H-1236

AN ACT Relating to the release and commercial use of genetically engineered organisms and the products of genetically engineered organisms; adding a new chapter to Title 15 RCW; creating a new section; prescribing penalties; making an appropriation; and providing an effective date.

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

NEW SECTION. Sec. 1. The legislature finds that biotechnology has the potential to benefit many fields of human endeavor, including agriculture, health care, and environmental protection. The state of Washington is recognized as a center for agricultural, chemical, forest products, and food processing industries and as such may gain from advances in biotechnology.

The legislature further finds that as products of biotechnology move from contained laboratories into the environment for testing and commercialization, the citizens of Washington will have concerns about the potential effects of planned environmental introductions of genetically engineered organisms and the products of genetically engineered organisms on agriculture, public health and safety, the economy, and the social well-being of the state. While many of these releases may be benign, the introduction of new entities may pose unknown risks and, therefore, require appropriate oversight.

The legislature 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 protect agriculture, public health and safety, the environment, the economy, and the social well-being of the state, and to address concerns regarding the impact of biotechnology while at the same time allowing research to continue and advance with proper safeguards.

To these ends the department of ecology shall create a biotechnology review board responsible for reviewing and, where appropriate, approving proposed introductions of genetically engineered organisms or the products of genetically engineered organisms into the environment. The board shall cooperate with the federal authorities to assess the potential risks and effects of releases of genetically engineered organisms and the products of genetically engineered organisms without undue governmental interference with the progress and development of biotechnology.

NEW SECTION. Sec. 2. As used in this chapter, the following terms have the meanings indicated unless the context clearly requires otherwise.

(1) "Adverse effect" means an injury to or an impact to the detriment of agriculture, the public's health and safety, the environment, the economy, or the social well-being of the state.

(2) "Board" means the biotechnology review board.

(3) "Department" means the department of ecology.

(4) "Director" means the director of the department of ecology.

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

(6) "Federal coordinated framework" means the coordinated framework for the regulation of biotechnology described in 51 C.F.R. Secs. 23302-23350.

(7) "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 other methods as may be designated by the board under section 4 of this act.

(8) "Genetically engineered organism" means a living organism or dormant stage of life derived from genetic engineering.

(9) "Local government" means a county, city, or town.

(10) "Organism" includes any animal, plant, bacterium, fungus, mycoplasma, mycoplasma-like organism, protist, virus, or any entity related to the foregoing.

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

(12) "Release" means the placement or use of a genetically engineered organism, or the placement or use of a product of a genetically engineered organism, outside a contained laboratory, fermentation facility, greenhouse, or other structure or contained facility, or under other conditions not specifically determined by the board to be adequately contained.

NEW SECTION. Sec. 3. (1) There is created in the department of ecology a biotechnology review board that consists of the following members:

(a) The directors of the departments of ecology, agriculture, health, natural resources, and wildlife or their designees.

(b) Two persons, one selected by the University of Washington and one selected by Washington State University, representing faculty who have experience in the techniques and applications of genetic engineering, or experience and expertise in either public policy, health and safety ramifications of genetic engineering, or with the principles of ecology and environmental science, or any combination of the three areas.

(d) A representative of the biotechnology industry, appointed by the governor.

(e) A representative of a nonprofit public interest organization, appointed by the director of the department of ecology.

(f) A practicing farmer who is an active member of a farm organization, appointed by the director of the department of ecology from a list of applicants selected by the director of the department of agriculture.

(g) Two representatives of the general public chosen by the director of the department of ecology from the list of applicants responding to a publicly advertised announcement of the positions.

(2) Except for those members described in (d), (e), and (f) of this subsection, no member of the board may have a financial, contractual, or research interest in, or tie to, a biotechnology company or product.

(3) The members of the board shall be appointed within sixty days of the effective date of this section and serve three-year terms. Members designated by an ex officio member shall serve at the pleasure of that ex officio member.

(4) The board shall elect a chair from among its members for a one-year term but who shall serve no more than two consecutive terms. The director may appoint a member of the board to serve as interim chair for one year or until the board elects a chair, whichever is sooner.

(5) A vacancy shall be filled by the appropriate appointing authority. An appointment to fill a vacancy on the board created by any cause shall be for the balance of the unexpired term.

