Biological Safety FAQs
Biological Materials
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What is a biosafety level?
A biosafety level is an assigned containment, which consists of combinations of facility design features and safety equipment (primary and secondary barriers), facility practices and procedures, and personal protective equipment.
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I was told that my work must be conducted at a Biosafety Level-2 (BSL-2). What do I have to do?
Biosafety Level 2 (BSL-2) is suitable for work with agents associated with human disease and pose moderate hazards to personnel and the environment. Such agents may be spread via percutaneous injury, ingestion and/or mucous membrane contact.
In Duke Labs, work at BSL-2 requires the following:
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Laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures. To assist with the documentation of agent-specific training, The Biological Safety Division has created a BSL2 Standard Operating Procedures (SOP) Template. The online training module “Biosafety Level 2 Training” is required (this is found on the on-line training section of OESO’s site). If working with human blood and body fluids, the student or employee(s) must be offered the Hepatitis B Vaccine through Student Health (919) 681-9355 or Employee Health (919-684-3136).
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Access to the laboratory is restricted when work is being conducted.
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All procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment.
For more information regarding work at BSL-2, visit Section IV of the current edition of Biosafety in Microbiological and Biomedical Laboratories.
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What is a risk group?
Risk groups are assigned to microbes (agents). The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) has incorporated an agent Risk Group (RG) classification for laboratory use that describes four general Risk Groups based on these principle characteristics and the route of transmission of the natural disease; this list is found in Appendix B of the NIH Guidelines.
ABSA International also has a compendium of organisms and Risk Group assignments from several countries and organizations available at https://my.absa.org/Riskgroups. Agent Risk Group assignments assist with an initial estimate of the pathogen’s risk; the assessment must be modified appropriately based on the unique risks faced by each laboratory for the specific work being done. The four groups address the risk to both the laboratory worker and the community and correlate with, but do not equate to, Biosafety Levels.
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What are safer sharps devices, and do we always have to use them?
Safer sharps devices are those needles and sharps used on patients or in laboratories that work with human blood or body fluids and tissues to help reduce the incidence of needlesticks or sharps exposures. They are engineered to provide a safer means of use by providing either a sheathing or push-button mechanism to cover a used sharp. OSHA requires that safer sharps devices be evaluated and used wherever work with human material occurs. Sometimes, however, they cannot be used for specific procedures for clinical reasons (ex. the needle size is inappropriate and the correct needle size does not come in a safety version). These situations must be reported to the Biological Safety Office (919-684-8822) to be recorded in the Duke University Bloodborne Pathogens Exposure Control Program.
Non Select Toxins
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What is a non-select toxin?
Non Select Toxins (biological toxins) are toxic substances that are produced or carried by microorganisms, animals, and plants. Biological toxins are non-replicating and non-infectious materials. However, they may be extremely toxic in very small quantities and must be managed like hazardous chemicals in the workplace. Examples include diphtheria toxin, cholera toxin, and resiniferatoxin.
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What do I need to know about diphtheria toxin (DT)?
DT is useful in biomedical research using mice because it can be used to selectively target and kill cells or organs without requiring surgery. The Diphtheria Toxin Policy describes the medical considerations (vaccination or titer), SOP development for defined high and standard risk work, and OESO clearance required before the work can begin.
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Where can I find an SOP template and guidelines?
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Do I have to register with the IBC?
Research at Duke University and Health System using recombinant DNA (rDNA) materials must comply with the NIH Guidelines for rDNA Research. Experiments involving the deliberate formation of recombinant or synthetic nucleic acid molecules containing genes for the biosynthesis of toxin molecules must be registered.
Animal Research
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When do I need to submit a biosafety SOP with my animal protocol?
If you will be using bacteria, virus, biologically-derived toxins, yeast/mold/fungi, mammalian cell lines submit an SOP to biosafety@duke.edu for assessment. At BSL-2, the SOP template is here.
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I am using recombinant DNA and/or viral vectors. How do I register this work?
Register the work with the Institutional Biosafety Committee (IBC) via email (biosafety@duke.edu) using this form. Submit your biosafety SOP(s) (where applicable) with the registration at the same time.
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I registered with the IBC. When will I get approval?
Registrations submitted to biosafety@duke.edu are reviewed for completeness. Once the IBC meets, biosafety@duke.edu will contact you with the results of the vote. The IBC meets once a month according to this schedule.
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IACUC says OESO has not cleared my protocol. Who do I contact to find out why?
Contact OESOAnimalProtocols@duke.edu.
A/BSL-3
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When do I need to use an A/BSL-3 laboratory?
When working with biological materials that could cause serious or lethal disease through the inhalation route of exposure.
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What are the prerequisites to work in an A/BSL-3 laboratory?
There are both medical clearances and specialized training needed to work in an A/BSL-3 lab. You must complete your medical clearance for respiratory protection and the High Containment Special Pathogens Health Review. If you are working with or in a room containing Mycobacterium tuberculosis, then you need an annual Tuberculin Skin Test. If you are working with materials that have a vaccine available, you may be required to be assessed by EOHW for the vaccine prior to starting work. For training, you need to take annual BSL-3 training and respiratory protection training, as well as go through a period of mentored training before being evaluated for independent work in the A/BSL-3 lab.