GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2001
H	1
HOUSE BILL 1472*
     

 
Short Title:	Biological Agents Registry.	()	
Sponsors:	Representatives Culpepper;  Goodwin and M. Crawford.	
Referred to:	Judiciary II.	
October 30, 2001

A BILL TO BE ENTITLED
AN ACT DIRECTING THE DEPARTMENT OF HEALTH AND HUMAN SERVICES TO ESTABLISH A BIOLOGICAL AGENTS REGISTRY, AND IMPOSING CIVIL PENALTIES FOR VIOLATION OF  REGISTRY REQUIREMENTS.

The General Assembly of North Carolina enacts:
SECTION 1.  Part 1 of Article 6 of Chapter 130A of the General Statutes is amended by adding the following new section to read:
"§ 130A-149. Biological agents registry; rules; penalties.
(a)	The Department shall establish and administer a program for the registration of biological agents. The biological agents registry shall identify the biological agents possessed or maintained by any laboratory, medical facility, or research facility in this State and shall contain other information required under rules adopted by the Commission. As used in this section, the term 'biological agent' means any microorganism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bioengineered component of any such microorganism, virus, infectious substance, or biological product capable of causing:
(1)	Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(2)	Deterioration of food, water, equipment, supplies, or material of any kind;
(3)	Deleterious alteration of the environment; or
(4)	Any other risk of serious harm to the public health or safety.
(b)	The Commission shall adopt rules for the implementation of the registry program, as follows:
(1)	Determining the biological agents required to be reported under this section.
(2)	Designating specific information required to be reported including time limits for reporting, form of reports, and to whom reports shall be submitted.
(3)	Providing for the release of information in the registry to State and federal law enforcement agencies and the United States Centers for Disease Control and Prevention pursuant to a communicable disease investigation commenced or conducted by the Department, the Commission, or other State or federal law enforcement agency having investigatory authority, or in connection with any investigation involving release, theft, or loss of biological agents.
(4)	Establishing a system of safeguards to be followed by laboratories, medical facilities, and research facilities, including a process for the  laboratories or facilities to alert appropriate authorities of unauthorized possession or attempted possession of biological agents. The rules shall designate appropriate authorities for receipt of alerts from laboratories or facilities.(c)	Any person having administrative authority over a laboratory, medical facility, or research facility that possesses or maintains any biological agent required to be reported shall report to the Department the information required by the Commission for inclusion in the biological agent registry.
(d)	Except as otherwise provided in this section, information maintained in the registry pursuant to this section shall be confidential and shall not be a public record under G.S. 132-1. The Department may, in accordance with rules adopted by the Commission, release information contained in the biological agent registry for the purpose of conducting or aiding in a communicable disease investigation. The Department shall cooperate with and may share information contained in the biological agent registry with the United States Centers for Disease Control and Prevention, and state and federal law enforcement agencies in any investigation involving the release, theft, or loss of a biological agent required to be reported under this section. Release of information from the registry as authorized under this subsection shall not render the information released a public record under G.S. 132-1.
(e)	The Department shall impose a civil penalty for violation of this section in the amount of up to one thousand dollars ($1,000). Each day of a continuing violation shall be a separate offense. Any laboratory or facility wishing to contest a penalty shall be entitled to an administrative hearing in accordance with Chapter 150B of the General Statutes."
SECTION 2.  G.S. 130A‑29(c) is amended by adding the following subdivision to read:
"(10)	Pertaining to the biological agents registry in accordance with G.S. 130A-149."
SECTION 3.  This act becomes effective January 1, 2002.