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Date: Oct. 21, 2019
Version: 01

Policy

It is the mission of the University of ÁùºÏ±¦µä, Reno to ensure a safe learning, research and work environment for faculty, staff, students, and visitors. To that end, the Environmental Health and Safety Department shall maintain a program for tracking the annual certification of biosafety cabinets and other similar ventilation safety devices used to contain biohazardous agents.

Responsible Authority

Vice President for Research and Innovation; Environmental Health & Safety department.

Scope

This policy applies to all University of ÁùºÏ±¦µä, Reno biosafety cabinets (BSCs), clean benches, HEPA filter banks, Animal Transfer Stations (ATSs), and related ventilated equipment used to ensure the safe handling of respirable biohazardous materials.

Background

Respirable biohazardous materials present a source of risk to the University. Pathogens can adversely affect human and/or animal health, the environment, or otherwise compromise the integrity of research samples. A major mitigating factor for these respirable hazards is the regular certification and maintenance of biological safety cabinets. These devices employ HEPA filtration and directional airflow to provide personnel, product, and environmental protection.

There are various agencies that recommend and/or require the annual certification and maintenance of biosafety cabinets.

Reference Regulations and/or Consensus Standards

• American National Standards Institute (ANSI)-National Sanitation Foundation (NSF) 49
• Biosafety in Microbiological and Biomedical Laboratories (BMBL), most recent edition
• 29 CFR 1910.1030 OSHA Bloodborne Pathogens Standard
• NIH Guidelines
• Select Agents Regulations (7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73)

Procedures

The ventilation equipment owned by the University is extensive and diverse, so these procedures may not always be consistent between laboratories. Consult with EH&S if you have specific questions about equipment certification that is not listed in this policy.

Generally, EH&S will notify the certifying agent whenever a change to the equipment inventory is noted. EH&S coordinates and pays the certifying agent to perform one annual certification of each BSC and ATS, but doesn’t pay for certification of clean benches, building HEPA banks, chemical disinfection, HEPA filter changes, or other maintenance work. However, EH&S does work with labs and the certifying agent to coordinate such work around the certifying agent’s regularly-scheduled visits to campus.

The certifying agent will provide estimates, invoices and final reports to EH&S and/or the lab which has requested work. EH&S acts to facilitate communication between the certifying agent and the laboratories. They will also assist the certifying agent in gaining access to laboratory spaces that are locked or require special entrance procedures.

Summary of Responsibilities

Laboratory Supervisors

• Notify EH&S when a biosafety cabinet is purchased, in need of repair, has been moved, or needs removal/disposal.
  • Notification for certification work should be made to EH&S at least 7 days before certifying technicians arrive on campus. Repair and decontamination work must be coordinated at least 30 days prior to certifying technicians arriving on campus, as this type of work requires significant lead-time and special travel considerations.

• Ensure that cabinets are surface-decontaminated and other equipment are accessible and clear of clutter that may impact certification work.
• Communicate known scheduling conflicts to EH&S as soon as possible.
• Ensure on an ongoing basis that the equipment is maintained, cleaned, and properly disinfected.
• Provide prompt payment to the certifying agent for all work performed that is beyond the one annual BSC or ATS certification that is paid by EH&S, to include off-schedule travel fees and other special fees. Payment should be submitted within 10 business days, or it should be communicated to EH&S if there are extenuating circumstances.
• Notify EH&S if the lab chooses to certify or repair their equipment with a company other than the certifying agent. The PI is responsible for coordinating this work, as well as for payment of all services conducted by companies other than the regular certifying agent.

Biosafety cabinet users

• Receive proper training before using biosafety cabinets.
• Abide by EH&S and lab-specific procedures while using this equipment.
• Notify their PI and EH&S if problems are encountered while using their biosafety cabinet.
• Do not attempt to move, service, or perform other actions which may cause the certification of a cabinet to become voided.
• Work with certifying technicians and EH&S to allow access to biosafety cabinets and other equipment that requires certification, maintenance, or repair.

