GENERAL ASSEMBLY OF NORTH CAROLINA

SESSION 1989

H	1 

HOUSE BILL 748

Short Title:  Genetic Engineering Act.	(Public)
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Sponsors: Representative Rogers.
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Referred to:  Basic Resources.
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March 20, 1989

A BILL TO BE ENTITLED
AN ACT TO REGULATE THE RELEASE AND COMMERCIAL USE OF GENETICALLY ENGINEERED ORGANISMS.
The General Assembly of North Carolina enacts:
Section 1.  Chapter 106 of the General Statutes is amended by adding a new Article to read:
“ARTICLE 63.
"Genetically Engineered Organisms Act.
"§ 106-755.  Declaration of findings.
The General Assembly of North Carolina finds and declares that biotechnology has enormous potential to benefit many fields of human endeavor, including agriculture, health care, and environmental protection, and that North Carolina, as a center for the agricultural, pharmaceutical, health care, fermentation, chemical, and food processing industries has much to gain from advances in biotechnology and genetic engineering.
The General Assembly further finds that as products of biotechnology move from contained laboratories into the environment for testing and commercialization, the citizens of North Carolina may have concerns about the potential effects of planned introductions of new genetically engineered organisms on agriculture, public health, and the natural environment.  While the majority of these introductions will be environmentally benign and comparable to the introduction of new genetic entities derived from selective breeding, certain introductions might pose unknown risks and, as such, require appropriate oversight.
The General Assembly therefore determines that it is incumbent upon the State, working in concert with the federal regulatory authorities, to take responsible, timely and minimally burdensome measures to ensure that the public and the environment are protected and that risks from the environmental use of new genetically engineered organisms are promptly addressed, while simultaneously allowing biotechnological research and product development to advance.  To do so, the State will create, in the Department of Agriculture, a Genetic Engineering Review Board responsible for reviewing and approving proposed introductions of genetically engineered organisms into the environment.  This Board will allow the State, in cooperation with the federal authorities, to assess the potential risks and effects of releases of genetically engineered organisms without undue governmental interference with the progress and commercial development of biotechnology.
"§ 106-756.  Title.
This Article shall be known as the ‘Genetically Engineered Organisms Act.'
"§ 106-757.  Purpose.
The purpose of this Article is to regulate the release and commercial use of genetically engineered organisms in order to protect agriculture, public health, and the environment.  This Article does not apply to the breeding of plants, animals, and other organisms by traditional methods, such as artificial insemination or hand pollination.
"§ 106-758.  Definitions.
As used in this Article:
(1)	‘Adverse effect' means physical injury to agriculture, public health, or the environment.
(2)	‘Board' means the Genetic Engineering Review Board.
(3)	‘Commercial use' means the sale, offering for sale, or distribution of a genetically engineered organism.
(4)	‘Commissioner' means the Commissioner of Agriculture.
(5)	‘Department' means the Department of Agriculture.
(6)	‘Genetic engineering' means the introduction of new genetic material to an organism or the regrouping of an organism's genes, except for the breeding of plants, animals, and other organisms by traditional methods, such as artificial insemination or hand pollination, and such other methods as may be designated by the Board under G.S. 106-760.
(7)	‘Genetically engineered organism' means a living organism derived from genetic engineering.
(8)	‘Organism' means any animal, plant, bacterium, cyanobacterium, fungus, protist, or virus.
(9)	‘Release' means the placement or use of a genetically engineered organism outside a contained laboratory, fermentation facility, greenhouse, building, structure, or other similar facility or under any other conditions not specifically determined by the Board to be adequately contained.
"§ 106-759.  Genetic Engineering Review Board.
(a)	There is created the Genetic Engineering Review Board in the Department of Agriculture.  The Board shall consist of nine members as follows:
(1)	The Secretary of the Department of Natural Resources and Community Development or his designee;
(2)	The Secretary of Human Resources or his designee;
(3)	The Commissioner of Agriculture or his designee;
(4)	The President of the North Carolina Biotechnology Center or his designee;
(5)	The Dean of the College of Agriculture and Life Sciences at North Carolina State University or his designee;
(6)	The Dean of the School of Public Health of The University of North Carolina at Chapel Hill or his designee;
(7)	A practicing farmer who is an active member of a farm organization, appointed by the General Assembly upon the recommendation of the Speaker of the House of Representatives;
(8)	A representative of a nonprofit public interest organization appointed by the General Assembly upon the recommendation of the President Pro Tempore of the Senate; and
(9)	A representative of the biotechnology industry appointed by the Governor.
(b)	The appointed members of the Board shall serve for three-year terms.  Members designated by an ex officio member shall serve at the pleasure of the ex officio member.  Appointments and designations shall be made within 60 days after the effective date of this Article.
(c)	A chairman shall be elected by the Board from among its members for a one-year term, and shall serve no more than two consecutive terms.  The Commissioner of Agriculture may appoint a member of the Board to serve as interim chairman for one year or until the Board elects a chairman, whichever is sooner.
(d)	Any vacancies shall be filled by the appropriate appointing authority.  Any appointment to fill a vacancy on the Board created by resignation, dismissal, death, disability or any cause shall be for the balance of the unexpired term.  Vacancies in appointments made by the General Assembly shall be filled in accordance with G.S. 120-122.  Any appointed member of the Board may be removed by the appointing authority for misfeasance, malfeasance or nonfeasance.
(e)	The members of the Board who are not State employees shall receive per diem and travel and subsistence allowances as provided by law.  All clerical and other services required by the Board shall be supplied by the Department of Agriculture.  A majority of the Board shall constitute a quorum for the transaction of business.  Rule making and administrative proceedings shall be governed by the North Carolina Administrative Procedure Act.
"§ 106-760.  Board's powers and duties.
(a)	The Board shall:
(1)	Delegate to the Commissioner any of its duties, other than rule making, but including issuance of permits, as the Board deems necessary or convenient for the administration and enforcement of this Article; and
(2)	Adopt regulations designating those activities that will not be treated as genetic engineering for the purposes of this Article.
(b)	The Board may:
(1)	Grant, deny, suspend, modify or revoke permits as provided by this Article, and charge fees for such permits, not to exceed two hundred fifty dollars ($250.00);
(2)	Adopt, amend, or revoke regulations to implement and carry out the purposes of this Article; and
(3)	Establish advisory committees to assist the Board in carrying out its duties.
"§ 106-761.  Commissioner's powers and duties.
The Commissioner may:
(1)	Enforce this Article, administer the permit process, and  exercise the powers and duties imposed upon him by this Article or by rules adopted in accordance with this Article; and  
(2)	Designate such employees of the North Carolina Department of Agriculture, and  enter into cooperative agreements with federal and State agencies, as may be necessary to carry out the duties and exercise the powers provided by this Article.
"§ 106-762.  Permits required; applications; federal review; permit revocation.
(a)	A genetically engineered organism may not be released into the environment, or sold, offered for sale, or distributed for release into the environment unless a permit for its release has been issued pursuant to this Article.  The Board may, by regulation, provide for general permits for classes of activities for which individual permits will not be required.
(b)	Permit applications shall be on forms or in the format prescribed by the Board, and shall include such information as the Board deems necessary in order to determine compliance with this Article.  To the extent feasible, the Board shall authorize the use of forms or formats required by the federal government for actions similar to those regulated under this Article.  Applicants shall, upon request by the Board, submit copies of data submitted with corresponding federal permit applications.
(c)	The Board may require such additional data as it deems necessary to determine potential adverse effects of the release of the organism on agriculture, public health, and the environment.  To the extent possible, the Board shall accept for review and base its decision on the data submitted with the federal application.
(d)	The Board may, if it deems it necessary to protect agriculture, public health, or the environment from potential adverse effects of the release of a genetically engineered organism:
(1)	Place restrictions on the number and location of organisms released, method of release, training of persons involved with the release of organisms, disposal of organisms, and other conditions of use;
(2)	Require measures to limit dispersal of released organisms or spread of inserted genes or gene products;
(3)	Require monitoring of the abundance and dispersal of the released organism or inserted genes or gene products; and
(4)	Deny, suspend, modify, or revoke the permit.
(e)	The Board may submit written comments to any federal agency reviewing a proposed or completed release, and otherwise participate in any such reviews.  The Board may issue a permit under this Article based on the federal review and approval of the proposed release if the Board determines that federal regulation of the release sufficiently protects agriculture, public health, and the environment in North Carolina.  The Board shall minimize duplication of federal regulatory requirements to the extent possible.
(f)	The Board may deny, suspend, modify, or revoke a permit for failure to comply with this Article or with any rule adopted in accordance with this Article.  Such proceedings shall be in accordance with the Administrative Procedure Act.  The Board may summarily suspend a permit in accordance with G.S. 150B-3, pending further proceedings, if the Board determines that an adverse effect is occurring or is likely to occur because of a release authorized by such permit.
(g)	A decision shall be made on a permit application within 90 days from the date the completed application is received by the Board, unless a public hearing is held pursuant to G.S. 106-763.  The Board may, for good cause, extend the time for making a decision by no more than 30 days.
(h)	Issuance of permits under this Article is not subject to the provisions of Article I of Chapter 113A.
(i)	An application may be withdrawn at any time by written notice to the Board.
"§ 106-763.  Public notice of releases; public hearing.
(a)	Within 15 days after receiving a completed application for a proposed release, the Board shall publish notice and a brief description of the proposed release, unless the Board intends to deny the application.  Notice shall also be provided to any person who has filed a written request to be notified of such releases.  The Board shall prescribe the form, content and extent of the notice.  However, at a minimum, notice shall be given by publication one time in a newspaper having general circulation in each county where the release is proposed to be made.  In addition, subject to the provisions of this Article regarding confidential business information, any documents submitted as part of the application shall be available for public inspection or copying at or near the site of the proposed release and at the offices of the Board.  Any person may submit written comments to the Board regarding the proposed release.
(b)	Any person may request a public hearing on a permit application by filing a written request with the Board within 30 days after the date of the notice of the application.  The Board shall consider all such requests for hearing and, if it determines that there is significant public interest and justification for holding such a hearing, a hearing shall be held in the county where the release is proposed to be made.  If the Board determines that a public hearing should be held, it may do so even though no hearing has been requested.  Notice of the hearing shall be published at least 30 days before the hearing date.  The Board shall prescribe the form, content, and extent of the notice.  However, at a minimum, notice shall be given by publication one time in a newspaper having general circulation in each county where the release is proposed to be made.
(c)	If a public hearing is held, a decision shall be made on the permit application within 120 days after the date the completed application is received by the Board.  The Board may, for good cause, extend the time for making a decision by no more than 30 additional days.
(d)	The Board may, with the written consent of the applicant, extend the period to review the application.
"§ 106-764.  Confidential business information.
(a)	In submitting information pursuant to this Article, an applicant for a permit may designate as ‘confidential' any portions of which the applicant believes are entitled to treatment as confidential business information.  A designation of confidentiality shall be made in writing and in such manner as the Board may prescribe.  Information designated as ‘confidential' may be submitted separately from other material submitted.
(b)	Any person engaged in the review of the effects of a proposed release of a genetically engineered organism who believes that access to undisclosed confidential business information is necessary in order to perform such review effectively may request the disclosure of material designated as confidential business information by submitting a written petition to the Board.  Such a petition shall state the reasons that such confidential business information is necessary to the performance of the petitioner's review.  The party who made the designation of confidentiality shall be notified of the petition and shall have an opportunity to respond to the petition.  By mutual written agreement of the petitioner and the applicant, the Board may delay a  decision on the petition until further written notice by the petitioner.  Where the Board determines that the petitioner does require access to the confidential business information in order to make an effective, independent review of the proposed release, the Board shall notify the applicant, and the applicant shall provide the information to the petitioner.  If the application is withdrawn, all confidential business information shall be returned to the applicant and shall not be disclosed.
(c)	Except as provided in this Article, no person may reveal or use for his own benefit any confidential business information received pursuant to this Article.
(d)	Nothing in this section, or in rules adopted under this section, authorizes the Board or any person to withhold from the public information regarding the adverse effects of a proposed release of any organism.
"§ 106-765.  Local regulation.
No county municipality shall enact any regulation or ordinance regulating the release of genetically engineered organisms.
"§ 106-766.  Unlawful acts; penalties; injunctions.
(a)	No genetically engineered organism may be released, sold, offered for sale, or distributed in violation of this Article or rules adopted in accordance with this Article.
(b)	A civil penalty of not more than ten thousand dollars ($10,000) may be assessed by the Board against any person who violates any provision of this Article or any rule of the Board.  In determining the amount of the penalty, the Board may consider the degree and extent of harm caused by the violation.  No civil penalty may be assessed under this section unless the person has been given the opportunity for a hearing pursuant to the Administrative Procedure Act. Each day's violation shall constitute a separate offense.
(c)	A person who interferes with or attempts to interfere with the Commissioner or any of his agents while engaged in the performance of their duties under this Article, or violates any provision of this Article or any rule of the Board, is guilty of a misdemeanor and is punishable by a fine of not less than two hundred fifty dollars ($250.00) nor more than one thousand dollars ($1,000) for each offense.  Each day's violation shall constitute a separate offense.
(d)	Notwithstanding any remedy at law, the Commissioner is authorized to apply to the Superior Court, and the court shall have jurisdiction upon hearing and for cause shown, to grant a temporary or permanent injunction to prevent or stop a violation of this Article."
Sec. 2.  There is appropriated from the General Fund to the Department of Agriculture the sum of two hundred thirty-eight thousand five hundred fourteen dollars ($238,514) for the 1989-90 fiscal year and the sum of one hundred seventy-seven thousand five hundred eighty-five dollars ($177,585) dollars for the 1990-91 fiscal year for implementation and enforcement of this act.
Sec. 3.  This act is effective upon ratification, but no permits shall be required under G.S. 106-762 until July 1, 1990.