The purpose of this Institutional Biosafety Committee (IBC) policy is to provide guidance for the UW-Madison research community on the certification, use, and maintenance of BSCs, ATSs, and CADs.
A contract is maintained by the UW-Madison for the purchase of all classes of BSCs, ATSs, and CADs. Before ordering one, consult the BSC Certification Program and Office of Biological Safety (OBS) at Environment, Health & Safety (EH&S) for an evaluation and selection of BSC suitability for the intended work and of the available space. OBS and the BSC Certification Program must approve all BSC purchases. Additional approvals (e.g. the Office of Chemical Safety and UW Facilities Planning & Management) may be needed depending on materials used in the BSC and the type of BSC to be purchased.
The purchase or transfer of ownership of used BSCs, ATSs, and CADs from non-UW-Madison entities must be approved by OBS and the BSC Certification Program. This includes units that are transferred to UW-Madison laboratories from companies owned by UW faculty. The age, repair history, materials previously used in the unit, and type of decontamination performed will be considered as part of the approval process.
To ensure adequate function of BSCs, ATSs, and CADs, airflows are balanced, HEPA filters are tested, and other tests are performed according to NSF Standard 49 during certifications. Certification services are available for a fee through the BSC Certification Program at EH&S or through an EH&S approved vendor. Laboratories and facilities must ensure that a thorough surface decontamination of the unit is performed prior to certification.
All biological safety cabinets must be certified when initially installed and/or moved. Annual certification (every 12 months) is required unless it is waived by OBS, which is considered on a case-by-case basis for low-risk activities. Upon approval by OBS, certifications may be extended to no more than 18 months. Certification extensions for BSCs at BSL3 must also be approved by the IBC Chair. Cabinets are labeled to indicate that they either were certified on a given date or that the equipment must not be used with biohazardous materials. If a BSC is neither certified nor waived, OBS may request the lock-out of the unit.
Animal transfer stations are used to reduce animal allergen exposures to users during cage changes or normal animal husbandry practices. They are not biological safety cabinets and should never be used for work with potentially hazardous biologicals or chemicals in order to protect users and BSC certifiers. In addition, ATSs shall never be used for cage changes or other activities (e.g. animal husbandry practices) at ABSL2 and higher due to an increased risk of exposure to BSC certifiers and the difficulty or inability to gas decontaminate for repairs or disposals.
All animal transfer stations shall be certified when initially installed and annually thereafter. Certification can never be waived.
CADs only provide product protection and shall not be used with potentially hazardous biologicals or chemicals in order to protect users and BSC certifiers. CADs may not be used with animals. CADs are not required to be certified annually however, it is recommended they be certified in order to verify the unit is continuing to provide product protection.
A certification waiver may be requested through OBS for BSCs where only low-risk work (e.g. non-pathogenic materials, naive mouse cells) is performed. A risk assessment for activities performed in the BSC is conducted by OBS to determine if a waiver from certification may be granted. The PI must request a new waiver each year and every third year the BSC must be certified to verify that it is still functioning adequately. Any BSCs used for animal research cannot be waived.
Certifications are recommended but waivers are not required to forego certification.
Units may be locked out to prevent their use. This is to ensure the protection of personnel and/or environment. Only OBS or IBC can determine if locking out the unit from use is necessary or required. A BSC or ATS may be locked out if it has failed certification or requires certain repairs. A BSC may also be locked out if it is neither certified nor waived. Since CADs do not provide personnel or environment protection, they are excluded from locking out unless there are safety concerns regarding their use (e.g. electrical).
All BSC, ATS, and CAD service, maintenance and certification must be either be provided by or approved by the BSC Certification Program at EH&S. The unit must be decontaminated prior to all services. OBS will determine the method of decontamination (surface or gas) and who is to perform the decontamination (e.g. BSC Certification Program, laboratory personnel) based on the services required and the materials used in the unit.
