AN ACT Relating to the release and use of genetically engineered organisms in the environment; adding a new chapter to Title 15 RCW; adding new sections to chapter 43.131 RCW; creating a new section; prescribing penalties; and making an appropriation.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION. Sec. 1. FINDINGS. The legislature finds that genetic engineering has an enormous potential to benefit many fields of human endeavor by providing new services and products for human health, crop protection, veterinary medicine, and pollution control; that the United States is now a world leader in biotechnology and this leadership is derived from a strong science base, vigorous entrepreneurial spirit, and the availability of venture capital; and that the state of Washington is becoming a recognized center for the agricultural, health care, pharmaceutical, chemical, and food processing industries, all of which now benefit from, and will increasingly depend upon, advances in biotechnology.

The legislature further finds that as the products of biotechnology move from contained research laboratories into contact with the environment through commercial testing and applications, the protection of human health and the environment must be assured. The legislature, therefore, determines that it is incumbent upon the state to take responsible and timely measures to ensure that the public health and safety and the environment are protected; that societal concerns about the impact of biotechnology are promptly addressed while allowing biotechnological research to advance with proper safeguards.

A method of balancing these important factors is to require that the department of agriculture receive adequate advance notice of each release of genetically engineered organisms into the environment and ensure assessment of potential risks to the public and the environment. A biotechnology advisory committee shall also be created to provide expert advice and input on policy formulation to the department on the subject of biotechnology.

NEW SECTION. Sec. 2. DEFINITIONS. The definitions set forth in this section apply throughout this chapter.

(1) "Director" means the director of the department of agriculture.

(2) "Genetically engineered organism" means the genetic modification by recombinant DNA techniques of any active, infective, or dormant stage or life form of an entity characterized as living, including vertebrate and invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-like organisms, as well as entities such as viroids, viruses, or any entity characterized as living, related to the above.

(3) "Environment" means all the land, air, and water, and all living organisms in association with land, air, and water.

(4) "Committee" means the biotechnology advisory committee.

(5) "Local jurisdiction" means a county, city, or town.

(6) "Person" means an individual, firm, corporation, association, partnership, consortium, joint venture, commercial entity, state government agency, unit of local government, or federal government agency.

(7) "Release into the environment" means the use of genetically engineered organisms outside the constraints of physical confinement that are found in a laboratory, contained greenhouse, a fermenter, or other contained structure.

(8) "NIH guidelines" means the federal guidelines for research involving recombinant DNA molecules (51 Fed. Reg. 16958-16985 or as amended).

(9) "Institutional biosafety committee" means a committee formed in accordance with the national institutes of health guidelines (51 Fed. Reg. 16958-16985 or as amended).

(10) "Department" means the Washington state department of agriculture.

(11) "Federal coordinated framework" means the coordinated framework for the regulation of biotechnology (51 Fed. Reg. 23302-23350 or as amended).

NEW SECTION. Sec. 3. BIOTECHNOLOGY ADVISORY COMMITTEE. (1) There is created in the department of agriculture a biotechnology advisory committee, which shall consist of ten members appointed by the governor as follows: (a) The directors of the departments of agriculture, ecology, and social and health services, or their designees; (b) two persons, one selected by the University of Washington and one selected by Washington State University, who have no financial or contractual interest in a biotechnology company or product, representing the scientific community and who have expertise and experience in the techniques and applications of genetic engineering as well as the principles of ecology and environmental science; (c) one person representing local jurisdictions as selected by the Washington association of counties; (d) two persons representing the commercial biotechnology industry; and (e) two representatives of the general public.

(2) The members of the committee shall be appointed within sixty days of the effective date of this act. The members of the committee shall serve without compensation but shall be reimbursed for travel expenses under RCW 43.03.050 and 43.03.060.

NEW SECTION. Sec. 4. REPORT TO GOVERNOR AND LEGISLATURE. (1) The committee shall study, analyze, and review state and federal laws, rules, and regulations that may be applicable to the release into the environment of genetically engineered organisms.

