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 3, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a request for comments on two documents related to the potential deregulation of a canola variety genetically engineered (GE) to convert oleic acid to docosahexaenoic acid (DHA) and eicosapentaeonic acid (EPA), as well as for resistance to an imidazolinone herbicide. The documents are a draft Environmental Assessment (dEA) and a draft Plant Pest Risk Assessment (dPPRA). While the dEA analyzes potential issues and environmental impacts, the dPPRA examines any plant pest risks. DHA and EPA are omega-3 fatty acids that support brain development and protect neurological function. The aforementioned GE canola accumulates higher concentrations of these fatty acids. Therefore, in a petition submitted by BASF Corporation (BASF), it stated that this canola provides a plant-based and scalable production system for omega 3-fatty acids that can be another source of EPA and DHA for consumers either as a food ingredient or as an aquaculture feed ingredient. Based on BASF’s statement and the draft documents, USDA will be accepting comments until May 6, 2019. APHIS intends to thoroughly review and consider the information provided in the completion of the final environmental documents and regulatory determinations.

Tags: USDA, APHIS, GE

 

By Lynn L. Bergeson

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.

Tags: Salmon, FDA, GE

 

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 January 17, 2019, DOE BETO announced that the deadline for submission to its Manufacturing Innovator Challenge has been extended to February 10, 2019.  As DOE seeks new concepts in biobased materials to address today’s manufacturing challenges, the Manufacturing Innovator Challenge is an effort to incentivize solutions that increase energy productivity and strengthen the U.S. industrial base.  Prizes are open for ideas focused on Biobased Additive Manufacturing (BAM) and will be distributed to three winners.  BAM involves the production of rapid prototyping of complex structures through biobased three-dimensional printing.  To qualify for the BAM prize, candidates are required to identify new materials that are made from at least 90 percent plant matter or algae, and that can meet or improve the performance of current three-dimensional printing materials.


 

By Lynn L. Bergeson

On December 6, 2018, U.S. Senator Charles E. Schumer (D-NY) wrote a letter to President Donald Trump requesting that, in 2019, any infrastructure package to be considered include a focus on the clean energy economy to address climate change. Emphasizing that climate change is, in fact, real and caused by humans, Senator Schumer refers to the Administration’s recent National Climate Assessment report and the drastic need to reduce emissions. In the letter, Senator Schumer outlines a number of policies that must be included in an infrastructure package in the next Congress. Among these policies are the need to:

  • Invest in research, development, and deployment of clean energy, energy efficiency, carbon reduction, and energy storage technologies;
  • Provide permanent tax incentives and investments for domestic production of clean energy and renewable power; and
  • Invest in upgrades in clean energy for public schools, buildings, and other infrastructure.

Senator Schumer concludes his letter to President Trump highlighting that “[t]he challenge is immense, but so is the opportunity to revitalize and modernize our infrastructure, create new jobs and economic opportunities, and position the United States as a leader in clean energy innovation.”


 

By Lynn L. Bergeson

On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to its announcement, it should reflect four broad regulatory reform priorities: advancing regulatory reform, public notice of regulatory development, transparency, and consistent practice across the Federal Government.
 
Included in the Agenda are the Administration’s estimated timelines for the rulemakings on year-round sales of 15 percent ethanol (E15) sales and the Renewable Fuel Standard (RFS) resetting renewable volume obligations (RVO). It is expected that EPA will release a proposed rule on permitting E15 sales year-round in February 2019, with a final rulemaking expected in May 2019. While the final rulemaking on RFS Biomass-Based Diesel (BBD) volume is expected to be announced in November 2018, the rulemaking on the RFS modification of applicable volumes is predicted to be announced in 2019. According to the Agenda, the proposed rule will be announced in January 2019 and the final rule should follow in December 2019.

Tags: EPA, TSCA, Agenda

 

By Lynn L. Bergeson

On August 1, 2018, the Center for Food Safety filed a lawsuit against the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) for its delay in the establishment of a national mandatory bioengineered (BE) food disclosure standard. In its lawsuit, the plaintiffs allege that AMS’ failure to implement a final rule is “inimical to the democratic process” and damaging to the public and stakeholders. On May 4, 2018, USDA announced a request for comments on the proposed new rule under the Agricultural Marketing Act of 1946 on the establishment of a national mandatory BE food disclosure standard. The proposed rule would require food manufacturers and labelers to unveil information to consumers about BE foods. The notice also included a request for comments on AMS’ intent to request approval by the Office of Management and Budget for information collection on the proposed BE disclosure standard. Comments on this proposed rule were due on July 3, 2018, with a final ruling to be made on or before July 29, 2018, according to the 2016 Public Law 114-216. AMS received over 14,000 comments out of which USDA staff claim to still be sorting through, meaning a final ruling has not yet been made and many entities are not happy about this.

Tags: USDA, BE, GE

 

By Lynn L. Bergeson

On July 25, 2018, the European Union (EU) Supreme Court of Justice ruled that plants with genes that have been altered, even without the insertion of foreign DNA, are classified as genetically modified organisms (GMO) and therefore must undergo the same safety checks for their impacts on the environment and human health as organisms with foreign DNA.  According to Bio-Based World News, the ruling “is seen as a victory for environmentalists but a blow for the bio-economy” due to the much stricter rules that apply to GMOs.  Bio-based chemicals often require genome editing to provide renewable substitutes for petrochemical building blocks.  EuropaBio’s Secretary General, John Brennan, commented on this new ruling stating that it lacks regulatory clarity that is needed by EU researchers, academics, and innovators in the industry to deliver solutions.  EuropaBio plans to engage EU Member States and citizens in providing a fact-based dialogue on what genome editing is, and what it will or will not be used for.  The Max Planck Institute for Developmental Biology’s Director, Detlef Weigel, also criticized the ruling, stating that it was “a sad day for European science.”

Tags: EU, GE

 

By Lynn L. Bergeson and Carla N. Hutton

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms.  APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts.  Comments are due July 30, 2018.
 
Our full memorandum provides some background, context, and a commentary regarding APHIS’ announcement.  

Tags: USDA, APHIS, GE

 

By Lynn L. Bergeson

On July 2, 2018, Midwest AgEnergy announced that the North Dakota Industrial Commission, a division of North Dakota’s State Department of Mineral Resources, Oil and Gas, had awarded it a $83,810 grant to research using North Dakota barley to produce ethanol with a protein concentrate byproduct for use in aquaculture.  This would be the first ethanol produced North Dakota from a feedstock other than corn, and would include an expansion of the Dakota Spirit AgEnergy (DSA) ethanol plant.  "We're looking to move ahead with a more formal study on a barley protein concentrate project," stated Jeff Zueger, CEO of Midwest AgEnergy, the parent company of DSA.  "If built, it would be a co-located process at DSA that would dehull and mill barley to produce high protein feed and a feedstock for the ethanol process."


 
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