(6) An appointed member of the board may be removed by the appointing authority for misfeasance, malfeasance, or nonfeasance.

(7) The members of the board who are not otherwise paid for the time expended on the board shall receive per diem and travel expenses as provided by law under RCW 43.03.050 and 43.03.060.

(8) All clerical and other services required by the board shall be supplied by the department of ecology.

(9) A majority of the board shall constitute a quorum for the transaction of business.

(10) Rule-making and administrative proceedings shall be governed by chapter 34.05 RCW.

NEW SECTION. Sec. 4. (1) The board shall:

(a) Adopt regulations designating those activities that are not treated as genetic engineering for the purposes of this chapter;

(b) Establish criteria for environmental impact statements to accompany applications for permits granted under this chapter;

(c) Set fines for the transgression of any of its rules and for the release of genetically engineered materials or their products without a license;

(d) Charge fees for actions taken under section 6(6) of this act equal to the actual cost necessary to review each permit;

(e) Delegate to the director any of its duties, other than rulemaking, but including issuance of permits, as the board deems necessary for the administration and enforcement of this chapter; and

(f) Keep the public informed and, where possible, involved in the work of the board.

(2) The director and members of the board, employees of the department of ecology, the state and its political subdivisions, and other state entities and employees involved with issuing a permit under section 6 of this act are immune from civil liability, whether direct or derivative, for issuing the permit. The permit certifies only that the holder met all state requirements for the purposes of issuing the permit.

(3) The board may:

(a) Adopt, amend, or revoke rules to implement and carry out the purposes of this chapter;

(b) Establish advisory committees to assist the board in carrying out its duties; and

(c) Either (i) establish a fund to which all applicants shall contribute a designated amount and from which may be drawn the costs of cleanup of unforeseen and undesirable consequences of environmental release, the fund being a designated fund and therefore not to be used for other purposes, or (ii) require of permit applicants a bond or proof of financial ability to pay for potential accidents and consequences of release, with full liability payment to victims and all cleanup costs to be paid by the involved parties.

NEW SECTION. Sec. 5. (1) The director shall enforce this chapter, administer the permit process, and exercise the powers and duties imposed on him or her by this chapter or by the rules adopted under this chapter.

(2) The director may designate employees of the department of ecology to assist him or her and enter into cooperative agreements with federal and state agencies necessary to carry out the duties and exercise the powers provided by this chapter.

NEW SECTION. Sec. 6. (1)(a) A genetically engineered organism or a product of 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 the release has been issued by the board. Release without a permit is governed by the fines and penalties established in section 9 of this act.

(b) Prior to an intended release of a genetically engineered organism or a product of a genetically engineered organism into the environment, or the sale, offer for sale, or distribution in this state of a genetically engineered organism or its product for release into the environment, a person shall apply in writing to the board for a permit.

(i) If federal notification is required prior to release, a person shall apply to the board within seven working days of submitting an application, or other written notice, to the federal coordinated framework or federal regulatory agency.

(ii) If no federal notification is required, a person shall apply to the board at least one hundred twenty days prior to the proposed release of a genetically engineered organism or its product into the environment, or the sale, offer for sale, or distribution of a genetically engineered organism or its product for release into the environment.

(c) The board may provide, by rule, for general permits for classes of activities for which individual permits are not required.

(2) Permit applications must be on forms or in the format prescribed by the board, and include an environmental impact statement and other information deemed necessary by the board in order to determine compliance with this chapter. To the extent feasible, the board shall authorize the use of forms or format required by the federal government for actions similar to those regulated under this chapter. Applicants, upon request by the board, shall submit copies of data submitted with corresponding federal permit applications.

(3) The board may require additional data it deems necessary to determine potential adverse effects of the release of a genetically engineered organism or its products. To the extent possible, the board shall accept for review and base its decision on data submitted with the federal application.

(4) If the board finds it necessary for the protection against potential adverse effects of the release of a genetically engineered organism or the product of a genetically engineered organism, the board may:

(a) Restrict the number and location of organisms or products released and method of release, prescribe the training of persons involved with the release, regulate the disposal of organisms or products or organisms, and other conditions of use;

(b) Require measures to limit dispersal of released organisms or products of organisms or spread of inserted genes or gene products;

(c) Require monitoring of the abundance and dispersal of the released organisms or products of organisms or inserted genes or gene products; or

(d) Deny, suspend, modify, or revoke the permit.