A BSC without manufacture installed wheels shall not be moved without prior approval from OBS and the BSC Certification Program. All BSCs must be either surface or gas decontaminated prior to being moved from one space to another. OBS will determine the method of decontamination needed and the BSC Certification Program will perform the decontamination unless OBS determines otherwise. Before a unit is moved, laboratory staff are responsible for arranging surface or gas decontamination with the BSC Certification Program at EH&S. After being moved, all BSCs without wheels must be recertified through the BSC Certification Program at EH&S or through an EH&S approved vendor. For those BSCs with manufacturer installed wheels, movements between floors or buildings would require recertification before use whereas movement on the same floor would not.
Animal transfer stations with manufacturer installed wheels can be moved within the same vivarium floor without requiring a recertification. Movements between vivariums, floors, or buildings would require recertification unless OBS and Animal Research Safety at EH&S determines otherwise. Animal transfer stations without manufacturer installed wheels always require recertification after movement. Prior to relocation, facility staff should perform a surface decontamination using an appropriate disinfectant.
Clean air devices may be moved without recertification though it is strongly recommended that they are recertified to verify the unit is continuing to provide product protection. Prior to relocation, laboratory staff should perform a surface decontamination of the unit.
PIs must obtain approval from their department and Business Services Property Control before taking equipment with them.
While transporting units, it is feasible that damage to the contaminated plenum and/or HEPA filters can occur, exposing movers and research personnel. Thus, all BSCs must be gas decontaminated by trained personnel prior relocation onto or off of campus. Documentation of the decontamination should accompany the BSC.
Prior to relocation, OBS must be contacted to determine the method of decontamination needed (i.e. gas decontamination, surface decontamination).
BSCs, ATSs, and CADs may not be sent to UW-Madison’s Surplus With a Purpose (SWAP) to be sold. These units must be dismantled by the BSC Certification Program or an EH&S approved vendor prior to disposal by campus metal recycler. Gas decontamination is always required prior to disposal of a BSC and may be required for ATSs and CADs depending on their use. Gas decontamination must be done by trained personnel; through the BSC Certification Program or an EH&S approved vendor. There is a fee associated with the disposal of BSCs, ATSs, and CADs.
Prior to the disposal or removal from campus the Principal Investigator must determine if the BSC is listed by Property Control as an inventory (capital) asset by their department. If so, the BSC must be removed from the inventory list. The Department’s Property Administrator will be able to help the PI with the list and inventory removal.
Heat from a device (e.g. Bunsen burner, alcohol lamp, bacteria incinerator) affects the air flow in BSCs and as a result can compromise containment and increase contamination. The use of flammable gas inside a BSC is also an explosive hazard. Thus, the use of a continuous open flame (e.g., standard Bunsen burner) is prohibited. The use of an alternative heat-generating or intermittent flame source such as a safety Bunsen burner or a bacteria incinerator is strongly discouraged and would require approval from OBS/IBC for use inside a BSC. Non-flame and non-heat-generating alternatives should be used whenever possible.
Responsible for day-to-day maintenance, proper use of equipment, surface decontamination, training staff on proper use of equipment, updating OBS/IBC with any research activities or changes to research activities, and request of: BSC purchase, waiver, move, gas decontamination, dismantle.
Select, evaluate and approve purchases of BSCs, ATSs, and CADs. Provide the service, maintenance, decontamination and certification for all BSCs, ATSs, and CADs. Approve and manage vendors for BSC/ATS/CAD service and certification.
Chemical Safety: The use of chemicals in BSCs, ATSs, and CADs are under the purview of Chemical Safety.
Approve research materials and activities including containment and disinfection.
Perform laboratory risk assessment and BSC/ATS/CAD decontamination determination.
Provides approval for BSC/ATS/CAD purchase, certification waivers, and BSC lock-outs.
Perform animal facility risk assessment.
UW-Madison, Office of Biological Safety - The UW-Madison Researchers’ Biosafety Manual; found on the EH&S website.
U.S. Department of Health and Human Services, National Institutes of Health (NIH) - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, current version and/or any subsequent revisions.
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) - Biosafety in Microbiological and Biomedical Laboratories (BMBL), Current Edition.
NSF International Standard/American National Standard (NSF/ANSI) – NSF/ANSI 49 Annex E, 2016
02/04/2015, 05/04/2016, 10/02/2019