USDA Proposes New Regulations for Genetically Engineered Organisms

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USDA, Animal & Plant Health Inspection Service, Biotechnology Regulatory Services (APHIS-BRS) has proposed revisions to current biotechnology regulations, which were established in 1987.  This marks the third attempt by USDA to alter these regulations, previously in 2008 and 2017; however, the proposals were withdrawn in the face of substantial pushback in public comments.

The changes now proposed would impact the introduction, importation, interstate movement, or release into the environment, of genetically engineered (GE) organisms.  APHIS cites guiding principles using the acronym SECURE, which stands for Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient.  SECURE intends to protect plant health and allow agricultural innovations to thrive.

As the name SECURE implies, this proposed rule incorporates the need for efficient and sustainable agricultural production to help feed and clothe the world combined with responsible and predictable regulatory oversight to safeguard America’s ecology and plant health,” said USDA Under Secretary for Marketing and Regulatory Programs, Greg Ibach.

“SECURE would enable APHIS to evaluate GE organisms for plant pest risk with greater precision than the current rule allows, ensuring oversight and risk are based on the best available science,” said Ibach. “This common-sense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store.”

Citing over three decades of experience and new technologies, APHIS asserts that GE organisms can now be developed in a manner that does not automatically pose a risk of becoming a pest.  The agency now plans to move forward with first evaluating a GE organism’s pest risk and then implementing regulations if deemed necessary.  The current system calls for regulations first followed by a risk assessment. 

The new guidelines would 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 would 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.

Public comments are being accepted now, through August 5, via the federal rulemaking portal  AmericanHort generally supports efficient and transparent regulatory processes that limit the regulatory burden on our stakeholders and welcomes input as we consider providing official comment on the proposal.

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