APHIS Reopens Comment Period for Proposed Rule on Import Permits, Etc. for Genetically Engineered Organisms
The Animal and Plant Health Inspection Service has reopened the comment period on its proposed rule which would revise and update certain procedures and requirements for the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in order to bring the regulations under 7 CFR Part 340 into alignment with the Plant Protection Act.
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Comments are now due by March 17, 2009 (instead of November 24, 2008). Comments received between November 25, 2008 and January 16, 2009 will also be considered.
APHIS Seeks Further Comments, Information, and Suggestions
While all aspects of the proposed rule may be addressed by the public, APHIS is particularly seeking further comments, more specific information, and detailed suggestions regarding the following issues:
scope of the regulation and which GE organisms should be regulated;
incorporation of the Plant Protection Act noxious weed provisions;
elimination of notification procedure and revision of the permit procedure; and
environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.
APHIS Proposes to Reorganize, Clarify, Specify Permit Procedures/Conditions
APHIS' 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.
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 10/16/08 news, 08101635, for initial BP summary of APHIS' proposed rule.
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.
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.)
APHIS contact - Biotechnology Regulatory Services (301) 734-5710
APHIS notice reopening of comment period (D/N APHIS-2008-0023, FR Pub 01/16/09), available at http://edocket.access.gpo.gov/2009/pdf/E9-905.pdf
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