Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Genetically engineered plants eligible for release under the notification
procedure.
In accordance with Minnesota Statutes, section 116C.98,
genetically engineered plants that meet the eligibility criteria of items A to
F and whose release meets the performance standards in subpart
2 are eligible for release
under the notification procedure of subpart
3.
A. The genetically engineered plant is:
(1) one of the following species: corn
(Zea mays L.), cotton (Gossypium hirsutum
L.), potato (Solanum tuberosum L.), soybean (Glycine
max L. Merr.), tobacco (Nicotiana tabacum L.), or
tomato (Lycopersicon esculentum L.); or
(2) additional plant species that the
commissioner, after public notice and after complying with Minnesota Statutes,
chapter 18F, and the rules adopted under it, has determined may be safely used
in accordance with the organism eligibility criteria in items B to F and the
release performance standards in subpart
2. Supplemental notice of
Federal Register items announcing changes in the list of plant species must be
published in the EQB Monitor and sent to the Minnesota Department of
Agriculture GEO mailing list. The Minnesota Department of Agriculture shall
accept comments during the federal comment period.
B. The genetically engineered material is
stably integrated into the plant genome.
C. The function of the genetically engineered
material is known and its expression in the genetically engineered organism
does not result in disease.
D. The
genetically engineered material does not:
(1)
cause the production of an infectious entity;
(2) encode substances that are known or
likely to be toxic to nontarget organisms known or likely to feed or live on
the plant species; or
(3) encode
products intended for pharmaceutical use.
E. To ensure that the introduced genetic
sequences do not pose a significant risk of the creation of any new plant
viruses they must be:
(1) noncoding
regulatory sequences of known function;
(2) sense or antisense genetic constructs
derived from viral coat protein genes from plant viruses that are prevalent and
endemic in the area where the use will occur and that infect plants of the same
host species; or
(3) antisense
genetic constructs derived from noncapsid viral genes from plant viruses that
are prevalent and endemic in the area where the use will occur and that infect
plants of the same host species.
F. The plant has not been modified to contain
the following genetic material from animal or human pathogens:
(1) any nucleic acid sequence derived from an
animal or human virus; or
(2)
coding sequences whose products are known or likely causal agents of disease in
animals or humans.
Subp.
2.
Performance standards for release under the notification
procedure.
A. The performance
standards in this subpart must be met for any releases under the notification
procedure.
B. If the genetically
engineered plants or plant materials are shipped, they must be shipped in such
a way that the viable plant material is unlikely to be disseminated while in
transit and must be maintained at the facility in such a way that there is no
release into the environment.
C.
The genetically engineered plants must be planted in such a way that they are
not inadvertently mixed with nonregulated plant materials of any species which
are not part of the release.
D. The
plants and plant parts must be maintained in such a way that the identity of
the material is known while it is in use, and the plant parts must be contained
or devitalized when no longer in use.
E. There must be no viable vector agent
associated with the genetically engineered plants.
F. The field trial must be conducted so that:
(1) the genetically engineered plants will
not persist in the environment; and
(2) no offspring can be produced that could
persist in the environment.
G. Upon termination of the field test:
(1) no viable material may remain which is
likely to volunteer in subsequent seasons; or
(2) plant volunteers must be managed to
prevent persistence in the environment.
Subp. 3.
Notification procedure.
Notification must be directed to the commissioner, including
the following:
A. the name, title,
address, telephone number, and signature of the responsible person;
B. information necessary to identify the
genetically engineered plant or plants, including:
(1) the scientific, common, or trade name and
the phenotype of the genetically engineered plant;
(2) the designations for the genetic loci,
the encoded proteins or functions, and the donor organisms from which used
genetic material was derived; and
(3) the method by which the recipient was
transformed;
C. the
names and locations of the origination and destination facilities for movement
or the field site location for the environmental release, and the size of the
use;
D. the expected date of
release and the expected duration of the release; and
E. a statement that certifies that the use of
the genetically engineered organism will comply with this chapter.
Subp. 4.
Federal
notification as application.
A copy of the federal notification information including all
confidential business information necessary to determine that the guidelines
are met by the applicant as well as complete site identification may be used as
the application.
Subp. 5.
Notification before release.
Notification must be submitted at least 30 days before the day
of use.
Subp. 6.
Release reports.
Release reports, if required by the commissioner, must
include:
A. the release
number;
B. methods of observation,
resulting data, and analysis regarding all deleterious effects on plants,
nontarget organisms, or the environment; and
C. any other available information requested
by the commissioner regarding the impact of the genetically engineered organism
on human health or the environment.
Subp. 7.
Unexpected occurrences.
The commissioner must be notified of any unexpected occurrences
relating to the release within 48 hours.
Subp. 8.
Access.
Access 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 the provisions of subparts
1 to
6. Access of regulatory
officials from state agencies other than the Department of Agriculture must be
coordinated through the department.
Subp. 9.
Administrative action in
response to notification.
A. The
commissioner shall publish notice of the proposed release at the earliest
opportunity in the EQB Monitor and shall mail notice to the chair of the county
board of the county and the tribal council of any reservation within which the
release will take place.
B. The
commissioner shall grant or deny permission to release the noticed genetically
engineered plant within 30 days of the receipt of the notification.
C. A person denied permission for use of a
genetically engineered plant under notification may apply for a permit for
release of that genetically engineered plant without prejudice.
D. The commissioner shall notify the chair of
the Environmental Quality Board of any unexpected occurrences relating to the
release.
E. The commissioner has
the right to rescind any notifications if there is evidence of unreasonable
adverse effects on human health or the environment.
Statutory Authority: MS s
18F.12
