan Schakowsky (D-IL), chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. This article summarizes the measure, and speculates on its likelihood of passage.

Carla N. Hutton and Karin F. Baron, MSPH, "Expert Briefing: What could the European Commission’s plan to strengthen CLP mean for industry?," Chemical Watch, August 2, 2021.

To help achieve the ambitious goals of the European Green Deal, the European Commission adopted the chemicals strategy for sustainability in October 2020. The strategy suggests that the Commission can address pressing human health and environmental concerns by reinforcing Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures – one of the EU’s cornerstones for regulating chemicals.

Lynn L. Bergeson, "PFAS: Is Anything Not Reportable?," Chemical Processing, July 19, 2021.

The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS), as covered in July’s column “EPA Announces Blockbuster PFAS Actions.” This column focuses on one of them: an ambitious proposal intended to obtain comprehensive data on more than 1,000 PFAS manufactured in or imported into the United States. As discussed in this article, the proposal’s scope is enormous.

Lynn L. Bergeson, "Avoiding costly supply chain disruption: a cautionary tale," Financier Worldwide, July 2021.

By any independent standard, the US electronics industry is huge – it was worth over $300bn in 2019 – and growing annually. Would it surprise you to know that as big, essential and powerful as it is, a single rule issued in January of this year by the US Environmental Protection Agency (EPA) nearly brought this sector to a halt? To this day, the rule is causing extraordinary disruption as electric and electronic device manufacturers, importers, processors, distributors and others scramble to adjust in its aftermath. This article tells the cautionary tale of PIP (3:1). This sad and largely avoidable tale crystalises the importance of understanding the long reach of the US industrial chemical control law, the Toxic Substances Control Act (TSCA) and its seemingly limitless potential for disrupting global supply chains.

Lynn L. Bergeson, "EPA Announces Blockbuster PFAS Actions," Chemical Processing, June 23, 2021.

When it comes to per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) is not messing around. The agency announced on June 10, 2021, three actions intended to protect communities from PFAS. This article summarizes the actions.

Lynn L. Bergeson, "The essential role of evolving technologies in securing a safe and sustainable food supply," Agricultural Law Section of the International Bar Association, June 1, 2021.

Emerging tools enabled by nanotechnology, synthetic biology, and other innovative technologies are today increasingly supplementing the ploughs and tractors so emblematic of the agricultural community of the past. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges, while diminishing worldwide greenhouse gas emissions. Genetically modified E coli is being used to produce synthetically-derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Agricultural stakeholders use nanopesticides and nanofertilisers in drought-stricken regions, minimising the need for more conventional and environmentally consequential agricultural chemicals. GPS-based auto-steering systems for tractors augment human labour, freeing up effort better spent on other tasks. These technologies enable global agricultural professionals to address the climate change imperatives which threaten an increasingly fragile global food supply.

Lynn L. Bergeson, "TSCA: A change of course," Specialty Chemicals Magazine , May/June 2021.

Just as the industrial chemical community was getting into a predictable, somewhat comfortable groove regarding commercializing new chemicals under the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) decided to blow up the process. With it went any hope for business certainty in this highly volatile regulatory area.  While new administrations are entitled to shape policies to align with their agendas, the Biden Administration’s decision to rescind the new chemicals policies bodes badly for chemical innovation at the very time new, sustainable chemical innovations are most needed.  This article explains why the new chemicals policies portend major delays.

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, "Don’t Ignore Game-Changing EU Environmental Initiatives," Bloomberg Law Insights, April 21, 2021.

Two developments in the European Union in 2020 involving chemical regulations will almost certainly impact U.S. chemical stakeholders, according to Lynn L. Bergeson, managing partner of Bergeson & Campbell P.C. One initiative restricts certain chemicals in order to comply with the European Green Deal, while the other amends chemical disclosure requirements, she explains.

Lynn L. Bergeson, "EC Scientific Committee's Preliminary Opinions for Certain Gold and Platinum Nanomaterials Open for Comment," Nanotechnology Now, April 19, 2021.

On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment: Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano).

