All Knowledge & Insights By Date

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on August 23, 2019, proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 44300.  The notice and supporting docket materials identify the proposed designation for each of the chemical substances and instructions on how to access the chemical-specific information, analysis, and basis used by EPA...

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 44300.  The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation for each of the chemical substances, and instructions on how to access the chemical-specific information,...

The U.S. Environmental Protection Agency (EPA) posted an August 7, 2019, petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER) under Section 21 of the Toxic Substances Control Act (TSCA).  PEER asks that oil refineries be prohibited from using hydrofluoric acid in their manufacturing processes and that oil refineries be required to phase out the use of hydrofluoric acid within two years.  According to PEER, TSCA and the Clean Air...

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site.  The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol...

Health and safety studies provide invaluable insights into the hazards posed by chemical substances. The cost of generating these studies is also considerable, and access to them should be commensurate with the intellectual property interests they reflect. This article explores two current challenges under the Toxic Substances Control Act (TSCA) and offers practical tips for managing these issues....

By Lynn L. Bergeson On August 15, 2019, the U.S. Department of Energy (DOE) announced approximately $40 million in funding for 29 projects to advance the H2@Scale concept.  H2@Scale is a concept that explores the potential for wide-scale hydrogen production and utilization in the United States to enable resiliency of the power generation and transmission sectors while also aligning diverse domestic industries, competitiveness, and job creation. Funded through DOE’s Office of Energy...

By Lynn L. Bergeson On August 16, 2019, DOE Under Secretary of Energy Mark W. Menezes announced funding for new and innovative advanced vehicle technologies research. DOE’s EERE is providing $59 million to 43 projects dedicated to advanced batteries and electric drive systems, co-optimized engine and fuel technologies, materials for more efficient power trains, and alternative fuels and new energy-efficient mobility systems....

By Lynn L. Bergeson On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which...

By Lynn L. Bergeson On August 21, 2019, Iowa Democratic Representative Cindy Axne asked the U.S. Environmental Protection Agency’s (EPA) Inspector General (IG) to investigate how EPA decided to grant the exemptions from the Renewable Fuel Standard (RFS) requested by oil refiners. EPA approved 31 petitions for waivers from the 2018 requirements.  Lawmakers are not pleased at what appears to be EPA favoring the oil industry. Hence, Representative Axne’s call for an IG...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On August 16, 2019, the Instituto de Pesquisa Econômica Aplicada (Ipea – Institute of Applied Economic Research) announced its partnership with the Ministério da Agricultura, Pecuária e Abastecimento (Mapa – Brazilian Agriculture, Livestock, and Supply Ministry) to develop indicators to evaluate the implementation of the Programa Nacional de Insumos para Agricultura Orgânica (Bioinsumos – National...