By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S.

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from 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. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023.

EPA states the final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. The final rule reflects the biotechnological advances made since 2001, when EPA 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.

In the rule, EPA provides criteria and definitions that identify two categories of PIPs that are exempted through this action from FIFRA registration and FFDCA tolerance requirements:

• “PIPs created through genetic engineering from a sexually compatible plant” in which genetic engineering has been used to insert or modify a gene to match a gene found in a sexually compatible plant (to be codified at 40 C.F.R. Section 174.26); and
• “Loss-of-function PIPs” in which the genetically engineered modification reduces or eliminates the activity of a gene, which then helps make the plant resistant to pests (to be codified at 40 C.F.R. Section 174.27).

For the first exempted category, EPA will require a notification process for EPA to confirm that the PIP is eligible for the exemption. For the second exempted category (loss-of-function PIPs), developers of PIPs can submit to EPA a self-determination letter that the exemption applies. EPA also is establishing recordkeeping requirements for these exempted PIPs, clarifying general qualifications for exemption at 40 C.F.R. Section 174.21; clarifying the relationship between the existing exemptions for PIPs from sexually compatible plants (40 C.F.R. Section 174.25) and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant” (40 C.F.R. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R. Section 174.705 to include genetic engineering.

EPA notes that in the future, as biotechnology advances further, it intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility.

Additional information, including the response to comment document, is available in docket EPA-HQ-OPP-2019-0508.

Commentary

This final rule is the next step for EPA’s Office of Pesticide Programs (OPP) on the path of EPA’s regulation of biotechnology pesticide products. It sets forth how OPP will handle products created by “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR). In more general terms, CRISPR refers to manipulating plant genes with a method that was not available at the time the first biotechnology regulations were developed by EPA in the mid-1990s. This is why EPA needs to “update” its regulations, which is the purpose of the final rule.

Proponents of biotechnology methods argue that CRISPR allows the genes of plants to be manipulated more precisely and can be used to “simply” drop out a gene or add one from the same -- sexually compatible -- genome of the target plant. It follows that this is much like “traditional plant breeding” only done more precisely and more rapidly. Critics will likely raise questions about whether any product using this method, and not using traditional methods, might have some kind of unexpected result or unintended eventual effect. One can expect some adverse comments regarding these products even though EPA (among many others) lays out a rationale that this is an extension of its current regulations exempting products of traditional plant breeding from regulation under FIFRA/FFDCA (and not exempting such products from other regulatory authorities).

There also were concerns raised in comments submitted in response to the October 9, 2020, proposed rule. In particular, some in industry remain concerned that the final rule creates differential treatment for products due solely to the methods of development (i.e., biotechnology vs. conventional), thus subjecting products created using biotechnology to additional regulatory and recordkeeping requirements, even in cases when those products could have been created using older research and development approaches.

EPA’s basic requirements for biotechnology products that regulate inter-species gene manipulation would not change. Also worth noting is that the rule also would allow a developer to submit the product for EPA review to affirm that it qualifies for the exemption (i.e., a M009 Pesticide Registration Improvement Act (PRIA) action, which can lead to EPA delays in processing). The EPA docket includes a slide deck with a helpful summary of the final rule and its rationale.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 30, 2023, that the Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on June 14, 2023, on “Perspectives on Engineered Catalyst Design and Forming.” ChemCatBio is a consortium of eight DOE national laboratories overseen by BETO. According to BETO, the performance evaluation, and ultimate commercial adoption, of next-generation catalyst materials requires the development of strategies to prepare complex engineered catalysts suitable for operation in commercially relevant reactor configurations and scales. To leverage the fundamental advancements ChemCatBio has made in catalyst technology, BETO states that the consortium recently implemented a new vision to address risks by focusing on process integration and fuel production with engineered catalysts.
 
In the webinar, Bruce Adkins (Oak Ridge National Laboratory), Frederick Baddour (National Renewable Energy Laboratory), and Matthew Greaney (Clariant) will present critical considerations for the “engineered” catalyst; an industrial perspective on catalyst design and forming; and ChemCatBio’s industry-informed capabilities that support the transition to more commercially relevant catalyst forms. The webinar will end with a question and answer session.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) announced on May 24, 2023, the launch of the Clean Fuels & Products Shot^TM, a new initiative that aims to reduce significantly greenhouse gas emissions (GHG) from carbon-based fuels and products. DOE notes that this is its seventh DOE Energy Earthshot, which focuses on reducing carbon emissions from the fuel and chemical industry through alternative, more sustainable sources of carbon to achieve a minimum of 85 percent lower GHG emissions as compared to fossil-based sources by 2035. According to DOE, the Clean Fuels & Products Shot^TM supports the national goal of achieving net-zero emissions by 2050 by developing the sustainable feedstocks and conversion technologies necessary to produce crucial fuels, materials, and carbon-based products that are better for the environment than current petroleum-derived components. It aims to meet projected 2050 net-zero emissions demands for 100 percent of aviation fuel; 50 percent of maritime, rail, and off-road fuel; and 50 percent of carbon-based chemicals by using sustainable carbon resources.
 
