APHIS Finalizes New Regulations on Imports of GE Organisms
The Animal and Plant Health Inspection Service on May 18 issued new regulations on importation and other movements of genetically engineered organisms. Under the final rule, importers will 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 are also able to self-determine that their GE organism is exempt, though invalid self-determinations will be subject to penalties.
The final rule adopts the more flexible approach put forth by APHIS in a reissued proposed rule in June 2019 (see 1906050019). The agency had originally proposed a more stringent, permit-focused approach in a January 2017 rule that was subsequently withdrawn in the face of industry opposition (see 1701180058 and 1711060047).
Some GE Organisms With Some Modifications Exempt
Under the final rule, not all genetic modifications are 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. The final rule regulates GE organisms that are, in and of themselves, plant pests, as well as other GE non-plant organisms that pose plant pest risks. These GE organisms will require a permit. On the other hand, some GE non-plant organisms that do not pose a plant pest risk do 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 new regulations would allow developers of GE organisms the option of requesting either a permit or a regulatory status review (RSR) 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 will not regulate the GE plant. If APHIS is unable to reach that finding, the GE plant may only be allowed to move (or be imported) under permit. A developer that initially requests a permit will also have the option of following up with a request for regulatory status review.
APHIS said it anticipates reviews will take from 60 to 180 days, and that publication of the review results in the Federal Register and an opportunity for comments will come within 15 months. Import permits will generally be issued within 45 days.
Self-Determinations of Exempt GE Organisms
Under the final rule, developers also 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 allows 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 has said.
Phased Implementation Over Next 17 Months
APHIS will phase in implementation of the new regulations over a period of 17 months. The agency will stop accepting “Am I Regulated” requests June 17, and will instead begin issuing confirmation letters to developers that self-determine they are exempt on Aug. 17. On that day the exemptions from the final rule become effective. “In the intervening 60-day period, developers can self-determine regulated status according to the legacy definition of regulated article; APHIS is available to respond to requests for assistance in such determinations,” the agency said. “Alternatively, developers may seek permits or use the legacy notification process during that time period in order to import regulated articles.”
New regulatory provisions on permitting will be in effect on April 5, 2021. Also beginning that date, APHIS will begin accepting regulatory review requests for corn, soybean, cotton, potato, tomato, and alfalfa. Beginning Oct. 1, 2021, the agency will accept regulatory review requests for any genetically engineered plant.
“Until RSR is available for a particular crop based on the schedule set forth in the previous paragraph, APHIS will continue to receive petitions for determination of nonregulated status for the crop in accordance with the current regulations,” it said. “Accordingly, developers may submit petitions for deregulation for any GE plants through April 4, 2021; beginning April 5, 2021, APHIS will discontinue receiving petitions for corn, soybean, cotton, potato, tomato, and alfalfa, but will continue to receive petitions for all other GE plants and organisms. As is currently the case, a developer may seek a permit or use the notification process instead of, or in addition to, submitting a petition. On October 1, 2021, APHIS will discontinue receiving petitions altogether.”
(Federal Register 05/18/20)