What do we mean by "biological agent"?
In the UAB, the concept of biological agent goes a little beyond what is defined in article 2 of RD 664/1997. Therefore, we consider a biological agent as any organism, including those which have been genetically modified, biotoxin, protein (ex. prion), allergen, cell cultures and endoparasite, which may be able to provoke any infection, allergy or toxicity in humans, animals, plants or harmful effects to the environment.
What do we mean by confined activities with biological agents?
It is an operation in which genetically modified or pathogenic organisms are cultured, stored, transported, destroyed, disposed or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment. An operation can take place in a laboratory (research, diagnosis), an animal facility (small and / or large animals), a greenhouse or a large-scale process facility (production).
What is a Genetically Modified Organism (GMO)?
Law 9/2003 defines GMO as "any organism, with the exception of human beings, which has been modified, through specific techniques of genetic manipulation, a modification of its genetic load (genome)". It is therefore induced modifications, different from those that occur naturally in mating, recombination or in any other biological process of transfer of genetic material. The modification may consist of a modification of the expression of their genes, deletions or partial losses thereof, or the incorporation of genetic material from other species or varieties.
What is self-cloning?
According to Directive 2009/41/EC (Annex II Part A), self-cloning in risk group 1 or multicellular organisms (excluding germ cells of human origin) consists in "the removal of nucleic acid sequences from a cell of an organism, which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), with or without prior enzymatic or mechanical steps, into cells of the same species or into cells of the same species or of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants.
Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms.
Are the risk/hazard group and the biosafety/biocontainment level synonymous?
Previous versions of the WHO "Laboratory Biosafety Manual" described the classification of biological agents and laboratories in terms of risk/hazard groups and biosafety/containment levels. While this may be a logical starting point for the handling and containment of biological agents, it has led to the misconception that the risk group of a biological agent directly corresponds to the biosafety level of a laboratory. In fact, the actual risk of a given scenario is influenced not only by the agent being handled, but also by the procedure being performed and the competency of the laboratory personnel engaging in the activity.
Who can be a Principal Investigator (PI) on an IBC protocol?
The PI is a member of the academic staff or senior research who bears responsibility for the intellectual leadership of a project. The PI accepts overall responsibility for directing the research, the financial oversight of the award's funding, as well as compliance with relevant University policies and sponsor terms and conditions of the award.
Are an experimental procedure and a research project synonymous?
No, although they may match. A project may have one or several experimental procedures (work with animals, plants, microorganisms, cell lines, arthropods, samples, large scale, etc.) with different biosafety levels that require facilities and work practices clearly differentiated.
My research involves work with E.coli K-12, plasmids, and Saccharomyces spp. Is this research required to be registered with the IBC?
Yes. It is dependent upon the genetic material that is being manipulated as to whether or not the work just needs to be registered or if the work needs to go to the IBC for full approval. Submit an IBC Registration Form.
Can I just submit a research summary via e-mail to be reviewed and approved?
No. There is an electronic application form for IBC registration. Contact the Biosafety Officer (tel. 8049) for assistance with access to the web-based application.
When does an IBC-UAB protocol approval expire?
An approved protocol of BSL1 or BSL2 expire after 3 years from its initial approval date. If the protocol require a BSL3 the validity is for one year.
How do I amend my biosafety protocol to reflect updates to lab personnel?
A formal amendment to a biosafety protocol for the addition or deletion of individuals from the protocol personnel list is not necessary as it is for grants and research changes. Simply send an email to firstname.lastname@example.org with your updated list of personnel. The IBC-UAB will note this change and file with your currently approved protocol.
Why do we have to keep our laboratory doors closed?
There are numerous reasons that doors to labs should be closed:
• Work at all biosafety levels requires limited or restricted access to the lab when work is in progress.
• Some laboratories are designed to be under negative pressure to surrounding rooms and corridors (air flows into the lab) and building ventilation systems are balanced when doors and windows are closed. Keeping doors open causes the pressure differential to drop and makes the directional airflow negligible and easily disturbed.
• Closed doors help contain chemical vapors and aerosolized infectious agents and confine flames and smoke.
• Closed doors help deter thieves.
Why is hand washing with soap and water better than using an alcohol-based disinfectant?
CDC (Centers for Disease Control and Prevention) recommends washing hands with soap and water whenever possible because handwashing reduces the amounts of all types of germs and chemicals on hands. But if soap and water are not available, using a hand sanitizer with at least 60% alcohol can help you avoid getting sick and spreading germs to others. That said, it can be added that:
-Soap and water are more effective than hand sanitizers at removing certain kinds of germs, like Cryptosporidium, norovirus, and Clostridium difficile. Although alcohol-based hand sanitizers can inactivate many types of microbes very effectively when used correctly (ex. coronavirus), people may not use a large enough volume of the sanitizers or may wipe it off before it has dried.
-Many studies show that hand sanitizers work well in clinical settings like hospitals, where hands come into contact with germs but generally are not heavily soiled or greasy. Hands may become very greasy or soiled in community settings, such as after people handle food, play sports, work in the garden, or go camping or fishing. When hands are heavily soiled or greasy, hand sanitizers may not work well.
-Hand sanitizers without 60-95% alcohol 1) may not work equally well for many types of germs; and 2) merely reduce the growth of germs rather than kill them outright.
-The presence of alcohol in the disinfectant solution and applied with high frequency can lead to certain problems for certain people with particularly sensitive skin.
Hand hygiene is the most efficient and cheapest way to limit the spread of disease.
