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On May 18, 2020, the U.S. Department of Agricultures (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 USDAs 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 APHISs 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 organisms 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:

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

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 APHISs 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 rules 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:

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

[View source.]

Excerpt from:
Final SECURE Rule Will Update and Modernize USDAs Biotechnology Regulations - JD Supra

This entry was posted on May 20, 2020 at 12:41 pm and is filed under Genetic Engineering. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |