Biobased Products News and Policy Report
Negotiated Agreement On RFS
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
- EPA intends to take final
action on this front later
- In the most recent compliance
year, EPA granted 31 small refinery exemptions.
- 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.
- 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
- 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.
FDA Publishes Technical Specifications Guidance
For Bioanalytical Methods Templates
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.
Government Of Quebec Publishes Draft Regulation
On Renewable Fuel Minimum Volume
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.
Green Party Of Canada Action Plan Calls For Plant Waste Biofuels
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.
Governor Tim Walz Announces Applications For
Seats On The Governor’s Biofuels Council
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.