Minnesota Administrative Rules

1558.0030 CONSIDERATIONS.

Subpart 1.

Considerations.

In determining whether a release permit, notification, or exemption for commercial use should be issued, denied, modified, suspended, or revoked, and in specifying or modifying conditions of release, the commissioner must consider the following:

A.

the familiarity and predictability of the ecologically relevant biological properties of the introduced DNA, the vector if one exists, the recipient, and the engineered organisms;

B.

the history of previous environmental releases, evidence from laboratory studies, or other uses of the genetically engineered organisms;

C.

the potential for the genetically engineered organism to cause any adverse effects on humans or the environment, such as:

(1)

whether the organism is native, currently found in the area, or nonnative to the release area;

(2)

whether the genetically engineered organism is pathogenic to target or nontarget organisms and to what extent this trait has been changed from the nontransgenic parents;

(3)

the extent of the changes to the genetically engineered organism's competitiveness and survivability under normal and environmentally stressful conditions, such as resource base, dormancy, temperature tolerance, fire resistance, drought resistance, or ability to disperse in the environment, that have been made as a result of the genetic engineering;

(4)

the potential for the genetically engineered organisms' genes to transfer to other organisms and the resultant effects on other organisms' competitiveness, dispersal, dormancy, pathogenicity or toxicity, fertility, expansion of their resource base or range, and any other fitness characteristics; and

(5)

the potential of the genetically engineered organism to affect adversely the groundwater environment or to pass transgenes to organisms found in groundwater;

D.

the adequacy of and appropriateness of the measures, if any are needed, for confinement of the genetically engineered organism;

E.

any previous risk assessments for the same or similar organisms prepared by federal or state agencies and their adequacy and relevance to the current proposal, such as consideration of the following:

(1)

the environmental conditions that existed in previous releases and their relationship to the proposed use;

(2)

whether the genetically engineered organisms failed to demonstrate an ability to be self-reproducing or competitive because of transient factors; and

(3)

whether the scale of the assessment was adequate to assess potential for establishing a self-reproducing population;

F.

the conclusions reached and conditions imposed by federal agencies with jurisdiction over the proposed release;

G.

the conclusions reached or conditions imposed by federal or state agencies on previous releases in Minnesota or elsewhere and their adequacy and relevance to the current proposal;

H.

the type, extent, and reversibility of adverse environmental effects;

I.

the cumulative potential effects of related or anticipated future projects; and

J.

the extent to which the environmental effects are subject to mitigation by ongoing public regulatory authority.

Subp. 2.

Federal documents.

Relevant federal documents may be used to address some or all of the considerations in subpart 1.

Statutory Authority:

MS s 18F.12

History:

20 SR 1037

Published Electronically:

June 26, 2003