Posted on May 03, 2023 by Lynn L BergesonBy 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.
Posted on April 12, 2023 by Lynn L BergesonBy 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:
Posted on March 23, 2023 by Lynn L BergesonBy 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.
Posted on January 09, 2023 by Lynn L BergesonBy 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.
Posted on October 24, 2022 by Lynn L BergesonBy 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.
Posted on October 11, 2022 by Lynn L BergesonBy 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.
Posted on October 07, 2022 by Lynn L BergesonBy 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 its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations, including the new Regulatory Status Review and Confirmation Request processes, and other 2022 activities.
BRS seeks feedback on discussion topics for the meeting. Comments or suggestions on potential topics of interest are due October 14, 2022, to .(JavaScript must be enabled to view this email address). BRS will send out further meeting details and registration information. BRS states that stakeholders should check the BRS website for future meeting updates.
Posted on September 01, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:
These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).
Posted on May 22, 2020 by Lynn L BergesonBy Lynn L. Bergeson
On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum here.
Posted on June 14, 2019 by Lynn L BergesonBy Lynn L. Bergeson
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk posed by them, “thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks.” APHIS notes that the proposed rule “would mark the first comprehensive revision of the regulations since they were established in 1987.” It would provide “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel [GE] organisms that are unlikely to pose plant pest risks.” Comments on the proposed rule are due by August 5, 2019. For further details, see the Bergeson & Campbell, P.C. (B&C) memorandum here.
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