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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>62425</law_id><section_number>2.2-5501</section_number><catch_line>Definitions</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><structure><unit label="title" level="1" order_by="1" identifier="2.2">Administration of Government</unit><unit label="subtitle" level="2" order_by="1" identifier="II">Administration of State Government</unit><unit label="part" level="3" order_by="1" identifier="B">Transaction of Public Business</unit><unit label="chapter" level="4" order_by="1" identifier="55">Virginia Biotechnology Research Act</unit></structure><text>
						<section><p>As used in this chapter, unless the context requires a different meaning:
		&#x201C;<span class="dictionary">Affected localities</span>&#x201D; means the <span class="dictionary">locality</span> in which a <span class="dictionary">regulated introduction</span> is proposed to be made and any <span class="dictionary">locality</span> within a three-mile radius of the location where the <span class="dictionary">regulated introduction</span> is proposed to be made.
		&#x201C;<span class="dictionary">Confidential business information</span>&#x201D; means information entitled to confidential treatment under subdivision A 1 or A 2 of &#xA7;&#xA0;<a class="law" title="Confidential business information; Department to establish procedures" href="/2.2-5506/">2.2-5506</a>.
		&#x201C;<span class="dictionary">Coordinated Framework</span>&#x201D; means the federal <span class="dictionary">Coordinated Framework</span> for the Regulation of Biotechnology set forth in 51 Fed. Reg. 23,302 through 23,350 (June 26, 1986), as amended.
		&#x201C;<span class="dictionary">Department</span>&#x201D; means the <span class="dictionary">department</span> designated by the Secretary of Commerce and Trade to implement the requirements of this chapter for certain types or classes of <span class="dictionary">regulated introductions</span>. Where possible, the Secretary shall designate the <span class="dictionary">department</span> whose purpose most closely resembles the purpose of the <span class="dictionary">federal regulator</span> that will be responsible under the <span class="dictionary">Coordinated Framework</span> for reviewing and authorizing the <span class="dictionary">regulated introduction</span>.
		&#x201C;<span class="dictionary">Federal regulator</span>&#x201D; means a federal <span class="dictionary">department</span>, agency, or other instrumentality of the federal government, or a designee of such federal instrumentality, which is responsible for regulating an introduction of a <span class="dictionary">genetically engineered organism</span> into the environment under the <span class="dictionary">Coordinated Framework</span>.
		&#x201C;<span class="dictionary">Genetically engineered organism</span>&#x201D; 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.
		&#x201C;<span class="dictionary">Locality</span>&#x201D; means any county, city or town located within the Commonwealth.
		&#x201C;<span class="dictionary">Planned introduction into the environment</span>&#x201D; means the intentional introduction or use in the Commonwealth beyond the de minimis level of a <span class="dictionary">genetically engineered organism</span> anywhere except within an indoor facility that is designed to physically contain the <span class="dictionary">genetically engineered organism</span>, including a laboratory, greenhouse, building, structure, growth chamber, or fermenter.
		&#x201C;<span class="dictionary">Regulated introduction</span>&#x201D; means a <span class="dictionary">planned introduction into the environment</span> for which the <span class="dictionary">Coordinated Framework</span> requires that the person proposing to commence the introduction into the environment do one or more of the following:</p></section>
						<section id="1"><p><span class="prefix-number">1.</span> Notify a <span class="dictionary">federal regulator</span> of the proposed introduction into the environment; <a id="paragraph-227631" class="section-permalink" href="https://vacode.org/2.2-5501/#1"><i class="fa fa-link"/></a></p></section>
						<section id="2"><p><span class="prefix-number">2.</span> Secure the approval of or a permit or license from a <span class="dictionary">federal regulator</span> before commencing the introduction into the environment; or <a id="paragraph-227632" class="section-permalink" href="https://vacode.org/2.2-5501/#2"><i class="fa fa-link"/></a></p></section>
						<section id="3"><p><span class="prefix-number">3.</span> Secure a determination by a <span class="dictionary">federal regulator</span> of the need for notification, approval, licensing or issuance of a permit by the <span class="dictionary">federal regulator</span> if the determination is part of a procedure specified in the <span class="dictionary">Coordinated Framework</span>. <a id="paragraph-227633" class="section-permalink" href="https://vacode.org/2.2-5501/#3"><i class="fa fa-link"/></a></p></section></text><history>1994, c. 472, &#xA7; 2.1-770; 2001, c. 844.</history><metadata></metadata></law>
