By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On July 2, 2020, DOE announced that it has selected seven projects to conduct R&D to accelerate the adoption of performance-advantaged biofuel blendstocks. A total of $1.94 million in funding is available for the projects, which will leverage National Laboratory capabilities as part of the Co-Optimization of Fuels & Engines (Co-Optima) initiative. The Co-Optima initiative focuses on simultaneous innovations in fuels and engines that can boost fuel economy and vehicle performance while reducing emissions.
Each of the Co-Optima initiative awardees will receive up to $300,000 in National Laboratory assistance for experimental or computational projects that leverage:
- Capabilities in areas of bioblendstock fuel property and production research;
- Combustion performance modeling;
- Bioblendstock fuel property and production research;
- Bioblendstock target identification; and/or
Each awardee has committed to a 20 percent cost share contribution.
Assistant Secretary for DOE’s EERE, Daniel R. Simmons, stated that “[t]hese projects are designed to help improve energy efficiency for passenger vehicles through the use of biofuels, translating into savings at the pump.”
By Lynn L. Bergeson
On June 26, 2020, the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the winners of its 2020 Start-Up Stadium competition. The competition had 30 finalists that were evaluated during BIO Digital in June, by expert judges with backgrounds in investment, entrepreneurship, start-ups, economic development, capital formation, and academia. Five winners were chosen based on their commercially viable cutting-edge technologies and therapeutic solutions. Competition winners will receive:
- A one-year membership in BIO;
- Four hours of complimentary legal services;
- One-hour advisory discussion with two venture capital firms; and
- A “fast-track” accelerator application and nomination into the final selection phase for up to a $10,000 sequencing grant.
By Lynn L. Bergeson and Carla N. Hutton
On June 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2020 Green Chemistry Challenge Awards. EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.” The 2020 winners and their innovative technologies are:
- Genomatica, San Diego, California, for creating Brontide™, a new brand of 1,3-butylene glycol, commonly used in cosmetics for moisture retention and as a carrier for plant extracts. Butylene glycol is traditionally produced from fossil fuels. Brontide™ is produced by fermenting E. coli using renewable sugars in a one-step production process, however. This method reduces greenhouse gas emissions and avoids the use of hazardous chemicals in the production process.
- Merck, Rahway, New Jersey, for improving the process used to produce certain antiviral drugs used for the treatment of diseases including hepatitis C and HIV. According to EPA, the new process improved manufacturing efficiency and sustainability of one important antiviral by more than 85 percent. This method reduces waste and hazards associated with the existing process and results in substantial cost savings.
- Johns Manville, Littleton, Colorado, for developing a biobased, formaldehyde-free thermoset binder for fiberglass reinforcement applications. Thermoset binders are used to bind glass fibers of fiberglass mats used in carpet tile backing. EPA states that this technology eliminates the use of hazardous chemicals, reduces water and energy use, and produces a product with a longer shelf life.
- Professor Steven Skerlos, University of Michigan and Fusion Coolant Systems, for creating Pure-Cut™, an alternative to traditional metalworking fluids that uses high-pressure carbon dioxide instead of oil-based lubricants. According to EPA, Pure-Cut™ can improve performance and machining tool life span compared to traditional metalworking fluids, while greatly reducing hazards to the environment and worker health.
- Vestaron, Kalamazoo, Michigan, for producing a new biopesticide called Spear®. This pesticide is based on a naturally occurring component inspired by spider venom that can effectively control target pests while showing no adverse effects on people, the environment, and non-target wildlife, such as fish and bees. EPA notes that Spear® should provide growers with a new pest management tool that also lessens environmental impacts.
EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year. EPA and the American Chemical Society co-sponsor the awards. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners.
By Lynn L. Bergeson
On June 4, 2020, the Missouri Agricultural and Small Business Development Authority (MASBDA) announced the creation of the Biofuel Infrastructure Program (BIP). Designed to increase the availability of higher blends of ethanol and biodiesel in Missouri, BIP partners with private entities to support biofuel producers in applying for U.S. Department of Agriculture (USDA) Rural Development’s Higher Blends Infrastructure Investment Program (HBIIP) funding. The MASBDA Board of Directors has allocated up to $2 million statewide in grant funds. The maximum grant amount is $200,000 for each business entity and can be used to fulfill up to 25 percent of the cash match obligation required for HBIIP. Eligible project costs include but are not limited to:
- Retrofitting of existing, or purchase and installation of new, fuel dispensers (gas and/or diesel pumps) and attached equipment, underground storage tank system components, and other infrastructure required at a location to ensure the environmentally safe availability of fuel containing ethanol blends greater than 10 percent or fuel containing biodiesel blends greater than 5 percent;
- Construction, retrofitting, replacement, and improvements;
- Fees for construction permits and licenses; and
- Professional service fees for qualified consultants, contractors, installers, and other third-party services.
The application deadline for these grants is July 1, 2020. A non-refundable fee of $150 must accompany applications up to $25,000, and a fee of $300 for applications of $25,000 and over. For funded grants, an administrative fee of 10 percent of the grant amount will be assessed when the contract is executed. Further information can be accessed here, and the application here.
