On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia. 84 Fed....
May 10, 2019
EC JRC Announces Publication of Article on Measuring Nanoparticles in Medicinal Products
The European Commission’s (EC) Joint Research Center (JRC) announced on May 10, 2019, publication of an article entitled “Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL. A step by step approach combining orthogonal measurements with increasing complexity” in the April 10, 2019, issue of the Journal of Controlled Release. JRC, in close collaboration with researchers from the French Commissariat...
The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum “EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation.” Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6. Industry...
By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of...
By Lynn L. Bergeson On May 3, 2019, DOE announced over $79 million in funding for bioenergy R&D, which includes biofuels, bioproducts, and biopower. Under Secretary of Energy, Mark W. Menezes, stated that the FOA will contribute to ensure the nation’s competitive advantage in the bioeconomy and offer more energy choices. The FOA’s objectives are to reduce the price of drop-in biofuels, lower the cost of biopower, and enable high-value products from waste or biomass...
By Lynn L. Bergeson On May 2, 2019, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) announced funding of approximately $11 million for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II research projects. Small businesses that demonstrated technical feasibility for innovations during Phase I were required to compete for Phase II funding. Eleven projects have been awarded the funds, which will be used to build prototypes or...
By Lynn L. Bergeson On May 8, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced the pilot launch of its new online permitting system: APHIS eFile. Launching on July 23, 2019, APHIS will be inviting, at the end of May, those who have been issued a BRS permit or notification in the past two years to apply for the pilot program. The plan is...
By Lynn L. Bergeson From March 4-8, 2019, DOE’s Bioenergy Technologies Office (BETO) hosted the 2019 Project Peer Review in Denver, CO. According to BETO, this was one of the largest Peer Review events in BETO history, with almost 600 attendees present. The purpose of the event was for bioenergy researchers to present results from early-stage R&D projects across BETO’s technology areas. These presentations, as of May 2, 2019, have been made available online for...
By Lynn L. Bergeson On April 30, 2019, 15 U.S. Senators signed and submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, urging him to protect U.S. consumers and account for the ethanol blend wall when setting annual target volumes under the Renewable Fuel Standards (RFS) requirements. According to the letter, a decrease in consumer demand for gasoline has occurred since the RFS Program was passed into law. Instead of the...
By Lynn L. Bergeson On May 7, 2019, Energy Secretary Rick Perry announced a U.S. Department of Energy (DOE) funding opportunity of up to $89 million in support of innovative, advanced manufacturing research and development (R&D) projects. The opportunity aims to tackle key DOE priorities, which include domestic manufacturing for energy storage. Perry stated that “[e]mbracing new technologies that drive innovation in American manufacturing is the key to creating real-world progress that...
May 9, 2019
NIA Webinar on Nanosafety Available on YouTube
The Nanotechnology Industries Association (NIA), a “cross-sectoral, responsible voice for nanotechnology value chains and the global commercial eco-system,” hosts frequent webinars and then posts the webinars on its YouTube channel. On May 7, 2019, NIA held a webinar on “Nano in Action: Nanosafety.” Participants heard about the latest research and support tools intended to advance the development of safe materials from speakers involved in human and environmental safety research...
On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 19782. In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential...
On April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials. The Federal Ministry of Education and Research is providing 2.22 million euro to fund the project, which will be coordinated by BfR and includes ten partners from public authorities, academia, and industry. BfR states that until now, nanosafety...
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300: Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests. The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel...
The Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials. The Report notes that the applicability of OECD Test Guidelines for nanomaterials continues to be a major concern of the work of the Working Party on Manufactured Nanomaterials (WPMN). WPMN agreed to work on three new projects related to testing...
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...
By Lynn L. Bergeson On April 25, 2019, the Environmental Law Institute (ELI) held an event to provide an overview of their latest publication, a book titled Legal Pathways to Deep Decarbonization in the United States. Providing an overview of the book, a few of the authors were part of a panel discussion opened by William K. Reilly, former EPA Administrator under President George H. W. Bush. In his opening remarks, Mr. Reilly emphasized the...
By Lynn L. Bergeson In April 2019, Navius Research Inc. (Navius Research) published a report titled “Biofuels in Canada 2019: Tracking biofuel consumption, feedstocks and avoided greenhouse gas emissions.” Using public data, the report analyzes the volume of transportation biofuels consumed in each Canadian province and estimates the impact of this consumption on greenhouse gas (GHG) emissions and transportation energy costs. An increase in both ethanol and renewable fuel consumption...
By Lynn L. Bergeson On April 29, 2019, the National Chicken Council submitted a letter to EPA’s Office of Transportation and Air Quality outlining the potentially negative impact of the changes to the biofuels policy on the poultry industry. In his letter to EPA, Mike Brown, President of the National Chicken Council, reported concern with EPA’s proposal on year-round ethanol-15 (E15) use under the Renewable Fuels Standard (RFS) Program. The National Chicken Council believes that...
By Lynn L. Bergeson On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of...