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On 18 May 2020, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) released a final rule updating the rules surrounding the movement of genetically engineered (GE) organisms defined as plant pests or potential plant pests.
Verisk 3E Review
The APHIS regulations govern the movement, importation and environmental release of GE organisms and works in combination with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) for oversight of GE organisms in the United States. The APHIS regulations specifically govern "plant pest" GE organisms or GE organisms suspected of being plant pests. APHIS has updated its regulations several times since its original promulgation in 1987 but has not completely overhauled its regulations until 2020. The reasoning for these changes is to incorporate the level of analysis of GE organisms that it has developed in the 33 years since the original regulations.
APHIS had originally published a proposed rule in 2017 to overhaul the regulations but was met with significant pushback on multiple provisions of the proposed rule. APHIS withdrew the proposed rule and conducted research and outreach to achieve a better solution. Many comments also focused on the need to evaluate risk rather than use the method for creating the GE organisms in regulatory oversight. The new APHIS regulations focus on the "properties of the GE organism itself" in contrast to how the GE organism was created.
These new regulations require that GE organisms shall not be moved unless permitted if they conform to the following specifications:
- The GE organism is a plant that has a plant-trait-mechanism of action (MOA) that has not been reviewed by APHIS.
- The GE organism meets the APHIS definition of "plant pest" (defined as: "any living stage of a protozoan, nonhuman animal, a parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the foregoing that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product.")
- The GE organism is not a plant but has received DNA from a plant pest and is capable of releasing an infectious agent that can cause plant disease.
- The GE organism is a microorganism, invertebrate predator, or parasite used to control plant pests that could pose a plant pest risk.
APHIS will conduct a regulatory status review (RSR) for plants that have not yet been regulated if the developing business or entity requests it. The RSR will look at the plant pest risk of the GE organism itself, rather than looking at the method by which the GE organism was created, i.e.:
- the biological properties of the plant
- the trait (or new characteristic)
- the mechanism of action (or how the genetic modification causes the new trait to occur)
These reviews have two further steps. Step One will be completed by APHIS within 180 days of submittal and will identify whether or not APHIS can identify a "plausible pathway" for increased plant pest risk. If APHIS cannot identify a plausible pathway, the GE organism will not be subject to regulation. If APHIS identifies a potential for increased plant pest risk, the business or entity has several options. It can take no more action, request field trials or permits to move the GE organism, or request APHIS to begin Step Two of the RSR process which will take fifteen months.
Under Step Two, APHIS will publish the Step One review in the Federal Register to solicit comments on the plant pest risk. Based on those comments and its own evaluation, if APHIS determines that there is not a plausible pathway for increased plant pest risk after the comment process, the GE organism will not be subject to regulations. However, if APHIS completes the review and the plant still has an increased plant pest risk, it will remain regulated.
Under the new rule, some genetically engineered plants could be exempt from regulations if they have been developed using conventional breeding techniques, which are seen as posing a low plant pest risk to other conventionally bred plants. There are two main other exemption paths. All exemption processes will begin on August 17, 2020.
Under the new rules, a GE organism can be exempted from regulation if it contains a single modification from one of the following categories:
- "A change resulting from the cellular repair of a targeted DNA break in the absence of an externally provided repair template; or
- A targeted single base pair substitution; or
- Introduction of a gene known to occur in the plant’s gene pool, or a change in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool."
Also, a GE organism that contains a plant-trait-mechanism of action (MOA) that has already been evaluated by APHIS, that APHIS decided did not pose a plant pest risk, can be exempted. If a business or entity wishes to confirm that their GE organism is exempt or not exempt, they can submit a written request detailing the organism and the specific exemption to APHIS, who will respond in writing within 120 days of receiving the request, provided it is "sufficiently detailed."
Timeline and Deadlines
APHIS has released a timeline on its website to illustrate deadlines for each piece of the new rules. The timeline stretches to 1 October 2021 for certain pieces of the regulation. A summary of the timeline is below:
- 17 June 2020: APHIS will stop processing "Am I Regulated?" requests, which companies can submit to ask whether or not any of their GE organisms will be regulated under the new rules.
- 17 August 2020: New exemptions and confirmation described above begin. The permitting process remains the same as pre-rule.
- 5 April 2021: The new permitting process begins for plants that pose a plausible plant pest risk. The RSR process begins for certain crops, but APHIS will still accept petitions on these crops until 30 September 2021.
- 1 October 2021: The previously described RSR process begins in earnest for all crops and APHIS will not accept further petitions.
Verisk 3E Analysis
This move will likely have a large business impact on genetically engineered organisms that may be considered or are considered plant pests. This is the first rule overhaul of APHIS regulations since 1987, as all previous changes have been relatively minor. APHIS expects these regulatory changes to save the agricultural industry money and reduce complicated review timelines
APHIS expects that relatively few plants that are not currently regulated will be subject to new regulations under the new rules.