APHIS Proposes Rule on Import Permits, Etc. for Genetically Engineered Organisms

(The regulations at 7 CFR Part 340 govern the introduction of GE organisms that might be plant pests. Among other things, APHIS is proposing to reorganize its GE regulations to improve the clarity of the permit application and evaluation procedures, which is more a reorganization than substantive change.

APHIS states that the permitting procedure will continue to identify and obtain information relevant to evaluating the risks associated with a proposed importation, interstate movement, or release into the environment, and determine and document whether, and under what conditions, the activity should be allowed.)

APHIS Proposes to Reorganize, Clarify, Specify Permit Procedures/Conditions

According to APHIS, the proposed changes to the permit procedures under 7 CFR Part 340 include the following (partial list):

Division of permit regulations. APHIS proposes to reorganize the permit regulations by dividing them into two sections: (i) 7 CFR 340.2, procedure for permits, which describes permit types, the procedure for permit application (including information requirements), and APHIS' administrative actions for permits; and (ii) 7 CFR 340.3, permit conditions, which describes the general types of conditions that APHIS may add to a permit, and the obligations of the responsible person after permit issuance.

Three types of permits. The proposed changes would also specify the different types of permits (importation, interstate movement, and environmental release¹) and new subcategories of environmental release permits.

Procedures for amendment, transfer, revocation of permits. APHIS proposes explicit procedures for amendment, transfer of responsibility, and revocation of permits in order to establish clear regulatory procedures that can increase efficiency yet maintain adequate safety. (Currently the APHIS administrative practices to amend, transfer, and revoke permits are not explicit in the regulations.)

(The proposed regulations also detail the types of information that must be submitted with a permit application and outline the procedural and administrative steps of issuing a permit.)

Elimination of courtesy permits. APHIS is also proposing to eliminate the issuance of "courtesy permits," which are currently issued under the regulations to facilitate the movement of organisms which are outside the scope of these regulations, but whose movement might otherwise be hindered because of their similarity to organisms regulated under these regulations.

APHIS to Hold Three Public Forums on Proposed Rule

APHIS is also announcing public forums in Davis, CA on October 28, 2008; in Kansas City, MO on October 30, 2008; and in Riverdale, MD on November 13, 2008, which are designed to engage interested individuals from the public and elicit comments related to the proposed rule.

¹The proposed regulations specify that environmental release permits are for the environmental release of GE organisms. In cases in which importation and interstate movements would occur incidental to an environmental release, the importation and interstate movements would also be authorized under the environmental release permit.

(See ITT's Online Archives or 07/23/07 news, 07072399 5, for BP summary of APHIS' request for comments on a draft environmental impact statement regarding the importation, interstate movement and environmental release of GE organisms.

See ITT's Online Archives or 09/23/08 news, 08092399 18, for BP summary of APHIS' request for comments and data regarding the import or interstate movement of GE animals.)

APHIS proposed rule (D/N APHIS-2008-0023, FR Pub 10/09/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-23584.pdf