(5) The board may submit written comments to any federal agency reviewing a proposed or completed release, and otherwise participate in those reviews. The board may issue a permit under this chapter based on the federal review and approval of the proposed release if the board determines that the federal regulation of the release sufficiently protects agriculture, public health and safety, the environment, social well-being, and the economy of Washington. The board shall minimize duplication of federal regulatory requirements to the extent possible. This section is in addition to and does not supplant the requirements of other provisions of law, including, but not limited to, the state environmental policy act, chapter 43.21C RCW, and the administrative procedure act, chapter 34.05 RCW.

(6) The board may deny, suspend, modify, or revoke a permit for failure to comply with this chapter or any rule adopted by the board in accordance with chapter 34.05 RCW. The board may summarily suspend a permit if it determines that an adverse effect is occurring or is likely to occur because of a release authorized by a permit.

(7) The board shall make a decision on a permit application within ninety days from the date the completed application is received by the board unless a public hearing is held pursuant to section 8 of this act. The board may, for good cause, extend the time for making a decision by no more than ninety days, by notifying the applicant in writing.

(8) The application may be withdrawn at any time by written notice to the board.

NEW SECTION. Sec. 7. (1) In submitting data pursuant to this chapter, an applicant for a permit shall:

(a) Clearly mark portions of the material that the applicant believes are entitled to treatment as trade secrets as defined in RCW 19.108.010 or commercial or financial confidential business information that are exempt from disclosure under RCW 42.17.310; and

(b) Submit the marked material separately from other material required to be submitted under this chapter.

Material not clearly marked as a trade secret or as confidential may be released by the department to the public.

(2) Except as otherwise provided by this subsection, the board may not make public material marked as provided in subsection (1) of this section or material that in the board's judgment should be privileged or confidential because it contains or relates to trade secrets or confidential commercial or financial information. The board may, however, reveal information acquired under this chapter at a public hearing or in findings of fact issued by the board when it deems such disclosure necessary to carry out the purposes of this chapter.

(3)(a) A person engaged in the review of the effects of a proposed release of a genetically engineered organism or the products of a genetically engineered organism who believes that access to undisclosed confidential business information is necessary in order to perform a review effectively may request the disclosure of material designated as confidential business information by submitting a written petition to the board. The petition must state the reasons that such confidential business information is necessary to the performance of the petitioner's review. In addition, the petitioner shall sign an affidavit affirming that the petitioner does not represent in any capacity a person engaged in business or enterprise in competition with the applicant or in which the confidential business information could be utilized for commercial or product development purposes.

(b) The applicant must be notified of the petition and have an opportunity to respond to the petition. The response may include an offer by the applicant to produce the confidential business information for the petitioner under terms expressed in a written agreement between the applicant and the petitioner and an explanation by the applicant as to why the petitioner does not need the confidential business information, or an offer by the applicant to provide the petitioner with other information that is not confidential and responds to the petitioner's reasons for requesting the confidential business information. By written stipulation of the petitioner and the applicant, the board may delay a decision on the petition until further written notice by the petitioner.

(c) The board shall make a determination as to whether the petitioner requires access to some or all of the confidential business information requested by the petitioner in order to make an effective, independent review of the proposed release. Where the board determines that the petitioner requires access to some or all of the confidential business information requested by the petitioner, the board shall notify the applicant and the petitioner of its decision whereupon the applicant shall provide that confidential business information to the petitioner or withdraw its application. If the board's decision is appealed, the applicant is not required to disclose the confidential business information pending appeal. If the application is withdrawn, all confidential business information must be returned to the applicant and shall not be disclosed.

(4) If the board proposes to release for inspection information that the applicant believes to be protected from disclosure under subsection (2) of this section, the applicant shall notify the board by certified mail and provide a statement that explains why the particular information should not be released. The board shall not release this data until thirty days after receipt of the notice by the applicant. During this period, the applicant may institute an action in the superior court of Thurston county for declaratory judgment as to whether the information is subject to protection under this subsection. In deciding whether to allow the information to be released, the court shall balance the interests of the applicant in the confidentiality of the material against the public's interest in access to the material to determine the impact of the proposed release on agriculture, public health and safety, the environment, and the social well-being and economy of the state.

