Office of the Revisor of Statutes
Minnesota Session Laws - 1994, Regular Session
Key: (1) language to be deleted (2) new language
CHAPTER 454-H.F.No. 2212
An act relating to the environment; genetically
engineered organisms; authorizing the department of
agriculture to exempt certain federally monitored
releases; authorizing the environmental quality board
to adopt rules relating to certain releases; providing
for certain exemptions; amending Minnesota Statutes
1992, sections 18F.01; 18F.02, subdivisions 1, 5, and
by adding a subdivision; 18F.04; 18F.07; 18F.12;
116C.91, subdivision 1; 116C.94; and 116C.96;
proposing coding for new law in Minnesota Statutes,
chapters 18F; and 116C; repealing Minnesota Statutes
1992, section 18F.02, subdivision 7.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1. Minnesota Statutes 1992, section 18F.01, is
amended to read:
18F.01 [PURPOSE.]
The purpose of sections 18F.01 to 18F.12 18F.13 is to
establish permits for the release of certain genetically
engineered agriculturally related organisms to protect humans
and the environment from the potential for significant adverse
effects of those releases.
Sec. 2. Minnesota Statutes 1992, section 18F.02,
subdivision 1, is amended to read:
Subdivision 1. [SCOPE.] As used in sections 18F.01 to
18F.12 18F.13, the terms defined in this section have the
meanings given them.
Sec. 3. Minnesota Statutes 1992, section 18F.02, is
amended by adding a subdivision to read:
Subd. 2a. [AGRICULTURALLY RELATED ORGANISM.]
"Agriculturally related organism" means any organism that is
used in agricultural production or processing of agricultural
products. It includes livestock and livestock products; dairy
animals and dairy products; poultry and poultry products;
domestic fur-bearing animals; animal feeds; horticultural stock;
nursery stock, as defined in section 18.46, subdivision 3;
fruit; vegetables; forage grain; wild rice; seeds; bees; apiary
products; and products for the control or mitigation of noxious
weeds. It excludes vaccines and drugs for use in humans; genetic
engineering of human germ cells and human somatic cells intended
for use in human gene therapy; vaccines for use in livestock,
dairy animals, poultry, domestic fur-bearing animals, or private
aquatic life; genetically engineered wild animals; and forestry
products.
Sec. 4. Minnesota Statutes 1992, section 18F.02,
subdivision 5, is amended to read:
Subd. 5. [GENETICALLY ENGINEERED PLANT ORGANISM.]
"Genetically engineered plant organism" means a plant an
organism that has been modified directly or indirectly using
genetic engineering.
Sec. 5. Minnesota Statutes 1992, section 18F.04, is
amended to read:
18F.04 [POWERS AND DUTIES OF THE COMMISSIONER.]
The commissioner shall administer, implement, and enforce
sections 18F.01 to 18F.12 18F.13. The board of animal health
shall be consulted on permits that relate to livestock and
domestic animals.
Sec. 6. Minnesota Statutes 1992, section 18F.07, is
amended to read:
18F.07 [GENETICALLY ENGINEERED PLANT AGRICULTURALLY RELATED
ORGANISM PERMIT.]
Subdivision 1. [REQUIREMENT.] A person may not conduct a
release of a genetically engineered plant agriculturally related
organism until a permit for the release has been obtained from
the commissioner. Each release of a plant genetically
engineered agriculturally related organism requires a new permit
until the commissioner determines by rule that the plant
proposed use of the agriculturally related organism is no longer
subject to regulation under this chapter.
Subd. 2. [PERMIT APPLICATION AND REVIEW.] (a) After
reviewing a completed application, the commissioner may issue a
genetically engineered plant agriculturally related organism
permit if the commissioner determines that the applicant has
adequately demonstrated that the proposed release does not have
the potential for unreasonable adverse effects on the
environment. The commissioner may prescribe terms and
conditions including, but not limited to, the period for the
genetically engineered plant agriculturally related organism
permit, the amount or number of genetically engineered plants
agriculturally related organisms to be used, monitoring
activities, department inspection schedules, reporting of
experiment results, and experiment termination procedures. A
person may not violate terms or conditions of a permit issued
under this section. After a genetically engineered plant
agriculturally related organism permit is issued, the
commissioner may revoke or change the 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 the environment.
