Department of Health and Human Services

Biological Agents Registry

Frequently asked Questions about the
Biological Agents Registry
of North Carolina

Why is the new Biological Agent Registry law necessary?

After the terrorist attacks of September 11, 2001 and the subsequent anthrax attacks, the North Carolina General Assembly passed a law (G.S. 130A-149 ) establishing a registry of all potentially dangerous biological materials that are possessed and maintained in North Carolina. The registry is a list of 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 new law?

Effective January 10, 2002, 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 U.S. Department of Health and Human Services document, 42 C.F.R. Part 72 (see www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html or below for a list of the agents.)

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 (R) that are used medically are exempted in the federal regulations.

What specific information is required?

The report to the registry must include 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 information must be submitted on a form (see below).

When is reporting necessary?

The biological agent registry law was adopted effective Jan. 10, 2002. Those who possessed and maintained a listed biological agent as of Jan. 10, 2002 are to make a report within 45 days of that date, or by Feb. 25, 2002. Those who receive such an agent after Jan. 10, 2002 are to report to the registry within seven 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 days. The suspected release, loss or theft of any listed biological agent must be reported within 24 hours by calling the Office of the Bioterrorism Coordinator (919-733-3421).

How is information to be reported?

The required information is to be submitted on an official form to the Office of the Bioterrorism (BT) Coordinator in the N.C. Division of Public Health. The form, instructions, and other related documents are on the N.C. Epidemiology website at http://epi.ncpublichealth.com/bioagent/ or from the BT Coordinator's office (see contact information below).

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, Epidemiology Section in Raleigh, N.C.

Who will have access to this biological agent registry?

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

The reportable biological agents include the following viruses, bacteria, rickettsiae, fungi, toxins, and recombinant organisms/molecules:

Viruses

1. Crimean-Congo haemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Equine Morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan Equine Encephalitis virus
12. Viruses causing hantavirus pulmonary syndrome
13. Yellow fever virus

Exemptions: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.

Bacteria

1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
6. Francisella tularensis
7. Yersinia pestis

Exemptions: Vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.

Rickettsiae

1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii

Fungi

1. Coccidioides immitis

Toxins

1. Abrin
2. Aflatoxins
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
5. Conotoxins
6. Diacetoxyscirpenol
7. Ricin
8. Saxitoxin
9. Shigatoxin
10. Staphylococcal enterotoxins
11. Tetrodotoxin
12. T-2 toxin

Exemptions: Toxins for medical use, inactivated for use as vaccines, or toxin preparations for biomedical research use at an LD50 for vertebrates of more than 100 nanograms per kilogram body weight are exempt. National standard toxins required for biologic potency testing as described in 9 CFR Part 113 are exempt.

Recombinant organisms/molecules

1. Genetically modified microorganisms or genetic elements from the above organisms, shown to produce or encode for a factor associated with a disease.
2. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed above, or their toxic subunits.

Other restrictions

1. The deliberate transfer of a drug resistance trait to microorganisms above that are not known to acquire the trait naturally is prohibited by NIH "Guidelines for Research Involving Recombinant DNA Molecules," if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.

Additional Exemptions

1. Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. § 136 et seq.) and the Toxic Substances Control Act (15 U.S.C. § 2601 et seq.) are exempt.
2. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in 42 C.F.R. Part 72, Appendix A. Individuals seeking an exemption should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future exemptions will be published in the Federal Register for review and comment prior to inclusion in the Appendix.

Please direct all questions and correspondence to:

Office of the Bioterrorism Coordinator
Epidemiology Section
NC Division of Public Health
1902 Mail Service Center
Raleigh, NC 27699-1902
Phone: (919) 733-3421

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