DOE notes that a ribbon-cutting took place on May 30, 2023, for the Biofuels National User Facility, a $15 million, three-year-long facility upgrade at Idaho National Laboratory funded by DOE’s Bioenergy Technologies Office (BETO) and an important asset to reach the goals of the Clean Fuels & Products Shot^TM. According to DOE, the facility “is designed to solve critical biofuels production challenges associated with the feeding, handling and preprocessing of diverse biomass and waste materials.” DOE states that industry use of the facility “will enable rapid technology development and large-scale commercialization of biofuels and bioproducts, an important component of the Biden-Harris Administration’s goals related to clean fuels and products.”

• Email This
• Print
• Comments

 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) has launched a new, comprehensive web page dedicated to one of its priority subprograms, Renewable Carbon Resources (RCR), which helps develop RCR technologies and creates strategies for bioenergy and bioproducts production. In its May 19, 2023, announcement, BETO states that RCR supports applied research and pilot-scale projects for the production, harvesting/collection, supply logistics, storage, and preprocessing of biomass and wastes to feedstock. According to BETO, RCRs are carbon-based resources generated through photosynthesis (plants and algae) or through waste generation (non-recycled portions of municipal solid waste, biosolids, sludges, plastics, and carbon dioxide and industrial waste gases). The subprogram aims to optimize responsibly the use of each of these resources using sustainability indicators such as land-use changes, greenhouse gas emissions, biodiversity, resource conservation, wildlife habitat, fire mitigation, food security, social well-being, and water, soil, and air quality.
 
The newly launched RCR web page is organized around the following activities:

• Production and sourcing;
• Logistics;
• Feedstock-conversion interface;
• Waste management technologies;
• Environmental remediation; and
• Carbon management.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 15, 2023, that a new workflow developed by researchers at the Agile BioFoundry (ABF), a BETO-funded consortium of national laboratories and Agilent Research Laboratories (Agilent) addresses the need for faster analytical tools. According to BETO, the workflow “combines state-of-the-art analytical technologies with a machine learning-based algorithm, providing a faster and more powerful way to process data that could accelerate the Design-Build-Test-Learn framework, a bio-engineering cycle used to improve biomanufacturing research and processes.”
 
BETO notes that speeding up the bio-engineering cycle could ultimately speed up biomanufacturing research. According to BETO, one of the biggest barriers to accomplishing this is the ability to improve the Learn step of the cycle, which involves using data to improve future cycles. Improvements to the Learn step can happen only if large amounts of high-quality data are gathered in the Test step of the cycle, however.
 
BETO states that the consortium teams set out to create a workflow that could generate high-quality analytical Test data that could feed into the Learn step. The workflow they developed includes several components:

• A high-throughput analytical method developed in collaboration with Agilent that enables a threefold reduction in sample analysis time (compared to previous conventional approaches) by using optimized liquid chromatography conditions;
• The Automated Method Selection Software tool, which predicts the best liquid chromatography method to use for analyzing new molecules of interest; and
• PeakDecoder, a novel algorithm that processes multi-dimensional metabolite data and automatically calculates errors in metabolite identification.

To test the workflow’s effectiveness, the researchers used it to study metabolites of various strains of microorganisms engineered by ABF. The microorganisms they tested all have the capacity to make various bioproducts, such as polymer and diesel fuel precursors. According to BETO, using their workflow, the researchers were able to interpret 2,683 metabolite features across 116 microbial samples.
 
BETO states that the researchers see PeakDecoder “as a stepping stone towards creating an automated data-gathering pipeline.” According to BETO, the team is already working on leveraging state-of-the-art artificial intelligence methods like computer vision used in other fields. The next version of PeakDecoder is expected to have improved automation and identification performance and to be more applicable to other types of molecular profiling, including proteomics workflows.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
 
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or e-mail request.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) and Advanced Materials and Manufacturing Technologies Office (AMMTO) will host a workshop on “Transitioning to a Sustainable, Circular Economy for Plastics.” The June 8-9, 2023, workshop will convene stakeholders for a discussion of the current challenges and opportunities in transitioning to a sustainable domestic economy for plastics. According to DOE, it will include experts in recycling technologies and processes; polymer sciences; biobased plastics innovation and manufacturing; and plastics policy, economy, and sustainability. It will feature facilitated panel presentations and discussions on:

• The current landscape of plastics sustainability and circularity;
• Industry metrics in plastics sustainability and circularity;
• Supply chain and technology gaps;
• Decarbonization opportunities and pathways to achieve them; and
• Collaboration across the plastics value chain to accelerate transition to a more sustainable, circular economy.

DOE states that desired workshop outcomes include:

• Direct connections between stakeholders across the value chain to facilitate collaborations to accelerate innovation toward our collective decarbonization and circular economy goals;
• A publicly available, DOE-issued workshop report recording the discussed problems, research ideas, and industry feedback; and
• Input to ensure the DOE Strategy for Plastics Innovation evolves with the rapidly changing landscape to reflect current needs and challenges related to plastics sustainability and circularity.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 28, 2023, that it issued an emergency fuel waiver to allow E15 gasoline -- gasoline blended with 15 percent ethanol -- to be sold “during the summer driving season.” EPA states that this action will provide relief from ongoing market supply issues “created by Russia’s unprovoked war in Ukraine by increasing fuel supply and offering consumers more choices at the pump.” According to EPA, the waiver will help protect Americans from fuel supply crises by reducing reliance on imported fossil fuels, building U.S. energy independence, and supporting American agriculture and manufacturing. EPA notes that current estimates indicate that, on average, E15 is about 25 cents a gallon cheaper than E10.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
On April 11, 2023, a bipartisan group of legislators led by Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) sent a letter to the U.S. Environmental Protection Agency (EPA), urging it to strengthen the Renewable Fuel Standard (RFS) by maintaining the blending requirements for 2023; denying all pending Small Refinery Exemptions (SRE); eliminating proposed retroactive cuts to the renewable volume obligations (RVO); and setting RFS volumes at the statutory levels. According to Klobuchar’s April 14, 2023, press release, the letter states that the RFS “creates competition in the marketplace, keeping fuel costs low for consumers while bringing down carbon emissions.” By taking the suggested steps, EPA “can set the RFS on a path that provides stability and growth for the U.S. biofuel sector.” This would guarantee that this “essential program” continues to function as intended by reducing emissions, driving economic growth in rural communities, keeping gas prices low, and “bolstering national security by promoting an essential homegrown energy source.”

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to:

• Protect agriculture from plant and animal diseases and pests. Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework.” This includes:
   
  • Conducting efficient risk-based permit review and issuance for organisms developed using genetic engineering to ensure they are safely contained or confined during movement or release;
     
  • Using plain language to communicate clearly APHIS regulations, expectations, and guidance to stakeholders, particularly those working with modified non-plant organisms potentially subject to APHIS regulations; helping stakeholders understand regulations through outreach, workshops, toolkits, and other means; and
     
  • Working with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to increase coordination and harmonization of regulatory oversight for biotechnology products within each agency’s existing statutory framework;
     
• Cultivate a talented, diverse, and public service-focused workforce where employees are supported, valued, and engaged;
   
• Reduce the impacts of zoonotic and emerging diseases and climate change. Objective 3 is “Mitigate and adapt to the effects of climate change.” This includes:
   
  • Incorporating climate change scenarios when evaluating the plant pest risk associated with biotechnology products; and
    ​
  • Working with federal partners to develop clear, efficient, predictable, and risk-based regulatory pathways for safely bringing microbial and other new products that help address climate change to market, and helping developers of such products navigate the regulatory system;
     
• Maintain and expand the safe trade of agricultural products nationally and internationally. Objective 2, “Maintain and expand the Agency’s leadership role through international standard setting and collaboration,” includes promoting engagement, collaboration, and harmonization of agricultural biotechnology regulation with trading partners, the Organization for Economic Cooperation and Development (OECD), and other international and regional organizations. Objective 3, “Create safe export opportunities,” includes:
   
  • Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
     
  • Working with trade agencies on technical aspects of trade in biotechnology products; and
     
  • Working with the regulatory authorities of U.S. trading partners to harmonize further regulatory frameworks for biotechnology products;
     
• Manage wildlife damage and threats to agriculture, natural resources, property, and people; and
   
• Promote the welfare of animals.

• Email This
• Print
• Comments