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Public Health Preparedness & Response

Biological Agents Registry

Frequently Asked Questions

Why is the Biological Agent Registry law necessary?

After the terrorist attacks of September 11, 2001, and the subsequent anthrax crisis, the North Carolina General Assembly passed a law (G.S. 130A-149, recodified as G.S. 130A-479 in 2002) establishing a registry of all potentially dangerous biological materials that are possessed and maintained in North Carolina. The registry is a list of U.S. DHHS-specified biological agents , along with the names of laboratories and other facilities that use and keep those materials. This information is vital in the event of a possible terrorist biological attack. The Registry will also provide a listing of experts knowledgeable about these biological agents.

Who is covered by this law?

Any organization or individual who possesses and maintains a qualifying biological agent is covered by the biological agent registry law. The agents are specified in the Code of Federal Regulations Title 42 Part 72 and on the federal website www.selectagents.gov.

Who is exempted from this law?

The registry is intended for those who keep biological agents for extended periods of time and exempts those who possess the substances in the course of certain types of testing or analysis for short periods of time. Those not required to report to the registry are persons who detect or use a listed biological agent during environmental or clinical analysis for the purpose of diagnosing disease, epidemiological surveillance, exposure assessment, reference, or for verification or proficiency testing. To qualify for the exemption, the agents must be discarded within 14 calendar days after isolation, use, or after receiving notice of completion of confirmation testing.

Can a substance on the list be exempted from reporting if it is used in small doses for therapeutic use only?

No. The North Carolina Biological Agent Registry law does not allow for exemptions based on amounts. However, certain toxins such as Botox® that are used medically are exempted in the federal regulations.

What specific information is required?

Registrants must use a DHHS Biological Agents Registry Reporting Form (available in Microsoft Excel, 22KB, or PDF format, 7KB) to report the following:

• a list of the specified biological agents that are possessed and maintained at the facility;
• the form of the agents; how they are used (such as research, vaccine development, etc.);
• the physical location of the laboratories and the storage areas where the agents are used or kept; and
• the person(s) in charge of the agents.

The form must be filled out completely and according to the instructions document (PDF, 20KB). All information is required. The completed report form must be submitted to the Bioterrorism (BT) Coordinator in the Public Health Preparedness and Response Branch:

Bioterrorism Coordinator
Public Health Preparedness and Response Branch
N.C. Division of Public Health
1902 Mail Service Center
Raleigh, N.C. 27699-1902
Phone: (919) 546-1820

When is reporting necessary?

The recipient of a listed biological agent must report to the registry within seven (7) days of receipt of the agent. In the event of any change in the information contained in the original report, an amended report must be submitted within seven (7) days. The suspected release, loss or theft of any listed biological agent must be reported within 24 hours by calling the Bioterrorism Coordinator, Public Health Preparedness and Response Branch: (919) 546-1820

How is information to be reported?

The DHHS Biological Agents Registry Reporting Form (Excel, 23KB / PDF, 7KB) and the form instructions (PDF, 20KB) specify the required information. The completed form must be submitted to the Public Health Preparedness and Response Branch Bioterrorism Coordinator in the N.C. Division of Public Health:

Bioterrorism Coordinator
Public Health Preparedness and Response Branch
N.C. Division of Public Health
1902 Mail Service Center
Raleigh, N.C. 27699-1902
Phone: (919) 546-1820

Who in the State of North Carolina is administering this biological agent registry?

The biological agent registry is administered by the N.C. Department of Health and Human Services, Division of Public Health, Public Health Preparedness and Response Branch in Raleigh, N.C.

Who will have access to this biological agent registry?

The registry is confidential. The N.C. Department of Health and Human Services will release information contained in the Biological Agents Registry only by order of the State Health Director if that information becomes necessary for conducting a communicable disease investigation or for investigating a release, theft or loss of a biological agent.

What biological agents are reportable under this new law?

The U.S. Centers for Disease Control and Prevention (CDC) has established a list of select agents in 42 C.F.R. Part 72, which is published on the Internet at www.selectagents.gov.

Please direct all questions and correspondence to:

Bioterrorism Coordinator
Public Health Preparedness and Response Branch
N.C. Division of Public Health
1902 Mail Service Center
Raleigh, N.C. 27699-1902
Phone: (919) 546-1820