--NEW LAW--

OKLAHOMA AGRICULTURE BIOTECHNOLOGY ACT

2 O.S.  1990 SUPPLEMENT SECTIONS 2011 THRU 2019

AN ACT RELATING TO AGRICULTURE; PROVIDING SHORT TITLE; CREATING THE OKLAHOMA AGRICULTURE BIOTECHNOLOGY ACT; STATING PURPOSE; DEFINING TERMS; PROVIDING FOR REGULATION OF CERTAIN PERSONS AND ARTICLES; PROVIDING FOR PROMULGATION OF RULES; ADDING TO POWERS AND DUTIES OF THE STATE BOARD OF AGRICULTURE AND THE DEPARTMENT OF AGRICULTURE; PROVIDING FOR ENFORCEMENT; ESTABLISHING PROCEDURE FOR DISCLOSURE OF CONFIDENTIAL INFORMATION; PROVIDING CERTAIN PROCEDURES; ESTABLISHING FEES; PROVIDING FOR CRIMINAL AND ADMINISTRATIVE PENALTIES;  PROVIDING FOR CODIFICATION;  AND DECLARING AN EMERGENCY.

BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

          SECTION 2011               This act shall be known and may be cited as the “Oklahoma Agriculture Biotechnology Act.”

          SECTION 2012               The Purpose of this act is to protect agriculture and public health from intentional or unintentional release of genetically engineered biological articles into the environment.

          SECTION 2013               As used in the Oklahoma Agriculture Biotechnology Act:

1.                “Board” means the State Board of Agriculture, or an authorized agent of the Board;

2.                “Donor” means the organism from which genetic material is obtained for transfer to the recipient organism;

3.                “Environment” means all of the land, air, and water and any organism that is living in association with these elements;

4.                “Gene” means the unit of heredity within an organism;

5.                “Genetic engineering” means the technology used to manipulate or alter an organism’s genetic material through recombinant DNA or RNA techniques;

6.                “Organisms” means any life stage form of microorganisms, viruses, plants, invertebrate animals, such as insects, or vertebrate animals, including livestock, which is capable of supplying genetic materials or affecting the genetic expression of another living entity;

7.                “Permit” means a document issued by the Board authorizing a person to maintain, manipulate, and/or release a regulated article into the environment;

8.                “Person” means any individual, partnership, firm, corporation, company, association, organized groups whether incorporated or not or any other legal entity;

9.                “Quarantine” means the isolation and/or safeguarding of an organism to prevent it from becoming established in the environment;

10.           “Recombinant DNA or RNA” means hybrid molecules constructed outside or inside an organism by joining, deleting, or rearranging natural or synthetic DNA (deoxyribonucleic acid)  or RNA ( ribonucleic acid);

11.           “Release into the environment” means the use of a regulated article outside the constraints of physical confinement that are found in a laboratory, greenhouse, or a fermenter or other contained structure;

12.           “Vector or vector agent” means an organism or object used to transfer genetic material from the donor organism to the recipient organism;  and

13.           “Regulated article” means any organism altered or produced through genetic engineering.

SECTION 2014            A.  A designated employee of the Board shall have the authority to inspect any premise within this state when such employee has reasonable grounds to believe that activity governed by this act is or may be occurring during regular business hours to determine if the provisions of this act are being carried out and the environment is being protected from the possibility of being contaminated by a regulated article.

B.            The Board is authorized to promulgate those rules and regulations needed for the control of regulated articles as authorized by the Oklahoma Agriculture Biotechnology Act.  All rules and regulations shall be promulgated pursuant to the Oklahoma Administrative Procedures Act, Section 215 et seq. and Section 301 et seq. of Title 75 of the Oklahoma Statues.

          SECTION 2015          A.  In submitting information pursuant to this act, an applicant for a permit may designate as “confidential” any portions thereof 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 State Board of Agriculture may prescribe.  Information designated as “confidential” may be submitted separately from other material submitted.

B.                Information that would be protected from disclosure under the Freedom of Information Act (5 U.S.C. 552(b) (4) ) will be classified as Confidential Business Information (CBI).  This includes trade secrets and commercial or financial information found to be confidential.

C.                Documents containing trade secrets and which the person submitting asserts are trade secrets will be deemed CBI.  “Trade secrets” means information relating to the production process.  This includes production data, formulas, and processes and quality control tests and data, as well as research methodology and data generated in the development of the production process.  Such information must be:

1.     Commercially valuable;

2.     Used in one’s business; and

3.     Maintained in secrecy.

D.               Documents containing commercial or financial information will be deemed confidential if review established that substantial competitive harm would result from disclosure.  Information such as safety data, efficacy or potency data, and environmental data may be such confidential information.  Persons desiring protection for confidential information must submit a detailed statement containing facts to show that the person faces active competition in the area to which the information relates, and that substantial competitive harm would result from disclosure.

E.                The applicant may withdraw the application at any time by providing written notice to the Board.  If the application is withdrawn, all confidential business information shall be returned to the applicant and shall not be disclosed.

F.                 Except as provided herein, no person shall reveal or use for his own benefit any confidential business information received pursuant to this act.

SECTION 2016                    A.  The State Board of Agriculture shall have the authority to issue, renew, deny, suspend, and revoke any permit issued according to the provisions of the Oklahoma Agriculture Biotechnology Act.

B.                   No person shall  maintain a regulated article without a permit issued by the Board.

C.           All persons who have filed Assurances of Compliance with federally established guidelines with their Institutional Biosafety Committee and/or applied for regulatory approval(s) from the appropriate federal agency, will be exempt from the provisions of this act.

D.          Any person not in compliance with a federal agency shall provide the Board with the following information prior to issuance of same:

1.                 Name, title, address, telephone number, signature of the responsible person and type of permit requested (for importation, interstate movement, or release into the environment);

2.                 All scientific, common, and trade names, and all designations necessary to identify the:  Donor organism(s); recipient organism(s); vector or vector agent(s); constituent of each regulated article which is a product; and regulated article;

3.                 Names, addresses, and telephone numbers of the persons who developed and/or supplied the regulated article;

4.                 A description of the means of movement (e.g., mail, common carrier, baggage, or hand carried (and by whom));

5.                 A description of the anticipated or actual expression of the altered genetic material in the regulated article and how that expression differs from the expression in the nonmodified parental organism (e.g., morphological or structural characteristics, physiological activities and processes, number of copies of inserted genetic material and physical state of this material inside the recipient organism (integrated or extra chromosomal), products and secretions, growth characteristics);

6.                 A detailed description of the molecular biology of the system (e.g., donor-recipient-vector) which is or will be used to produce the regulated article;

7.                 Country and locality where the donor organism, recipient organism, vector or vector agent, and regulated article were collected, developed, and produced;

8.                 A detailed description of the purpose for the introduction of the regulated article including a detailed description of the proposed experimental and/or production design;

9.                 The quantity of the regulated article to be introduced     and proposed schedule and number of introductions;

10.            A detailed description of the processes, procedures, and safeguards which have been used or will be used in the country of origin and in the United States to prevent contamination, release, and dissemination in the production of the:  Donor organism; recipient organism; vector or vector agent; constituent of each regulated article which is a product; and regulated article;

11.            A detailed description of the intended destination (including final and all intermediate destinations), uses, and/or distribution of the regulated article (e.g., greenhouses, laboratory, or growth chamber location; field trial location; pilot project location; production, propagation, and manufacture location; proposed sale distribution location);

12.                A detailed description of the proposed procedures, processes, and safeguards which will be used to prevent escape and dissemination of the regulated article at each of the intended destinations;

13.      A detailed description of any biological material (e.g.,  culture medium, or host material)  accompanying the regulated article during movement; and

14.      A detailed description of the proposed method of final   disposition of the regulated article.

E.                Any person or their employees who is issued a permit shall comply with regulations established by the Board as are necessary to prevent the uncontrolled dissemination and establishment of a regulated article in the environment. 

F.                In accordance with the administration of this act, the Board is given the authority to charge the following fee schedule:  A fee of One Hundred Dollars ($100.00) shall be charged each person for a permit to develop, maintain, manipulate and/or release a regulated article.  The fees shall be deposited in the State Department of Agriculture Revolving Fund.

SECTION 2017           It shall be a violation of the Oklahoma Agriculture Biotechnology Act for any person not exempt from the provisions of this Act:

1.                 To maintain a regulated article without a permit from the State Board of Agriculture;

2.                 To move a regulated article without permission;

3.                 To release a regulated article into the environment without a permit;

4.                 To fail to comply with a quarantine or destruction order; and

5.                 To fail to pay a permit fee.

SECTION 2018          A.    Any person violating the provisions of the Oklahoma Agriculture Biotechnology Act shall, upon conviction in a court of competent jurisdiction, be guilty of a misdemeanor and may be punished by a fine of not less than One Thousand Dollars ($1,000.00)  nor more than Ten Thousand Dollars ($10,000.00).  For the purposes of this section, each day upon which a violation is committed or is permitted to continue shall be deemed a separate offense.

B.                If, after public hearing in accordance with the Administrative Procedures Act, Section 215 et seq. and Section 301 et. seq. of Title 75 of the Oklahoma Statutes, the Board shall find any person to be in violation of any of the provisions of this act, the State Board of Agriculture has the authority to assess, after notice and hearing, an administrative penalty of not less than One Hundred Dollars ($100.00) and not more than One Thousand Dollars ($1,000.00) for each violation.  For the purpose of this section, each day upon which a violation is committed or is permitted to continue shall be deemed a separate offense.

SECTION 2019          It being immediately necessary for the preservation of the public peace, health and safety, an emergency is hereby declared to exist, by reason whereof this act shall take effect and be in full force from and after its passage and approval.