Earlier this week, the USDA Animal Plant and Health Inspection Services (APHIS) announced new guidance for extension requests for genetically engineered (GE) organisms. What does this mean for the public? Hopefully, it will lead to shorter review times, flexibility in extension requests, and more predictability from the government review processes. This should mean more innovation and less red tape, at least for extensions.
As I’ve explained in past posts, APHIS regulates the introduction of GE organisms. For now, APHIS treats genetically modified organisms (GMOs) and genetically-edited materials the same. I think there needs to be a distinction between those groups because gene editing often does not introduce any foreign genetic material into the plant or animal being engineered, but that is a story for another day. In this post, I’ll use GE to mean genetically engineered—GMOs and genetically-edited organisms.
All introductions of GE organisms into the US must be authorized by APHIS. Under the current framework, when a developer can show a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, she can petition APHIS for a determination of “nonregulated status.” If APHIS approves the petition, the GE organism may then be introduced into the US without further APHIS regulatory oversight.
Once achieved, APHIS can extend the nonregulated status to similar organisms or “regulated articles.” APHIS considers whether the organism under consideration is sufficiently similar to organisms that already have been granted nonregulated status (called antecedents). This week’s announcement should mean faster deregulated status for a new GE organism if the organism is sufficiently similar to a previously deregulated organism. APHIS says the new guidance will apply when a previously reviewed trait is introduced into different varieties of the same crop or when traits previously reviewed in a crop are stacked into the same crop through genetic engineering. APHIS said the new process would apply to at least a few factual circumstances. First, it would apply where a previously reviewed trait (like non-browning in an apple) is introduced into different varieties of the same crop (i.e., if it had been deregulated in Golden Delicious apples and a developer applied for an extension for Granny Smith apples). Second, it would apply where previously reviewed traits in a crop are stacked into the same crop (stacking previously deregulated non-browning and herbicide resistance into one plant). Third, it would apply where the trait being sought has been deregulated in the crop (like corn) and the mechanism of action, if new to that crop (corn) has been deregulated in another crop (like beans).
APHIS’s stated goal when considering nonregulated extensions is to ensure the organisms under consideration are not likely to pose plant pest risks beyond those considered in the antecedent article. When submitting a request for an extension of nonregulated status, an applicant should explain whether the mechanisms-of-action of the introduced traits are functionally similar. For example, one mechanism-of-action for resistance in plants to the herbicide glyphosate relies on an enzyme called EPSPS. EPSPS could be donated by corn or a bacteria strain. But the mechanism-of-action is similar, so the corn-based EPSPS organism could likely be used as an antecedent for the bacteria-based EPSPS, and vice versa. However, glyphosate resistance can be achieved through other mechanisms, like adding a protein that metabolizes glyphosate to an inactive form. This mechanism is not functionally equivalent to the EPSPS procedure, and so likely could not be an antecedent. In considering a request for extension, APHIS also considers the crop at issue. For example, if APHIS had not reviewed a glyphosate herbicide-resistant soybean before, a soybean transformed with the EPSPS gene could not receive an extension based solely on an antecedent EPSPS corn. But, APHIS could review its request for extension based on an antecedent EPSPS corn together with an antecedent soybean previously reviewed for a different herbicide resistance. Thus, to be considered for an extension, APHIS requires a prior determination of nonregulated status for the mechanism-of-action (i.e. EPSPS gene donation) and for the observable characteristic (i.e. herbicide-resistance).
Under the new guidance, a request for extension of nonregulated status should include descriptions of the genotype and phenotype of the article under consideration, a molecular characterization of the article, a comparison with any antecedent organisms, including the mechanism-of-action and expressed characteristics, and the petition number of the original grant of nonregulated status.
The APHIS extension of nonregulated status is only one part of the federal review required for GE organisms to be approved for release. The USDA evaluates a plant’s potential to become a weed, the FDA reviews plants that could enter the food supply, and the EPA regulates the genetically modified plants with pesticide properties. Most genetically modified organisms are reviewed by at least two of these agencies, if not all three. APHIS’s recent guidance announcement is a small step toward encouraging genetic innovation.