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
 
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
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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’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
 
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
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R. Part 340. According to APHIS, the corn plant, from Infinite Enzymes, Inc., was modified to produce the enzyme manganese peroxidase in corn seed and to make it resistant to the herbicide glufosinate. The potato plant, from J.R. Simplot Company, was modified to make it resistant to potato late blight and potato virus Y and to alter the potato tuber’s sugar profile and quality.
 
According to APHIS, in both cases, it “found these plants unlikely to pose an increased plant pest risk compared to other cultivated corn and potato plants.” As a result, they are not subject to regulation under 7 C.F.R. Part 340. From a plant pest risk perspective, these plants may be safely grown and used in breeding in the United States. 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 September 7, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it reviewed a new tomato from Norfolk Plant Sciences. The tomato was modified to alter its color and enhance its nutritional quality. APHIS found the plant is unlikely to pose an increased plant pest risk compared to other cultivated tomatoes and is not subject to regulation under 7 C.F.R. Part 340. That means, from a plant pest risk perspective, the plant may be safely grown and used in breeding in the United States.
 
APHIS announced on September 30, 2022, that it reviewed a modified corn plant from Agrivida, Inc. The corn was modified using genetic engineering to alter animal feed quality for improved digestion. APHIS also reviewed a modified potato from Toolgen, Inc. This potato was modified using genetic engineering to alter tuber quality by reducing browning. APHIS states that it found these plants are unlikely to pose an increased plant pest risk compared to other cultivated corn and potato and, thus, they are not subject to regulation under 7 C.F.R. Part 340.
 
APHIS’s Regulatory Status Review (RSR) responses under the revised biotechnology regulations at 7 C.F.R. Part 340 are available online. In each case, APHIS based its responses on information from the developers and its:

• Familiarity with plant varieties;
• Knowledge of the traits; and
• Understanding of the modifications.

Under 7 C.F.R. Part 340, developers may submit a request to APHIS for 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 APHIS’s review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, it will issue a response indicating the plant is not subject to the regulations.

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