|
Biosafety Committee
The new Biosafety Committee incorporates rDNA issues along with biohazards,
including infectious and toxic or carcinogenic agents, since many of the same issues
apply. The Biosafety Committee has replaced the Biohazard and rDNA Committees and will
review investigator-generated safety protocols for the use of infectious agents, toxic and
carcinogenic compounds, and DNA recombination. The Committee has prepared the following
outline of guidelines based on NIH/CDC guidelines to help investigators determine if their
procedures need Biosafety Committee review.
Forms for the Biosafety Committee are
located on the Forms
and Guidelines page.
Thank you to Dr. Soderberg for providing information on the
Biosafety Committee.
UAMS Biosafety Committee Guidelines
The principal investigator is responsible for ensuring that
adequate safety precautions, consistent with NIH/CDC recommendations, are followed. The
following includes a very shortened overview of NIH/CDC guidelines. Investigators should
refer to http://bmbl.od.nih.gov/
or http://www4.od.nih.gov/oba/guidelines.html
for more detailed information.
What projects require approval?
- Experimentation using BL2 or BL3 infectious microorganisms.
- Experimentation using carcinogenic (known or suspected) or
highly toxic compounds.
- Recombinant DNA, if BL2 or BL3 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.
- Modification of the germline genes of animals (transgenic).
- Human gene therapy even if the recombinant DNA is produced
elsewhere.
Containment (Biological safety levels)
- BL1: organisms pose little or no risk of infection to healthy
adults.
- BL2: pathogens which are readily contained by standard
microbiological techniques
- BL3: highly transmissible pathogens require special
containment facilities with controlled access. There is a BL3 facility in the Biomedical
Research building and one at the VA. 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.
- BL4: UAMS does not have the facilities to use BL4 organisms.
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 BL2 or BL3 organisms are to be cultivated from
them.
Animal or plant infections or gene transfections use similar
BL levels to minimize transmission to other animals or plants or to people (see NIH/CDC
Guidelines).
Recombinant DNA. Generalizations.
- Transfer of rDNA into BL2 organisms usually requires BL2
containment.
- Transfer of rDNA into BL3 organisms usually requires BL3
containment.
- Transfer of rDNA from BL2 or BL3 organisms into nonpathogenic
organisms or eukaryotic cells usually requires BL2 containment, sometimes BL1.
Gene transfer into animals
Transfer of rDNA into animals can be done with BL1
conditions. If the rDNA is transferred into the animals germline (transgenic
animals) or rDNA-modified microorganisms used to infect animals (except viruses which are
only transmitted vertically) require BL2 containment. Containment should be increased if
the trait increases transmission of a pathogen or introduces an undesirable trait.
Meeting Dates and Deadlines
The Biosafety Committee does not have
regularly scheduled meetings. Rather, biosafety protocols are reviewed as received. Thus,
there are no deadlines and Committee review is completed as soon as possible after
receiving a protocol.
UAMS Biosafety Committee
Lee S.F. Soderberg, Chair, Ph.D.
Gary Bannon, Ph.D.
Mary Ann Coleman
Lawrence Cornett, Ph.D.
Kathleen Eisenach, Ph.D.
Jack Hinson, Ph.D.
Tom Lynch, Ph.D.
Veronica MacLeod, M.S.
Victor Robbins, DVM, Ph.D.
Robert Saylors III, M.D.
Annice Steadman
|