All Knowledge & Insights By Date

By Lynn L. Bergeson On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be...

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 marketing...

The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.”  The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in a mixed dust industrial manufacturing environment.  The guidelines describe air sample...

On May 16, 2019, the American Chemical Society (ACS) will hold a webinar on working safely with nanomaterials in the laboratory.  Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), will moderate a panel including: Ken Kretchman, Director of Environmental Safety, NC State University; Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and Debbie Decker, Chemical and...

By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...

By Lynn L. Bergeson On March 25, 2019, the U.S. Environmental Protection Agency (EPA) finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258.  EPA issued the notice of availability in the Federal Register on March 27, 2019.  84 Fed. Reg. 11538.  EPA states that the draft guidance, issued...

The International Organization for Standardization (ISO) has published standard ISO/TR 19733:2019, “Nanotechnologies — Matrix of properties and measurement techniques for graphene and related two-dimensional (2D) materials.”  ISO states that since graphene was discovered in 2004, it has become one of the most attractive materials in application research and device industry due to its supreme material properties such as mechanical strength, stiffness and elasticity, high electrical and...

Registration is available for the National Nanotechnology Initiative’s (NNI) April 9, 2019, webinar on “Characterization and Quantification of Engineered Nanomaterials:  Drivers of NanoEHS Research.”  The speaker will be Dr. Robert MacCuspie, Natural Immunogenics Corp., and Dr. Debra Kaiser, National Institute of Standards and Technology, will moderate.  The webinar will examine the significant progress in characterization and measurement of engineered...

The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for fiscal years (FY) 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020.  CPSC seeks comment on the following questions: What are the priorities CPSC should consider emphasizing...

By Lynn L. Bergeson On, March 12, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) announced the publication of two draft documents related to the potential deregulation of a soybean variety GE for increased yield and resistance to the herbicide glufosinate.  The draft documents are Draft Plant Pest Risk Assessment (PPRA) and Draft Environmental Assessment (dEA) for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance. The PPRA will examine any...

The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available: Carlos Eduardo Lima da Cunha, EC, “EU...

The European Commission’s (EC) Joint Research Center (JRC) opens its scientific laboratories and facilities, including its Nanobiotechnology Laboratory, to people working in academia and research organizations, industry, and small and medium enterprises (SME).  JRC opened a call on February 1, 2019, for the Nanobiotechnology Laboratory for the following priority topics: Nanomaterial characterization, including their interactions with biological systems (culture media, proteins);...

By Lynn L. Bergeson On February 21, 2019, scientists Abdon Pena-Francesh and Melik C. Demirel, at Pennsylvania State University, published an article on the use of squid teeth tandem repeat proteins that can be functionally used for biodegradable fibers and films.  The flexible and tough material results from a protein present in the squid teeth, which can be grown biosynthetically by E. coli bacteria.  This biosynthetic expression of squid teeth proteins presents a number of...

On February 21, 2019, the White House Office of Science and Technology Policy (OSTP) posted a report entitled Science & Technology Highlights in the Second Year of the Trump Administration.  The report highlights science and technology achievements, including the following under “R&D Fundamentals”: Supporting and celebrating key advances in nanotechnology.  In December, OSTP’s National Nanotechnology Coordination Office celebrated the 15-year anniversary of the...

The December 2018 issue of the Journal of Nanoparticle Research includes an article entitled “A survey on the state of nanosafety research in the European Union and the United States.”  According to the abstract, the authors surveyed researchers in the field of environmental safety and health of nanomaterials between September 2017 and January 2018 to obtain a snapshot on the state of investigations.  The data received from 84 respondents provide information on exposure pathways,...

On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an...

On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149).  Specifically, EPA is proposing to amend subparts C,...

On November 5, 2018, the European Commission’s (EC) Joint Research Center (JRC) announced the availability of the NANoREG Toolbox, an inventory of publicly available tools for the safety assessment of nanomaterials.  As reported in our October 5, 2017, blog item, JRC first published the inventory as a Microsoft Excel®-based dataset.  JRC scientists have now published an article, “An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials,”...

The European Commission (EC) Joint Research Center (JRC) announced publication of a paper introducing a new standardized testing procedure for nanomaterial environmental toxicity, “Introducing a new standardized nanomaterial environmental toxicity screening testing procedure, ISO/TS 20787:  aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. nauplii.”  The abstract states that the testing procedure is intended to generate more reliable and...

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency...