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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.


 

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 ShotTM, 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 ShotTM 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 ShotTM. 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.”

Tags: DOE, GHG, Biofuel

 

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.

Tags: E15, Biofuel

 

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.”


 

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.

 

By Lynn L. Bergeson and Carla N. Hutton
 
Colorado State University (CSU) announced on April 11, 2023, that its chemists, led by Eugene Chen, University Distinguished Professor in the Department of Chemistry, have created a synthetic polyhydroxyalkanoate (PHA) platform. CSU states that PHAs are a class of polymers naturally created by living microorganisms or synthetically produced from biorenewable feedstocks. While they are biodegradable in the ambient environment, they are brittle and cannot easily be melt-processed and recycled. According to CSU, the synthetic PHA platform addresses each of these problems, “paving the way for a future in which PHAs can take off in the marketplace as truly sustainable plastics.”
 
The researchers searched for a strategy to address the intrinsic thermal instability of conventional PHAs. According to CSU, its chemists “made fundamental changes to the structures of these plastics, substituting reactive hydrogen atoms responsible for thermal degradation with more robust methyl groups. This structural modification drastically enhances the PHAs’ thermal stability, resulting in plastics that can be melt-processed without decomposition.” CSU notes that the newly designed PHAs are also mechanically tough, “even outperforming the two most common commodity plastics: high-density polyethylene -- used in products like milk and shampoo bottles -- and isotactic propylene, which is used to make automotive parts and synthetic fibers.” CSU notes that the new PHA can be chemically recycled back to its building-block molecule with a simple catalyst and heat, and the recovered clean monomer can be reused to reproduce the same PHA again.
 
The work was supported by the U.S. Department of Energy’s (DOE) Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment (BOTTLE™), a DOE multi-organization consortium “focused on developing new chemical upcycling strategies for today’s plastics and redesigning tomorrow’s plastics to be recyclable-by-design.” More information is available in a Science article entitled “Chemically circular, mechanically tough, and melt-processable polyhydroxyalkanoates.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that the bioeconomy refers to a segment of the total economy utilizing or derived from biological resources and includes manufacturing processes, technologies, products, and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
 
The Working Group, through OMB, seeks input on how to identify, classify, and measure best bioeconomy manufacturing, technology, and products, including those that are primarily or exclusively: (a) biobased, (b) components of traditional manufacturing processes, and (c) nascent biobased processes and products. Importantly, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:

  • What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
     
  • Which quantitative economic indicators and processes are currently used to measure the contributions of the U.S. bioeconomy? Are these indicators reasonably accurate measures of the product components, scope, and value of the bioeconomy? Please explain why.
     
  • Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications in NAPCS related to the bioeconomy should be considered? Please describe how a unique classification for such industry or product would meet the principles of NAICS and NAPCS. Please include a description of the industry or product, with specific examples. Please also provide an explanation of how such industry or product would advance understanding of measuring the bioeconomy.
     
  • How might potential changes to the NAICS impact existing industry measurements, such as assessing changes in the economic output across current industries, time series measures, or data accuracy?
     
  • What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
     
  • Biobased processes and products that are embedded in traditional industries pose challenges for differentiation and measurement. Are there methodologies that can differentiate these bioeconomy processes from current manufacturing processes to enable measurement? If yes, please explain.
     
  • What potential bioeconomy measurement strategies might be considered other than revisions to and inclusion in the NAICS or NAPCS? For example, are there ways the federal government could better collect information to provide better measurement on biobased processes or products in current industries?

 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers “highlighted the key role that the bioeconomy could play in achieving the environmental and climate goals under the European Green Deal, while also making the EU more competitive, helping it transition away from fossil-fuel dependency, and strengthening food security in the wake of Russia’s war of aggression against Ukraine.” The ministers also stressed the importance of promoting research and innovation and improving alignment between scientific advances and industry policy. The press release states that the conclusions will provide political guidance for the European Commission (EC) and EU member states on developing the potential of the bioeconomy in Europe.
 
While the Council of the EU welcomed the EC’s progress report on the implementation of the EU Bioeconomy Strategy, ministers put forward a number of recommendations intended to help boost the potential of the bioeconomy in Europe. In particular, they called on the EC to:

  • Better integrate bioeconomy into all policies and ensure policy coherence;
  • Facilitate knowledge transfer toward less developed regions and rural areas; and
  • Update the EU Bioeconomy Strategy and associated action plan and carry out an in-depth assessment of actions being taken at the EU level.

Ministers also noted that the bioeconomy was an integral aspect of the reformed Common Agricultural Policy (CAP) and invited the EC to follow up on how EU member states had incorporated it into their national strategic plans.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of synthetic biology to address environmental challenges by engineering organisms to use carbon dioxide, produce biofuels for vehicles, and transform methane into biodegradable plastics. GAO notes that the synthetic biology market could grow from about $10 billion in 2021 to between $37 billion and $100 billion dollars by 2030. Opportunities include:

  • Widely adaptable. Synthetic biology holds the potential to help diagnose and treat diseases, improve industrial processes, and address some environmental challenges;
  • More equitable access to biotechnology. Some of the tools needed for synthetic biology are low-cost and widely available, which could make access to beneficial applications more equitable; and
  • Conservation efforts. Synthetic biology could support endangered species conservation, for example, by altering the genes of endangered plants to make them resilient to diseases.

GAO notes the following challenges:

  • Safety and security concerns. Synthetic biology could pose a significant threat to national security if it were used for nefarious purposes, such as developing new biological or chemical weapons. Additionally, the computational tools used for synthetic biology could be vulnerable to cyberthreats such as automation hacking. For example, a bad actor could manipulate or steal information and use it to create drugs, weapons, or other harmful products.
  • Environmental effects. Organisms made using synthetic biology and released into the environment could have unknown, unintended, and potentially irreversible effects on ecosystems. Such effects could be widespread if, for example, these organisms negatively affected food or water systems.
  • Public acceptance and access. The public may hesitate to accept certain applications of synthetic biology due to concerns about interfering with nature and about unintended effects. In addition, some medical applications could be inaccessible for some patients due to cost or location of treatment centers.

GAO concludes the “Science & Tech Spotlight” with the following policy context and questions:

  • Do policymakers have adequate access to expertise and resources to evaluate the societal effects and public policy implications of synthetic biology research and development?
  • How effective is the coordination among 1) domestic and 2) global stakeholders for monitoring and assessing the risks associated with advances in synthetic biology research and applications?
  • Is the current regulatory framework sufficient to address ongoing and future applications and their effects without unnecessarily hindering U.S. competitiveness in synthetic biology?

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic engineering to resist corn rootworm and tolerate glufosinate herbicides. APHIS is seeking public comment on these documents for 30 days. APHIS will thoroughly review and consider all public input submitted during the comment period and will use this information to complete and publish final environmental documents and its regulatory determination. Comments are due May 11, 2023. APHIS has posted the following documents:


 
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