Biosafety:  Researcher Guidelines

Researchers that plan to use infectious agents and DNA recombination need to ensure that adequate safety precautions, consistent with NIH/CDC recommendations, are followed. The following includes a shortened overview of NIH/CDC guidelines. Investigators should refer to http://bmbl.od.nih.gov/ for more detailed information.

What projects require approval?

1. Experimentation using BSL2 or BSL3 infectious microorganisms.
2. Experimentation using carcinogenic (known or suspected) or highly toxic compounds.
3. Recombinant DNA, if BSL2 or BSL3 organisms are involved or if genetic modification might increase pathogenicity, transmissibility, host range or antibiotic resistance of a pathogen. The transfer of toxin genes lethal for vertebrates at an LD₅₀ of <100 ng/kg.
4. Modification of the germline genes of animals (transgenic).
5. Human gene therapy even if the recombinant DNA is produced elsewhere.

_{Containment (Biological Safety Levels)}

1. BSL1: organisms pose little or no risk of infection to healthy adults.
2. BSL2: pathogens which are readily contained by standard microbiological techniques
3. BSL3: highly transmissible pathogens require special containment facilities with controlled access.  BL3 containment is needed for certain organisms if grown to large numbers or if aerosol-inducing manipulations are used. BL3 is indicated in certain animal infection models.
4. BSL4: TBA

Containment levels can be raised or lowered from recommendations due to strain differences or gene insertion, but the investigator must justify such changes.

In general, human tissues are potentially infectious and require universal precautions. This does not require Biosafety Committee review, unless procedures might generate an aerosol or if BSL2 or BSL3 organisms are to be cultivated from them.

Animal or plant infections or gene transfections use similar BSL levels to minimize transmission to other animals or plants or to people (see NIH/CDC Guidelines).

Recombinant DNA. Generalizations.

1. Transfer of rDNA into BSL2 organisms usually requires BSL2 containment.
2. Transfer of rDNA into BSL3 organisms usually requires BSL3 containment.
3. Transfer of rDNA from BSL2 or BSL3 organisms into nonpathogenic organisms or eukaryotic cells usually requires BSL2 containment, sometimes BSL1.

Gene transfer into animals

Transfer of rDNA into animals can be done with BSL1 conditions. If the rDNA is transferred into the animal’s germline (transgenic animals) or rDNA-modified microorganisms used to infect animals (except viruses which are only transmitted vertically) require BSL2 containment. Containment should be increased if the trait increases transmission of a pathogen or introduces an undesirable trait.

For more information on USF Biosafety requirements and training for researchers contact:

Environmental Health and Safety Office

University of San Francisco

415-422- 6883