Regulatory Developments

Final SECURE Rule Will Update and Modernize USDA’s Biotechnology Regulations

May 18, 2020

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. APHIS states that the final rule marks the first comprehensive revision of the regulations since they were established in 1987, providing “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of genetically engineered organisms that are unlikely to pose plant pest risks.”

SECURE Regulatory Changes

According to APHIS, the SECURE rule differs from the previous regulatory framework by focusing on an organism’s properties and not on the method used to produce it. APHIS states that this approach enables it to regulate organisms developed using genetic engineering for plant pest risk with greater precision than the previous approach. This method will reduce regulatory burden for developers of organisms that are unlikely to pose plant pest risks and will continue to provide oversight of organisms developed using genetic engineering that pose a plant pest risk.

Under the new rule, no person shall move any GE organism, except under permit, that:

  • Is a plant that has a plant-trait-mechanism of action (MOA) combination that either has not been evaluated by APHIS previously or has been evaluated and regulated;
     
  • Meets the definition of plant pest;
     
  • Is not a plant but has received DNA from a plant pest, and the DNA from the donor organism either is capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease;
     
  • Is a microorganism used to control plant pests, or an invertebrate predator or parasite (parasitoid) used to control invertebrate plant pests, or could pose a plant pest risk; or
     
  • Is a plant that encodes a product intended for pharmaceutical or industrial use.
     

The new regulatory process for organisms developed using genetic engineering consists of the following steps:

  • Exemptions: Determine whether the plant meets the criteria for an exemption with the option for requesting confirmation of the plant’s exempt status. This step will be implemented 90 days after the SECURE rule is published in the Federal Register, or by August 16, 2020.
     
  • Regulatory status review: Request a regulatory status review (RSR) to determine if a plant developed using genetic engineering poses a plant pest risk. This step will be implemented for certain crops on April 5, 2021, and will be fully implemented on October 1, 2021.
     
  • Permitting: Apply for a permit for a regulated organism that does not undergo or pass the RSR. An RSR request may also be submitted for most plants moved under permit. This step will be implemented on April 5, 2021.
     

Exemptions from Regulation

Under the SECURE rule, certain categories of modified plants are exempt from the regulations because they could otherwise have been developed through conventional breeding techniques and thus are unlikely to pose an increased plant pest risk compared to conventionally bred plants. APHIS notes that it has historically not regulated conventionally bred plants under 7 C.F.R. Part 340. These exemptions apply only to plants because the long history of plant breeding gives APHIS extensive experience in safely managing associated plant pest risks.

The revised regulations also exempt plants developed using genetic engineering that contain a plant-trait-MOA combination that APHIS has already evaluated under the previous or new regulations and found to be unlikely to pose a plant pest risk. The results of all completed regulatory reviews will be publicly accessible on the APHIS website.

Determining Regulatory Status for GE Plants/Organisms

Under the previous regulations, APHIS assessed the plant pest risk of each plant transformation event (also sometimes referred to as the individual transformed line, transgenic line, or GE line) separately, even though the inserted genetic material may have been identical or very similar to transformation events already assessed. This part has been referred to as an “event-by-event” approach.

APHIS states that under the revised regulations, developers have the option of requesting a permit or an RSR of a plant developed using genetic engineering that has not been previously evaluated and determined to be nonregulated. This process replaces the petition process in the previous regulations. The revised regulations evaluate whether a plant requires oversight based on the characteristics of the plant itself and not on the method by which the plant was genetically engineered. Once APHIS determines that the plant is not regulated, subsequent transformation events using the same plant-trait-MOA combination would not be regulated.

Decisions on regulatory status are based on APHIS’s assessment of plant pest risk. If movement or release of a plant developed using genetic engineering is found to be unlikely to pose a plant pest risk, APHIS will not require regulation under 7 C.F.R. Part 340. If APHIS is unable to reach such a finding, it will regulate the plant and the plant will be allowed to move only under permit.