(b) The commissioner may deny issuance of a genetically
engineered plant agriculturally related organism permit if the
commissioner determines that the use to be made of the plant
agriculturally related organisms under the proposed terms and
conditions may cause unreasonable adverse effects on the
environment.
Subd. 3. [APPLICATION.] A person shall file an application
for a genetically engineered plant agriculturally related
organism permit with the commissioner. The application must
include:
(1) the name and address of the applicant;
(2) any United States Environmental Protection Agency,
United States Department of Agriculture, or other federal agency
regulatory application or approval document, if required under
federal law or rule;
(3) the purpose or objectives of the plant agriculturally
related organism;
(4) the name, address, and telephone number of cooperators
or participants in this state;
(5) the amount of plants, plant material or number of
organisms, materials, cultures, or seeds to be shipped or used
in this state; and
(6) other information requested by the commissioner.
Subd. 4. [APPLICATION FEE.] An application for a permit
for a genetically engineered plant agriculturally related
organism must be accompanied by a nonrefundable application fee
of $125.
Sec. 7. Minnesota Statutes 1992, section 18F.12, is
amended to read:
18F.12 [RULES.]
The commissioner shall adopt rules governing the issuance
of permits for proposed releases of genetically engineered
plants agriculturally related organisms, experimental
genetically engineered pesticides, and genetically engineered
fertilizers, genetically engineered soil amendments, and
genetically engineered plant amendments. The rules must include
a requirement for environmental review subject to the provisions
of chapter 116D and rules adopted under it. The rules must also
include provisions requiring concurrent permit review for
proposed releases that would require more than one permit under
this chapter, chapter 18B or 18C.
Sec. 8. [18F.13] [EXEMPTIONS.]
(a) The commissioner may provide exemptions to the
requirements to prepare an environmental assessment worksheet
and obtain a permit for release of genetically engineered
agriculturally related organisms for which substantial evidence,
including past releases, has shown that the organism can be
released without adverse effects on humans and the environment.
(b) The commissioner may provide exemptions from the
requirements to prepare an environmental assessment worksheet
and obtain a permit for release of genetically engineered
agriculturally related organisms for which substantial evidence,
including past releases, has shown that the organism can be
released under alternative oversight without adverse effects to
humans and the environment.
Sec. 9. Minnesota Statutes 1992, section 116C.91,
subdivision 1, is amended to read:
Subdivision 1. [SCOPE.] As used in sections 116C.91 to
116C.95 116C.98, the terms defined in this section have the
meanings given them.
Sec. 10. Minnesota Statutes 1992, section 116C.94, is
amended to read:
116C.94 [RULES.]
(a) Subdivision 1. [GENERAL AUTHORITY.] The board shall
adopt rules consistent with sections 116C.91 to 116C.96 that
require an environmental assessment worksheet and otherwise
comply with chapter 116D and rules adopted under it for a
proposed release and a permit for a release. The board may
place conditions on a permit and may deny, modify, suspend, or
revoke a permit.
(b) Subd. 2. [SIGNIFICANT ENVIRONMENTAL PERMIT.] The rules
shall provide that a permit from the board is not required if
the proposer can demonstrate to the board that a significant
environmental permit is required for the proposal by another
state agency the board shall authorize an agency with a
significant environmental permit to administer the regulatory
oversight for the release of certain genetically engineered
organisms.
(c) A person proposing a release for which a federal permit
is required may apply to the board for an exemption from the
board's permit or to an agency with a significant environmental
permit for the proposed release for an exemption from the
agency's permit. The proposer must file with the board or
agency, within 14 days of filing a federal application, a
written request for exemption with a copy of the federal
application and the information necessary to determine if there
is a potential for significant environmental effects under
chapter 116D and rules adopted under it. The board or agency
shall give public notice of the request in the first available
issue of the EQB Monitor and shall provide an opportunity for
public comment on the environmental review process consistent
with chapter 116D and rules adopted under it. The board or
agency may grant the exemption if the board or agency finds that
the federal permit issued is in compliance with the requirements
of chapter 116D and rules adopted under it and any other
requirement of the board's or agency's authority regarding the
release of genetically engineered organisms. The board or
agency must grant or deny the exemption within 45 days after the
receipt of the federal permit.
