USDA Withdraws Biotech Regulation Proposal

  • As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant pest and noxious weed risk posed by genetically engineered organisms.  These requirements have not been comprehensively revised since they were established in 1987.
  • On November 7, 2017, APHIS published a notice in the Federal Register (82 Fed. Reg. 51582) announcing its withdrawal of the January 19th proposed rule.  In withdrawing the proposed rule, APHIS cited stakeholder feedback critical of the proposed revisions.  As previously covered on our blog this summer, in comments submitted to APHIS, industry stakeholders applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology and for proposing to ease regulation of gene-edited products.  But at the same time, industry called out a number of proposed revisions as improperly expanding USDA’s review process in certain respects which could effectively hamstring developers before they can even begin testing products.
  • In its November 7th withdrawal of the proposed rule, APHIS stated that it is committed to exploring “a full range of policy alternatives” and that the Agency will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” Now that APHIS has decided to go back to the drawing board, industry has an opportunity to work with APHIS to develop revised requirements to facilitate a regulatory framework that promotes innovation in biotechnology.
This post was written by Food and Drug Law at Keller and Heckman of Keller and Heckman LLP., © 2017
For more Biotech, Food & Drug legal analysis, go to The National Law Review

EPA Approves Flint Hills Resources’ Plant For Cellulosic Ethanol Production

On October 12, 2017, Edeniq, Inc., a leading cellulosic and biorefining technology company, announced that Flint Hills Resources, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), received approval from EPA for cellulosic ethanol production at its Iowa Falls ethanol plant.  The 100 million gallons per year plant will use Edeniq’s Pathway technology to produce the cellulosic ethanol and will be eligible to qualify its cellulosic gallons for generating D3 Renewable Identification Numbers (RIN).  Iowa Falls is the second Flint Hills Resources plant, and the fifth overall, to receive approval for cellulosic ethanol production using Edeniq’s technology.  Edeniq announced in December 2016 that EPA approved Flint Hills Resources’ registration of its Shell Rock ethanol plant for cellulosic ethanol production.  According to Edeniq, its Pathway technology “remains the lowest-cost solution for producing and measuring cellulosic ethanol from corn kernel fiber utilizing existing fermenters at existing corn ethanol plants, and has already proven cellulosic ethanol yields of up to 2.5% or higher, as a percentage of its customers’ total volume output.”  Additionally, the technology allows for increases in corn oil production and greater overall ethanol yields.

This post was written by Lauren M. Graham, Ph.D. of Bergeson & Campbell, P.C., ©2017
For more legal analysis go to The National Law Review

DOE Announces $8.8 Million In Funding For Algae Technology Innovation Projects

On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million.  The projects aim to develop high-impact tools and techniques that will increase the productivity of algae organisms to reduce the costs of producing algal biofuels and bioproducts.  In total, DOE has awarded over $16 million in funding to the initiative.

The project winners include:

  • Colorado School of Mines, in partnership with Global Algae Innovations, Pacific Northwest National Laboratory, and Colorado State University, which will use advanced directed evolution approaches in combination with high-performance, custom-built, solar simulation bioreactors to improve the productivity of robust wild algal strains;
  • University of California, San Diego, which will work with Triton Health and Nutrition, Algenesis Materials, and Global Algae Innovations on the development of genetic tools, high-throughput screening methods, and breeding strategies for green algae and cyanobacteria, targeting robust production strains;
  • University of Toledo, in partnership with Montana State University and the University of North Carolina, which will cultivate microalgae in high-salinity and high-alkalinity media to achieve productivities without needing to add concentrated carbon dioxide, and deliver molecular toolkits, including metabolic modeling combined with targeted genome editing; and
  • Lawrence Livermore National Laboratory, which will ecologically engineer algae to encourage growth of bacteria that efficiently remineralize dissolved organic matter to improve carbon dioxide uptake and simultaneously remove excess oxygen.
This post was written by  Kathleen M. Roberts of Bergeson & Campbell, P.C. ©2017
For more Environmental & Energy legal analysis go to The National Law Review

Bioplastics Industry Responds To Revised European Parliament Report On Waste Legislation

European Parliament EU BioplasticsOn June 9, 2016, European Bioplastics (EUBP) announced the support of a European Parliament (EP) report emphasizing the role of bioplastics in the creation of a circular bioeconomy. The report, produced by Italian MEP Simona Bonafè¨, outlines legislation that is needed to use waste more efficiently to create bio-based materials. Increasing the value of waste by promoting its use to create other bioproducts will help shift the linear bioeconomy to a circular, more efficient, bioeconomy. The report suggested defining composting and anaerobic digestion of organic waste as recycling, and requiring the collection of biowaste by 2020 in order to increase organic recycling of biowaste to 65 percent by 2025. On June 15, 2016, the EP debated possible new definitions of litter, with the intent of reducing both land and marine based litter by 50 percent by 2030.

©2016 Bergeson & Campbell, P.C.

Swiss Researchers Develop Model to Assess How Nanoparticles “Flow Through the Environment”

Swiss NanoparticlesThe Swiss National Science Foundation issued a May 12, 2016, press release announcing that researchers from the National Research Program “Opportunities and Risks of Nanomaterials” have developed a new model to track the flow of the “most important nanomaterials in the environment.”  To assess how man-made nanoparticles make their way into the air, earth, or water, researchers developed a computer model to determine the environmental accumulation of nanosilver, nanozinc, nano-titanium dioxide, and carbon nanotubes.  The press release notes that knowing the degree of accumulation in the environment is only the first step in the risk assessment of nanomaterials.  This data must be compared with ecotoxicological test results and the statutory thresholds.  According to the press release, in the case of nanozinc, “its concentration in the environment is approaching the critical level.”  The press release states that it “has to be given priority in future ecotoxicological studies — even though nanozinc is produced in smaller quantities than nano-titanium dioxide.”  Furthermore, according to the press release, ecotoxicological tests have until now been carried out primarily with freshwater organisms.  The researchers conclude that complementary investigations using soil-dwelling organisms are a priority.

©2016 Bergeson & Campbell, P.C.

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

©2016 Bergeson & Campbell, P.C.

Six Biofuel Trade Associations Write Congress To Extend Advanced Biofuel Tax Credits

On April 5, 2016, the biofuel trade associations Advanced Biofuels Business Council, Algae Biomass Organization, Biotechnology Innovation Organization (BIO), Growth Energy, National Biodiesel Board, and Renewable Fuels Association sent a letter to House and Senate Leaders asking for a multiyear extension of advanced biofuel tax credits. The six organizations are specifically asking that the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit, and the Alternative Fuel Vehicle Refueling Property through the Protecting Americans From Tax Hikes Act of 2015 are extended before they expire at the end of 2016. Other energy production tax credits have been extended, and the biofuel trade associations argue that extending certain energy tax provisions and not others creates investment uncertainty across the energy sector, and puts biofuel producers at a disadvantage.

©2016 Bergeson & Campbell, P.C.