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By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...

On October 7, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.”  Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement.  Bitsch also explains what societal engagement is...

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from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...

On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines.  The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health...

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our...

The September 10, 2019, issue of the U.S. Environmental Protection Agency’s (EPA) Science Matters newsletter includes an article entitled “Keeping up with 3D Printing:  EPA Researchers Build on New Plastic Emissions Study.”  According to the article, EPA scientists, through an agreement with the Consumer Products Safety Commission (CPSC), are investigating whether increased use of 3D printers can lead to unintended adverse impacts to human health.  EPA states that...

On August 30, 2019, the National Nanotechnology Initiative published its supplement to the President’s 2020 budget request.  The supplement serves as NNI’s annual report required under the 21st Century Nanotechnology Research and Development Act and addresses the requirement for U.S. Department of Defense (DOD) reporting on its nanotechnology investments.  According to NNI, the President’s 2020 budget requests more than $1.4 billion for NNI, “a continued...

On September 11, 2019, from 12:00 p.m. to 1:30 p.m. (EDT), the Environmental Law Institute (ELI) will host a webinar titled “Genetic Engineering: The Good, The Bad, and The Necessary.” The webinar is designed to cover the vast possibilities offered by genetic engineering in a world where regulatory officials face increasing pressure to guarantee global food security. Along with the many possibilities associated with genetic engineering, however, there are great concerns about the...

On October 2, 2019, the National Nanotechnology Initiative (NNI) will hold a webinar on “Nanotechnology for a New Generation of Gas Sensors:  An Industrial Perspective on Fundamental, Applied, and Commercialization Aspects.”  According to the overview for the webinar, contemporary monitoring requirements of gases for applications ranging from environmental surveillance to medical diagnostics currently push the limit of existing detection.  The overview states that to...

On August 28, 2019, the U.S. Environmental Protection Agency (EPA) released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines.  As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018: 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for...

On August 26, 2019, the National Institute of Environmental Health Sciences (NIEHS) announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing.  The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences.  According to the abstract, the researchers hypothesized that graphene films may provide...

On August 20, 2019, the National Institute for Occupational Safety and Health (NIOSH) posted a one-pager on the Nanotechnology Research Center (NTRC).  NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures.  NTRC focuses on the following areas “to help industry move safely and responsibly into the future”: Increasing understanding of potential health risks...

The American Chemical Society (ACS) National Meeting and Expo:  Chemistry and Water will be held August 25-29, 2019, in San Diego, California.  On August 25, 2019, “Tiny Solutions to Big Problems:  Water Sustainability through Nanotechnology” will be held in support of the National Nanotechnology Initiative’s (NNI) Water Sustainability through Nanotechnology Signature Initiative (Water NSI).  The session will feature an overview of the Water NSI, as well as...

Registration has begun for the National Nanotechnology Initiative’s (NNI) September 10, 2019, webinar on “Respiratory Effects of Engineered Nanomaterials in Relation to Physicochemical Properties.”  The speaker will be Dr. Junfeng (Jim) Zhang, Nicholas School of the Environment and Duke Global Health Institute, Duke University, and Dr. William Boyes, U.S. Environmental Protection Agency, will moderate.  NNI states that the interaction between engineered nanomaterials...

On August 1-2, 2019, the National Nanotechnology Initiative (NNI) held “The Future of the NNI:  A Stakeholder Workshop.”  The NNI has played a pivotal role in fostering and advancing a dynamic nanotechnology ecosystem in support of the initiative’s four goals:  advance world-class research; foster commercialization; develop and sustain research infrastructure; and support the responsible development of nanotechnology.  Building on this foundation, experts from the...

On July 3, 2019, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on the solubility of synthetic amorphous silica (SAS). The EC asked whether SCCS considers that SAS materials are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation. Having considered the data provided in this dossier and that available in published...

By Lynn L. Bergeson On July 10, 2019, Senators Chris Coons (D-DE) and Tom Cotton (R-AR) and Representatives Steve Stivers (R-OH) and Bill Foster (D-IL) reintroduced the STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2019. This legislation, an improvement on legislation introduced last year under the same name, would reform the inter partes post-grant review process, ensure all fees paid to the Patent and Trademark Office (PTO)...

Registration has opened for the National Nanotechnology Initiative’s (NNI) July 9, 2019, webinar, “Nanotechnology-Related Standards: Availability and Applications.”  According to NNI, the development and use of nanotechnology-related standards is critical to ensuring validated measurements and methods to specify nanomaterial-containing products.  NNI states that standards are also necessary for comparative evaluation and assessment of the environmental, health, and...

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By Lynn L. Bergeson Two food-producing companies have jointly launched an initiative to drive the adoption of products and services on-farm at scale to increase sustainability on Earth. The initiative invites companies and entrepreneurs with new and emerging on-farm sustainability products and services, focused on greenhouse gases (GHG) reduction, to submit solutions to the leading companies’ experts. In August 2019, participants will be selected to present their solutions to an audience...