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On May 9, 2020, the European Commission (EC) began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and the environment — in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The regulatory...
July 10, 2020
Industry Associations Petition EPA to Develop Risk Management Procedural Rule under TSCA Section 6
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) develop a risk management procedural rule under TSCA Section 6. According to the petition, such a rule is necessary to implement the Frank R. Lautenberg Chemical Safety...
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...
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 the 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 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...
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: EPA has posted a pre-publication version of the proposed rule. Publication in the Federal Register will begin a...
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...