APHIS Again Proposes New Regulations on Imports of GE Organisms
The Animal and Plant Health Inspection Service is proposing an overhaul of its regulations on importation and other movements of genetically engineered organisms. Under the proposed rule, importers would have the choice of either an APHIS review pre-importation to determine whether a permit is necessary, or just applying for a permit. Developers of GE organisms would also be able to self-determine that their GE organism is exempt, though invalid self-determinations would be subject to penalties.
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The proposal takes a more flexible approach than a now-withdrawn proposed rule on movements of GE organisms issued in January 2017 (see 1701180058 and 1711060047). Feedback on the previous proposal “centered on the need to focus regulatory efforts and oversight upon risk, rather than the method used to develop GE organisms,” APHIS said. “Stakeholders also expressed a desire for flexible and adaptable regulations so that future innovations do not invalidate the regulations.”
Some GE Organisms With Some Modifications Exempt
Under the proposal, not all genetic modifications would be subject to regulatory review or permitting requirements. GE organisms with modifications that are similar to those which can be made through traditional breeding are exempt from the requirements, because they should result in similar plant pest risks, APHIS said. In a similar vein, once products have been reviewed by APHIS and have been found unlikely to pose a plant pest risk, similar products would be exempt from further review, the agency said.
Some non-plant GE organisms need permits. On the other hand, some non-plant organisms would be subject to permit requirements. “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,” it said. “Such organisms would require permits for movement. Other GE non-plant organisms that do not pose a plant pest risk would not fall under the scope of the regulations and therefore would not require permits for movement.”
Choice of Regulatory Review or Application for Permit
The proposed regulations would allow developers of GE organisms the option of requesting either a permit or a regulatory status review of a GE plant that has not been previously determined to be unregulated. If the developer opts for regulatory review, and APHIS finds that movement of the GE plant, including importation, is unlikely to pose a plant pest risk, APHIS would not regulate the GE plant. If APHIS is unable to reach that finding, the GE plant would only be allowed to move (or be imported) under permit. A developer that initially requests a permit would also have the option of following up with a request for regulatory status review, APHIS said.
Self-Determinations of Exempt GE Organisms
Under the proposed rule, developers would have the option of making a self-determination as to whether the GE plant belongs to a list of categories exempt from the regulations (i.e., the plant has undergone one of several types of exempt modifications). A developer that makes a self-determination that APHIS determines not to be valid “may be subject to remedial measures or penalties,” the agency said.
Confirmation letters. The proposal would allow developers to request a “confirmation letter” that their self-determination is valid. The letters “may be useful to developers wishing to market their products domestically or overseas by allowing them to provide verification to an importing country or other party that APHIS concurs with their self-determinations,” APHIS said. “APHIS anticipates a timely turnaround time in developing and providing these confirmation letters to developers.”
(Federal Register 06/06/19)