Lynn L. Bergeson, "The New Toxic Substances Control Act is Now Five Years Old: A Report Card - It Is a Mixed Bag, but We Are Getting There," The Debate, from ELI The Environmental Forum , May/June 2021.

June 22 of this year will mark the fifth anniversary since President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Popularly still known by the name of the 40-year-old statute it replaced, the new version of the Toxic Substances Control Act had a vision to follow in reforming a system for evaluating and regulating chemicals in commerce that everyone, from industry to green NGOs to government officials, agreed was weak and ineffective. The new TSCA, promising to fix a broken statute, received bipartisan support and was the first major environmental law in a quarter century.

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, "Better Understand TSCA’s Long Reach," Chemical Processing, March 14, 2021.

If anyone on planet Earth thinks the Toxic Substances Control Act (TSCA), as amended, is not commercially consequential, think again. The implementation of the 2016 amendments by the U.S. Environmental Protection Agency (EPA) is triggering tremendous commercial disruption. The EPA’s March 8, 2021, announcement seeking comment on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, and, importantly, granting a rare “No Action Assurance” regarding the PIP (3:1) rule, is demonstrable proof of TSCA’s enormous reach. The reasons behind this regulatory action are revealing and demonstrate why the PIP (3:1) experience is a cautionary tale.

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, "EPA Orders Testing For Nine Chemicals," Chemical Processing, February 21, 2021.

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. Many in the industrial chemical community expect the EPA to use its TSCA testing authority much more in the coming years. The January orders seem to confirm that expectation. This article discusses the significance of the action.

Lynn L. Bergeson, "Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny," American College of Environmental Lawyers (ACOEL) Blog, February 4, 2021.

The Biden Administration has embraced environmental justice with unprecedented gusto.  In its July 2020 Plan to Secure Environmental Justice and Equitable Economic Opportunity (Plan), the Biden Administration sets out in broad terms how it intends to use an “All-of-Government” approach to “rooting out systemic racism in our laws, policies, institutions, and hearts.”

Lynn L. Bergeson, "OECD Will Hold Webinar on Assessing the Dispersion Stability and Dissolution of Nanomaterials in the Environment," Nanotechnology Now, February 2, 2021.

On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on "Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment" to discuss the scope, content, and use of Test Guideline No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document. 

Lynn L. Bergeson, "EPA Proposes Revisions To TSCA Fees Rule," Chemical Processing, January 19, 2021.

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) proposed to amend the 2018 Toxic Substances Control Act (TSCA) fees rule. This column discusses the proposal and its improvements to the rule.

Lynn L. Bergeson and Lara A. Hall, "M&A activity in the analytical services sector: points to consider," Financier Worldwide, January 2021.

There has been remarkable consolidation in the analytical services sector in the US and elsewhere globally over the past few years. Make no mistake; the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialised expertise is also growing exponentially. This article summarises mergers and acquisitions (M&A) trends and explains why skilled help is essential to avoid liability. A PDF of this article can be downloaded here

Lynn L. Bergeson, "EPA Fee Controversy Continues," Chemical Processing, December 16, 2020.

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to collect fees from chemical manufacturers (including importers) to defray a portion of the costs associated with TSCA implementation efforts. The TSCA fees rule requires payment for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. The EPA must prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated Section 6 risk assessments, which it did (see, “Are You on the List?” and “EPA Tells Businesses to Pay Up”). Since then, who pays for what has led to significant controversy. 

Lynn L. Bergeson, "EPA Announces Carbon Tetrachloride Risks," Chemical Processing, November 20, 2020.

The U.S. Environmental Protection Agency (EPA) published the final risk evaluation for carbon tetrachloride on November 4, 2020. The EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of CCl4 use, but no unreasonable risks to the environment. According to the EPA, there are no consumer uses of this chemical. Most agree the findings are not unexpected. This article explains the assessment and the results.

Lynn L. Bergeson and Eve C. Gartner, "The essentials of TSCA practice," ABA Section of Environment, Energy, and Resources Trends, November/December 2020.

The Toxic Substances Control Act (TSCA) is not the arcane federal law it once was. Amended in 2016 in response to a demand so loud and persistent from nongovernmental organizations, consumers, and, eventually, the industrial chemical community that Congress could no longer ignore it, TSCA is now a force with which to be reckoned. While the U.S Environmental Protection Agency’s (EPA’s) implementation of the 2016 Lautenberg Act that amended TSCA invites criticism among stakeholders, there is no disagreement that today TSCA is a more consequential law, deserving of legal practitioners’ attention.

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 Tells Businesses To Pay Up," Chemical Processing, September 16, 2020.

On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released the much-anticipated interim final list of businesses subject to risk evaluation fees for the 20 chemicals designated as “high priority” under the Toxic Substances Control Act (TSCA). Making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy. It also provides time for businesses to reach out to form consortia to share in fee payments. That is a fancy way of saying the race is on to try to get off the list or find others to share in the not-so-trivial cost of $1.35 million — the EPA’s fee for work on the risk evaluation.

Lynn L. Bergeson, "Feeling the Pinch: who pays TSCA risk evaluation fees?," Financier Worldwide, September 2020.

Ordinarily, government fees command little interest in corporate finance and board-level business circles. Newly imposed fees to defray the US Environmental Protection Agency’s (EPA’s) risk evaluation of high-priority chemical substances under Section 6 of the Toxic Substances Control Act (TSCA) are extraordinary, however, and are commanding significant interest. This article explains why.

Lynn L. Bergeson, "Off to the Races—CDR Reporting Begins!," Washington Watch, Fall 2020.

As the expression goes, it is that time of year again.  Section 8 of the Toxic Substances Control Act (TSCA) requires manufacturers, including importers, to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce at four-year intervals.  The last reporting cycle for the requirement, known as the Chemical Data Reporting (CDR) requirement, was in 2016, so TSCA stakeholders have been gearing up since then for the current quadrennial reporting obligation, which commenced on June 1, 2020.  This column provides an overview of what is new and different since 2016.

Lynn L. Bergeson, "EPA Eyes Carpet Chemicals," Chemical Processing, August 21, 2020.

The U.S. Environmental Protection Agency (EPA) continues to regulate “forever chemicals,” named such for their persistence and risk to the environment and health. On July 27, 2020, the EPA issued a long-awaited final rule amending significant new use rules (SNUR) issued earlier on such chemicals — one pertinent to certain perfluoroalkyl sulfonate chemical substances and the other on long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances. To some, the final rule reflects comments on the proposed rule issued five years ago; to others, the rule weakens to the public’s detriment a proposal the Obama Administration issued. This article discusses the rule and its implications.

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, 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, "EPA-Initiated TSCA Risk Evaluations: Who Is on the Hook for Fees Has Changed," Washington Watch, Summer 2020.

Under the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with risk evaluation efforts.  The fees are quite substantial and who pays them has been the subject of considerable debate and uncertainty.  This column addresses issues that have caused confusion and anxiety for industry stakeholders regarding the self-identification criteria, time lines, and procedures, and seeks to add much needed clarity to this chaotic issue.

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, "TSCA Risk Evaluation Fees: Who Is on the Hook?," Washington Watch, 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?  It may well be.  This is a hot topic these days, given EPA’s Federal Register notice published on 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.  Until March 27, 2020, stakeholders are required to “self-identify” as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA (yes, you must submit a form to EPA even if your company name is already identified by EPA).  The preliminary lists are available in Docket EPA-HQ-OPPT-2019-0677 and on EPA’s website at http://www.epa.gov/TSCA-fees.  This article explains the notice and suggests way to respond to it.

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, "TSCA Citizen Petitions and Risk Evaluations: Are These Critical TSCA Tools Aligned?," Environmental Quality Management, Volume 29, Issue 2, Winter 2019.

The citizen suit provisions of the Toxic Substances Control Act (TSCA) are turning out to be a potentially powerful tool for advocates dissatisfied with risk evaluations conducted under TSCA Section 6. What is unclear is whether anyone intended this result. This column discusses the new and somewhat surprising role TSCA Section 21 citizen petitions may play in defining chemical risks under TSCA. The issue involves an interesting TSCA Section 21 petition filed in 2016 that has been the subject of litigation ever since. How the lawsuit plays out will have significant implications for TSCA stakeholders.

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.

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