MASBDA Executive Director, Jill Wood, expressed enthusiasm for the newly created BIP, stating that her team at MASBDA “is excited to stand in the financial gap that may help some agribusinesses from applying these federal funds.”
By Lynn L. Bergeson
On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to take two actions. The first action is for EPA to complete a study to determine whether renewable fuel volumes required under CAA Section 211(o) will adversely impact air quality given changes of vehicle and engine emissions of air pollutants. This study is often referred to as the anti-backsliding study and must include consideration of various blend levels, types of renewable fuels, and available vehicle technologies. The study must also include appropriate national, regional, and local air quality control measures. EPA has completed the study, which is available here.
The second action requires EPA to make a decision on whether it should proceed down one of the following paths:
- Promulgation of fuel regulations to implement appropriate measures to mitigate any adverse impacts on air quality as a result of the renewable volumes required by Section 211; or
- Determination that no such measures are required.
In this case, EPA is proposing a determination “that no additional appropriate fuel control measures are necessary to mitigate adverse air quality impacts of required renewable fuel volumes.”
By Lynn L. Bergeson
On June 3, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it will be hosting a public virtual workshop titled “Workshop on Predictive Models and High Performance Computing as Tools to Accelerate the Scaling-up of New Bio-Based Fuels.” The goal is to determine if predictive models and high performance computing can and should be used to reduce biotechnology uncertainty and accelerate scaling-up of biorefinery/chemical production equipment and optimize operations. The virtual workshop will be held from June 9 to June 11, 2020, from 10:30 a.m. to 4:30 p.m. (EDT) each day. Registration is required by 4:00 p.m. (EDT) June 5, 2020.
By Lynn L. Bergeson
On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:
- Bioanalytical method validation: history, process, and regulatory perspectives;
- Regulated bioanalysis for large molecules;
- Regulated bioanalysis for small molecules;
- Drugs and biologics;
- Bioanalysis of unstable analysis;
- Repeat analysis; and
- A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.
Registration is required.
By Lynn L. Bergeson
On May 21, 2020, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced a bill directing the U.S. Department of Agriculture (USDA) Secretary to establish a renewable feedstock reimbursement program. Aiming to support biofuel producers that have been negatively affected by the COVID-19 pandemic, this bill can be cited as the Renewable Fuel Feedstock Reimbursement Act of 2020. Under the reimbursement program, biofuel producers will be reimbursed for their feedstock purchases from January 1, 2020, through March 31, 2020, through the Commodity Credit Corporation (CCC). Eligible parties will consist of those that produce renewable fuel used as transportation fuel and eligible feedstocks mean renewable biomass intended for production of the aforementioned renewable fuel. Furthermore, to be eligible to receive reimbursements, eligible entities must enter into an agreement with the USDA Secretary.
The two U.S. Senators initially introduced this idea in April 2020 as an amendment to the Coronavirus Aid, Relief, and Economic Stabilization (CARES) Act, which assists the biofuels industry sector. Assistance, however, was not included in the CARES Act package. Senators Klobuchar and Grassley, with industry support, now hope that this second attempt in support of the biofuels industry follows through.
By Lynn L. Bergeson
On May 22, 2020, EPA’s Office of Pesticide Programs (OPP) announced the opening of a 15-day comment period on its proposal to register a new active ingredient and biopesticide product. The biopesticide product, PHC-91398, would contain Ea peptide 91398, the new active ingredient that was derived from naturally occurring bacterium and induces natural plant defenses. The plant’s reaction to the peptide “activates a hypersensitive response in treated plants, which enables resistance to bacterial and fungal infection, as well as suppression of nematode egg production.” PHC-91398, the biopesticide product, is intended for use on a wide range of agricultural crops and home and garden uses. There will be three product applications:
- Pre-plant foliar or root dip;
- Foliar application in greenhouses and fields through a conventional spray, drip, or aerial equipment; and
Upon review of the data submitted in support of Ea peptide 91398, EPA states that toxicity, allergenicity to humans, and/or adverse effects on non-target organisms is not expected.
EPA is seeking comments, particularly from pesticide users, registrants, public interest organizations, and state, tribal, and local governments. Comments are due on or prior to June 5, 2020.
By Lynn L. Bergeson
On May 18, 2020, USDA issued its final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (9003 Program), which incorporates the statutory definition changes as required in the Agricultural Act of 2018 (Farm Bill) and adopts the interim rule published on June 14, 2015. The 9003 Program replaces the Biorefinery Assistance Program (BAP), which guaranteed loans to fund the development, construction, and retrofitting of commercial-scale biorefineries using eligible technology. The final rule makes several specific changes to BAP, including:
- Renames the program as the 9003 Program;
- Revises the purpose statement for the program to include renewable chemicals and biobased product manufacturing;
- Expands the program to include biobased product manufacturing facilities;
- Adds definitions for “renewable chemicals” and “biobased product manufacturing”; and
- Ensures diversity in the types of projects approved by the program.
The final rule became effective on May 18, 2020.