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...

The National Nanotechnology Initiative (NNI) has published key takeaways and a transcript for the September 19, 2018, webinar, “Technology Pathways Toward Commercializing Nanotechnology.”  The webinar focused on quality control in the manufacturing process and built on NNI’s November 2017 Technology Pathways workshop.  Webinar panelists Katherine Barton, Laboratory and Production Manager at Nano-C, and Doug Singer, Executive Vice President in Charge of Manufacturing,...

The German Environment Agency (UBA) in October 2018 published a study entitled Health Effects of Ultrafine Particles:  Systematic literature search and the potential transferability of the results to the German setting.  The study notes that ultrafine particles represent the smallest size fractions of particles with sizes from one to about 100 nanometers in aerodynamic diameter.  Their specific health effects are thus related to their physical capacity to reach diverse organ...

The U.S. Environmental Protection Agency (EPA) published on October 10, 2018, a direct final  rule promulgating significant new use rules (SNUR) for 28 chemical substances, including  single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Section 5(e) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to manufacture...

On September 12-13, 2018, the Organization for Economic Cooperation and Development (OECD), NanoReg2, and GRACIOUS hosted a “Scientific Workshop:  Grouping of Nanomaterials.”  The Workshop brought together 120 nanotechnology specialists from Europe, North America, and Asia to discuss a bottleneck in nanomaterials development and testing.  The agenda and the following slides from the workshop have been posted online: Welcome slides. Session 1: Nanomaterial Grouping: ...

On September 21, 2018, the Organization for Economic Cooperation and Development (OECD) announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials — Genotoxicity of Nano-TiO2.  The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide (TiO2) for illustrating the practical use of IATA.  The case study applies the...

On September 26, 2018, the U.S. Consumer Product Safety Commission (CPSC) will discuss the Fiscal Year 2019 Operating Plan.  According to the Operating Plan, in fiscal year (FY) 2019, CPSC will continue supporting nanotechnology research and working with other federal agencies under the National Nanotechnology Initiative (NNI) to minimize duplication and overlap of existing research efforts.  CPSC will undertake the following collaborative research activities:...

Germany’s Federal Institute for Occupational Safety and Health (BAuA) has published a report entitled Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterisation of Granular Biopersistent Particles (GBP).  In Project F 2364, researchers conducted an in vivo validation study to evaluate the consistency of data with results obtained in the preceding intratracheal instillation study in Project F 2336.  The abstract states that the same...

The European Commission (EC) has published a success story, “Controlling light at the nanoscale thanks to graphene.”  The EC notes graphene, “an atomically thin lattice of carbon, has many exceptional properties.”  A European Union (EU)-funded project is focusing on the unique capabilities of graphene plasmons to transport and control light emissions at spatial scales far smaller than their wavelength.  They can be exploited in numerous applications, including for infrared biosensing...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on September 7, 2018, that a new study found gaps in the current knowledge on the hazard and risk assessment of nano-sized pigments.  The study, commissioned by EUON, identified 81 nano-sized pigments currently used in the EU market.  The study was done to collect publicly available information on the identified nano-sized pigments that are on the EU market.  EUON states that the findings “show that the risks of...

The National Nanotechnology Initiative (NNI) has published The National Nanotechnology Initiative Supplement to the President’s 2019 Budget.  The August 2018 document not only supplements the President’s budget request for fiscal year 2019, but also serves as NNI’s annual report and addresses the requirement for Department of Defense (DOD) reporting on its nanotechnology investments.  President Trump requests nearly $1.4 billion for NNI, “a continued investment in...

The European Commission’s (EC) Joint Research Center has published a Technical Report entitled Mapping Nanomedicine Terminology in the Regulatory Landscape.  According to the abstract, to support a better understanding of terms used in the regulatory domain, the Nanomedicines Working Group of the International Pharmaceutical Regulators Forum (IPRF) prioritized the need to map, compile, and discuss the currently used terminology of regulatory scientists coming from different geographic...

Registration has opened for an August 20, 2018, webinar on “NanoEHS and Nanomedicine:  Similarities and Synergisms.”  The National Nanotechnology Initiative (NNI) notes that there are many synergies between nanomedicine research, which addresses (among other topics) issues of efficacy and safety, and studies on the environmental, health, and safety effects of nanomaterials (nanoEHS), which include the exploration of potential toxicity and exposures.  Research in these...

In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos.  This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP) which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP...

