USDA Announces Finalized Biotech Regulations

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U.S. Secretary of Agriculture Sonny Perdue announced the modernization of regulations that govern plant biotechnology advancements. The final rule, titled Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE), marks the first major amendment to plant biotech regulations in over thirty years.

The SECURE rule touts an end to duplicative and antiquated processes and the advancement of a transparent, science-based regulatory system that encourages development and availability of new technologies for plant breeding and improvement.

Perdue commented, “Under President Trump’s leadership, USDA is implementing the first significant update to our plant biotechnology regulations in more than three decades.” “USDA’s SECURE rule will streamline and modernize our regulatory system, facilitate science-based innovations, and provide our farmers with the tools they need to produce the world’s safest, most abundant, and most affordable food supply, which will help us continue to Do Right and Feed Everyone – safely.”

The SECURE rule was proposed by USDA APHIS Biotechnology Regulatory Services last year. Citing over three decades of experience and new technologies, APHIS asserted that genetically engineered (GE) organisms can now be developed in a manner that does not automatically pose a risk of becoming a pest. The agency will now first evaluate a GE organism’s risk of becoming a pest and only then implement regulations if deemed necessary. The previous system, established in 1987, called for regulations first followed by a risk assessment.

The new guidelines focus on the GE organism itself as opposed to the method used to produce it, and only organisms posing a plant pest risk would require permits for movement. Organisms that could be produced through traditional breeding methods will be excluded from regulatory enforcement, with the thinking that since genetic modifications would be similar, so would the pest risk. Several exemptions are specified, such as:

  • A genetic modification that
    • Is a single deletion of any size,
    • Is a single base pair substitution, or
    • Uses only nucleic acid sequences from within the plant’s natural gene pool or from editing nucleic acid sequences from within the plant’s natural gene pool or from editing nucleic acid sequences in a plant to correspond to a sequence known to occur in that plant’s natural gene pool, or
  • The plant is an offspring of a GE plant and does not retain the genetic modification in the GE plant parent.

Furthermore, if a GE organism is developed to exhibit a trait already evaluated and approved, it would not necessarily need to be regulated unless a new trait that has not previously been reviewed is introduced.

The SECURE rule posted in the federal register, and the rule’s provisions will take effect on key dates over the next 18 months. The complete rule can be viewed on Regulations.gov.

AmericanHort supports efficient and transparent regulatory processes that ease the regulatory burden on our member plant breeders and commented accordingly when changes were proposed in the Federal Register.

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