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.
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By Lynn L. Bergeson

On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  84 Fed. Reg. 10491.  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include:

  • Seven chlorinated solvents;
  • Six phthalates;
  • Four flame retardants;
  • Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
  • A fragrance additive; and
  • A polymer pre-curser.

EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates.  The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria. 

Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however.  EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.”  Comments are due June 19, 2019.  EPA has opened a docket for each of the 40 chemicals; the dockets numbers are listed in the Federal Register notice.  EPA is directed to complete the prioritization process in the next nine to 12 months. 

Please be on the lookout for the Bergeson & Campbell, P.C.’s (B&C®) memorandum that will contain more information regarding EPA’s list.  It will be posted on our Regulatory Developments webpage.

Tags: EPA, TSCA

 
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By Lynn L. Bergeson

On February 27, 2019, Senators Rand Paul (R-KY) and Chuck Grassley (R-IA) introduced the Fuel Choice and Deregulation Act of 2019 (S. 581).  The legislation would remove “burdensome” regulations on domestic energy production.  The bill “provides new economic opportunity for Kentucky farmers by allowing fuel producers and automobile manufacturers to innovate and bring new products to market that will lower costs for consumers, increase domestic energy production, and protect the environment,” said Senator Paul.  The Fuel Choice and Deregulation Act would remove regulations blocking higher ethanol blends, such as gasoline blended with up to fifteen percent ethanol (E15), from entering the marketplace.  It also removes the requirement for EPA certifications on aftermarket vehicle conversions.  The bill specifically would reform Reid Vapor Pressure (RVP) requirements by allowing higher blend levels of ethanol to exceed the current 9.0 pounds per square inch (psi) standard, and it prevents EPA from regulating biomass fuel.  RVP is a measure of how quickly fuel evaporates into the atmosphere. EPA regulates RVP in conjunction with ozone emissions in the summer months.  Congress previously directed EPA to issue a “one pound waiver” for ethanol blends of ten percent, allowing E10 to be sold at 10.0 psi.  Last year, President Trump signed an executive order directing EPA to look into the possibility of allowing year-round sales of E15.  This bill extends the Congressional waiver to higher blends of ethanol, including E15.

Tags: Biofuel, E15

 
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By Lynn L. Bergeson

On March 18, 2019, (EPA) announced a public hearing to be held for the proposed rule: “Modifications to Fuel Registrations to Provide Flexibility for E15: Modifications to RFS RIN Market Regulations.”  84 Fed. Reg. 9734.  The proposed rule would implement regulatory changes allowing E15 to take advantage of a Renewal Fuels Standard (RFS) program waiver. Currently, the 1-psi Raid Vapor Pressure (RVP) waiver only applies to ten percent ethanol (E10) during the summer months. The proposed rule also includes an interpretative definition of E15 gasoline as “substantially similar” to the fuel used to certify Tier 3 motor vehicles.  Lastly, EPA is also proposing changes to some RFS compliance system elements that would improve renewable identification number market functioning and prevent market manipulation.  The public hearing will take place in Ypsilanti, MI, on March 29, 2019.  The proposed rule was published in the Federal Register on March 21, 2019.  84 Fed. Reg. 10584. Comments are due by April 29, 2019.

Tags: EPA, RFS, RIN, Biofuel

 
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By Lynn L. Bergeson

On March 18, 2019, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development (R&D) Technical Advisory Committee.   84 Fed. Reg. 9769.  The meeting will take place in Arlington, Virginia, on March 27 - 28, 2019, and will include discussions on developing advice and guidance promoting R&D leading to the production of biobased fuels and products.  The tentative agenda includes updates not only on DOE Biomass R&D activities, but also on U.S. Department of Agriculture (USDA) Biomass R&D activities.  Presentations from government and industry can also be expected to provide insight on the intersection of forest health and bioenergy growth.  DOE will allow oral statements to be made during the meeting and will also be accepting written comments either before or after the meeting.  Meeting minutes will be available for public review and copying on the Biomass Board’s website.

Tags: DOE, USDA, Biomass

 
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By Lynn L. Bergeson

On March 19, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the delay of the spring release for BRS’ updated permitting system in APHIS eFile.  The release is now expected to occur in mid-summer 2019, with periodic updates provided by APHIS BRS as the anticipated release approaches.  In its announcement, APHIS BRS highlighted its commitment to bringing a permitting system that takes advantage of USDA’s current capabilities and brings new features previously not available.

Tags: USDA, APHIS

 
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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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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

 
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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

 
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By Lynn L. Bergeson

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.

Tags: EC, Biofuels, ILUC, GHG

 
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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.


 
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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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By Lynn L. Bergeson

On March 1, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced $51.5 million for innovative research of technologies for trucks, off-road vehicles, and fuels.  Of particular interest to DOE EERE are:

  • Gaseous fuels research, including natural gas, biopower, and hydrogen;
  • Heavy duty freight electrification;
  • Hydrogen infrastructure and fuel cell technologies for heavy duty applications; and
  • Energy efficient off-road vehicles.

There are five topic areas for this funding opportunity, and concept papers are due March 29, 2019.  Full applications are due by May 15, 2019.

Tags: DOE, EERE, Biofuel

 
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By Lynn L. Bergeson

On March 4, 2019, DOE announced an opportunity for funding up to $31 million in support of advancing the H2@Scale concept.  The H2@Scale concept focuses on enabling affordable and reliable large-scale hydrogen generation across multiple sectors in the U.S.  Large-scale hydrogen generation, transport, storage, and utilization can “unite our Nation’s abundant energy resources,” according to U.S. Secretary of Energy Rick Perry.  By producing hydrogen when power generation exceeds load, “electrolyzers can reduce curtailment of renewables and contributes to grid stability.”  Hydrogen can also be stored and distributed for multiple applications.  Currently some key challenges of the H2@Scale concept are reliability, affordability, and performance of fuel cell technologies.  DOE is interested in overcoming these challenges, thus providing this funding opportunity for three topics.  Topics include advanced hydrogen storage and infrastructure research and development (R&D); innovative production and utilization concepts; and a H2@Scale pilot.  Concept papers are due on April 8, 2019, and full applications are due on May 29, 2019.

Tags: H2@Scale, DOE

 
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