26:13-22 Definitions relative to biological agents, Biological Agent Registry.

22. a. As used in this section:

"Biological Agent" means:

(1) any select agent that is a microorganism, virus, bacterium, fungus, rickettsia or toxin listed in Appendix A of Part 72 of Title 42 of the Code of Federal Regulations;

(2) any genetically modified microorganism or genetic element from an organism listed in Appendix A of Part 72 of Title 42 of the Code of Federal Regulations, shown to produce or encode for a factor associated with a disease;

(3) any genetically modified microorganism or genetic element that contains nucleic acid sequences coding for any of the toxins listed in Appendix A of Part 72 of Title 42 of the Code of Federal Regulations, or their toxic subunits;

(4) high consequence livestock pathogens and toxins as determined by the U.S. Department of Agriculture and the New Jersey Department of Agriculture;

(5) any agents defined pursuant to R.S. 4:5-107 et seq. and N.J.A.C. 2:6-1.1 et seq. and the Secretary of Agriculture;

(6) any other agent as determined by the commissioner to represent a significant risk to human and animal health.

"Possess or maintain" includes, but is not limited to, any of the following: development, production, acquisition, transfer, receipt, stockpiling, retention, ownership or use of a biological agent.

"Registry" means the Biological Agent Registry established pursuant to this section.

b. The commissioner, in coordination with the Secretary of Agriculture, shall establish a Biological Agent Registry and administer a program for the registration of biological agents. The registry shall identify the biological agents possessed or maintained by any person in this State and shall contain such other information as required by regulation of the commissioner pursuant to this section.

c. A person who possesses or maintains any biological agent required to be registered under this section shall report the information to the department by submitting a duplicate of the form required under Part 331 of Title 7, Part 121 of Title 9, and Parts 72 and 73 of Title 42 of the Code of Federal Regulations. Forms submitted pursuant to these provisions shall not be reproduced by photographic, electronic or other means, and shall be stored in a manner that is both confidential and secure.

d. Except as otherwise provided in this section, information prepared for or maintained in the registry shall be confidential.

(1) The commissioner may, in accordance with rules adopted by the commissioner, utilize information contained in the registry for the purpose of conducting or aiding in a communicable disease investigation.

(2) The commissioner shall cooperate, and may share information contained in the registry, with the United States Centers for Disease Control and Prevention, the Department of Homeland Security, the New Jersey Department of Agriculture, and State and federal law enforcement agencies pursuant to a communicable disease investigation commenced or conducted by the department, the New Jersey Domestic Security Preparedness Task Force established pursuant to P.L.2001, c.246 (C.App. A:9-64 et seq.), or other State or federal law enforcement agency having investigatory authority, or in connection with any investigation involving the release, theft or loss of a registered biological agent. Access to this information shall terminate upon the completion of the investigation.

(3) Release of information from the registry as authorized under this section shall not render the information released or information prepared for or maintained in the registry a public or government record under P.L.1963, c.73 (C. 47:1A-1 et seq.) and P.L.2001, c.404 (C.47:1A-5 et al.).

e. Any person who willfully or knowingly violates any provision of this section is liable for a penalty not to exceed $10,000 per day of the violation, and each day the violation continues shall constitute a separate and distinct violation. A penalty imposed under this section may be recovered with costs in a summary proceeding before the Superior Court pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

f. The commissioner shall adopt rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) that are consistent with Part 331 of Title 7, Part 121 of Title 9, and Parts 72 and 73 of Title 42 of the Code of Federal Regulations, to carry out the purposes of this section; except that, notwithstanding any provision of P.L.1968, c.410 to the contrary, the commissioner may adopt, immediately upon filing with the Office of Administrative Law, such regulations as he deems necessary to implement the provisions of this section, which shall be effective for a period not to exceed six months and thereafter be amended, adopted or readopted by the commissioner in accordance with the requirements of P.L.1968, c.410.

The regulations shall include, but not be limited to:

(1) a list of the biological agents required to be registered pursuant to this section;

(2) designation of the persons required to make reports, the specific information required to be reported, time limits for reporting, the form of the reports, and the person to whom the report shall be submitted;

(3) provisions for the release of information in the registry to State and federal law enforcement agencies, the Centers for Disease Control and Prevention, the Department of Homeland Security and the New Jersey Department of Agriculture pursuant to paragraph (2) of subsection d. of this section;

(4) establishment of a system of safeguards that requires a person who possesses or maintains a biological agent required to be registered under this section to comply with the federal standards that apply to a person registered to possess or maintain the agent under federal law;

(5) establishment of a process for a person that possesses or maintains a registered biological agent to alert appropriate authorities of unauthorized possession or attempted possession of a registered biological agent, and designation of appropriate authorities for receipt of the alerts; and

(6) establishment of criteria and procedures for the commissioner to grant exemptions to the requirements if it is determined that the public benefit of such exemption outweighs the need for regulation.

L.2005,c.222,s.22.