On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The proposed Update to the Coordinated Framework updates the 1986 Coordinated Framework for the Regulation of Biotechnology and provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to the regulation of biotechnology products. The National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) sets forth a long-term strategy intended to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology. The Update to the Coordinated Framework is now available for comments per the Federal Register notice. Comments will be due by November 1, 2016, at 5:00 p.m. (EDT). Read the full memorandum on the Bergeson & Campbell P.C. (B&C®) website.
On September 14-15, 2016, the U.S. Department of Energy (DOE) hosted a two-day workshop with lead experts on aviation biofuels exploring opportunities to increase competitiveness of alternative jet fuels. The Alternative Aviation Fuel Workshop was organized in four parallel breakout sessions covering the economic and technical competitiveness, fuel conversion and scale-up, environmental sustainability and life-cycle benefits, and feedstock and product supply chains of lignocellulosic biomass based aviation biofuels. During the workshop, Wally Tyner, a professor of Agricultural Economics from Purdue University, presented preliminary results from his team's research into greenhouse gas (GHG) emissions from the production of soybean based biodiesel. The study focuses on biofuels-induced land use change (LUC) emissions, critically finding that emissions could be as much as 70 percent lower than previously thought (based on induced land use change emissions recently adopted by the California Air Resources Board). Tyner's team used the most recent version of the Global Trade Analysis Project model that reflects changes in agriculture and biofuel that occurred between 2004 and 2011. This model includes expanded biofuel policies as well as improvements in agriculture efficiency such as double cropping. The combination of advancing LUC emissions science and improved agricultural practices are continually increasing confidence in the real environmental benefits of biobased fuels.
On September 16, 2016, the U.S. Navy announced the successful flight test of the EA-18G "Green Growler" plane on 100 percent advanced biofuel. Lt. Cmdr. Bradley Fairfax, project officer and test pilot, stated that "The information presented to us in the airplane is pretty simplified but, as far as I could tell, the aircraft flew completely the same as [petroleum-based] JP-5 for the whole flight." This program supports the Secretary of the Navy's (SECNAV) goal to increase the use of alternative fuels by 2020. The Green Growler flew on catalytic hydrothermal conversion-to-jet (CHCJ) fuel, produced by Applied Research Associates (ARA) and Chevron Lummus Global. "We are excited to work with the U.S. Navy as it takes this important step toward the use of 100-percent drop-in renewable jet and diesel fuels in its aircraft and ships," said Chuck Red, Vice President of fuels development for ARA. "Our renewable fuels continue to prove their viability as 100-percent replacements for petroleum in diesel and jet fuel applications."
On September 13, 2016, governors of seven ethanol producing states wrote to EPA Administrator Gina McCarthy requesting the removal of the Reid Vapor Pressure (RVP) limit on E15. RVP measures gasoline volatility, and E10 receives a one pound-force per square inch (psi) RVP waiver between June 1 and September 15 that is not extended to E15. The letter states "EPA's disparate handling of E10 and E15 with regard to fuel volatility regulation is stifling the widespread adoption of E15 and mid-level ethanol blends." The governors continue to argue that "This inequitable RVP treatment of E10 and E15 has no scientific basis since E15 and higher blends are lower in volatility than E10 when blended with the same base gasoline. We strongly urge you to take immediate action to establish a volatility regime that allows a uniform gasoline blendstock to be suitable for blending both E10 and E15 (and higher blends) year round." The American Coalition for Ethanol and the Iowa Renewable Fuels Association have both spoken out in support of the letter, stating the RVP limit is one of many barriers to ethanol being competitive in the fuel market.
Tuesday, September 27, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted, and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and B&C.
Webinar 4 will cover:
- Section 6(h) -- Chemicals That Are Persistent, Bioaccumulative, and Toxic (PBT);
- Section 18 -- State-Federal Relationship and Preemption;
- Section 19 -- Judicial Review; and
- Section 26 -- Fees.
- Moderator -- Lynn L. Bergeson, Managing Partner, B&C;
- Charles M. Auer, Senior Regulatory and Policy Advisor, B&C, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA);
- Richard E. Engler, Ph.D., Senior Chemist, B&C, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program;
- Lisa R. Burchi, Of Counsel, B&C; and
- Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C.
Additional Webinars in "The New TSCA: What You Need To Know" Series:
- Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
- Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
- Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14), presented September 12, 2016.
