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 July 3, 2018, the U.S. Environmental Protection Agency (EPA) announced it was holding a public hearing for the proposed rule “Renewable Fuel Standard Program:  Standards for 2019 and Biomass-Based Diesel Volume for 2020” on July 18, 2018, at 9:00 a.m. in Ypsilanti, Michigan.  83 Fed. Reg. 31098.  The proposed rule was published in the Federal Register on July 10, 2018.  83 Fed. Reg. 32024.   The notice states that the public hearing will provide interested parties the “opportunity to present data, views, or arguments concerning the [proposed rule],” and “EPA may ask clarifying questions during the oral presentations but will not respond to the presentations.”  Parties wishing to testify at the hearing should notify Julia MacAllister at (734) 214-4131 or via e-mail at .(JavaScript must be enabled to view this email address) by July 13, 2018.  EPA will be posting a complete set of documents related to the proposal for public inspection on http://www.regulations.gov, Docket ID No. EPA-HQ-OAR-2018-0167.  Comments on the Proposed Rule are due by August 17, 2018.  More information on the proposed rule is available in our blog item “EPA Releases Proposed Rule Setting 2019 RFS Requirements.”


 
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By Lynn L. Bergeson

On July 10, 2018, the U.S. Department of Agriculture’s (USDA) Office of Procurement and Property Management announced it was amending the Guidelines for Designating Biobased Products for Federal Procurement to add 12 sections that designate product categories within which biobased products will be afforded federal procurement preference by federal agencies and their contractors via a final rule.  83 Fed. Reg. 31841.  The Federal Register publication states that this final rule “designates the proposed product categories within which biobased products will be afforded Federal procurement preference” and that “USDA has determined that each of the product categories being designated under this rulemaking meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of section 9002:  to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the Nation’s energy security by substituting biobased products for products derived from imported oil and natural gas.”
 
The final rule revises the definition of the following categories in an effort to clarify or add examples of intermediates that can be included in each of these categories:

  • Intermediates -- plastic resins (revised to include the term “polymers”);
  • Intermediates -- chemicals (revised to list additional materials such as viscosity reducers, rheology modifiers, adhesion agents, polyols, and polymers);
  • Intermediates -- paint and coating components (revised to add additional examples of paint and coating components, such as humectants, open time additives, and polymers); and
  • Intermediates -- binders (revised to expand on the types of chemicals that typically make up binders, to include examples of materials that binders can be used to formulate, and to include the phrase “binders are generally polymers or polymer precursors (such as epoxies) and include the polymeric materials used to formulate coatings, adhesives, sealants and elastomers”).
This final rule will become effective on August 9, 2018.

 
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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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By Lynn L. Bergeson

On July 5, 2018, VTT Technical Research Centre of Finland Ltd announced that it had developed a 100 percent biobased, thermally formable, biodegradable material, that is suitable for furniture applications.  This product is an attractive alternative to wood and other biocomposite materials that are already available in the market, with the added benefit of formality and coloring properties.  "All the goals we set were achieved: the material is 100% bio-based, cellulose fibres account for a significant proportion, it looks good and it has excellent performance characteristics," states Lisa Wikström, Research Team Leader from VTT.  At the end of the product life-cycle, it can be re-used, composted (degrading into carbon dioxide and water), or burned for energy.


 
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By Lynn L. Bergeson

On June 28, 2018, the U.S. Senate passed S.3042 -- Agriculture Improvement Act of 2018 (Farm Bill) with a vote of 86-11. This bill includes mandatory funding for Energy Title programs, including the Biomass Research and Development Initiative; the Biobased Markets Program; the Biorefinery, Renewable Chemical and Product Manufacturing Assistance Program; the Bioenergy Program for Advanced Biofuels; the Rural Energy for America Program (REAP); and the Biomass Crop Assistance Program (BCAP). In addition to securing funding for a range of bioenergy programs, the legislation also expands the types of renewable chemical and biobased product technologies that are eligible for funding. The U.S. House of Representatives version of this bill, H.R. 2, was passed on June 21, 2018, and does not include mandatory funding for Energy Title programs. While this funding was not included in H.R. 2, a previous vote to repeal the Energy Title programs was defeated in the House on May 17, 2018, by a vote of 75-340, signaling strong bipartisan support of the programs. (See the Biobased and Renewable Products Advocacy Group (BRAG®) Blog post “Bipartisan Support Keeps Energy Title Programs In Farm Bill.”) The differences between the House and Senate versions of the Farm Bill will be resolved in committee.


 
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By Lynn L. Bergeson

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology.  According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to engineer such organisms.”  Some malicious applications of synthetic biology that may not seem plausible right now could become achievable with future advances.

The final report, which builds on and supersedes an interim report released in August 2017, explores and envisions potential misuses of synthetic biology, including concepts that are regularly discussed in open meetings.  In the interim report, the Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology proposed a strategic framework intended to identify and prioritize potential areas of concern associated with the field and to help biodefense analysts as they consider the current and future synthetic biology capabilities.  The Committee designed the framework for analyzing existing biotechnology tools to evaluate the dangers at present, understand how various technologies compare with and complement each other, and assess the implications of new experimental outcomes.  More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum.


 
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By Lynn L. Bergeson

On June 27, 2018, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) issued a new report, Moving Beyond Drop-In Replacements: Performance-Advantaged Biobased Chemicals Workshop Summary Report, that summarizes presentations and discussions from a workshop BETO held in June 2017 to gather stakeholder input on the research and development necessary for novel biobased compounds and functional replacements.  DOE states that performance-advantaged biobased products and functional replacements can offer many advantages to the U.S. bioeconomy.  The conclusion section of the report states that performance-advantaged biobased products present an important opportunity for the bioeconomy, and the ideal novel biobased compound would achieve the following:

  • Allow for new functionality in end products and generate new markets for manufacturers of biobased materials;
  • Increase the value of domestic biomass resources and provide a new revenue stream for biorefineries; and
  • Reduce the environmental impact of some manufacturing processes.

