July 8, 2020

Available On-Demand: “TSCA Reform—Four Years Later” Virtual Seminar

On June 24, 2020, Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform — Four Years Later.”  A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA), and comments by the Hon. John Shimkus U.S....
July 2, 2020

DOE Announces RFI On Improving Battery Critical Materials Supply Chains and Other Biobased Developments

Federal DOE Announces RFI On Improving Battery Critical Materials Supply Chains On June 29, 2020, the United States (U.S.) Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) published a request for information (RFI) on challenges and opportunities in the up- and mid-stream critical materials battery supply chains. As demand for critical materials such as lithium and cobalt for the manufacturing of batteries continues to grow, DOE is seeking ways to reduce...
July 1, 2020

EPA’s Temporary Enforcement Policy Will End August 31

The U.S. Environmental Protection Agency (EPA) issued a memorandum on June 29, 2020, announcing an “addendum on termination” to its March 26, 2020, COVID-19 temporary enforcement policy. The memorandum notes that as states and businesses begin to re-open, there will be a period of adjustment as regulated entities plan how to comply with environmental legal obligations and with public health guidance from the Centers for Disease Control and Prevention (CDC) and other agencies...
June 25, 2020

Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 24, 2020, announcing the availability of the final Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride. 85 Fed. Reg. 37942. This is the first risk evaluation that EPA has completed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA. After evaluating 53 conditions of use of methylene chloride, EPA determined that...
June 25, 2020

TSCA at Four — A Conversation with Alexandra Dunn, OCSPP AA

This week I sat down with EPA Assistant Administrator Alexandra Dunn.  As many of our listeners know, Alex Dunn heads the Office of Chemical Safety and Pollution Prevention and is responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively. Alex has an extensive background in the environmental field and is a leading voice on TSCA and...
June 17, 2020

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....
June 11, 2020

TSCA at Four — A Conversation with Richard E. Engler, Ph.D.

As we are now into June, Toxic Substances Control Act (TSCA) aficionados will be quick to note that “new TSCA” is now almost four years old.  Passage in June 2016 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act occasioned EPA’s implementation of a law that has transformed industrial chemical regulation in the United States.  This week, to mark Lautenberg’s fourth birthday, I sat down with Dr. Richard E. Engler, B&C’s Director of...
June 8, 2020

Senate Finance Committee Holds Hearing on FDA’s Foreign Drug Manufacturing Inspection Process

On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and Drug Administration (FDA), U.S. Government Accountability Office (GAO), and private sector companies. The hearing sought to examine the accountability of FDA’s vetting process, especially in regard to drugs necessitated by the COVID-19 pandemic. Lawmakers and witnesses...
June 4, 2020

China Publishes Draft Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12

The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released a Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances (Draft for Consultation) on June 3, 2020. The deadline to submit comments to MEE regarding the draft Notice is June 20, 2020. Comments can be submitted to MEE via e-mail (chem@mee.gov.cn). The key points in the draft Notice are summarized below: Commentary...
June 1, 2020

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...