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...
May 15, 2020
Find B&C’s Updates And Analysis Of Chemical Regulatory Impacts Of COVID-19 In One Place
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....
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...
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...
April 21, 2020
EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances
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. 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)...
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...