Biosafety Program
Introduction
Biosafety is a two way path - to be 'biosafe' implies creating a safe working environment for all personnel and ensuring that the work being done does not impact the environment. Biohazardous materials include any organism that can cause disease in humans, or cause significant environmental or agricultural impact, such as:
- Bacteria
- Viruses
- Parasites
- Prions
- Fungi
- Human or primate tissues, fluids, cells, or cell cultures/lines that are known to or are likely to contain infectious organisms
- Human or animal tissues, fluids, cells, or cell cultures/lines that have been exposed to infectious organisms
- Animals known to be reservoirs of zoonotic diseases
Recombinant DNA use is also covered by the Biosafety program. This includes:
- Recombinant DNA
- Transgenic animals
- Transgenic plants
- Human gene transfer/studies using rDNA
Biosafety Manual
Information regarding policies, procedures and requirements for doing research at Stanford University is found in the Stanford University Biosafety Manual. If you would like a hard copy, contact the Biosafety office (esegal@stanford.edu).
Charge to the Administrative Panel on Biosafety
The Stanford University Research Policy Handbook (RPH 1.4) describes the reporting functions of the Administrative Panel on Biosafety; the charge to the APB can be viewed here.
Administrative Panel on Biosafety
Use of any of the above materials may require approval by the Stanford University Administrative Panel on Biosafety (APB) prior to start of research. Go to Administrative Panel on Biosafety (APB) for additional information.
Information for PIs
Apply for APB Approval
Why: The NIH mandates the establishment of an Institutional Biosafety Committee (at Stanford it is the Administrative Panel on Biosafety (APB)) for all institutions that receive any support for rDNA research from NIH. The APB at Stanford is also charged with reviewing projects involving infectious agents (Charge to the APB).
Who needs to apply: Any work using biological agents classified as BSL-2 or above must have APB approval prior to commencing work. Any work using rDNA that is deemed by the NIH to be non-exempt from the rDNA Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH rDNA Guidelines, Material Safety Data Sheets (MSDS) for Infectious Substances, and CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. You can also check with the Biosafety personnel at EH&S (esegal@stanford.edu).
How to apply using eProtocol Biosafety: The APB uses the eProtocol Biosafety application process, a web-based system that coordinates new protocols, updates, renewals and reminders. To learn more about eProtocol Biosafety and access the system, go to https://eprobio.stanford.edu
DOD Funded Research
Click here to see information about DOD Funded Research.
PIs Role in Safety
Training
It is the responsibility of the PI or supervisor to identify job-specific hazards and ensure that personnel are up to date on all required and recommended training
There are three 'tiers' of training at Stanford applicable to Biosafety.
- Tier I: general training for laboratory workers.
- Tier II: training that is specified according to job-specific issues.
- Tier III: specific, job and project related training that is provided by the PI, supervisor or other appropriate personnel. Documentation of training is to be recorded by the PI.
Training required for Biosafety is listed here
Support for determining overall training needs can be found at Training
On-line training is obtained through Axess - Stanford University.
Universal Precautions
The concept of Universal Precautions is to treat all human/primate blood and other body fluids, tissues and cells as if they were known to be infectious for BBP's. Along with frequent handwashing, no mouth pipetting, no food or drink in the lab and proper disposal of biohazardous/medical waste are the inclusions of engineering controls and Personal Protective Equipment (PPE). Engineering controls include items such as biosafety cabinets, ventilation systems, closed top centrifuge rotors, etc. - these are the primary methods to control exposure. PPE such as gloves, lab coats, eye protection, face shields or others must be selected and used as appropriate. See PPE for additional information.
Safety Sharps
Manufacturers have developed "engineered sharps"; these are commonly used items (e.g. scalpels, syringes, needles) that have various mechanical devises to vastly decrease the occurrence of injuries due to sharps. CAL-OSHA requires any laboratory using human or primate blood, blood products, cell lines, tissues or other potentially infectious materials to use needleless systems/and or engineered sharps. If a PI/supervisor decides that a non-compliant sharps is necessary for a certain procedure, the reason must be documented.
Emergency Response
It is the responsibility of the PI to ensure that personnel are trained in actions to take if an emergency occurs. Biosafety specific emergencies would involve accidental exposures or spills. Information on actions to take for theses events is provided in the Stanford University Biosafety Manual, Chapter 7.
SUOHC: Stanford University Occupational Health Center (SUOHC) is used to care for the occupational health needs of Stanford University faculty and staff. SUOHC is a campus-based medical clinic that offers evaluation and treatment for work-related injuries and illnesses, work-related preventative medical services, and required medical surveillance programs for students and university staff.
If an exposure or injury occurs during work hours and it is not a medical emergency, personnel should go to the SUOHC. After hours and on weekends personnel should go to the Stanford Hospital Emergency Department. Detailed information is available on the SUOHC web page.