Environmental Health & Safety

• Provide the certifying agent with a list of known ventilation equipment.
• Pay for one annual certification of each BSC or ATS that is owned by UNR.
• Check the accuracy of estimates, invoices, and final reports submitted by the certifying agent.
• Send verified invoices to campus users for other work conducted by the certifying agent.
• Assist certifying technicians in gaining access to research spaces when laboratory occupants are not present.
• Assist with the scheduling of repair work that coincides with regular certification visits (March, July, and September of each year).
• Maintain a database of biosafety cabinets and associated equipment currently in-use.
• Communicate identified problems to lab users when certifying technicians are unable to do so while in lab.

Related Material

Chemical Hygiene Plan
Biosafety Manual

Appendix I: Frequently Asked Questions

Q: When does my biosafety cabinet need to be certified?

A: BSCs should be certified at the time of installation and at least annually thereafter. Additionally, certification is needed whenever HEPA filters are changed, repairs involving internal components are performed, or a cabinet is relocated.

Q: What work is performed during a certification?

A: Certifying technicians will perform airflow velocity profiles, check the HEPA filter(s) for leaks, and ensure that the cabinet is operating in accordance with NSF 49 and manufacturer specifications.

Q: How long does a certification take?

A: Certification of a Class IIA2 cabinet can generally be done in less than an hour. Additional time is required for decontamination and repair work.

Q: What do I need to do prior to BSC certification?

A: You must remove excess equipment from the cabinet prior to the certifying agent conducting the certification. You should also wipe down the work surface, interior walls and grille with an appropriate disinfectant so that technicians aren’t exposed to biological hazards while performing their work.

Q: Do I need to certify my chemical Fume Hoods?

A: No, there is no need to certify chemical fume hoods. EH&S verifies their function independently of this biosafety cabinet certification policy. Similarly, clean benches and PCR hoods do not require annual certification, although labs may choose to have these certified at their own expense if they like.

Q: Why does EH&S include Animal Transfer Stations (ATSs) in its list of equipment that it will pay to certify?

A: ATS equipment functions similarly to biosafety cabinets in that they provide personnel protection from pathogenic materials. Other pieces of ventilation equipment, such as clean benches, do not provide personnel protection and are not required to be certified annually; such “elective” certification is not paid for by EH&S.

Q: How do I get rid of a biosafety cabinet that is no longer used?

A: Biosafety cabinets must be decontaminated before they can be safely disposed of. Contact EH&S to request a paraformaldehyde decontamination at least one month prior to the certifying agent’s next scheduled visit (March, July, or September). The lab will be responsible for the decontamination fee, as well as for arranging removal/disposal of the unit after it has been decontaminated.

Q: How do I purchase a new biosafety cabinet?

A: Estimates can be obtained from many leading manufacturers. Lead times for getting a new cabinet delivered to campus can exceed one month, and the lab will also have to account for the time needed by UNR movers to get the cabinet installed. The lab is also responsible for working with the UNR Facilities group to ensure that proper installation can be completed prior to the certifying agent’s arrival on campus.

Q: What is NSF Standard 49?

A: NSF is the National Sanitation Foundation, and Standard No. 49 is the design, construction and testing document that establishes a minimum standard for field certification of Class II biological safety cabinets.

Q: What type of biosafety cabinets are found around campus? What should I purchase?

A: The vast majority of biosafety cabinets at UNR are Class II, Type A2 (also known as IIA2 cabinets). Other biosafety cabinets that may be encountered include IIA1, IIB1, and IIB2. All of these Class II biosafety cabinets will provide personnel, product, and environmental protection, although there are differences that should be considered if a lab will be working with radionuclides or volatile chemicals. For more information on biosafety cabinet selection, please consult chapter 8 of the UNR Biosafety Manual or contact EH&S.