Biobased Products News and Policy Report
Federal
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
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.
- 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
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.
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.
International
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.
State
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.
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