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 and Ligia Duarte Botelho, M.A.

On October 28, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental proposal on adjustments to the percentage standards for 2020 that result from the amended definitions of two terms used to calculate the percentage standards under the Renewable Fuel Standard (RFS). Signed and pre-published on October 15, 2019, by EPA Administrator Andrew Wheeler, the notice of the proposed rule is no surprise. The proposed supplemental proposal, if approved, will establish the cellulosic biofuel, advanced biofuel, and total renewable fuel volumes for 2020 and the biomass-based diesel volume for 2021. Although the rule does not change the volumes for 2020 and 2021 proposed in July 2019, it proposes and seeks comment on adjustments to the way that annual renewable fuel percentages are calculated. Annual renewable fuel percentage standards are used to calculate the number of gallons each obligated party is required to blend into their fuel or to obtain otherwise renewable identification numbers (RIN) to demonstrate compliance. Specifically, EPA is seeking comment on projecting the volume of gasoline and diesel that will be exempt in 2020 due to small refinery exemptions based on a three-year average of the relief recommended by DOE, including where DOE had recommended partial exemptions. EPA intends to grant partial exemptions in appropriate circumstances when adjudicating 2020 exemption petitions. EPA proposes to use this value to adjust the way it calculates renewable fuel percentages.

Comments must be received on or prior to November 29, 2019.

On October 30, 2019, EPA held a public hearing on the proposed rule in Ypsilanti, Michigan, where affected stakeholders had a chance to provide testimony. One of the testimonies given was from Renewable Fuels Association (RFA) President and Chief Executive Officer (CEO) Geoff Cooper. Cooper told EPA that “this proposal fails to reflect the letter and spirit of the president’s commitment to restore integrity to the RFS, fails to assure that the statutorily-required 15-billion-gallon level for conventional biofuels will be met, and fails to restore stability in the marketplace by definitively ending the practice of allowing small refinery exemptions from eroding RFS biofuel demand.” Outlining the weaknesses of EPA’s proposal, Cooper highlighted that not only has EPA seldom followed DOE’s recommendations in deciding small refinery exemption (SRE) petitions, but also that it will not succeed. According to Cooper, because EPA bases averages of what DOE recommends and not of the waivers actually granted, and the former is significantly less than the latter, the proposed rule is not promising. Cooper’s full written testimony can be accessed here.

Tags: RFS, Industry

 
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By Lynn L. Bergeson

On October 25, 2019, Iowa State University’s (ISU) Vice President for Research, Dan Kirkpatrick, announced that Sundeep Vani, Ph.D., has joined the team as the Chief Technology Officer (CTO) for Biobased Products, a newly created role. Announced in an ISU press release, Dr. Vani’s role will be to serve as a conduit between research and industry. Dr. Vani will work closely with the Biobased Product platform leader, Brent Shanks, his team, and the Iowa Innovation Corporation (IIC) CEO. Identifying promising emerging technologies and facilitating their development into market scale will also be at the top of Dr. Vani’s list of priorities. Dr. Vani stated that he is “excited to join Iowa State in this mission to grow Iowa’s economy through the state’s overall Biosciences initiative.” His addition to the team is partially attributed to Iowa’s legislature in July 2019 granting the university $825,000 in fiscal year 2020.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 23, 2019, the Alliance to End Plastic Waste (AEPW) announced a partnership with innovation platform Plug and Play to develop an accelerator program focused on the plastics value chain to identify start-ups with innovative ideas addressing plastic waste. Named the End Plastic Waste Innovation Platform (EPWIP), this initiative will focus on solutions to lower the impact of plastic waste in the environment. Focus areas include but are not limited to collecting, managing, and sorting plastic waste; recycling and processing technologies; and creating value from post-recycled plastics. Two programs will be run throughout the calendar year in Silicon Valley, Paris, and Singapore. Plug and Play will source specific start-ups working on solutions in selected focus areas. Running for 12 weeks, the programs will accept ten start-ups each, under which Plug and Play will invest in 20 selected start-ups per year. Engaging start-ups to AEPW members throughout the entire plastics value chain on infrastructure, education and engagement, innovation, and cleanup efforts, the programs will serve as a bridge between start-ups and access to new markets through AEPW members. Applications are now open for the first program, which will run from February through May 2020.


 
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By Lynn L. Bergeson

On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019. It is co-sponsored by Representative John Moolenaar (R-MI). The bill is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems, by establishing a coordinating entity under the National Science and Technology Council within the Office of Science and Technology Policy. The legislation would allow the agencies involved in this entity to work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the United States and encourage the validation of tools for assessment of sustainable chemistry processes or products. The agencies would include the U.S. Environmental Protection Agency (EPA), the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, the Department of Agriculture, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and other related federal agencies, as appropriate. The bill also supports improved education and training in sustainable chemistry.


