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§ 2.2-5500. Purpose
The purposes of this chapter are to establish a state regulatory scheme to ensure state participation in the federal Coordinated Framework for the Regulation of Biotechnology to protect human health and the environment and to stimulate the growth of the biotechnology industry within the Commonwealth. To do this, the Secretary of Commerce and Trade shall cooperate with federal authorities in accordance with the federal Coordinated Framework for the Regulation of Biotechnology to assess the potential risks and effects of proposed regulated introductions of genetically engineered organisms into the environment without undue governmental interference with the progress and commercial development of biotechnology within the Commonwealth. The General Assembly does not intend to create a regulatory scheme that duplicates federal regulatory efforts regarding biotechnology, or one that overly burdens biotechnology efforts within the Commonwealth. This chapter is intended to institute a process in which the Commonwealth can monitor the federal regulatory process and protect its interests in agriculture, public health, and the natural environment, as needed, by participation in the federal regulatory process.
§ 2.2-5501. Definitions
As used in this chapter, unless the context requires a different meaning:
“Affected localities” means the locality in which a regulated introduction is proposed to be made and any locality within a three-mile radius of the location where the regulated introduction is proposed to be made.
“Confidential business information” means information entitled to confidential treatment under subdivision A 1 or A 2 of § 2.2-5506.
“Coordinated Framework” means the federal Coordinated Framework for the Regulation of Biotechnology set forth in 51 Fed. Reg. 23,302 through 23,350 (June 26, 1986), as amended.
“Department” means the department designated by the Secretary of Commerce and Trade to implement the requirements of this chapter for certain types or classes of regulated introductions. Where possible, the Secretary shall designate the department whose purpose most closely resembles the purpose of the federal regulator that will be responsible under the Coordinated Framework for reviewing and authorizing the regulated introduction.
“Federal regulator” means a federal department, agency, or other instrumentality of the federal government, or a designee of such federal instrumentality, which is responsible for regulating an introduction of a genetically engineered organism into the environment under the Coordinated Framework.
“Genetically engineered organism” means an organism (any organism such as animal, plant, bacterium, cyanobacterium, fungus, protist, or virus), altered or produced through genetic modification from a donor, vector, or recipient organism using modern molecular techniques such as recombinant deoxyribonucleic acid (DNA) methodology, and any living organisms derived therefrom.
“Locality” means any county, city or town located within the Commonwealth.
“Planned introduction into the environment” means the intentional introduction or use in the Commonwealth beyond the de minimis level of a genetically engineered organism anywhere except within an indoor facility that is designed to physically contain the genetically engineered organism, including a laboratory, greenhouse, building, structure, growth chamber, or fermenter.
“Regulated introduction” means a planned introduction into the environment for which the Coordinated Framework requires that the person proposing to commence the introduction into the environment do one or more of the following:
- Notify a federal regulator of the proposed introduction into the environment;
- Secure the approval of or a permit or license from a federal regulator before commencing the introduction into the environment; or
- Secure a determination by a federal regulator of the need for notification, approval, licensing or issuance of a permit by the federal regulator if the determination is part of a procedure specified in the Coordinated Framework.
- Provides to the Department all of the following information within seven days after the person submits or should have submitted the information specified in subdivisions 1 a and 1 b to a federal regulator, whichever is sooner:
- a. A copy of all information that the person is required to submit to the federal regulator and that is not confidential information; and
- b. A summary of any confidential information that the person submits or is required to submit to a federal regulator. The summary shall provide sufficient information to enable the Department to exercise its notice and comment functions under §§ 2.2-5504 and 2.2-5505, to provide public notice pursuant to § 2.2-5504, and to prepare comments pursuant to § 2.2-5505, and shall have minimal extraneous and irrelevant information. The summary shall also provide sufficient information to enable the locality in which the introduction is proposed to be made to exercise its comment function under § 2.2-5505.
- Provides such additional information, if any, as is necessary to enable the Department to fulfill any functions it undertakes, on a case-by-case basis, under § 2.2-5505.
- Hold an informational meeting on the proposed regulated introduction;
- Provide an opportunity for the public to comment on the proposed regulated introduction;
- Request any additional information necessary on the proposed regulated introduction from the person providing information under § 2.2-5503;
- Conduct a technical review of the proposed regulated introduction; and
- Seek the assistance of the faculty and academic staff of any Virginia public institution of higher education, the Department of Health, the Department of Agriculture and Consumer Services, the Department of Environmental Quality, or any other appropriate state agency or organization, including but not limited to an institutional biosafety committee, in reviewing the proposed regulated introduction.
- Hold an informational meeting on the proposed regulated introduction. When possible, that meeting shall be held in conjunction with an informational meeting held by the Department; and
- Provide an opportunity for the public to comment on the proposed regulated introduction.
- The federal regulator to whom the information has been submitted has determined that the information is entitled to confidential treatment and is not subject to public disclosure under the federal Freedom of Information Act, 5 U.S.C. § 552, as amended, or under the Coordinated Framework; or
- The person submitting the information to the Department and any locality has submitted a claim to the federal regulator that the information is entitled to confidential treatment under the federal Freedom of Information Act or under the Coordinated Framework, and the federal regulator has not made a determination on that claim.
- The person providing the information expressly agrees in writing to the public access of the information; or
- After information has been granted confidentiality under subdivision A. 2., the federal regulator makes a determination that the information is not entitled to confidential treatment under the federal Freedom of Information Act or under the Coordinated Framework.
- (i) provide that information that is the subject of the agreement shall be subject to confidential treatment;
- (ii) prohibit the release or sharing of the information with any other person except at the direction of the Department and in compliance with this chapter;
- (iii) acknowledge the penalties in § 59.1-338 of the Virginia Uniform Trade Secrets Act (§ 59.1-336, et seq.) and any other applicable law of the Commonwealth identified by the Department for the unauthorized disclosure of the information; and
- (iv) contain a statement that the person receiving the information, any member of his immediate family or any organization with which he is associated has no substantial financial interest in the regulated introduction that is the subject of the information.
- (i) the planned introduction of genetically engineered organisms into the environment or
- (ii) biotechnology research activities; however, the siting of biotechnology research activities shall be subject to the zoning and land-use laws and regulations of the localities in which such activities are conducted, the Uniform Statewide Building Code (§ 36-97 et seq.), the Statewide Fire Prevention Code (§ 27-94 et seq.), local public utility and public works ordinances and regulations of general application, and local tax ordinances of general application.