The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on June 24, 2020, on “Advances in self-powered wearable sensors: A biofuel-powered electronic skin.” NNI states that the development and commercialization of self-powered, battery-free sensors with wireless capabilities would represent a significant step toward meeting the requirements for next-generation biosensors, medical devices, and robotics. Dr. Wei Gao, California Institute of Technology, will...
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 6, 2020
Ninth Circuit Vacates EPA’s Renewal of Conditional Registrations for Lower Volatility Dicamba Formulations
On June 3, 2020, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in National Family Farm Coalition v. EPA, No. 19-70115, vacating the U.S. Environmental Protection Agency’s (EPA) 2018 decisions to extend the conditional registrations for three reduced volatility dicamba herbicides, Bayer’s XtendiMax, Corteva’s FeXapan, and BASF’s Engenia. The manufacturers of these dicamba products designed them to facilitate control of glyphosate...
June 5, 2020
EPA Issues Pre-Publication Version Of Its Proposed Anti-Backsliding Determination For Renewable Fuel
By Lynn L. Bergeson On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to...
By Lynn L. Bergeson EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates...
By Lynn L. Bergeson On June 3, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it will be hosting a public virtual workshop titled “Workshop on Predictive Models and High Performance Computing as Tools to Accelerate the Scaling-up of New Bio-Based Fuels.” The goal is to determine if predictive models and high performance computing can and should be used to reduce biotechnology uncertainty and accelerate scaling-up...
By Lynn L. Bergeson On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include: Bioanalytical method...
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...
The Household & Commercial Products Association’s (HCPA) virtual mid-year meeting webinar series, IMPACT2020, focused on public policy issues impacting the household and commercial products industry. Karin F. Baron, MSPH, Senior Regulatory Consultant with Bergeson & Campbell, P.C. (B&C®), presented during the “International Affairs Council: Europe – South & Central America – Asia & Australia” session on June 4, 2020. ...
The Nanotechnology Industries Association (NIA) will hold a webinar on July 7, 2020, on “Introducing the NanoHarmony project.” Funded through Horizon 2020, NanoHarmony began on April 1, 2020. NanoHarmony brings together 14 expert partners from ten European countries and will work alongside the Organization for Economic Cooperation and Development (OECD) and European Chemicals Agency (ECHA) to support the development of test guidelines and guidance documents for...