§ 130A-479. Biological agents registry; rules; penalties. - North Carolina Statutes

§ 130A‑479.  Biologicalagents registry; rules; penalties.

(a)        The Departmentshall establish and administer a program for the registration of biologicalagents. The biological agents registry shall identify the biological agentspossessed and maintained by any person in this State and shall contain otherinformation required under rules adopted by the Commission.

(b)        The followingdefinitions apply in this section:

(1)        "Biologicalagent" means:

a.         Any select agentthat is a microorganism, virus, bacterium, fungus, rickettsia, or toxin listedin Appendix A of Part 72 of Title 42 of the Code of Federal Regulations.

b.         Any geneticallymodified microorganisms or genetic elements from an organism on Appendix A ofPart 72 of Title 42 of the Code of Federal Regulations, shown to produce orencode for a factor associated with a disease.

c.         Any geneticallymodified microorganisms or genetic elements that contain nucleic acid sequencescoding for any of the toxins listed on Appendix A of Part 72 of Title 42 of theCode of Federal Regulations, or their toxic submits.

(2)        "Person"means any association, business, corporation, facility, firm, individual,institution of higher education, organization, partnership, society, Stateagency, or other legal entity.

(c)        The Commissionshall adopt rules for the implementation of the registry program, as follows:

(1)        Determining andlisting the biological agents required to be reported under this section.

(2)        Designating personsrequired to make reports and specific information required to be reportedincluding time limits for reporting, form of reports, and to whom reports shallbe submitted.

(3)        Providing for therelease of information in the registry to State and federal law enforcementagencies and the United States Centers for Disease Control and Preventionpursuant to a communicable disease investigation commenced or conducted by theDepartment, the Commission, or other state or federal law enforcement agencyhaving investigatory authority, or in connection with any investigationinvolving release, theft, or loss of biological agents.

(4)        Establishing asystem of safeguards that requires persons possessing and maintainingbiological agents subject to this section to comply with the same federalstandards that apply to persons registered to possess the same agents underfederal law.

(5)        Establishing aprocess for persons that possess and maintain biological agents to alertappropriate authorities of unauthorized possession or attempted possession ofbiological agents. The rules shall designate appropriate authorities forreceipt of alerts from these persons.

(d)        Any person thatpossesses and maintains any biological agent required to be reported under thissection shall report to the Department the information required by the Commissionfor inclusion in the biological agent registry.

(e)        Except as otherwiseprovided in this section, information prepared for or maintained in theregistry under this section shall be confidential and shall not be a publicrecord under G.S. 132‑1. The Department may, in accordance with rulesadopted by the Commission, release information contained in the biologicalagent registry for the purpose of conducting or aiding in a communicabledisease investigation. The Department shall cooperate with and may shareinformation contained in the biological agent registry with the United StatesCenters for Disease Control and Prevention, and state and federal lawenforcement agencies in any investigation involving the release, theft, or lossof a biological agent required to be reported under this section. Release ofinformation from the registry as authorized under this subsection shall notrender the information released a public record under G.S. 132‑1. Releaseof information from the registry as authorized under this subsection also shallnot render the information prepared for or maintained in the registry a publicrecord under G.S. 132‑1.

(f)         The Departmentshall impose a civil penalty for a willful or knowing violation of this sectionin the amount of up to one thousand dollars ($1,000). Each day of a continuingviolation shall be a separate offense. Any person wishing to contest a penaltyshall be entitled to an administrative hearing in accordance with Chapter 150Bof the General Statutes. (2001‑469, s. 1; 2002‑179, s. 2(a).)