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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...

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.

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 Chemistry and...

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...

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:...

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...

Download transcript. This week, as employees around the country are returning to their offices and work stations, I was excited to visit with Larry Sloan, CEO of the American Industrial Hygiene Association (AIHA), located here in the Washington, D.C., area. AIHA may not be a well-known organization to many of our listeners, but that could be about to change.  Founded in 1939, AIHA is a non-profit organization serving professionals dedicated to the identification, evaluation, control, and...

The Acta Group (Acta®) and EPPA were pleased to present the complimentary webinar “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements.” Lynn L. Bergeson, President, Acta; Heather J. Blankinship, Senior Regulatory Consultant, Acta; Arkady Murashev, Chair, EPPA; Katia Filippova, Senior Adviser, EPPA; and Kate Stolbova, Regulatory Consultant, EPPA presented. 

On May 19, 2020, the U.S. Environmental Protection Agency (EPA) released its “first ever” proposed rule intended to improve the transparency of guidance. According to EPA, the new rule will significantly increase the transparency of its practices around guidance and will improve its process for managing guidance documents. When final, the rule will: Establish the first formal petition process for the public to request that EPA modify or withdraw a guidance document;  Ensure...

From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.