Minn. R. agency 105, ch. 1558, pt. 1558.0040
Release permits, including EAWs prepared by the commissioner, are required from the commissioner for all releases of GEOs except those exempted under subpart 13, or those regulated under part 1558.0060, 1558.0070, or 1558.0080. The commissioner shall provide application forms.
An application must be accepted or rejected by the commissioner within 14 days of its receipt. The commissioner may reject an application if the regulation of the genetically engineered organism is not authorized under Minnesota Statutes, chapter 18B, 18C, or 18F, or if the application does not contain all the required information.
If the commissioner rejects an application, the applicant must be informed in writing of the deficiencies that exist and requirements that, if corrected, will allow acceptance of the application. The applicant may submit the additional information or withdraw the application. Acceptance of the application does not constitute issuance of the permit.
Within 14 days of the application acceptance, a copy of the application with not public data deleted, including the EAW prepared by the Minnesota Department of Agriculture, must be distributed to: the chair of the EQB, the Legislative Reference Library, local government units within whose boundaries the release is proposed, and any other person upon request to the commissioner. Those persons shall be added to the mailing list maintained by the commissioner of persons interested in receiving information on the release of GEOs. EAWs must be distributed according to the EQB distribution list. Not public data is available for review by any state agency according to provisions of Minnesota Statutes, section 13.05, subdivision 9, of the Minnesota Government Data Practices Act.
The application must be reviewed using an interdisciplinary approach that will ensure the integrated use of the natural and environmental sciences, including involvement of the following disciplines as appropriate: microbiology, ecology, public health, biological safety, agronomy, animal science, plant biology, risk assessment, molecular biology, biochemistry, entomology, vertebrate biology, physical and biological containment, and other appropriate disciplines. Application review must address the considerations in part 1558.0030, including federal documents, and evidence from laboratory studies and previous releases. After reviewing a completed release permit application including the EAW and comments from reviewers, the commissioner may issue a release permit for GEOs if the commissioner determines that the applicant has adequately demonstrated that the proposed release does not have the potential for unreasonable adverse effects on human health or the environment. The commissioner may deny issuance of a GEO release permit if the release of the GEO under proposed terms and conditions of the release permit may cause unreasonable adverse effects on human health or the environment.
The Board of Animal Health must be consulted during the review on permits that relate to livestock and domestic animals.
The commissioner may prescribe terms and conditions such as the period for the GEO release permit, the amount or number of GEOs to be released, monitoring activities, department inspection schedules, reporting of experimental results, and experiment termination procedures. The commissioner may impose additional reasonable and appropriate release permit conditions to mitigate or minimize the adverse effects of the release on human health or the environment.
A person shall not violate terms or conditions of a permit issued under this section. The commissioner may modify, suspend, or revoke the release permit at any time if the commissioner finds that its terms or conditions are being violated or are inadequate to avoid unreasonable adverse effects on human health or the environment pursuant to Minnesota Statutes, section 18F.07, subdivision 2. If adverse effects are observed, the permit will be suspended. If adverse effects can be mitigated by modification of the conditions for release, the permit may be reinstated. Revocation shall result in termination and disposal of all GEOs if the commissioner determines that the GEOs pose a significant environmental risk. Minnesota Statutes, section 18D.301, subdivision 1, authorizes procedures and penalties as outlined in Minnesota Statutes, chapter 18D, to be applied to violations of Minnesota Statutes, chapter 18B, 18C, or 18F.
It is the responsibility of the applicant to notify the commissioner of any unexpected occurrences or adverse effects within 48 hours.
An application for a release permit for a GEO must be accompanied by a nonrefundable application fee of $125 in accordance with Minnesota Statutes, section 18F.07, subdivision 4, or $150 if an experimental use permit is required under Minnesota Statutes, section 18B.28, subdivision 4.
Releases that are substantially the same as a previous release may be eligible for a permit renewal. The applicant must submit a written permit renewal request to the commissioner at least 30 days before release of the GEO. A request may be denied based on evidence of unreasonable adverse effects on human health or the environment.
Release reports are required by the commissioner for all releases. Release reports must include:
Access to the release site must be allowed for state regulatory officials to inspect facilities or the field test site, or both, and any records necessary to evaluate compliance with this chapter. Records must be kept for three years. Access of regulatory officials from state agencies other than the Department of Agriculture must be coordinated through the Department of Agriculture.
Partial or complete exemptions from the permit procedures may be given by the commissioner based on the considerations in part 1558.0030 and adequacy of alternative oversight as it relates to those considerations.
Minn. R. agency 105, ch. 1558, pt. 1558.0040
Statutory Authority: MS s 18F.12