 
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By Lynn L. Bergeson

On October 22, 2019, Frank Pallone, Jr. (D-NJ), Energy and Commerce (E&C) Committee Chair, and Paul Tonko (D-NY), Environment and Climate Change Subcommittee (ECCS), announced that a legislative hearing will be held on October 29, 2019, at 10:30 a.m. (EDT) on Capitol Hill. Titled “Protecting the RFS: The Trump Administration’s Abuse of Secret Waivers,” the hearing will focus on the EPA’s mismanagement of the Renewable Fuel Standard (RFS) Program under the Trump Administration. The Subcommittee has not yet released the witness list for the legislative hearing; it has, however, stated that the purpose of the meeting is to examine H.R. 3006, the RFS Integrity Act of 2019, introduced by Representative Collin Peterson (D-MN). Further information for the hearing, including the Committee Memorandum, legislation, witness list, testimony, and a live webcast will be posted online as soon as it becomes available.

Tags: RFS

 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 16, 2019, the University of Surrey, United Kingdom, announced that its researchers have partnered with colleagues from France, Germany, and Spain to start working on a new technique to tackle plastic waste. According to the university’s article, this novel technique may revolutionize the recycling industry. The plan is to create engineered microbial communities that will digest two types of plastic polymers -- polyethylene terephthalate (PET) and polyurethane (PU) -- and transform them into molecules that can be used to develop a more environmentally friendly material called Bio-PU. This more environmentally friendly material is often used as a construction and insulation material.

According to the University of Surrey, current physical or chemical methods to degrade PET and PU are inefficient. Impurities in PET polymers and high energy costs associated with the high temperatures required to break down the material make its degradation very difficult. Similarly, degradation of PU is limited due to the difficulty in breaking down urethane bonds in the material. Given these challenges, University of Surrey Senior Lecturer in synthetic biology Dr. Jose Jimenez highlights that “[m]oving away from the reliance on single use plastics is a positive step; however, the problem of how we deal with current plastic waste still needs to be addressed.” Hence, the project will investigate the ability of microorganisms to digest plastic waste and turn it into a more environmentally friendly material that can be recycled.


 
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By Lynn L. Bergeson

On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program. According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process. OIG states that Safer Choice “is a voluntary labeling program that helps consumers and commercial buyers find chemical-based products that are safer for human health and the environment.” OIG plans to conduct work at headquarters and at various third-party assessor and auditor locations. It will use applicable generally accepted government auditing standards in conducting its audit. The anticipated benefits of the audit “are reducing the use of chemicals of concern and empowering consumers to protect their health.”


 
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By Lynn L. Bergeson

On October 15, 2019, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service (RBCS) announced via the Federal Register the solicitation of applications for funds under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program). Under the Program, USDA provides guaranteed loans to fund the development, construction, and retrofitting of commercial scale biorefineries using eligible technology. The loans are also used to fund the development of biobased product manufacturing facilities that use technologically new commercial-scale processing and manufacturing equipment to convert renewable chemicals and other biobased outputs of biorefineries into end-user products on a commercial scale. There will be two separate application cycles. The first cycle closed on October 1, 2019, and the second cycle will close on April 1, 2020. Applications filed after the aforementioned dates will be considered for the next application cycle, should funding be available.


 
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By Lynn L. Bergeson

On October 15, 2019, EPA Administrator, Andrew Wheeler, signed a supplemental notice of the proposed rule on the Renewable Fuel Standard (RFS) that proposes to establish the cellulosic biofuel, advanced biofuel, and total renewable fuel volumes for 2020 and the biomass-based diesel volume for 2021. Although the rule does not change the volumes for 2020 and 2021 proposed in July 2019, it proposes and seeks comment on adjustments to the way that annual renewable fuel percentages are calculated. Annual renewable fuel percentage standards are used to calculate the number of gallons each obligated party is required to blend into their fuel or to otherwise obtain renewable identification numbers (RIN) to demonstrate compliance. Specifically, EPA is seeking comment on projecting the volume of gasoline and diesel that will be exempt in 2020 due to small refinery exemptions based on a three-year average of the relief recommended by the U.S. Department of Energy (DOE), including where DOE had recommended partial exemptions. EPA intends to grant partial exemptions in appropriate circumstances when adjudicating 2020 exemption petitions. EPA proposes to use this value to adjust the way it calculates renewable fuel percentages.

According to the prepublication notice, comments must be received on or prior to November 29, 2019. EPA will hold a public hearing in Ypsilanti, Michigan, on October 30, 2019, starting at 9:00 a.m. (EDT).


 
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By Lynn L. Bergeson

In response to EPA supplemental proposal outlined above, on October 15, 2019, U.S. Senator James Lankford (R-OK) issued a statement expressing his disappointment with EPA’s RFS mandates. Senator Lankford’s statement reads in part:

The RFS has been a problem since day one, and the proposed increase to the mandate only further complicates a broken federal requirement to blend biofuels into gasoline. This proposal continues allowing exemptions for small refineries but spreads their biofuels-blending obligation out to other refiners in the market. Despite the possibility that small refiners will get waivers from the Standard, the cost of compliance will likely go up for everyone else trying to provide fuel to American consumers—a cost that will surely be passed down to the consumer. As I have said many times, if the market demands higher biofuel blends, our producers can supply it, but we should not require biofuels to be blended, since it will ultimately increase gas prices for Oklahomans. Higher gas prices mean higher prices for many things our families need, like groceries. Higher gas prices especially affect those on a fixed income.