(2) Within eighteen months of the appointment of its members, the committee shall prepare and transmit to the governor and the legislature a report containing the following:

(a) An assessment of the potential impact of the environmental release of genetically engineered organisms on the state's economy, public health and safety, and the environment;

(b) An assessment of whether federal laws and regulations, without state laws or regulations, are adequate to protect the economy, public health and safety, and environment of the state from adverse impacts of the environmental release of genetically engineered organisms; and

(c) Recommendations for the enactment of laws or promulgation of regulations the committee finds necessary and prudent for the state review and oversight of biotechnology activities, including those for governing the environmental release of genetically engineered organisms.

(3) The committee shall also submit biennially beginning July 1, 1991, a report to the governor and legislature concerning the review activities of the committee and the progress of the state's biotechnology industry during the preceding biennium.

NEW SECTION. Sec. 5. REVIEW OF PROPOSED RELEASES OF GENETICALLY ENGINEERED ORGANISMS INTO THE ENVIRONMENT. (1) No person may intentionally release into the environment in this state, or intentionally import or distribute for release into the environment, any genetically engineered organism unless that person gives advance notice of the intended importation, distribution, or release to the department. Notice shall be given in writing within seven days of submission of an application or other written notification under the federal coordinated framework, or, where no federal notification is required, within at least one hundred twenty days prior to an intended importation, distribution, or release under this section, and shall comply with subsection (3) of this section.

(2) If any person accidentally causes any genetically engineered organism to be released into the environment in this state, the person shall notify the department of the accidental release as soon as reasonably possible, but in no event more than seventy-two hours after the person becomes aware of the accidental introduction.

(3) Where federal application or other notification is required, notice under subsections (1) and (2) of this section is limited to copies of all materials provided to the federal administering agency or agencies. It is the intent of this subsection that there be no duplication of federal reporting requirements.

(4) Where federal notification is not required, notice to the department under subsections (1) and (2) of this section shall include all of the following:

(a) The name and address of the person who is responsible for importing, distributing, or introducing the organism into the environment;

(b) A description of the organism which is to be imported, distributed, or introduced into the environment, or which has been accidentally introduced into the environment;

(c) The purpose for which the organism is to be imported, distributed, or introduced, or the purpose for which it was being held when it was accidentally introduced into the environment;

(d) The approximate date on which the organism is to be imported, distributed, or introduced into the environment, or the approximate date and time when the organism was accidentally introduced into the environment;

(e) The identity of every person to whom the organism will be intentionally imported or distributed for introduction into the environment. The persons may be identified as a class if the organism is to be widely distributed. This subsection does not apply to an organism which is accidentally introduced into the environment;

(f) The locations and circumstances under which the organism has been, or will be introduced into the environment, and pertinent conditions governing any intended introduction into the environment; and

(g) In what other states or countries, if any, the proposed introduction has been reviewed and approved for release into the environment.

(5) Where no federal notification is required, participating agencies shall send a notice of completeness to the person submitting materials under subsection (4)(a) of this section within fourteen days of receipt.

(6) In submitting data required by this section, the person shall:

(a) Mark clearly any portions of the material which are trade secrets or commercial or financial information;

(b) Submit such market material separately from other material required to be submitted under this chapter; and

(7) Notwithstanding any other provision of this chapter or other law, the department shall not make public information any material marked as provided in subsection (6) of this section or which in its judgment should be privileged or confidential because it contains or relates to trade secrets or commercial or financial information except that when necessary to carry out this chapter information relating to unpublished formulas of products acquired by authorization of this chapter may be revealed at a public hearing or in findings of fact issued by the department.

(8) If the department proposes to release for inspection, information which the person believes to be protected from disclosure under subsection (7) of this section, the person shall be notified, by certified mail, and provided with a statement that describes, with particularity, the informational material proposed to be released. The department shall not make this data available for inspection until thirty days after receipt of the notice by the person. During this period, the person may institute an action in the superior court of Thurston county for a declaratory judgment as to whether the information is subject to protection under subsection (7) of this section.

(9) The University of Washington and Washington State University faculty and staff shall cooperate and provide assistance to the fullest extent possible, upon the request of the department, during review of a proposed release of a genetically engineered organism into the environment.

(10) The department shall not authorize any proposed release of genetically engineered organisms into the environment without providing public notice and opportunity for public comment.

