Memoranda

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...

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...

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...

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...

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...

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...

On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene. According to EPA, it reviewed 68 conditions of use and preliminarily found unreasonable risk to workers, occupational non-users (ONUs), consumers, bystanders, and the environment from certain uses. EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation. EPA notes that if its final risk evaluation finds there are...

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 implementation efforts. The EPA fees rule, which became effective on October 18, 2018, required payment of fees for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. As part of the final fees rule, EPA...

The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE)...

On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of...

On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of...

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment. EPA released draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation, and stated that it will soon release and accept public comments on the seven remaining draft scope documents. According to EPA, the scope...

The Russia Federation issued in final the Technical Regulation on the Safety of Chemical Products (TRSCP; Decree No. 1019) in October 2016 to establish a framework for regulation of chemical substances. Its implementation created a chemical inventory to include chemicals and mixtures in circulation and those intended for circulation in the territory of the Russian Federation. Inventory information is to be submitted online to the Russian Federation’s Governmental Industry Information Exchange...

The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020. EPA will publish a notice of availability in the Federal Register, beginning a 60-day comment period. EPA will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation April 27-30, 2020. The virtual peer review meeting is open to the public to attend and provide...

On March 30, 2020, the U.S. Environmental Protection Agency (EPA) published the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States. The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes. The inventory report also provides a broad view of U.S. mercury stored, sold,...

India released the fourth draft Chemicals (Management and Safety) Rules to select groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The government is accepting comments until March 31, 2020. The draft Rules include significant revisions to the list of priority substances that are subject to importation notifications, and hazard communication obligations...

On March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). According to the plaintiffs’ complaint, EPA fails to publish full and complete notices of its receipt of new chemical applications in a timely fashion and does not disclose...