The July 2018 issue of the EFSA Journal includes an article entitled “Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171).”  The European Commission (EC) asked the European Food Safety Authority (EFSA) to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide used as a food additive (E 171) and to indicate whether they would merit re-opening EFSA’s 2016 opinion on the safety of titanium...

By Lynn L. Bergeson On July 16, 2018, the National Science Foundation (NSF) announced a $12 million investment in the Semiconductor Synthetic Biology for Information Processing and Storage Technologies (SemiSynBio) program, a partnership between NSF and Semiconductor Research Corporation (SRC).  Researches expect that integrating biological structures with semiconductor technology could increase current data storage capabilities by 1,000 times, while using less energy than current...

On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497).  These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and...

The Organization for Economic Cooperation and Development (OECD) has published a May 22, 2018, report entitled Assessment of Biodurability of Nanomaterials and their Surface ligands.  The purpose of the report was to compile the relevant information on the biodurability of the pristine and functionalized nanomaterials in biological and environmental media in vitro and in vivo, as well as describing methods for measuring the stability and halftimes of nanomaterials. ...

The 32nd Triennial Congress of the International Commission on Occupational Health (ICOH) was held April 29 through May 4, 2018, in Dublin, Ireland.  Occupational and Environmental Medicine (OEM) has published the abstracts for the Congress online, including the following ones concerning nanomaterials: “Update of potential hazards of nanomaterials,” by PA Schulte, I Iavicoli; “Overview — update of potential hazards of engineered nanomaterials,” by PA Schulte;...

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on April 24, 2018, announcing the availability of a draft research plan entitled Continuing to Protect the Nanotechnology Workforce:  NIOSH Nanotechnology Research Plan for 2018-2025 for public comment.  The draft Nanotechnology Research Plan presents the Nanotechnology Research Center (NTRC) strategic plan for fiscal years (FY) 2018-2025, highlighting how the...

On April 10, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin.  According to EPA, the document, Draft Interim Science Policy:  Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science...

In April 2018, the International Standardization Organization (ISO) published standard ISO 19007:2018, “Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles.”  The standard specifies a method for evaluating the effects of nano-objects and their aggregates and agglomerates on cellular viability using the MTS assay.  The assay design includes performance requirements and control experiments to identify and manage variability in the...

The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials.  The Testing Program for the Testing of Manufactured Nanomaterials tested 11 manufactured nanomaterials to generate information, including their physico-chemical properties, environmental fate, and environmental and mammalian...

The U.S. Consumer Product Safety Commission (CPSC) published a Federal Register notice on March 1, 2018, announcing that it will hold a public hearing on April 11, 2018, to receive comments about CPSC’s agenda and priorities for fiscal years (FY) 2019-2020.  CPSC’s Fiscal Year 2019 Performance Budget Request to Congress states that CPSC “will continue supporting nanotechnology research, coordinating with other federal agencies to extend limited...

On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines.  The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests.  83 Fed. Reg. 8666.  The three final guidelines are: OCSPP 810.2000 --...

On February 26, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study topics on nanomaterials.  EUON states that it intends to conduct up to three studies annually to address knowledge gaps about nanomaterials on the EU market.  The studies should be considered of interest for either a specific audience, such as regulators or researchers, but can also be for a wider use such as the general public.  Proposals should address an...

The U.S. Environmental Protection Agency (EPA) released its fiscal year (FY) 2019 budget proposal on February 12, 2018.  According to EPA’s press release, the proposed budget will provide $6.146 billion to support EPA’s new FY 2018-2022 Strategic Plan and mission of protecting human health and the environment.  EPA states that the “Back-to-Basic” agenda set out in the Strategic Plan has three over-arching goals reflecting EPA Administrator...

On February 12, 2018, the U.S. Consumer Product Safety Commission (CPSC) posted its Fiscal Year 2017 Annual Performance Report.  According to the Report, in fiscal year (FY) 2017, CPSC exceeded its target of five collaborations by establishing seven research collaborations on the environmental health and safety of nanomaterials.  The collaborations “will increase knowledge of the potential exposure to consumers from products that contain nanomaterials and explore methods to...

The European Commission (EC) Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory.  The Nanobiotechnology Laboratory features state-of-the-art equipped facilities designed to foster interdisciplinary studies, with a special emphasis on the characterization of nanomaterials, nanomedicines, advanced materials and their interactions with biological systems, as well as on the detection, identification, and characterization of nanomaterials in food...

On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced.  In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment...

On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule.  Final revisions were published on January 19, 2017.  On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) proposing revisions to each agency’s codification of the Federal Policy for the...