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
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  • 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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the embedded silver nanoparticles then release silver ions that act as antibacterial agents and kill harmful bacteria. USDA notes that in their research, scientists found that the wipes killed 99.9 percent of harmful bacteria S. aureus and P. aeruginosa on surfaces.
 
USDA states that the advantages to this technology include omitting the conventional pretreatments of raw cotton fibers (such as scouring and bleaching), which consume a large number of chemicals and energy, and not requiring any chemical agents except for a silver precursor. According to USDA, the technology “also transforms cotton fibers themselves into antimicrobial agents rather than serving as a carrier of antimicrobial agents, which is what makes them reusable.” USDA notes that the antimicrobial wipes are made from “natural cotton fibers, rather than conventional petroleum-based synthetic fibers.” The wipes can be reused by being washed in the laundry.
 
More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”

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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:

• Petition;
• Draft Environmental Assessment; and
• Draft Plant Pest Risk Assessment.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, 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.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.
   
• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, DOD announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.
   
• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.

According to the fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.

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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 March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to assist developers with preparing a permit application for movement activities with modified microorganisms under 7 C.F.R. Part 340 (Movement of Organisms Modified or Produced through Genetic Engineering). The draft guide states that genetic engineering is defined in 7 C.F.R. Section 340.3 as “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.” According to the draft guide, regulated microorganisms include plant pests and other modified microorganisms that could pose a plant pest risk. Developers require a permit for regulated activities involving any modified microorganism that:

• Meets the definition of a plant pest in Section 340.3; or
• Is not a plant but has received deoxyribonucleic acid (DNA) from a plant pest, as defined in Section 340.3, and the DNA from the donor organism is either capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or
• Is a microorganism used to control plant pests and could pose a plant pest risk.

Comments on the draft guide are due May 22, 2023. APHIS states that it will consider all comments received by May 22, 2023, prior to issuing the final version of the guide.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Department of Agriculture (USDA) announced the kickoff of the inaugural National Biobased Products Day and highlighted the accomplishments of people and organizations working to improve sustainability within the federal government. USDA notes that its ongoing work includes the National Institute of Food and Agriculture’s (NIFA) Agriculture and Food Research Initiative programs, which fund research that advances climate-smart agriculture and forestry and strengthens the bioeconomy. USDA states that in line with President Biden’s September 12, 2022, Executive Order (EO) on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, “these programs develop sources of clean energy and power, biomass systems and high-value biobased products from agricultural feedstocks to foster economic development.” The Bipartisan Infrastructure Law funded innovative new USDA programs such as NIFA’s $9.5 million Bioproduct Pilot Program, which supports research into the benefits of using materials derived from agricultural commodities to manufacture construction and consumer products. USDA notes that the projects have special emphasis on benefits to underserved communities.
 
USDA states that National Biobased Products Day is an annual celebration on March 8 to raise awareness of the benefits of biobased products. The day recognizes the Biden Administration’s commitment to use the vast array of federal resources to combat climate change and help rural communities address its impacts. The day also aligns with President Biden’s Federal Sustainability Plan and EO Number 14057, which focuses on making the federal government carbon-neutral by 2050 and reducing planet-warming greenhouse gas emissions by 65 percent by 2030.
 
A key component of these federal sustainability efforts is USDA’s BioPreferred^® Program, the federal government’s “official advocate and market accelerator for biobased products.” USDA congratulates the four winners of the BioPreferred^® Program’s “Excellence in Procurement Award” for 2022 for reducing their respective agencies’ environmental impact by using biobased products and championing farmers in rural America:

• The U.S. Department of Energy’s (DOE) Y-12 National Security Complex in Oak Ridge, Tennessee;
• Christina Graves with USDA’s Forest Service;
• Brian McCabe with the National Park Service (NPS); and
• Brooke Siegel with the Federal Bureau of Investigation (FBI).

According to USDA, all of these efforts support President Biden’s EO to advance U.S. biotechnology and biomanufacturing. USDA states that it is supporting this effort by providing tools, resources, and scientific research to ensure American farmers and producers remain globally competitive.

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By Lynn L. Bergeson and Carla N. Hutton
 
On February 16, 2023, Representative Randy Feenstra (R-IA) introduced a legislative package that includes bills regarding researching the potential of biofuels to power jet engines and developing a commercially viable fuel cell system for cars and trucks powered exclusively by biofuels. The package includes:

• The Comparison of Sustainable Transportation (COST) Act would direct the Comptroller General of the U.S. Government Accountability Office (GAO) and the U.S. Secretary of Energy to compare the financial and environmental costs between replacing the entire federal gasoline-powered fleet with either electric vehicles or E-85 capable flex-fuel cars and trucks;
   
• The Biojet Fuel Research Act would direct the Federal Aviation Administration (FAA) to establish a working group focused on identifying research and development needs to produce biojet fuel. The working group would consist of the Bioenergy Technologies Office of the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), biorefinery stakeholders, agriculture research universities, and others; and
   
• The Biofuel Cell Research Act would direct the DOE Secretary to establish a research, development, and demonstration program for a commercially viable fuel cell system that uses biofuels as the main fuel source.

Feenstra introduced similar legislation in the 117th Congress.
 

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our January 4, 2023, blog item, on January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled “Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft)” for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. The draft report focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane.
 
ERG, an EPA contractor, is organizing an independent external peer review of the draft report. The peer review meetings are open to anyone who would like to attend as an observer and will include a brief public comment period on the first day (February 24, 2023). Registration is required. Panel peer review meetings will be held:

• February 24, 2023, 11:00 a.m.-6:45 p.m. (EST);
   
• February 27, 2023, 11:00 a.m.-6:30 p.m. (EST); and
   
• February 28, 2023, 1:00 p.m.-3:40 p.m. (EST).

Comments on the draft report are due March 6, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not previously reviewed. Developers may submit a request for an RSR when they believe a modified plant is not subject to regulation. APHIS will review the modified plant and consider whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS will post the request, its response letter, the plant, trait, and a general description of the Mechanism of Action (MOA) on its website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if APHIS is unable to make such a finding, the modified plant is subject to regulation.

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 By Lynn L. Bergeson and Carla N. Hutton
 
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented Symbiont^TM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
 
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.

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