(11) The department shall review submitted data and shall submit its findings to the applicant and may submit its findings to any federal agency responsible for federal approval. Such department findings shall include a recommendation on whether the proposed release should proceed. No release may proceed until these findings are issued and required federal approvals are granted, or one hundred twenty days from the date of notification under subsection (1) of this section, whichever is first. The department may notify the person in writing that the review period is being extended for up to an additional one hundred twenty days. This section does not preclude the requirements for other state permits, approvals, or reporting requirements for which the person may need to comply.

(12) The notification requirements under subsections (1) and (2) of this section do not apply to an organism which is affirmatively approved for use as a drug under the federal food, drug, and cosmetic act, (21 U.S.C. Sec. 301 et seq.), or which is registered as a pesticide under section 3 of the federal insecticide, fungicide, and rodenticide act (7 U.S.C. Sec. 136 et seq.), to the extent that the release of the organism into the environment is authorized under the terms of that federal approval or registration.

NEW SECTION. Sec. 6. CIVIL PENALTIES. (1) Every person who fails to comply with this chapter or the rules adopted under this chapter may be subject to a civil penalty, as determined by the director, of not more than ten thousand dollars. Each and every such violation shall be a separate and distinct offense. Every person who, through an act of commission or omission, procures, aids, or abets in the violation shall be considered to have violated this section and may be subject to the civil penalty provided in this section.

NEW SECTION. Sec. 7. INJUNCTION AGAINST VIOLATION. The director may bring an action to enjoin the violation or threatened violation of any provision of this chapter or any rule adopted under this chapter in a court of competent jurisdiction of the county in which the violation occurs or is about to occur.

NEW SECTION. Sec. 8. LABORATORY RESEARCH. Persons conducting laboratory work involving genetically engineered organisms shall comply with containment conditions, certification conditions, laboratory practices, reporting requirements, and establishment of institutional biosafety committees, as prescribed by national institutes of health guidelines. Institutional biosafety committees and their members shall be registered with the department.

NEW SECTION. Sec. 9. RULES. The director may adopt rules for the implementation of this chapter under chapter 34.05 RCW.

NEW SECTION. Sec. 10. LOCAL JURISDICTIONS. (1) The department shall provide notice to local jurisdictions sixty days prior to a release of genetically engineered organisms.

(2) The department shall hold a public hearing if requested by the local jurisdiction or ten or more citizens within the local jurisdiction. Such a hearing, if requested, shall be held in that local jurisdiction, and the department shall provide, except in emergency circumstances, a minimum of twenty days public notice of the hearing by publication in a newspaper of general circulation.

NEW SECTION. Sec. 11. ASSISTANCE IN IDENTIFYING REGULATORY REQUIREMENTS. The department shall assist biotechnology companies by identifying all local, state, and federal regulatory requirements pertaining to the environmental release of genetically engineered organisms.

NEW SECTION. Sec. 12. CAPTIONS. Section captions as used in this act do not constitute any part of the law.

NEW SECTION. Sec. 13. APPROPRIATION. The sum of one hundred ninety-seven thousand dollars, or as much thereof as may be necessary, is appropriated for the biennium ending June 30, 1991, from the general fund to the department of agriculture for the purposes of this act.

NEW SECTION. Sec. 14. Sections 1 through 11 of this act shall constitute a new chapter in Title 15 RCW.

NEW SECTION. Sec. 15. A new section is added to chapter 43.131 RCW to read as follows:

BIOTECHNOLOGY ADVISORY COMMITTEE‑-TERMINATION. The biotechnology advisory committee and its powers and duties shall be terminated on June 30, 1995, as provided in section 16 of this act.

NEW SECTION. Sec. 16. A new section is added to chapter 43.131 RCW to read as follows:

BIOTECHNOLOGY ADVISORY COMMITTEE‑-REPEAL. The following acts or parts of acts, as now existing or hereafter amended, are each repealed, effective June 30, 1996:

(1) Section 1 of this act;

(2) Section 2 of this act;

(3) Section 3 of this act;

(4) Section 4 of this act;

(5) Section 5 of this act;

(6) Section 6 of this act;

(7) Section 7 of this act;

(8) Section 8 of this act;

(9) Section 9 of this act;

(10) Section 10 of this act; and

(11) Section 11 of this act.