Subpart 1.
Standard for issuing a release permit.
Except as provided in subpart
2, the board must issue or
modify a release permit if the board determines that the applicant will, with
respect to the release, comply or will undertake a schedule of compliance to
achieve compliance with the conditions of the release permit and all applicable
Minnesota statutes and rules administered by the board, and that all applicable
requirements of Minnesota Statutes, chapter 116D, and the rules adopted under
chapter 116D, have been fulfilled.
Subp.
2.
Standard for denying or revoking a release permit.
The following findings by the board constitute justification
for the board to deny or to revoke a release permit or to deny a modification
to a release permit:
A. that the
applicant will not comply or has not complied with the conditions of the
release permit or applicable law;
B. that the applicant has failed to disclose
fully all facts relevant to the release or has submitted false or misleading
information to the board;
C. that
the release will result or has resulted in significant or material adverse
effects on human health or the environment; or
D. that all applicable requirements of
Minnesota Statutes, chapter 116D, and the rules adopted under chapter 116D,
have not been fulfilled.
Subp.
3.
Considerations.
In determining pursuant to subparts
1 and
2 whether a release permit
should be issued or denied, modified, or revoked and in specifying or modifying
permit conditions, the board 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 engineered organisms;
B. the history of any previous environmental
uses of the genetically engineered organism;
C. the potential for the genetically
engineered organisms to cause adverse environmental effects including, but not
limited to:
(1) whether the recipient organism
is native or nonnative to the release area;
(2) whether the genetically engineered
organism is pathogenic or toxic to target or nontarget organisms and to what
extent has this trait been introduced or altered as a result of the genetic
engineering;
(3) the extent to
which the genetically engineered organism's competitiveness, survivability
under environmental stress including, but not limited to, dormancy, temperature
tolerance, fire resistance, and drought resistance, or ability to disperse in
the environment has been changed or potentially changed as a result of the
genetic engineering. The determination of potential changes must be based
minimally on the natural history of the recipient organism and the potential
effects of natural selection on the genetically engineered organism;
(4) the extent of change or potential change
to the recipient organism's resource base including, but not limited to, the
ability of plants to grow on new soil types, of bacteria to metabolize new
nutrients, and of fish to eat new foods;
(5) the potential for the genetically
engineered organism's genes to transfer to other hosts and the resultant
effects on the other hosts' competitiveness, dispersal, dormancy, pathogenicity
or toxicity, or on the expansion of their resource bases; and
(6) the potential of the genetically
engineered organism to enter or adversely affect the groundwater environment or
to pass unusual genes to a microorganism resident in the groundwater;
D. the adequacy and
appropriateness of proposed measures, if any, for confinement of the
genetically engineered organism;
E.
any previous risk assessment for the release of the same or similar organisms
prepared by federal or state agencies and the risk assessment adequacy and
relevance to the current proposal including, but not limited to:
(1) the range of soils, ecological biotypes,
and meteorological conditions that existed in previous field releases and their
relationship to the proposed release area;
(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 release 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 and their adequacy and relevance to the
current proposal;
G. the
conclusions reached or conditions imposed by federal or state agencies on
previous environmental releases in Minnesota or elsewhere and their adequacy
and relevance to the current proposal;
H. the type, extent, and reversibility of
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.