(d) Subd. 3. [COMMERCIALIZATION.] The board may adopt
rules providing exemptions to the requirements to prepare an
environmental assessment worksheet and obtain a permit for
releases of genetically engineered organisms for which
substantial evidence from past releases has shown to the board's
satisfaction that the organism can be released without
jeopardizing public health or the environment.
(e) Subd. 4. [ALTERNATIVE REGULATORY OVERSIGHT.] The board
may adopt rules providing alternative regulatory oversight to
the requirements to prepare an environmental assessment
worksheet and obtain a permit for releases of genetically
engineered organisms for which substantial evidence from past
experience, including releases and laboratory data, has shown to
the board's satisfaction that the alternative oversight will
protect public health and the environment.
(f) Subd. 5. [RULES; FEDERAL OVERSIGHT.] The board may
adopt rules to implement the authorities granted to it in
section 116C.97, subdivision 2.
(g) Subd. 6. [CONSULTATION.] The board shall consult with
local units of government and with private citizens before
adopting any rules.
Sec. 11. Minnesota Statutes 1992, section 116C.96, is
amended to read:
116C.96 [COST REIMBURSEMENT.]
The board shall assess the proposer of a release for the
necessary and reasonable costs of processing exemptions from a
release permit under rules authorized by sections 116C.94,
subdivisions 1, 3, and 4, and 116C.97, subdivision 2, paragraph
(c), or applications for a release permit. An estimated budget
shall be prepared for each exemption or application by the chair
of the board. The proposer must remit 25 percent of the
estimated budget within 14 days of the receipt of the estimated
budget from the chair. The unpaid balance shall be billed in
periodic installments, due upon receipt of an invoice from the
chair. Costs in excess of the estimated budget must be
certified by the board and upon certification constitute prima
facie evidence that the expenses are reasonable and necessary
and shall be charged to the proposer. The proposer may review
all actual costs and present objections to the board, which may
modify the cost or determine that the cost assessed is
reasonable. The assessment paid by the proposer shall not
exceed the sum of the costs incurred. All money received under
this section shall be deposited in the special account
established under section 116D.045, subdivision 3, for the
purpose of paying costs incurred in processing exemptions and
applications.
Sec. 12. [116C.97] [EXEMPTIONS.]
Subdivision 1. [HUMAN GENE THERAPY.] The requirements of
sections 116C.91 to 116C.96 and of the rules of the board
adopted pursuant to section 116C.94 do not apply to genetic
engineering of human germ cells and human somatic cells intended
for use in human gene therapy.
Subd. 2. [FEDERAL OVERSIGHT.] (a) If the board determines,
upon its own volition or at the request of any person, that a
federal program exists for regulating the release of certain
genetically engineered organisms and the federal oversight under
the program is adequate to protect human health or the
environment, then any person may release such genetically
engineered organisms after obtaining the necessary federal
approval and without obtaining a state release permit or a
significant environmental permit or complying with the other
requirements of sections 116C.91 to 116C.96 and the rules of the
board adopted pursuant to section 116C.94.
(b) If the board determines the federal program is adequate
to meet only certain requirements of sections 116C.91 to 116C.96
and the rules of the board adopted pursuant to section 116C.94,
the board may exempt such releases from those requirements.
(c) A person proposing a release for which a federal
authorization is required may apply to the board for an
exemption from the board's permit or to a state agency with a
significant environmental permit for the proposed release for an
exemption from the agency's permit. The proposer must file with
the board or state agency a written request for exemption with a
copy of the federal application and the information necessary to
determine if there is a potential for significant environmental
effects under chapter 116D and rules adopted under it. The
board or state agency shall give public notice of the request in
the first available issue of the EQB Monitor and shall provide
an opportunity for public comment on the environmental review
process consistent with chapter 116D and rules adopted under
it. The board or state agency may grant the exemption if the
board or state agency finds that the federal authorization
issued is adequate to meet the requirements of chapter 116D and
rules adopted under it and any other requirement of the board's
or state agency's authority regarding the release of genetically
engineered organisms. The board or state agency must grant or
deny the exemption within 45 days after the receipt of the
written request and the information required by the board or
state agency.
