APHIS Proposes Rewrite of Regulations on Importation of GE Organisms
The Animal and Plant Health Inspection Service is proposing major changes to its regulations on importation, interstate movement and release of genetically engineered (GE) organisms. The proposed rule (here) would modify current definitions of what is a GE organism, as well as the criteria used by APHIS to judge whether it regulates GE organisms based on the risk of introduction of plant pests or noxious weeds. Time-limited import permits would be eliminated, as would current notification procedures. Record-keeping requirements would be increased. Comments on the proposal are due May 19.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
GE Organisms Require Permit if Pest Risk Found or Not Yet Evaluated
The proposal would continue the current approach of APHIS determinations, based on petitions filed with the agency, on whether a GE organism falls under the agency’s regulations, though with a modified approach. Under the proposed rule, GE organisms would fall under the regulations, and require a permit, if:
- APHIS evaluates a GE plant and determines that the plant and trait combination causes it to act as a plant pest or noxious weed; or
- APHIS is presented with a GE plant with a novel plant and treat combination, and has not yet evaluated it for its plant pest and noxious weed risk.
List of non-regulated organisms. APHIS would maintain a list on its website of GE organisms that are not subject to its regulations because they are unlikely to pose a risk as a plant pest or noxious weed. The agency plans to publish draft lists of regulated and non-regulated GE organisms for comment, it said.
Plant pest material. Under the proposal, APHIS would no longer regulate a GE organism as a plant pest just because it includes material from a pest plant, it said.
Reconsiderations. If it receives new information that indicates a previously deregulated GE organism may present a plant pest or noxious weed risk, APHIS would be able to re-evaluate the organism and reconsider its decision that it is not regulated, the agency said.
Permitting and Recordkeeping Changes
APHIS also proposes to “reorganize the regulations to improve the clarity of the permit application and evaluation procedures,” it said. The agency would also make some more substantial changes to permitting and record keeping.
Permits after evaluations. Generally, APHIS would not issue a permit unless a GE organism has been evaluated, it said. If APHIS implements these proposed regulations, it “believes that such evaluations will take a matter of months,” the agency said. Most applicants “would wait for APHIS to issue a final determination of regulatory status” before submitting an application,” it said.
Immediate permits in some cases. In instances in which there is an immediate need to import a GE organism that APHIS has not yet evaluated, APHIS may issue a permit. APHIS would assume the organism presents a high risk as a plant pest or noxious weed, so “permitting conditions could be significantly more stringent for such unevaluated organisms than they would be for the same organisms, following evaluation.”
Limited permits. The proposed regulations no longer include provisions that limit import permits to single importations.
Record keeping. The proposed rule would extend the record-keeping requirement for all records related to permits, other than records that an imported organism arrived at its intended destination, from one to 10 years. Proof that the organism arrived would have to be maintained for two years, instead of the current one year.
Notification Procedure Eliminated
APHIS’s current regulations provide for a notification procedure whereby certain GE plants can be authorized for importation, interstate movement or release without a permit. The notification procedure relies on “performance-based standards” rather than the customized requirements of permits. APHIS is proposing to remove current notification procedures, and require a permit for all authorizations for importation, interstate movement or release.
Container Requirements
Instead of the current “prescriptive” container requirements for regulated organisms, the proposed rule would “reflect the performance-based standard that APHIS used to develop the requirements,” APHIS said. The proposal would also make the standard “more explicit,” the agency said. Making the requirements less prescriptive would eliminate “the need for a request process for variances,” APHIS said. The proposed rule would also require that containers of regulated organisms be accompanied by a document that includes the names and contact details for the sender and the recipient.
(Federal Register 01/19/17)