GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2001
SESSION LAW 2001-469
HOUSE BILL 1472
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 and maintained by any person in this State and
shall contain other information required under rules adopted by
the Commission.
(b) The following definitions apply in this
section:
(1) 'Biological agent' means:
a. 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.
b. Any genetically modified
microorganisms or genetic elements from an
organism on 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.
c. Any genetically modified
microorganisms or genetic elements that
contain nucleic acid sequences coding for any
of the toxins listed on Appendix A of Part 72
of Title 42 of the Code of Federal
Regulations, or their toxic submits.
(2) 'Person' means any association,
business, corporation, facility, firm, individual,
institution of higher education, organization,
partnership, society, State agency, or other legal
entity.
(c) The Commission shall adopt rules for the
implementation of the registry program, as follows:
(1) Determining and listing the biological
agents required to be reported under this
section.
(2) Designating persons required to make
reports and 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
that requires persons possessing and maintaining
biological agents subject to this section to comply
with the same federal standards that apply to
persons registered to possess the same agents under
federal law.
(5) Establishing a process for persons
that possess and maintain biological agents to
alert appropriate authorities of unauthorized
possession or attempted possession of biological
agents. The rules shall designate appropriate
authorities for receipt of alerts from these
persons.
(d) Any person that possesses and maintains any
biological agent required to be reported under this section
shall report to the Department the information required by the
Commission for inclusion in the biological agent registry.
(e) Except as otherwise provided in this section,
information prepared for or maintained in the registry under
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.
Release of information from the registry as authorized under
this subsection also shall not render the information prepared
for or maintained in the registry a public record under G.S. 132-
1.
(f) The Department shall impose a civil penalty
for a willful or knowing 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 person 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.
In the General Assembly read three times and ratified
this the 20th day of November, 2001.
s/ Beverly E. Perdue
President of the Senate
s/ James B. Black
Speaker of the House of
Representatives
s/ Michael F. Easley
Governor
Approved 11:14 a.m. this 28th day of November, 2001