Permitting GE Plants and Organisms That Pose a Plausible Plant Pest Risk

Permits are required for the importation, interstate movement, or environmental release of any plant or organism developed using genetic engineering that may post a plant pest risk to plant health. For plants, developers must apply for a permit if the plant does not qualify for an exemption or if the RSR process determines that the plant poses a plausible plant pest risk. APHIS will approve or deny an application for an importation or movement permit within 45 days, and an application for a permit for an environmental release in 120 days. Developers may also choose to request a permit rather than an RSR, or they may elect to obtain a permit and request an RSR. Applicants will still apply for a permit using the same methods as before -- a paper application, ePermits, or APHIS eFile.

Under the previous regulations, APHIS also offered an option for notifications for certain plants as an administratively streamlined alternative to a permit. Under the SECURE rule, the notification process has been eliminated and replaced by the RSR and permitting process.

SECURE Implementation Time Line

The SECURE rule’s provisions will take effect on key dates over the next 18 months. According to APHIS, the biotechnology community will have to learn some new processes and meet new requirements in accordance with the implementation schedule. APHIS states that it is available to support stakeholders through this process. The key dates include:

  • May 18, 2020: The SECURE rule is published in the Federal Register. Regulatory activities will remain unchanged for 90 days, or until August 16, 2020.
     
  • June 17, 2020 (30 days after the rule is published):
     
    • “Am I Regulated?” Request -- The “Am I Regulated?” (AIR) Process is discontinued. APHIS no longer accepts AIR requests.
       
    • Permitting/Notifications -- Developers continue using the preexisting permitting and notification processes until April 4, 2021.
       
    • Petitions -- Developers continue to use the preexisting petition process until April 4, 2021.
       
  • August 17, 2020 (90 days after the rule is published):
     
    • Exemptions and Confirmations -- The new exemptions and confirmation process takes effect, and it replaces the AIR and extension processes. If the organism does not qualify for exemption, applicants can continue to use the existing petition process.
       
    • Permitting -- For plants and organisms developed using genetic engineering that fall within the scope of the regulations, applicants continue to use the preexisting permitting and notification processes until April 4, 2021.
       
    • Sections 340.3, 340.4, 340.6, 340.7, 340.8 -- With exception of the permitting and RSR processes, all other aspects of the rule are implemented (definitions, record retention, compliance, CBI, costs).
       
  • April 5, 2021 (key changes are implemented):
     
    • Permitting --- The notification process is discontinued. Applicants begin following the new permitting process described in Section 340.5.
       
    • Petitions/RSR -- The RSR process described in Section 340.4 is implemented for certain crops, including corn, soybean, cotton, potato, tomato, and alfalfa. APHIS will continue accepting petitions for all other crops until September 30, 2021.
       
  • October 1, 2021 (the rule is fully implemented):
     
    •  Petitions/RSR -- The RSR process takes effect for all crops. APHIS will no longer accept any petitions.
       

Commentary

The final rule is a welcome change for biotechnology enthusiasts. The Biotechnology Industry Organization (BIO) praised the final rule, welcoming the diminished barriers to innovation as sensible and efficient. The Center for Food Safety condemned the final rule, noting that under it, “the overwhelming majority of GE plant trials would not have to be reported to USDA, or have their risks analyzed before being allowed to go to market.”

Most would agree that the previous regulations, first drafted in 1987, were in dire need of modernizing. Whether the dramatic shift away from the method of production to focus on the properties of the plant will invite consumer concern with too little regulatory oversight and thus erode public confidence remains to be seen.

Additional Resources

SECURE Biotechnology Website;

Questions and Answers on the final SECURE Rule;

Final Programmatic Environmental Impact Statement;

Documents Associated with the Proposed Rule; and

Bergeson & Campbell, P.C.’s June 7, 2019, memorandum on the proposed rule, “APHIS Proposes Revised Regulatory Framework Regarding the Movement of Certain Genetically Engineered Organisms.”


 
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