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 April 4, 2019, DOE EERE’s Bioenergy Technologies Office (BETO) announced the appearance of 23 journal articles from some of the nation’s leading biomass experts in the journal Frontiers in Energy Research. The collection of articles, titled Advancements in Biomass Feedstock Preprocessing: Conversion Ready Feedstocks, focuses on the many years of research and development into biomass preprocessing that has been largely supported by DOE EERE’s BETO. According to the announcement, researchers from Idaho National Laboratory, National Renewable Energy Laboratory, Oak Ridge National Laboratory, and Lawrence Berkeley National Laboratory were part of more than 100 authors representing more than 30 research institutions, universities, and private companies who contributed to the special issue containing these 23 articles.


 

By Lynn L. Bergeson

The Minnesota Department of Agriculture is offering an opportunity for funding to advance a bioenergy or biochemical production technology toward commercial scale through the construction and operation of a pilot plant. To be eligible for the AGRI Bioenergy/Biochemical Pilot Project Grant, applicants must be a Minnesota-based company, learning institution, local government unit, Native American Tribal community, or individual (including for-profit businesses and colleges/universities). Eligible grant projects will be for the development of innovative bioenergy or biochemical production technology ideas that have advanced beyond the proof of concept and are at the scaling up to pilot-plant stage. Up to $150,000 will be awarded and must be used for:  (1) wages, software, or anything else necessary to perform the tasks of the grant project’s work plan; and (2) equipment needed for the project implementation. Applications are due by 4:00 p.m. (CDT) on April 26, 2019.  For further details, see the Request for Proposals.


 

Last week, from April 3-5, 2019, Biofuels Digest hosted its annual Advanced Bioeconomy Leadership Conference (ABLC) in Washington, D.C.  Among those present were various industry stakeholders, government representatives, and federal agency staffers. Innovative technologies were presented and much networking was done. The Biobased and Renewable Products Advocacy Group’s (BRAG®) presence was welcomed and provided an opportunity for industry stakeholders to gain insight into regulatory developments in the biobased sector, particularly during the Regulatory Workshop that took place on April 4, 2019. The workshop was moderated by Richard Engler, Ph.D., Bergeson & Campbell, P.C.  While Engler covered timelines for approval of new substances, Ray Matulka, The Burdock Group, covered new food or feed additives, which is especially important if fermentation byproducts will be used as animal feed. Graham Noyes, Noyes Law Firm, covered California’s Low Carbon Fuel Standard Program, its success, and similar other state-level efforts.
 
A large number of panels held during the conference circled back to concerns with the U.S. Environmental Protection Agency’s (EPA) Renewable Fuel Standard (RFS) Program and measures associated with its implementation. Highlighting the importance of the intersection between policy and commerce, panelists in the Bioeconomy Policy Forum were particularly frustrated with the number of small refinery exemptions under the Trump Administration. The fact that, under President Trump’s two years, a greater number of small refinery waivers has been granted than during the Obama Administration’s eight years was highly criticized.  Panelists went as far as stating that these measures under the RFS Program are leading to demand destruction for renewable fuels.
 
In agreement with industry, U.S. Senator Chuck Grassley (R-IA) expressed frustration with the small refinery exemptions granted thus far. Despite these obstacles, however, Senator Grassley also stated that he is encouraged by the Trump Administration in working on short- and long-term solutions for issues that often create barriers towards alternative energy goals. Senator Grassley ensured his support for industry, emphasizing alternative energy’s key role in supporting national security, the economy, good environment, and energy independence.

Tags: ABLC, Biofuel

 

 

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.


 
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