Movement of Certain Genetically Engineered Organisms (Proposed Rule, 84 FR 26514)

Policy Details

Policy Details

Last Action
Comment period closed
Date of Last Action
Aug 5 2019
Date Introduced
Jun 6 2019
Publication Date
Jun 6 2019

SciPol Summary

The Animal and Plant Health Inspection Service (APHIS) proposed a rule updating the movement and transportation regulations for developers of genetically engineered (GE) organisms, particularly plants, that may classify as plant pests. According to the rule, APHIS would regulate the movement of GE organisms that either meet the definition of “plant pest,” are non-plants that receive DNA from a plant pest, are microorganisms used to control plant pests, or are plants not previously evaluated under this rule. GE organisms fitting any of these criteria require a permit from APHIS prior to transportation or environmental release. According to APHIS, these regulatory changes will promote the creation of GE plants without plant pest risk.

Plant pest risks are determined using the “plant-trait-mechanism of action” criteria, which evaluates the biology of the plant, the inserted trait, and the mechanism of action (i.e., the biochemical basis for the new trait). After these assessments are completed, any plant that poses, or fails to establish that it does not pose, a potential plant pest risk requires a permit for transportation.

If APHIS determines that a GE plant does not pose a risk based on these metrics, they publicly post this information on the APHIS website. This notification allows developers of similar GE plants to self-determine that they qualify for an exemption from regulation and request that APHIS review their self-determination. In turn, this provision prevents APHIS from conducting repetitive studies regarding the need for a permit.

Other exemptions to this permitting process are given to GE plants with genetic modifications that:

Non-plant genetically modified organisms that pose a plant pest risk and plant-incorporated protectants are still regulated for transportation, while certain plants exempt from regulation prior to this proposed rule retain their non-regulated status. Failure to comply with the rule may result in revocation of permits and potentially criminal and/or civil penalties.

Genetically modified organisms (GMOs) include GE plants and are organisms that have had their genetic material altered in a non-natural way, usually through the insertion of genes that provide a desirable trait or advantage.

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