By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold their annual Stakeholder Meeting on November 15, 2023. BRS will offer in-person -- at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737 -- and virtual options for attendance. The Stakeholder Meeting will include:

• Highlights from fiscal year 2023;
• Key updates for fiscal year 2024;
• New and revised guides to help navigate regulatory processes; and
• Strategic planning.

BRS invites feedback on discussion topics for the meeting. Suggestions on potential topics of interest are due October 1, 2023, and should be submitted to .(JavaScript must be enabled to view this email address).

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By Lynn L. Bergeson and Carla N. Hutton
 
The Congressional Research Service (CRS) published an updated report on August 4, 2023, on the U.S. Department of Agriculture’s (USDA) Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The revisions note that USDA’s Animal and Plant Health Inspection Service’s (APHIS) five-year Strategic Plan for fiscal years (FY) 2023-2027 states that “one of its objectives is to ensure the safe development of agricultural biotechnology products using a science-based regulatory framework, including efficient permit review for [genetically engineered (GE)] organisms, clear communication of regulations to stakeholders, coordination with other agencies, and harmonization of regulatory oversight for biotechnology products.”
 
As reported in in our September 13, 2022, blog item, in 2022, the Biden Administration issued Executive Order (EO) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” ordering USDA, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) to improve further the clarity and efficiency of regulatory processes for biotechnology products and increase coordination and communication among federal regulatory agencies. The report states that FDA “encourages developers of all new plant varieties to request premarket food safety consultations with the agency, which involves a discussion of the safety protocols and regulatory issues before the food is distributed in the market.” The report notes that in response to EO 14081, in May 2023, EPA announced changes to its regulations concerning GE plant-incorporated protectants (PIP). According to the report, these changes exempt certain PIPs from registration and tolerance requirements while implementing a notification process for transparency. EPA “intends to consider additional exemptions and expand the list of categories not requiring EPA confirmation as biotechnology progresses.” EPA’s rule (88 Fed. Reg. 34756) went into effect in July 2023.
 
According to the updated report, Congress “may be interested in monitoring how USDA’s revised regulatory requirements have affected the development and commercialization of GE and genome-edited products.” The updated report suggests that beyond that, Congress may consider monitoring how USDA, FDA, and EPA are assessing the effectiveness of the revised regulations, “as underlined by the self-determination aspect of the exemption status of new GE and genome-edited products.” The updated report states that further, Congress may also oversee how well the three agencies are working together to harmonize the regulation of biotechnology products moving forward.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities:

• Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to pose plant pest risks, providing over $8 million in annual cost savings;
• Issued two Regulatory Status Review (RSR) decisions, the first under the new RSR process in the revised regulations;
• Responded to nine requests for confirmation that a plant met the criteria for exemption from regulation, confirming all nine and issuing responses within an average of 39 days from receiving the requests;
• With state agricultural officials, performed more than 660 inspections of authorized field trials involving organisms developed using genetic engineering, with an 88 percent rate of compliance;
• Completed one petition for non-regulated status under the legacy regulations, bringing the total number of determinations to 136;
• Delivered more than 13 presentations to international stakeholders representing 40 countries to offer technical information and build capacity abroad for regulating biotechnology; and
• Processed over 758 authorizations in 42 states for the movement or field testing of organisms developed using genetic engineering.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 24, 2023, Senators Amy Klobuchar (D-MN), Joni Ernst (R-IA), Debbie Stabenow (D-MI), and Pete Ricketts (R-NE) introduced the Biomanufacturing and Jobs Act to strengthen the U.S. Department of Agriculture’s (USDA) BioPreferred program. According to Klobuchar’s July 24, 2023, press release, the bill would:

• Strengthen markets for farmers while also supporting well-paying manufacturing jobs;
• Allow the Secretary of Agriculture to set acceptable price premiums under the program;
• Require each federal agency to increase their procurement of biobased-only contracts or biobased volume purchased under those contracts; and
• Improve reporting of biobased products that are purchased through online federal procurement systems.

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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 June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants:

• InnerPlant modified two soybean plants and one tomato plant to produce an optical signal. One soybean plant was modified to emit the signal when there is pest damage, while the other soybean and the tomato plant continuously emit the signal. InnerPlant has a system to detect these signals using remote sensing devices from tractors, drones, airplanes, and satellites to aid crop management. APHIS states in its responses to the soybean requests that it determined that each soybean “is unlikely to pose an increased plant pest risk relative to its comparators.” APHIS made a similar response to the tomato request.
   
• Ohalo Genetics modified a potato plant to produce an increased concentration of beta-carotene for altered nutritional value. APHIS states in its response that it “did not identify any plausible pathway by which your modified potato would pose an increased plant pest risk relative to comparator potato plants.”

Regulatory Status Review (RSR) requests from InnerPlant and Ohalo Genetics and APHIS’ response letters are available on the APHIS website. APHIS notes that its responses are based on information from the developers and its own:
 
•           Familiarity with plant varieties;
 
•           Knowledge of the traits; and
 
•           Understanding of the modifications.
 
Under 7 C.F.R. Part 340, developers may request an RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers 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 issues a response indicating the plant is not subject to the regulations.

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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.

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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
 
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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