Reporting
It is the responsibility of the PI to report any exposures or unauthorized research to the Biosafety Manager (esegal@stanford.edu, 725.1473). Initial reporting must be done at the earliest time possible, and within 24 hrs of the incident; a more detailed report is to be submitted within 10 days. See the rDNA Incident Reporting Template for additional information.
For additional information on Investigator Responsibilities under the NIH Guidelines see NIH Investigator Responsibilities
Research Personnel Training
Requirements
There are three 'tiers' of training at Stanford applicable to Biosafety:
- Tier I: general training for laboratory workers.
- Tier II: training that is specified according to job-specific issues.
- Tier III: specific, job and project related training that is provided by the PI, supervisor or other appropriate personnel. Documentation of training is to be recorded by the PI.
Training required for Biosafety is listed here.
Support for determining overall training needs can be found at Training.
On-line training is obtained through Axess - Stanford University.
Shipping
Regulations: Federal Law requires all persons who ship (this includes the actual packing of the material and filling out of assorted forms) Dangerous Biological Goods, INCLUDING DRY ICE, to be trained and certified prior to shipping.
To help determine if what you are shipping falls under Dangerous Biological Goods, click here.
Training: Training MUST be taken every two years. Training to become certified is found in AXESS, EHS-2700.
A guide has been published by the University of New Hampshire (click here) and is available for additional reference data.
24 hour contact: Stanford University contracts with ChemTrek to provide 24-hour emergency service for shipping dangerous goods. Click here to access the Dangerous Goods Shipping Procedure form.
Administrative Panel on Biosafety (APB)
Why: The NIH mandates the establishment of an Institutional Biosafety Committee (at Stanford it is the Administrative Panel on Biosafety (APB)) for all institutions that receive any support for rDNA research from NIH. The APB at Stanford is also charged with reviewing projects involving infectious agents (Charge to the APB).
Who needs to apply: Who needs to apply: Any work using biological agents classified as BSL-2 or above must have APB approval prior to commencing work. Any work using rDNA that is deemed by the NIH to be non-exempt from the rDNA Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH rDNA Guidelines, Material Safety Data Sheets (MSDS) for Infectious Substances, and CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. You can also check with the Biosafety personnel at EH&S (esegal@stanford.edu).
Determining if rDNA is Exempt from NIH Guidelines
How to apply using eProtocol Biosafety: The APB uses the eProtocol Biosafety application process, a web-based system that coordinates new protocols, updates, renewals and reminders. To learn more about eProtocol Biosafety and access the system, go to https://eprobio.stanford.edu
How to determine if unknown biological agent(s) require APB approval is found here.
For Clinical APB protocols - Complete the APB Clinical application and attach all documents that have also been attached to the IRB protocol.
Note that all applications to the APB must be under the name of a Faculty member.
Members: a list of current members of the APB is found here.
Dates: a list of APB meeting and submission dates is found here.
Biosafety Levels and Practices
Biosafety levels
Stanford University follows the categorizing of infectious agents into levels as described in Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition written and published by the Centers for Disease Control (CDC) and NIH. The BMBL describes combinations of microbiological practices, laboratory facilities, and safety equipment in combination with four biosafety levels for various agents infectious to humans. The descriptions of Biosafety Levels (BSL) 1 - 4 parallel those in the OBA - NIH Guidelines. Biosafety levels are also described for infectious disease activities that involve laboratory animals.
Additional resources for determining Biosafety Risk level of infectious agents can be found at:
http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_B.htm
Material Safety Data Sheets (MSDS) for Infectious Substances - Public Health Agency of Canada
ABSA - Risk Group Classification for Infectious Agents
The following Biosafety Level related documents are available:
- A summary of Biosafety Level Work Practice Requirements for infectious agents
- A summary of Work Practice Requirements as related to Biosafety levels
Biosafety Manual
Information regarding policies, procedures and requirements for doing research at Stanford University is found in the Stanford University Biosafety Manual. If you would like a hard copy, contact the Biosafety office (esegal@stanford.edu).
APB Approval
Any work using biological agents classified as BSL-2 or above must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH rDNA Guidelines, Material Safety Data Sheets (MSDS) for Infectious Substances, and CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. You can also check with the Biosafety personnel at EH&S (esegal@stanford.edu).
Viral Vectors
Viruses and viral vectors have become a staple of the molecular biology community. As such, it is important for users to understand the origins of these tools and potential implications of their use.
The following Viral Vector related documents are available:
- Working with Viral Vectors - Sections for each virus contain information on virology, clinical features, epidemiology, treatment, laboratory hazards, Personnel Protective Equipment (PPE), disinfection, and use with animals.
- Recombinant Viral Vector Biosafety Levels - recombinant viral vectors and the resulting Biosafety levels.
