The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH. As...
October 8, 2019
EFSA Opens Consultation Period on Two Pilot Assessments on the Risks Caused by Multiple Pesticide Residues in Foods
On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food. EFSA is seeking comments from interested parties on the assessments. The first assessment considers the chronic effects of multiple pesticides on the thyroid system. The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...
October 4, 2019
Lynn L. Bergeson and Carla N. Hutton Co-Author Article on Nanotechnology and Regulatory Certainty
We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.” Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...
October 4, 2019
FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P
By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...
By Lynn L. Bergeson On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL)...
By Lynn L. Bergeson On September 30, 2019, DOE announced that the Lawrence Livermore National Laboratory (LLNL) will host an informational webinar about the High Performance Computing for Energy Innovation (HPC4EI) Program. In honor of National Manufacturing Day, the webinar is scheduled for October 4, 2019, at 12:00 p.m. (EDT). The HPC4EI Program pairs national laboratory scientists with partners in industry to apply high-performance computing technology and improve energy utilization in the...
October 4, 2019
DOE Announces Funding For Bioenergy R&D Projects
By Lynn L. Bergeson On October 1, 2019, the U.S. Department of Energy (DOE) announced that 35 projects have been selected to receive funding for bioenergy research and development (R&D). Totaling $73 million in funding provided by DOE’s Office of Energy Efficiency and Renewable Energy (EERE), the selected projects aim to: Reduce the price of drop-in biofuels; Lower the cost of biopower; and Enable high-value products from biomass or waste resources. According to DOE, the United States...
According to an item in the September 2019 issue of NIOSH eNews, the National Institute for Occupational Safety and Health (NIOSH) is working with RTI International to distribute a survey to companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials. The item states that the goal of the survey is to assess the impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of...
October 3, 2019
EPA Publishes TSCA SACC Meeting Minutes and Final Report on Draft Risk Evaluation for PV29
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29). SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation. As reported in our...
On October 2, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and soliciting public comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP) A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy). EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants...