By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:
The PIPs Exemption Final Rule went into effect on July 31, 2023. More information on the final rule is available in our June 2, 2023, memorandum.
On May 31, 2023, EPA released a final rule exempting two categories of PIPs created using genetic engineering from certain registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. According to EPA, the rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.
EPA notes that the final rule reflects the biotechnological advances made since 2001, when it first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
The rule contains conditions for exempting:
- PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and
- Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. EPA states that for this category of PIP, “biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.”
EPA notes that it indicated in the preamble to the final rule that it would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.
By Lauren M. Graham, Ph.D.
On August 14, 2017, Flint Hills Resources, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that construction is underway to install a new, bolt-on technology, known as Maximized Stillage Co-Products™ (MSC), at its ethanol plant in Fairmont, Nebraska. The MSC technology will be used to convert a portion of the distiller grains, a coproduct of ethanol manufacturing, to a high protein animal and fish feed ingredient, known as NexPro™. NexPro will be a combination of corn gluten (protein) and spent yeast with close to 50 percent protein and an improved amino acid profile, compared to traditional corn gluten meal.
The $50 million project, which involves the addition of a new building and two protein dryers, is expected to last 12 months. The patented MSC technology was developed by Fluid Quip Process Technologies (FQPT) exclusively for dry mill ethanol plants to separate protein from the solids leftover after ethanol distillation. Once isolated, the protein is dried into a high-quality meal.
By Lauren M. Graham, Ph.D.
On May 31, 2017, Deinove, a biotech company focused on producing high-value compounds from rare bacteria, announced the beginning of the second phase of a project with Flint Hills Resources to develop a nutritional supplement for animal feed. Flint Hills Resources is a member of BRAG and a leading refining, petrochemicals, and biofuels company in the United States.
During the first phase of the project, which began in November 2015, several bacterial strains were selected from Deinove’s library to produce target compounds. The second phase will involve:
- Producing the additives in sufficient quantities to test their beneficial effects on the target animal species and analyze the results obtained;
- Optimizing the fermentation parameters; and
- Defining the technical and economic conditions for the development of the production process.
Depending on the results of efficacy tests, one or two strains may be selected for the industrialization step.
On September 13, 2016, Biobased and Renewable Products Advocacy Group (BRAG®) member Flint Hills Resources, along with Benefuel® Inc., announced the startup of the Duonix Beatrice biodiesel plant, and the first successful commercial-scale application of Benefuel's innovative ENSEL technology. ENSEL technology is capable of converting a range of lower cost feedstocks such as recycled cooking oil and distillers corn oil into high-quality biodiesel. Once fully operational, the Duonix Beatrice plant will produce approximately 50 million gallons of biodiesel annually. The plant has already made commercial sales of product that meets or exceeds ASTM specifications for biodiesel.
The ENSEL technology uses a solid catalyst that combines esterification of high free fatty acid feedstocks and transesterification of triglycerides into a single step, which eliminates waste, improves process efficiency, and expands feedstock options. The product is further enhanced by an upgraded, backend distillation process that removes additional impurities which, when used on high free fatty acid feedstocks such as distillers corn oil, produces a higher quality biodiesel with superior cold weather performance. In addition to producing 50 million gallons of biodiesel, Duonix Beatrice is expected to produce a variety of coproducts such as glycerin, which can be used as a food additive and as a compound found in a number of medical, pharmaceutical and personal care products.
On December 18, 2013, President Obama announced that he will nominate Senator Max Baucus (D-MT) to be the next Ambassador to China. The nomination is expected to pass quickly and without much opposition. Senator Baucus serves as the Chair of the Senate Committee on Finance, the tax writing Committee. When he leaves the Senate, current Senate Committee on Energy and Natural Resources Chair Ron Wyden (D-OR) is expected to assume the chairmanship.
These moves will impact the fate of incentives for the biofuels and renewable chemicals and products industries, including whether and when the Senate considers a tax extenders package, or tax reform, among other tax policies impacting the industry.
On September 18, 2013, the 9th Circuit Court of Appeals reversed a December 2011 district court ruling and held that California's Low Carbon Fuel Standard (LCFS) does not violate the Dormant Commerce Clause of the U.S. Constitution on its face. The district court had sided with groups from the oil and gas, ethanol, and trucking industries and found that the LCFS violated the Dormant Commerce Clause because the statute gave higher carbon intensity values to out-of-state, Midwest, ethanol, putting that fuel at a disadvantage in California. At the time of the 2011 decision, the district court had also issued a preliminary injunction preventing the California Air Resources Board (CARB) from enforcing the LCFS.
In its decision this week, the appeals court held that the LCFS does not violate the Dormant Commerce Clause on its face, and it remanded to the district court whether the statute violates the clause "in purpose or in practical effect." The appeals court also vacated the preliminary injunction.
It has been reported that the ethanol industry is looking at their legal options in light of the appeals court decision.