What Must Be Registered

Experiments involving the following must be registered with the Institutional Biosafety Committee (IBC):

• Pathogens affecting humans, animals, or plants;
• Materials potentially containing human pathogens (for example, unfixed human specimens, human blood)
• Recombinant DNA molecules including virus vectors
• Human cell lines that are not well characterized or require Risk Group 2 containment
• Generation of de novo transgenic animals: defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval. Those transgenic animals that already exist or which have been purchased also do not require IBC approval.
• All research involving the use of recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus, or biohazards.
• Animal subjects: All research involving the use of recombinant molecules or biohazards in whole animals requires both IBC and Institutional Animal Care and Use Committee (IACUC) approval.
• Human subjects: Any research involving the introduction of recombinant molecules or biohazards into human subjects must be approved by the IBC and by the Institutional Review Board (IRB).

Human Cells and Tissues

Human and nonhuman primate cells should be handled using Risk Group 2 (RG-2) practices and containment. All work should be performed in a biosafety cabinet and all material should be decontaminated by autoclaving or disinfection before discarding. Appropriate training in the handling of blood-borne pathogens and up-to-date hepatitis B vaccinations may be required.

Select Agents and Toxins

Select agents are specific pathogens and toxins that have the potential to pose a severe threat to public health and safety as defined by the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The institution must be registered with the Centers for Disease Control and Prevention (CDC) and/or U.S. Department of Agriculture (USDA) before these materials are obtained, used, or stored.

Risk Group 1 (RG-1)

Risk Group 1 (RG-1) agents are usually not placed on a list but include all microorganisms that do not pose a health risk to healthy adult humans. It must not be assumed that an organism not listed as an RG 2, 3, or 4 agent is an RG-1 agent; emerging or unknown organisms should be treated as biohazardous until research proves otherwise. Examples of agents in RG-1 are: Bacillus subtilis, infectious canine hepatitis viruses; influenza reference strains A/PR/8/34, A/WS/33, Escherichia coli K12, Saccharomyces cerevisiae, and other agents listed in Appendix C-II of the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules; and other vectors such as Baculovirus.

Additional low-risk oncogenic viruses identified as RG-1 agents
Adenvirus 7-Simian virus 40 (Ad7-SV40)	Lucke (frog) virus	Polyoma virus
Avian Leucosis virus	Hamster leukemia virus	Rat leukemia virus
Bovine leukemia virus	Marek’s disease virus	Rous sarcoma virus
Bovine papilloma virus	Mason-Pfizer monkey virus	Shope vibroma virus
Chick-embryo-lethan orphan (CELO) virus	Mouse mammary tumor virus	Shope papilloma virus
Dog sarcoma virus	Murine leukemia virus	Simian virus 40 (SV-40)
Guinea pig herpes virus	Murine sarcoma virus

Risk Group 2 (RG-2)

RG-2 agents are of moderate potential hazard to healthy adult humans and the environment. Such agents may produce disease of varying degrees of severity from accidental inoculation, injection, or other means of cutaneous penetration but can usually be adequately and safely contained by ordinary laboratory techniques. Some agents may cause disease by contact or respiratory routes, but they are self-limiting and do not cause a serious illness, such as the cause of the common cold, the rhinoviruses. The following organisms have been identified as RG-2 agents:

Bacteria
Acinetobacter baumannii	Dermatophilus congolensis	Pasteurella spp.
Acinetobacter baumannii	Edwardsiella tarda	Plesiomonas shigelloides
Actinomyces pyogenes	Erysipelothrix rhusiopathiae	Proteus spp.
Aeromonas hydrophila	Escherichia coli	Salmonella spp.
Amycolata autotrophica	Haemophilus ducreyi	Sphaerophorus necrophorus
Archanobacterium haemolyticum	Helicobacter pylori	Staphylococcus aureus
Bacteroides spp.	Klebsiella spp.	Streptobacillus moniliformis
Borrelia recurrentis	Leptospira interrogans	Streptococcus spp
Burkholderia (except those in RG-3)	Listeria spp.	Treponema pallidum
Campylobacter coli	Moraxella spp.	Vibrio cholera
Clostridium chauvoei	Mycobacterium spp.	Yersinia enterocolitica
Corynebacterium diphtheria	Nocardia asteroids

 

Fungal Agents
Blastomyces dermatitidis	Exophiala dermatitidis	Paracoccidiodes brasilensis
Cladosproium bantianum	Fonsecaea pedrosoi	Penicillium marneffei
Cryptococcus neoformans	Microsporum spp.	Sporothrix schenckii
Epidermophyton spp.	Ochroconis gallopavum	Trichophyton spp.

 

Parasitic Agents
Ancylostoma spp.	Fasciola spp.	Onchoerca spp.
Ascaris spp.	Giardia spp.	Plasmodium spp.
Babesia spp.	Heterophyes spp.	Sarcocystis spp.
Brugia spp.	Hymenolepis spp.	Schistosoma spp.
Coccidian spp.	Isospora spp.	Strongyloides spp.
Cryptosporidium spp.	Leishmania spp.	Taenia solium
Cysticercus cellulosae	Loa loa filarial	Toxocara spp.
Echinococcus spp.	Microsporidium spp.	Trichinella spiralis
Entamoeba histolyitca	Naegleria fowleri	Trypanosoma spp.
Enterobius spp.	Necator spp.	Wuchereria bancrofti

 

Viruses
Adenoviruses	Encephalomyocarditis	Influenza viruses
Adenovirus 2	Parainfluenza virus	Lymphogranuloma venereum agent
Arboviruses	Reoviruses	Measles virus
Arenaviruses	Rhinoviruses, all types	Molluscum contagiosum virus
Coronaviruses	Feline sarcoma virus (FeLV)	Rubella virus
Coxsackie A and B viruses	Gibbon leukemia virus	Paravaccina virus
Echoviruses	Hepatitis A, D, E	Respiratory syncytial virus