Doesn’t the UV light in my BSC disinfect everything?
The international standards on laminar flow cabinets (EN12469: 2000, NSF 49) explicitly discourage the use or even the installation of UV lights in BSCs. In order to be effective, UV lamps must be cleaned weekly to remove dirt and dust and should be checked periodically (approximately every 6 months) with a meter to ensure the appropriate intensity of UV light is being emitted for germicidal activity. UV lights must be turned off when the room is occupied to protect eyes and skin from UV exposure.
How often should our biosafety cabinet (BSC) be certified?
BSCs must be certified at the time of installation and annually thereafter. They should also be certified anytime they have been moved and after some repairs (HEPA filter replaced, maintenance to internal parts).
Why aren’t Bunsen burners or open flames permitted inside the BSC?
The use of open flames, flammable gases, and flammable liquids inside a BSC:
• Disrupts the air flow, compromising protection of both the worker and the work.
• Causes excessive heat buildup which may damage HEPA filters and/or melt the adhesive holding the filter together, thus compromising the cabinet’s integrity
• Presents a potential fire or explosion hazard. Electrical components such as the BSC fan motor, lights and electrical outlets are not designed to operate in flammable atmospheres, where a flash fire could be ignited by a spark. A majority of BSCs, recirculate 30-70% of the air in the cabinet through a HEPA filter; gas leaking in the cabinet from a faulty connection or burner can quickly build to explosive levels due to this recirculation process.
• Cabinet manufacturers will assume no liability in the event of fire, explosion or worker exposure due to the use of a flammable gas in the cabinet.
Alternatives to Bunsen burners and open flames include:
• Alternative technology such as electric incinerators, glass bead sterilizers
• Disposable loops, spreaders, and other instruments
• Pre-sterilized packs of instruments such as tweezers, scissors and scalpels
If it is deemed absolutely necessary for the work being done, a small alcohol burner containing only enough alcohol for one day’s work, or a touch-plate microburner, providing a flame on demand may be used.
What is the difference between Sterilization, Disinfection and Decontamination?
Sterilization is a process (physical or chemical) which destroys all viable, or living, forms of microorganisms.
Disinfection is a process which reduces or eliminates microorganisms in their vegetative state from a surface or space. Spores may not be killed by disinfection.
Decontamination is a process that eliminates or reduces biological agents to a safe level in terms of the transmission of disease or other adverse effects and rendering an object safe for handling.
Why should you not autoclave waste which is contaminated with hazardous chemicals?
The hazardous chemical may volatilize and cause exposures to the operator when the autoclave is opened. It can also damage it (corrosive) or contaminate it (toxic or radioactive).
Our lab needs to order a product from ATCC which requires the signature of the Biosafety Officer. How can we accomplish this?
Please send the completed ATCC forms to email@example.com, indicating the biological material being ordered and the code of the approved experimental procedure by the IBC-UAB, if applicable. The Biosafety Officer will verify the information provided and, if everything is correct, sign the required form and send a scanned copy to the applicant PI via campus mail.
What is a biological spill kit and do I need one?
Advance preparation for management of a biological spill is essential. A biological spill kit can easily be assembled using items that should already be available in the lab. A complete biological spill kit consists of:
• Dust pan & scoop or tongs for broken glass/sharps.
• Paper towels or other absorbent material.
• Concentrated household bleach.
• Several pairs of latex or nitrile gloves.
• Safety glasses.
• Biohazardous waste (autoclave) bags.
These items should be placed in a labeled box or bucket and kept in areas where biohazards are used (and kept separate from the required chemical spill kit). All labs working with infectious/potentially infectious material or recombinant DNA should have a biological spill kit assembled. Spill handling procedures should be posted in the lab and all individuals should know how to properly clean a spill.
What type of disinfectant should I use?
When considering which disinfectant to use, you need to ensure that the disinfectant you choose is effective against the organism(s) you are trying to kill. Additionally, you should consider the surface or item that needs to be disinfected, corrosive nature or other hazards associated with the disinfectant and its ease of use. The IBC recommends a freshly-diluted (within 24 hrs) bleach solution for routine surface disinfection as bleach is effective, low cost, readily available, and may be disposed down the drain after use. If you do not wish to use bleach, choose another disinfectant and follow manufacturer’s instructions for the appropriate concentrations and contact times to be used and for disposal requirements. Please note that aqueous alcohol solutions (e.g. 70% ethanol) are not appropriate for surface decontamination as these solutions evaporate too quickly to achieve the necessary contact time (10 minutes).
What is the shelf-life of undiluted bleach?
Undiluted household bleach stored at room temperature in the original container maintains its label strength active level for approximately 6 months after the manufacturing date before starting to degrade into salt and water. The hotter the temperature the bottle is stored at, the faster the decomposition. For this reason, it is important to date your bleach containers when you receive them. You should also periodically replace the bleach in your biological spill kit to be sure that you are using the bleach at label strength which is required for use.
Will my laboratory be inspected?
Yes. The IBC-UAB is responsible for conducting regular facilities inspections where confined biological agent activities are carried out (e.g., laboratory, animal facilities, cell cultures labs, greenhouses, etc.). In addition, the laboratories are subject to inspection by state and local regulatory agencies.
How can I prepare for the biosafety inspection?
Be sure all laboratory personnel have completed required training and are familiar with policies and practices for the safe use and disposal of biological materials (e.g. human, animal, and plant pathogens, recombinant DNA, biological toxins). Inspection checklists (intranet) are aligned with legal and international standards requirements.