On June 5, 2019, the Animal Plant Health Inspection Service of the USDA (APHIS) announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.” The proposed rule was published on June 6, 2019. On June 7, the 449 pages long draft environmental impact statement of the proposed rule also was made available.
Among other things, APHIS oversees the importation, interstate movement and environmental release of genetically engineered organisms to ensure they do not pose a plant pest risk. The current regulations have been in place since 1987. They require that APHIS consider a new genetically engineered (GE) plant as regulated until APHIS determines that the plant does not fall under the agency’s authority or does not pose a plant pest risk. Industry has long complained that the rules are outdated and an impediment to innovation in the sector. Moreover, for more than a decade the USDA Office of Inspector General, National Research Council and others have made recommendations and suggestions how to modernize and increase efficiency of APHIS regulation of GE plants. As described in the preamble to the proposed rule, since 2004, APHIS has considered options to modernize the regulations. The proposal marks the first significant change in three decades.
The proposed amendment is intended to promote process efficiency by allowing APHIS to focus its resources on oversight of GE organisms that in fact have potential plant pest risks and reduce its oversight of GE organisms that are unlikely to pose such risks. According to APHIS, it addresses and implements and is consistent with various recommendations by OIG. Under the proposed rule several categories of GE plants are exempt from permitting requirements and the notification procedure has been removed. Some major changes include:
- Exemption for certain categories of GE plants from the regulations because they could (also) be produced through traditional breeding techniques; APHIS claims that this exemption is justified because such GE plants are unlikely to pose new plant pest risks.
- Change of the basis for APHIS regulatory review from one in which GE plants are regulated based on the use of plant pests in their development, to one in which APHIS reviews the GE plants themselves for plant pest risks. Regulated status will be based on regulatory status reviews rather than on a petition process. (The regulatory status review applies only to GE plants not to GE plant pests or other GE non-plant organisms).
- Focuses APHIS oversight on those GE organisms that are found to be likely to pose plant pest risks, as determined by science-based risks assessments.
- Exemption for GE plants with plant-trait-mechanism of action combinations that APHIS has previously evaluated (under a regulatory status review) and found to be unlikely to pose a plant pest risk. APHIS proposes to publish the results of all completed regulatory status reviews on its website.
- APHIS will continue to regulate GE organisms that are, in and of themselves, plant pests, as well as other GE non-plant organisms that pose plant pest risks. Such organisms would require permits for movement. (APHIS requests public comments as to the option of applying regulatory status review to these products also).
- Elimination of the notification procedure and requirement for a permit for the interstate movement, importation, or environmental release for GE organisms for which APHIS was unable to reach a finding of unlikely to pose a plant pest risk.
- Provides an option for biotech developers to do a “self-determination” about whether new traits qualify for an exemption. APHIS would then give those developers a chance to request a confirmation letter from APHIS of the plant’s exempt status. According to the Agency, “these confirmation letters . . . would provide a clear and succinct statement about the regulatory applicability of the GE plants and the nexus to plant health.”
- The current rule includes details about timing/timeframes for APHIS reviews/responses/actions. The proposed rule no longer includes this type of provision, providing APHIS with greater flexibility.
Developers who are found to be commercializing crops that are found not to be exempt from the APHIS rules may be ordered to destroy their plants or pay penalties.
Comments to the proposal may be submitted by August 5, 2019.