- For a copy of any of these webinar recordings, click here.
Read B&C's TSCA blog for the latest news and analysis regarding TSCA reform, implementation, and related legal and administrative developments.
||Danforth Center, "National Science Foundation Supports Stony Creek Colors And Danforth Center Collaboration for Bio-Based Indigo Business Project"
||Business Wire, "Cardolite Corporation Earns USDA Certified Biobased Product Certification For Cardanol Product Line -- a Versatile Building Block for High Performance Biomaterials"
||RSC Bio Solutions, "RSC Bio Solutions Launches First-Of-Its Kind EAL Designed to Improve Performance, Increase Uptime and Enhance System Longevity"
||Corbion, "Thailand's Circular, Biobased Economy: Home Grown Bioplastics Set to Improve Efficiency of Local Rubber Agriculture"
||UPM Biofuels, "GoodFuels Marine and Boskalis Have Successfully Tested UPMs Sustainable Wood-Based Biofuel for Marine Fleet"
||Renmatix, "Renmatix Secures $14M Investment from Bill Gates and Total, The Global Energy Major, in Concert with Signing of 1 Million Ton Cellulosic Sugar License"
||Renewable Energy Group, "REG Reaches New Sales Milestone with 50 Million Gallons of Biomass-Based Diesel Sold in a Month"
||GW Today, "USDA Secretary Touts Bio-Based Goods, Conservation: Tom Vilsack Delivers Keynote Address At GW's GreenGov Symposium"
||Environmental Leader, "Think Bio-Based Materials Are Costly, Perform Poorly? Think Again"
||Virent, "Strategic Consortium Announced to Commercialize Virent's Bioforming Technology for Low Carbon Fuels and Bio-Paraxylene"
||Amyris, "Amyris & Ginkgo Bioworks Complete Collaboration Agreement to Accelerate Commercialization of Bio-Based Products"
By Lynn L. Bergeson and Margaret R. Graham
On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in 1992. The White House states that this is “an important step to ensure public confidence in the regulatory system for biotechnology products and to improve the transparency, predictability, coordination, and, ultimately, efficiency of that system.” The documents released are:
The Update document is intended to help product developers and the public understand what the regulatory pathway for products might look like. The White House states that the Update document presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework, and;
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
The White House is seeking public comment on this proposed Update. The comment deadline will be 40 days from the date of publication in the Federal Register.
The Strategy document, which the White House states “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” also details many existing activities at EPA, FDA, and USDA; new activities that have been instigated by the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” which directed EPA, FDA, and USDA to update the Coordinated Framework; and key commitments that these three agencies will keep going forward to continue the modernization process. These commitments are:
- EPA, FDA, and USDA will review existing communication tools and, as appropriate, may revise existing or develop new user-friendly sources of regulatory information for product developers and the general public.
- EPA, FDA, and USDA are emphasizing their commitments to interagency communication and collaboration in order to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments.
- EPA and FDA intend to clarify their respective approaches for oversight of products developed using genome editing techniques, including, for example, pesticidal products at EPA and genetically engineered animals at FDA.
- EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the U.S. Federal Government will regulate genetically engineered insects in an integrated and coordinated fashion to cover the full range of potential products.
- EPA, FDA, and USDA commit to reporting annually, for at least the next five years, on specific steps that they are taking to implement the Strategy, as well as any additional actions being taken to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies.
- EPA, FDA, and USDA will continue to provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products.
- EPA, FDA, and USDA commissioned a study by the National Academy of Sciences, entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This report is still forthcoming.
On Tuesday, September 20, 2016, at 2:00 p.m. (EDT), OSTP, EPA, FDA, and USDA will be participating in a conference call on the White House’s efforts in regards to the above. More information regarding registration for the call and submitting questions is available online.
More information concerning the Coordinated Framework, the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” and other current biotechnology issues are available in our memoranda on our website under the key phrase “Biobased Products, Biotechnology.”
On September 13, 2016, Biobased and Renewable Products Advocacy Group (BRAG®) member Flint Hills Resources, along with Benefuel® Inc., announced the startup of the Duonix Beatrice biodiesel plant, and the first successful commercial-scale application of Benefuel's innovative ENSEL technology. ENSEL technology is capable of converting a range of lower cost feedstocks such as recycled cooking oil and distillers corn oil into high-quality biodiesel. Once fully operational, the Duonix Beatrice plant will produce approximately 50 million gallons of biodiesel annually. The plant has already made commercial sales of product that meets or exceeds ASTM specifications for biodiesel.
