TSCA

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.

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, "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.

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.

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, "Political Turmoil Muddies Regulatory Moves," Chemical Processing, January 16, 2019.

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 Rodenticide Act (FIFRA), both of which maintain hugely important fees-for-service programs.

Lynn L. Bergeson, "EPA Issues Final TSCA Fees Rule," Chemical Processing, October 29, 2018.

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.

Lynn L. Bergeson, "EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory," Environmental Quality Management, Volume 28, Issue 1, Fall 2018.

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 (EPA) published a final rule responding to this legislative mandate. The rule requires certain entities to provide information to assist in the preparation of this inventory. This column outlines the final rule and discusses its implications.

Lynn L. Bergeson, "Compliance: CDR Rule Shows Room for Improvement," Chemical Processing, September 19, 2018.

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 their potential risks to human health and the environment. The OIG found that implementing policies for data quality checks will help tailor the information reported to meet the EPA’s needs. This column discusses the report.

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