Sec. 13. [116C.98] [NOTIFICATION FOR THE RELEASE OF
CERTAIN GENETICALLY ENGINEERED PLANTS.]
Subdivision 1. [GENERAL.] Certain genetically engineered
plants may be released without the regulatory oversight under
section 116C.94, provided that the release is in compliance with
the requirements of this section. Any other release of
genetically engineered organisms requires regulatory oversight
under section 116C.94 unless it is exempt under section 116C.97.
Subd. 2. [GENETICALLY ENGINEERED PLANTS ELIGIBLE FOR USE
UNDER THE NOTIFICATION PROCEDURE.] (a) Genetically engineered
plants which meet the eligibility criteria of paragraphs (b) to
(g) and whose release meets the performance standards in
subdivision 3 are eligible for release under the notification
procedure of subdivision 4.
(b) 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) any additional plant species that the commissioner of
agriculture, after public notice and after complying with
chapter 116D and the rules adopted under it, has determined may
be safely used in accordance with the organism eligibility
criteria set forth in paragraphs (c) to (g) and the release
performance standards set forth in subdivision 3.
(c) The genetically engineered material is stably
integrated in the plant genome.
(d) The function of the genetically engineered material is
known and its expression in the genetically engineered organism
does not result in plant disease.
(e) 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.
(f) The genetically engineered sequences 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.
(g) 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.
Subd. 3. [PERFORMANCE STANDARDS FOR RELEASES UNDER THE
NOTIFICATION PROCEDURE.] (a) The performance standards in this
subdivision 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 destination 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 identify of all 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 a viable vector agent associated with the
genetically engineered plants.
(f) The field trial must be conducted such 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 shall remain which is likely to
volunteer in subsequent seasons; or
(2) plant volunteers shall be managed to prevent
persistence in the environment.
Subd. 4. [NOTIFICATION PROCEDURE.] (a) Notification shall
be directed to the commissioner of agriculture.
(b) The notification shall include the following:
(1) name, title, address, telephone number, and signature
of the responsible person;
(2) information necessary to identify the genetically
engineered plant or plants, including:
(i) the scientific, common, or trade names, and phenotype
of the genetically engineered plant;
(ii) the designations for the genetic loci, the encoded
proteins or functions, and donor organisms for all genes from
which used genetic material was derived; and
(iii) the method by which the recipient was transformed;
(3) 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;
(4) the expected date of release and the expected duration
of the release; and
(5) a statement that certifies that use of the genetically
engineered organism will be in accordance with the provisions of
this section.
(c) Notification must be submitted at least 30 days prior
to the day of use.
(d) Release reports may be required by the commissioner of
agriculture. Release reports shall include:
(1) the release identification number;
(2) methods of observation, resulting data, and analysis
regarding all deleterious effects on plants, nontarget
organisms, or the environment; and
(3) any other available information requested by the
commissioner of agriculture or the chair of the board regarding
the impact of the genetically engineered organism on human
health or the environment.
(e) The commissioner of agriculture shall be notified of
any unexpected occurrences relating to the release.
(f) Access shall 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
subdivisions 2 and 3.
Subd. 5. [ADMINISTRATIVE ACTION IN RESPONSE TO
NOTIFICATION.] (a) The commissioner of agriculture shall publish
notice of the proposed release at the earliest opportunity in
the EQB Monitor and shall mail notice to the chief executive of
the county within which the release will take place.
(b) The commissioner of agriculture 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
use of that genetically engineered plant without prejudice.
(d) The commissioner of agriculture shall notify the chair
of the board of any unexpected occurrences relating to the
release.
Subd. 6. [REPEALER.] When the commissioner of agriculture
adopts rules under section 8, paragraph (b), this section is
repealed.
Sec. 14. [REPEALER.]
Minnesota Statutes 1992, section 18F.02, subdivision 7, is
repealed.
Sec. 15. [EFFECTIVE DATE.]
This act is effective the day following final enactment.
Presented to the governor April 14, 1994
Signed by the governor April 18, 1994, 3:07 p.m.
Official Publication of the State of Minnesota
Revisor of Statutes