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 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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By Lynn L. Bergeson

On October 1, 2019, the U.S. Department of Energy (DOE) announced that 35 projects have been selected to receive funding for bioenergy research and development (R&D). Totaling $73 million in funding provided by DOE’s Office of Energy Efficiency and Renewable Energy (EERE), the selected projects aim to:

  • Reduce the price of drop-in biofuels;
  • Lower the cost of biopower; and
  • Enable high-value products from biomass or waste resources.

According to DOE, the United States has the potential to produce 1 billion dry tons of non-food biomass without the disruption of agricultural markets for food and animal feed. These domestic resources, however, are currently underutilized. Given these circumstances, the main goal of the 35 selected projects will be to produce affordable biofuels that are compatible with the existing fueling infrastructure and vehicles in a range of transportation modes.


 
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By Lynn L. Bergeson

On September 30, 2019, DOE announced that the Lawrence Livermore National Laboratory (LLNL) will host an informational webinar about the High Performance Computing for Energy Innovation (HPC4EI) Program. In honor of National Manufacturing Day, the webinar is scheduled for October 4, 2019, at 12:00 p.m. (EDT). The HPC4EI Program pairs national laboratory scientists with partners in industry to apply high-performance computing technology and improve energy utilization in the manufacturing sector. Eighty-four projects currently exist under the HPC4EI Program, encouraging National Laboratories’ and industry collaboration to speedily bring these technologies to market. The 84 projects underway involve nine participating laboratories and are working to address problems in a variety of industries, including metal smelting, additive manufacturing, alloy design, mobility, pulp and paper production, and paint application. The LLNL webinar will include an overview of the HPC4EI Program and its impact followed by presentations by principal investigators on the progress of specific projects

Tags: DOE

 
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By Lynn L. Bergeson

On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL) Cyclotron Road program. Each of the programs recruits a cohort of entrepreneurial scientists and engineers from around the world for two years. The goal of the programs is to allow innovators to mature their ideas until they can align with the most suitable commercial partners to take their technology to scale. Selected participants will receive a two-year fellowship, which includes a stipend depending on education and experience, along with health insurance and a travel allowance. Research funding and access to research facilities, equipment, and expertise are also provided, accompanied by a startup curriculum and a community of peers. The startup curriculum includes intensive entrepreneurial training, mentorship, and networking opportunities. Again, applications are due by October 31, 2019, and can be found in the National Laboratories’ respective websites: ANL, ORNL, and LBL.


 
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By Lynn L. Bergeson

The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media. EPA is accepting comments on the draft GFI until November 29, 2019, before it starts working on the final version of it.

Tags: FDA

 
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By Lynn L. Bergeson

On September 18, 2019, the U.S. Department of Energy (DOE) and the National Oceanic and Atmospheric Administration (NOAA) announced a $3 million prize competition to power ocean observing platforms with marine renewable energy. To generate innovation, the Powering the Blue Economy Ocean Observing Prize will offer a series of contests to demonstrate marine renewable energy use for observing platforms. DOE hopes that this prize will help spur technological innovation through a path from concept to design to construction. Part of DOE’s Powering the Blue Economy initiative, the prize consists of two competitions. The first competition, “Discovery,” calls for novel concepts that pair ocean observing technologies with marine energy systems in five broad themes:

  • Charging unmanned systems;
  • Communications and underwater navigation;
  • Extreme environments;
  • Buoys, floats, and tags; and
  • Innovative ideas.

Following the first competition, will be the “Build” competition to bring innovators’ ideas to reality. The prize is led by DOE’s Office of Energy Efficiency and Renewable Energy (EERE) Water Power Technologies Office (WPTO) and NOAA’s Integrated Ocean Observing System Program.


 
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By Lynn L. Bergeson

On September 25, 2019, DOE EERE announced that its Better Buildings, Better Plants partners have saved more than 1.3 quadrillion British thermal units (BTUs) and $6.7 billion in energy costs. With more than 220 partners, DOE accepted 22 new companies this year, which include more than 3,200 facilities and represent approximately 12 percent of the U.S. manufacturing energy footprint. Designed to work with partners who have set ambitious energy, water, and/or waste reduction goals, DOE’s program collects partners’ energy performance data and solutions to expand innovation and savings throughout the industrial sector. Thus far, partners have met and exceeded 60 energy goals. A full update on the Better Building, Better Plants partners is available in the 2019 Better Plants Annual Progress Update.

Tags: DOE, EERE

 
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