Biobased Products News and Policy Report – Update from Bergeson & Campbell, PC
Biobased and Renewable Products Update
March 14, 2019
FDA Commissioner Releases Statement On Biotechnology Innovations
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon. In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S. According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal Biotechnology Innovation Action Plan, Dr. Gottlieb stated that FDA has taken important steps to help advance new products.
Part of these efforts includes FDA’s 2015 decision to approve an application related to GE salmon containing the first approved IGA in an animal meant for food consumption. In 2016, however, the U.S. Congress directed FDA not to allow into commerce any food containing GE salmon until it issues final labeling guidelines for informing consumers of the GE salmon content in the food. Consequently, in compliance with Congressional views, FDA implemented an import alert in that same year that prevented GE salmon from entering the U.S. With the enactment of the National Bioengineered Food Disclosure Standard (NBFDS) by Congress, the U.S. Department of Agriculture (USDA) was made responsible for the implementation of a mandatory standard for disclosing foods that are bioengineered. FDA was, therefore, divested of its authority over labeling GE content in human foods. Given the Congressional enactment of NBFDS, Dr. Gottlieb stated that FDA believes this Congressional mandate on GE salmon has been satisfied by USDA’s issuance of final regulations implementing NBFDS. NBFDS requires that human food containing GE salmon be labelled to indicate that it is bioengineered. Therefore, FDA has deactivated the import alert that prevented GE salmon from entering the U.S.
USDA Comment Request: Draft Documents Related To GE Soybean Deregulation
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 plant pest risks and the dEA will analyze the potential issues and environmental impacts. The draft documents can be accessed here, and the official notice of the review period can be viewed in the March 13, 2019, Federal Register. 84 Fed. Reg. 9077. Comments are due by April 12, 2019.
EC Publishes Fact Sheet On The Sustainability Criteria For Biofuels
On March 13, 2019, the European Commission (EC) published a fact sheet on the sustainability for biofuels specified. EC adopted a delegated act that sets out the criteria for determining high low indirect land-use change (ILUC) risk feedstock for biofuels and the criteria for certifying ILUC-risk biofuels, bioliquids, and biomass fuels. ILUC-risk fuels consist of fuels produced from food and feed crops that significantly expand globally into land with high carbon stock (high ILUC-risk fuels). The consequences of creating high ILUC-risk fuels relate to the release of greenhouse gas (GHG) emissions, which negates the emissions savings from the use of biofuels rather than fossil fuels. ILUC is addressed in the delegated act through two measures: one measure sets national limits for the total contribution towards the renewable energy targets for biofuels, bioliquids, and biomass fuels from food or feed crops; and the other measure sets national limits as Member States’ 2019 level for the period 2021-2023.
Scientists At UC Berkeley Discover Hidden Clues That Present Key Developments For Bioproducts
On March 11, 2019, scientists at the University of California Berkeley (UC Berkeley) published a study on nature microbiology on the gut anatomical properties of the passalid beetle that helps it transform decaying wood into energy-rich materials. Passalid beetles’ digestive tracts contain microbes that provide a roadmap for the production of affordable, nature-derived bioproducts and biofuels. The structure of these beetles’ guts allows for different microbial communities to coexist and perform unique biochemical metabolic processes in energy extraction. The published article can be accessed here.
LLNL Uses 3D Bioprinting To Produce Live Cells
On March 5, 2019, the Lawrence Livermore National Laboratory (LLNL) announced that their researchers have 3D printed live cells that are able to convert glucose to ethanol and carbon dioxide gas. The substance produced from this conversion resembles beer. This means that this newly developed technology can lead to highly efficient biocatalysis. According to LLNL’s announcement, the use of live microbes rather than inorganic catalysts is advantageous because of mild reaction conditions, low cost, self-regeneration, and catalytic specificity. The particular case study used to demonstrate this experiment’s success involved printing freeze-dried live biocatalytic yeast cells into porous 3D structures. These unique geometrical structures allow the live cells to then convert glucose to ethanol and carbon dioxide gas. The long-term viability and tunable cell densities of this new bio-ink material allow for the live cells to be genetically modified for the production of chemicals, food, pharmaceuticals, and biofuels.
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