(5) Except as provided by this section, a person may not reveal or use for his or her own benefit any confidential business information received pursuant to this chapter.

(6) Nothing in this section, or in rules adopted pursuant to this section, authorizes the board or any person to withhold from the public information regarding the adverse effects of a proposed release of any genetically engineered organism or the product of such an organism.

NEW SECTION. Sec. 8. (1) Within fifteen days of receiving a completed application for a proposed release, the board shall publish notice and a brief description of the proposed release. The board shall also notify any person who has filed a written request to be notified of releases. The board shall prescribe the form, content, and extent of the notice. However, at a minimum, the notice must be published once in a newspaper having a general circulation in the county where the release is proposed to be made. In addition, subject to section 7 of this act, any documents submitted as part of the application must be available for public inspection or copying at or near the site of the proposed release and at the offices of the board. A person may submit written comments to the board regarding the proposed release.

(2) The local government having jurisdiction where a person proposes to release a genetically engineered organism or its product, or ten or more citizens residing within the government's jurisdiction, may request a public hearing by filing a written request with the board within thirty days following the last date notice of the application was published. The hearing, if requested, must be held within the boundaries of the local government and the board shall provide, except in emergency circumstances, a minimum of twenty days' public notice of the hearing by publication in a newspaper of general circulation. Notice must be provided to any person who has filed written request to be notified of such hearings.

The board may order a public hearing even if no hearing has been requested.

(3) If a public hearing is held, the board shall accept or deny the permit application within one hundred twenty days from the date the completed application is received by the board. The board may, for good cause, extend the time for making a decision by not more than sixty days by notifying the applicant in writing.

(4) If no public hearing is held, the board shall accept or deny the permit application within sixty days from the date the completed application is received by the board. The board may, for good cause, extend the time for making a decision by not more than thirty days by notifying the applicant in writing.

(5) The board may, with the written consent of the applicant, extend the period to review the application.

NEW SECTION. Sec. 9. (1) The board may assess a civil penalty of not more than ten thousand dollars against a person who violates a provision of this chapter or a rule of the board. In determining the amount of the penalty, the board may consider the degree and extent of the harm caused by the violation. Each and every violation is a separate and distinct offense. Each day's violation is a separate offense.

(2) Every person who, through an act of commission or omission, procures, aids, or abets in the violation, violates this section and may be subject to the civil penalty provided in this section. A public employee who willfully releases a genetically engineered organism or the product of a genetically engineered organism in violation of this chapter is subject to the civil penalty provided in this section and may also be subject to dismissal.

(3) A person who interferes with or attempts to interfere with the director or any of his or her agents while engaged in the performance of their duties under this chapter, or who violates any provision of this chapter or any rule of the board adopted under this chapter is guilty of a misdemeanor and subject to a fine of not less than two hundred dollars nor more than one thousand dollars for each offense. Each day's violation is a separate offense.

(4) A person who releases a genetically engineered organism or the product of a genetically engineered organism in violation of this chapter is liable for the consequences and costs of remediation and cleanup of the effects of such a release.

(5) 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. 10. This chapter does not apply to genetically engineered organisms not proposed for release, and not released, to the environment.

NEW SECTION. Sec. 11. Section 6 of this act shall take effect September 1, 1992.

NEW SECTION. Sec. 12. The biotechnology review account is created in the state treasury. All receipts from fees charged under section 4 of this act, and from fines assessed under section 9 of this act shall be deposited into the account. Moneys in the account may be spent only after appropriation. Expenditures may be used only for the purposes of this chapter.

NEW SECTION. Sec. 13. The sum of one hundred ten thousand dollars, or as much thereof as may be necessary, is appropriated for the biennium ending June 30, 1993, from the biotechnology review account to the department of ecology for the purposes of this act.

NEW SECTION. Sec. 14. Sections 2 through 10 and 12 of this act shall constitute a new chapter in Title 15 RCW.