The ENSEL technology uses a solid catalyst that combines esterification of high free fatty acid feedstocks and transesterification of triglycerides into a single step, which eliminates waste, improves process efficiency, and expands feedstock options. The product is further enhanced by an upgraded, backend distillation process that removes additional impurities which, when used on high free fatty acid feedstocks such as distillers corn oil, produces a higher quality biodiesel with superior cold weather performance. In addition to producing 50 million gallons of biodiesel, Duonix Beatrice is expected to produce a variety of coproducts such as glycerin, which can be used as a food additive and as a compound found in a number of medical, pharmaceutical and personal care products.
On September 7, 2016, the Biotechnology Innovation Organization (BIO) released the report "Advancing the Biobased Economy: Renewable Chemical Biorefinery Commercialization, Progress, and Market Opportunities, 2016 and Beyond." This report documents substantial growth in the renewable chemical industry, and covers domestic policies impacting renewable chemical commercialization. Policy drivers that are explored include the Renewable Fuel Standard (RFS), the 2014 Farm Bill, draft legislation, state and federal tax incentives, and the Master Limited Partnerships Parity Act (MLP). The report also reviews currently operating biorefineries to identify biotechnology solutions beyond biofuels currently undergoing commercial development.
On August 29, 2016, the U.S. Geological Survey (USGS) published a study on the result of land-use changes on North and South Dakota commercial honey bee colonies in the journal Proceedings of the National Academy of Sciences. USGS scientists found that grasslands and other landscape features favored by beekeepers were decreasing, with crops that are avoided by beekeepers, such as corn and soybeans, replacing them. The study pointed out that biofuel crop production, including corn and soybeans, had increased in the Dakotas from 2006-2014, with a continual increase in biofuel crops totaling nearly three million acres around apiaries in the Dakotas. "According to the report, the Northern Great Plains have served as an unofficial refuge for commercial beekeepers because of their abundance of uncultivated pasture and rangelands, and cultivated agricultural crops such as alfalfa, sunflower and canola that provided forage for bees." The study identifies several areas in the Dakotas where honey bee habitat can be targeted for conservation, to increase forage availability and reduce the use of chemicals that negatively impact pollinators.
On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions." This meeting will receive public comments on EPA's algae guidance document, and will inform the development of EPA's "Algae Guidance for The Preparation of TSCA Biotechnology Submissions" document. Approximately 120 people will be able to attend in person, with unlimited access via web connect and teleconference. The meeting is scheduled for October 27, 2016, in Tempe, Arizona, immediately following the Algae Biomass Summit. ABO will post a specific time and location when more information becomes available.
On August 29, 2016, the Energy Regulatory Commission of Mexico (CRE) published fuel regulation NOM-016-CRE-2016 in the Mexican Federal Register. This fuel standard allows for the blending and sale of up to 5.8 percent ethanol in the nation's fuel supply outside of Mexico City, Guadalajara, and Monterrey. These new regulations will go into effect 60 days after publication of the bill, marking the first ethanol mandate to impact rural areas of Mexico. Guadalajara currently has a 2 percent ethanol blend mandate that is eventually expected to expand to Mexico City and Monterrey.
On September 5, 2016, a group of non-profits, including Oxfam International, Fern, and Greenpeace, published a report outlining policy measures that should be taken by the European Commission (EC) to ensure that bioenergy is as low-carbon and resource efficient as possible. The report, "A New EU Sustainable Bioenergy Policy Report," was published after EC stated a willingness to listen to new proposals to improve sustainable bioenergy policies. EC is planning on proposing an updated bioenergy sustainability policy for the use of biomass in heating, electricity, and transport by the end of 2016, as part of the Climate and Energy Package for 2030. To ensure the sustainability of new bioenergy policies, the report discusses the need and practicality of implementing the following safeguards:
- A limit to the use of biomass for energy production to levels that can be sustainably supplied;
- An efficient and optimal use of biomass resources, in line with the principle of cascading use;
- Robust and verifiable emission savings on the basis of correct carbon accounting for bioenergy emissions; and
- A comprehensive, binding set of environmental and social sustainability criteria.
This report proposed sustainability criteria across all energy uses of biomass that has been grown on land, as well as residues, waste, and side-products, but not for biomass from aquaculture and marine areas.