The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.


 

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on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258.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  EPA states that the draft guidance, issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA, thereby subjecting the products to regulation as pesticides under FIFRA.  EPA notes that when determining whether a plant biostimulant may trigger pesticide registration requirements, or may be excluded or exempt from FIFRA regulation, a “key consideration is what claims are being made on product labels.”  Comments on the draft guidance are due by May 28, 2019
 
Please see the Bergeson & Campbell, P.C. (B&C®) full memorandum for more information on this draft guidance including some background, information on the definition of a plant biostimulant, examples of product label claims, and B&C’s commentary.

Tags: EPA, FIFRA

 

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, patients, and U.S. trading partners. In his published statement, Dr. Gottlieb emphasizes FDA’s ongoing implementation of the Action Plan, particularly on intentional genomic alterations in animals. Using genetic engineering and genome editing technologies, these innovations are providing additional clarity about how FDA’s regulatory framework works and should continue to work. A key part of the Action Plan’s implementation involves FDA’s Center for Veterinary Medicine’s Innovation Program, which provides sponsors with innovative products based on genomic alterations in animals to benefit from early feedback and guidance.
 
In the released statement, Abram further highlights the impacts of intentional genomic alterations in animals on human health. DNA editing not only benefits animals by halting animal-to-animal transmission of diseases, but also has the potential to benefit humans. According to Abram, FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat human diseases, advance the studies of new drugs, as well as human organ and tissue transplants.  The Commissioners state that by ensuring safety of intentional genomic alterations to animals and animal-derived foods, FDA will continue to evaluate the effectivity of these alterations based on the totality of evidence provided rather than from any one particular assessment or result.
 
On April 25, 2019, FDA’s Center for Veterinary Medicine and the Center for Biologics Evaluation and Research will host a live webinar to discuss policy changes that may improve the Action Plan framework.


 

 

 

By Lynn L. Bergeson

In February 2019, the University of Utah published the article Algal lipid extraction using confined impinging jet mixers.  The article outlines the University of Utah engineers’ latest discovery of a new method for rapid lipid harvesting which is essential to energy parity for microbial derived biofuels.  This newly developed technique is not only faster but also more efficient, and uses confined impinging jet mixers (CIJM) to improve lipid extraction from microalgae.  CIJMs extract lipids rapidly and continuously creating a multistage unit operation of mixers that enhances microbial biofuel production.


 

 

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 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.

Tags: USDA, Soybean, GE

 

By Lynn L. Bergeson

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.


 

By Lynn L. Bergeson

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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