Blogs

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...

The International Organization for Standardization (ISO) has published standard ISO/TS 11308:2020, “Nanotechnologies — Characterization of carbon nanotube samples using thermogravimetric analysis.” The standard provides guidelines for the characterization of carbon nanotube (CNT)-containing samples by thermogravimetric analysis (TGA), performed in either an inert or oxidizing environment. The standard offers guidance on the purity assessment of the CNT samples through a quantitative...

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is hosting the following webinars to educate scientists on the more than 30 federal opportunities available in Research Triangle Park, North Carolina: Thursday, April 16, 2020, 2:00 p.m. to 3:00 p.m. (EDT).  Join the webinar;  Thursday, April 23, 2020, 2:00 p.m.to 3:00 p.m. (EDT).  Join the webinar; and  Thursday, April 30, 2020, 2:00 p.m. to 3:00...

This week, I sat down with Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD). Eric, like many of us these days, is working hard and under extraordinary circumstances ensuring that his member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.  Our conversation focused on these uniquely “in the moment” issues and a broad range of federal,...

On April 14, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA’s...

On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report).  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2017 Report discusses the completion...

The International Organization for Standardization (ISO) has published standard ISO/TS 21237:2020, “Nanotechnologies — Air filter media containing polymeric nanofibres — Specification of characteristics and measurement methods.”  According to ISO, in recent years, air filter media containing nanofibers have been commercialized and widely used by different industries due to their high filtration efficiency, along with a low pressure drop created by the slip flow effect.  ISO...

 The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020: CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)Cases in which the specific chemical identity is subject to CBI review3,326Cases in which...

The European Union (EU) Observatory for Nanomaterials (EUON) posted an article on April 6, 2020, announcing the availability of a study that found a lack of data on female fertility.  The study, A critical review of studies on the reproductive and developmental toxicity of nanomaterials, was commissioned by the European Chemicals Agency (ECHA) and carried out by DHI A/S and the Danish National Research Center for the Working Environment.  The scope of this project was to...

The U.S. Environmental Protection Agency (EPA) published on April 10, 2020, the quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020.  In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available.  EPA states that making this information publicly available...