Articles

Partially hydrogenated oils (PHO), the products of incomplete catalytic hydrogenation of food oils, have been widely employed by the food industry for more than a century. Their exceptional stability and technologic characteristics made them the preferred choice for the production of several food products including margarines, bakery goods, and frying oils. Some of these highly prized characteristics were provided by the high content in trans fatty acids (TFA), defined as fatty acids...

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...

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....

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...

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....

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...

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....

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....

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...

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,...

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...

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...

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...

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....

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....

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....

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...

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...

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...

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)...

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...

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...

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...

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,...

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....

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....

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....

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...

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....

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...

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...

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....

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...

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....

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...

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....

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...

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 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. ...

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....

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....

2019 started with a political bang. The President’s decision to allow a partial government shutdown in the absence of funding for the “wall” will continue to inspire federal administrative and regulatory havoc for months to come. This is particularly true of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as it administers the programs under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and...

In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, the US Department of Labor’s Occupational Safety and Health Administration (OSHA) published a Proposed Rule Stage item titled, “Update to the Hazard Communication Standard,” RIN 1218-AC93 (OSHA, 2018), and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March, 2019. This could be an important regulatory development for all...

Brexit is a moving target from a political viewpoint, but many matters for regulatory compliance and product stewardship teams globally appear clearer than before. This article suggests timely REACH compliance strategies companies should adopt and implement that account for wide-ranging Brexit repercussions....

Big retailers strive to source products responsibly. This typically includes recognition of chemicals in the products they market. As part of its commitment to responsible sourcing, Amazon recently posted its Chemicals Policy, which includes its first Restricted Substance List (RSL). This column discusses this milestone....

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN)....

The State of California now has over 900 chemical substances for which warning and labeling is required under Proposition 65 (Prop 65). Recently added to this list are soluble nickel compounds. Given the potential ubiquity of the substance, this could have big implications....

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued a final fees rule under the Toxic Substances Control Act (TSCA). The final rule largely tracks the proposed rule. The EPA will host a series of webinars focusing on TSCA submissions and fee payments under the final rule. The agency has posted a pre-publication version of the final rule, as well as its response to public comments on the proposed rule....

Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), directs that “[n]ot later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish” (Environmental Protection Agency [EPA], 2018a, p. 30056) an inventory of mercury or mercury-added products or uses of mercury in a manufacturing process. On June 27, 2018, the U.S. Environmental Protection Agency...

This summer, the U.S. Environmental Protection Agency’s Office of Inspector General (OIG) issued a report titled “EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.” The OIG conducted an audit to determine how the EPA is ensuring companies are compliant with the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA), and whether the EPA uses CDR data to prioritize chemicals for the purpose of identifying...