 
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By Lynn L. Bergeson

On June 27, 2018, representatives from 11 European companies and universities gathered in Örnsköldsvik, Sweden, to kick-off the EU-funded Rewofuel project.  This three-year, €19.7 million (about $23 million) project will demonstrate and evaluate how to best use wood residues from the forest industry to produce biofuels, with a long-term goal of starting new biorefineries across Europe. Rewofuel is a collaborative project that is expected to run for three years, and is being worked on by SEKAB E-Technology, Peab Asphalt, Sky NRG, Global Bioenergies, Neste Engineering Solutions, Repsol, Ajinomoto, Eurolysine, IPSB, TechnipFMC, and Linz University.  Jean-Baptiste Barbaroux, Chief Corporate Officer at Global Bioenergies, said of the project, “By combining technologies and know-how from the leading biofuels actors across Europe, the project Rewofuel will be able to demonstrate the increasingly important role of using forest materials in the European renewable energy transition. We look forward to contributing directly to the European climate and energy targets.”


 
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By Lynn L. Bergeson

On June 26, 2018, Scott Pruitt, Administrator of the U.S. Environmental Protection Agency (EPA), signed a proposed rule that includes 2019 Renewable Fuel Standard (RFS) percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel, as well as 2020 renewable volume obligations (RVO) for biomass-based diesel.
 




These blend levels increase requirements from 2018 but are still lower than the statutory levels set by Congress under the RFS. The levels, along with the fact that the proposed rule does not address the reduction in price that Renewable Identification Numbers (RIN) have suffered as a result of EPA’s increased use of small refiner hardship waivers, have resulted in criticism of the rule by biofuel groups. Brent Erickson, Executive Vice President of the Biotechnology Innovation Organization’s (BIO) Industrial & Environmental Section released a statement regarding the proposed rule, stating:
 
We welcome EPA’s decision to raise the advanced and cellulosic biofuel volumes in its proposal, which will help propel the industry forward in 2019. However, the advanced biofuels industry is still suffering the effects of the Agency’s decision to arbitrarily limit growth for low carbon biofuels in 2018, by setting a backward looking RFS requirement. The 2019 volumes should be higher, to correct from last year and also spur growth for the coming year.

EPA’s decision to forgo reallocation of gallons displaced from small refinery waivers at the behest of the petroleum industry is disappointing. In order to ensure a favorable and supportive investment climate for advanced and cellulosic biofuel producers, EPA must reallocate the gallons from the small refinery waivers already issued and into the future.

A comment period will start following publication of the proposed rule in the Federal Register and comments will be due by August 17, 2018. Comments can be filed online at www.regulations.gov under Docket ID No. EPA-HQ-OAR-2018-0167. EPA plans to schedule a public hearing on the proposed rule.

Tags: EPA, RFS, Biofuel

 
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By Lynn L. Bergeson

On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.”  Further, comments submitted to the docket “addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation.”  FDA states that after considering the public comments that were received on the draft guidance, it determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved, and that it intends to “issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.”  FDA will communicate publicly when new draft guidance is issued.

Tags: FDA

 
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By Lynn L. Bergeson

On June 20, 2018, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that the Fuels Institute and the national laboratories that comprise the DOE Co-Optimization of Fuels and Engines initiative would be co-hosting a series of collaborative, single-day stakeholder meetings entitled the Octane Workshop Series across multiple locations from July 9-12, 2018, to “review current research on the role of octane and other fuel properties relevant to producing fuels that could enable the design of more efficient spark ignition, internal combustion engines.”  Each session will present the latest findings of research concerning fuels and engine options that might enhance vehicle efficiency and reduce emissions, and the opportunities and challenges associated with delivering such products to market.
 
The Octane Workshop Series will include the following focus areas:

  • Regulatory (July 9, 2018; Irvine, California);
  • Biofuel (July 10, 2018; Wichita, Kansas);
  • Refinery (July 11, 2018; Houston, Texas); and
  • Auto Industry (July 12, 2018; Detroit, Michigan). 
DOE states that these workshops will be “highly informative for anyone engaged in petroleum refining, biofuels production, liquid fuel distribution and retailing, automotive engineering, fuels and vehicles regulations, and/or fuels and vehicles research.”  Registration for each separate event is available online.

 
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By Lynn L. Bergeson

On June 26, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced it was seeking public comment on a draft Environmental Assessment (EA) and a preliminary Plant Pest Risk Assessment (PPRA) prepared in response to a petition from Nuseed Americas Inc. (Nuseed) to deregulate a canola variety genetically engineered to convert oleic acid to docosahexaenoic acid (DHA).  83 Fed. Reg. 29742.  APHIS will thoroughly review and consider all public input submitted during the comment period, and use the information as it works to complete, and then publish, final environmental documents and its regulatory determination.

The Federal Register notice states that APHIS’ draft PPRA “has concluded that canola designated as event B0050–027, which has been genetically engineered to accumulate the long chain omega-3 fatty acid known as [DHA] in seed, is unlikely to pose a plant pest risk” and APHIS’ draft EA presents two alternatives “based on our analysis of data submitted by Nuseed, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition.”  The alternatives are:  “(1) Take no action, i.e., APHIS would not change the regulatory status of canola designated as event B0050-027, or (2) make a determination of nonregulated status of canola designated as event B0050-027.”  APHIS requests comments to be submitted by July 26, 2018.

Tags: USDA, APHIS

 

 
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