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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...

Join Bergeson & Campbell, P.C., The Environmental Law Institute, And George Washington University Milken Institute School Of Public Health For “TSCA Reform -- Four Years Later” Virtual Seminar: From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. Bergeson & Campbell, P.C. (B&C®), The Environmental Law...

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,...

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. Watch now....

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...

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of...

The Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the long-awaited revision of MEP Order No. 7 in final, “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12), on April 29, 2020, which will become effective January 1, 2021. MEE Order No. 12 is generally the same as the Notification Draft that MEE notified to the World Trade Organization (WTO) on September 2, 2019, except that...

“TSCA Reform -- Four Years Later” Leads an Exciting Slate of Upcoming TSCA Seminars, Workshops, and TrainingsBergeson & Campbell, P.C. (B&C®) is pleased to share information regarding a full slate of upcoming opportunities for chemical industry stakeholders to stay abreast of key developments, adjusted due dates, and future plans regarding the implementation of the amended Toxic Substances Control Act (TSCA).  These events are virtual, vital, affordable, and presented in a...

On May 5, 2020, the U.S. Government Accountability Office (GAO) released a report updating its open priority recommendations for the U.S. Environmental Protection Agency (EPA). According to GAO, in April 2019, it identified 17 priority recommendations for EPA. Since then, EPA has implemented three of those recommendations by, among other things, assessing established timeframes for each step in the Integrated Risk Information System (IRIS) process and publishing current information...