Critical of EPA’s management of the RFS program, Senator Lankford has called for a repeal of RFS a number of times in both the House and Senate. Senator Lankford continues to speak out about having a market-driven energy policy.

Tags: RFS

 
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By Lynn L. Bergeson

On October 4, 2019, U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, and U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced President Trump’s negotiated agreement on the Renewable Fuel Standard (RFS).  Under the agreement, EPA and USDA will undertake the following actions:

  • In a forthcoming supplemental notice building off the recently proposed 2020 Renewable Volume Standards and the Biomass-Based Diesel Volume for 2021, EPA will propose and request public comment on expanding biofuel requirements beginning in 2020.
    • EPA will seek comment on actions to ensure that more than 15 billion gallons of conventional ethanol be blended into the nation’s fuel supply beginning in 2020, and that the volume obligation for biomass-based diesel is met.  This will include accounting for relief expected to be provided for small refineries.
       
    • EPA intends to take final action on this front later this year.
       
    • In the most recent compliance year, EPA granted 31 small refinery exemptions.
       
  • Building on the President’s earlier decision to allow year-round sales of E15, EPA will initiate a rulemaking process to streamline labeling and remove other barriers to the sale of E15.
     
  • EPA will continue to evaluate options for [renewable identification number] RIN market transparency and reform.
     
  • USDA will seek opportunities through the budget process to consider infrastructure projects to facilitate higher biofuel blends.
     
  • The Administration will continue to work to address ethanol and biodiesel trade issues.
EPA Administrator Wheeler commended Trump’s leadership in this matter, stating that this agreement continues to promote domestic ethanol and biodiesel production in support of U.S. farmers.  In addition, the agreement, according to USDA Secretary Perdue, found a way to pursue policy that promotes economic growth and energy security. A number of other elected officials also applauded Trump’s agreement.
Tags: RFS, Biofuel, EPA

 
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By Lynn L. Bergeson

On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical procedures such as chromatographic assays (CC) and ligand-binding assays (LBA) that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.  The templates in this guidance can be used for new drug applications (NDA), biologics license applications (BLA), and supplements to these applications to provide information regarding bioanalytical methods for pharmacokinetic assessments.

Tags: FDA

 
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By Lynn L. Bergeson

On October 2, 2019, the government of Quebec, Canada, published in its Official Gazette a notice of a draft regulation setting standards for the integration of renewable fuels into gasoline and diesel fuel.  Under the draft regulation, the standards will apply on July 1, 2021, and will then increase. As of July 1, 2025, the integration of a minimum volume of ethanol of 15 percent into gasoline and a minimum volume of biobased diesel fuel of 4 percent into diesel fuel will be required. Given the evaluation by the Canadian government of this matter, the notice states that the proposed regulation would have no particular impact on small and medium-sized businesses because the petroleum products distribution sector is made up of large businesses.  Also on July 1, 2025, enterprises subject to the regulation will invest a total of 110 million Canadian dollars in infrastructure to comply with the set standards for the integration of renewable fuels into gasoline and diesel fuel.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 2, 2019, the Green Party of Canada commented, via a press release, on its Green Climate Action Plan called “Mission:  Possible.” Aiming to exceed the U.S. Green New Deal, under this plan, the Green Party outlines a 20-step action plan to achieve the goal of zero emissions by 2050.  Part of the strategy outlined emphasizes the idea that heavy-duty industrial machinery will need to rely on biofuels.  Although the plan is to ban internal combustion engines and ensure that cars, buses, and trains are powered by electricity by 2030, biofuels will still be needed for fishing, mining, and forestry equipment.  According to the plan, these biofuel needs will be addressed through the creation of biofuels using waste plant matter from forests and agriculture -- and only plant-based biofuels.  Claiming that food that would otherwise be used to feed Canadians, the Green Party highly opposes food-based biofuels.  Its plan, therefore, promotes development of local, small-scale biodiesel production that would rely primarily on used vegetable fat from restaurants across Canada, along with wood and agricultural waste.  Fuel switching to biodiesel would be required for agricultural, fishing, and forestry equipment.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 2, 2019, the Governor of Minnesota, Tim Walz, announced that applications are now open for all 15 seats on the Governor’s Biofuels Council.  Established in September 2019 by Governor Walz, the Governor’s Biofuels Council advises the Governor and cabinet on how best to support Minnesota’s biofuels industry. Council members will include representatives of agriculture, biofuels, and transportation industries and environmental and conservation groups.  The Governor’s Biofuels Council is tasked with creating a report to advise the Governor and cabinet on the best methods to expand the use of biofuels, increase the carbon efficiency of biofuels, and implement biofuels as part of Minnesota’s larger goal to reduce greenhouse gas (GHG) production in the transportation sector.  Under Governor Walz’s September 16, 2019, Executive Order, the Governor’s Biofuels Council must complete the report by November 2020.  Thus far, 30 individuals have applied, and Governor Walz encourages “Minnesotans in every corner of the state to apply and share their expertise on this critical issue.”  Interested parties can access the application here.


 
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