Recombinant DNA
APB approval: Any work using rDNA that is deemed by the NIH to be non-exempt from the rDNA Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH rDNA Guidelines or the Stanford Biosafety Manual, Chapter 2. You can also check with the Biosafety personnel at EH&S (esegal@stanford.edu).
The APB uses the eProtocol Biosafety application process, a web-based system that coordinates new protocols, updates, renewals and reminders. To learn more about eProtocol Biosafety and access the system, go to https://eprobio.stanford.edu
Note that all applications to the APB must be under the name of a Faculty member.
General Laboratory Safety
Universal Precautions
The concept of Universal Precautions is to treat all human/primate blood and other body fluids, tissues and cells as if they were known to be infectious for BBP's. Along with frequent handwashing, no mouth pipetting, no food or drink in the lab and proper disposal of biohazardous/medical waste are the inclusions of engineering controls and Personal Protective Equipment (PPE). Engineering controls include items such as biosafety cabinets, ventilation systems, closed top centrifuge rotors, etc. - these are the primary methods to control exposure. PPE such as gloves, lab coats, eye protection, face shields or others must be selected and used as appropriate. See PPE for additional information.
Safety Sharps
Manufacturers have developed "engineered sharps"; these are commonly used items (e.g. scalpels, syringes, needles) that have various mechanical devises to vastly decrease the occurrence of injuries due to sharps. CAL-OSHA requires any laboratory using human or primate blood, blood products, cell lines, tissues or other potentially infectious materials to use needleless systems/and or engineered sharps. If a PI/supervisor decides that a non-compliant sharps is necessary for a certain procedure, the reason must be documented.
Safety/Medical Monitoring
Laboratory Animal Occupational Health Program
The purpose of the Laboratory Animal Occupational Health Program (LAOHP) is to:
- protect individuals from work-related risks associated with research on animals
- protect the health of research animals from certain transmissible diseases
The LAOHP is specific to the researchers' work and the species to which they are exposed while being minimally intrusive and cost-effective. This program is relevant to faculty, staff, visiting scholars, and students who use vertebrate animals in research or teaching activities.
University policy requires that all faculty, staff, visiting scholars, and students who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas must participate in the LAOHP below. Continuing authorization to use animals is contingent upon your participation in the program.
For additional information on LAOPH and how to enroll, see Laboratory Animal Occupational Health Program.
Occupational Health Surveillance Program
The purpose of the Occupational Health Surveillance Program is to help assure the health of employees who:
- Have workplace exposure to particular health hazards (e.g., high noise levels, animal allergens) known to pose risk for a potentially serious health condition, illness, or injury; OR
- Perform specific work tasks (e.g., respirator use, driving commercial vehicles) that require a certain degree of health and fitness to assure employee and/ or public health and safety.
The Surveillance Program uses the facilities of the Stanford University Occupational Health Center (SUOHC). The SUOHC was established to care for the occupational health needs of Stanford University faculty and staff, and is dedicated to providing outstanding clinical care to improve the health and safety of university employees. SUOHC is a campus-based medical clinic that offers evaluation and treatment for work-related injuries and illnesses, work-related preventive medical services, and OSHA and departmentally-mandated medical surveillance programs for university staff.
Location of the Occupational Health Center
Environmental Safety Facility (ESF)
480 Oak Road, Room B15
Stanford, CA 94305-8007
Phone: (650) 725-5308
Fax: (650) 725-9218
Hours:
Monday - Friday
8:00 am - 5:00 pm
SUHOC
For additional information on the above see Occupational Health Surveillance Program.
Bloodborne Pathogens
The CAL/OSHA Bloodborne Pathogens Standard (1910.1030) describes an approach to infection control termed Universal Precautions. Universal Precautions assumes that all human blood, blood products, and certain body fluids are contaminated with HIV, HBV, HCV, or other bloodborne pathogens and that these materials be handled accordingly.
The following questions will help determine if your work is covered by the Bloodborne Pathogen standard.
Will you:
- work with human blood, blood products or body fluids?
- work with unfixed human cells (including tissue culture cells and cell lines),human tissues or organs?
- work with non-human primates (NHP) or NHP blood, blood products or body fluids?
- work with unfixed NHP cells (including tissue culture cells and cell lines), NHP tissues or organs?
- work with bloodborne pathogens (e.g. HIV, HepB, HepC or other infectious agents able to spread via blood?
- work with animals or animal tissues that have been infected with a BBP
- perform tasks which may potentially result in exposure to human or animal blood, body fluids, organs, or tissues which are infected with the hepatitis B virus or other bloodborne pathogens?
If the answer to ANY of the above questions is yes, then the worker is considered to be at occupational risk of contracting Bloodborne pathogens and must take the Bloodborne Pathogen Training (EHS-1600).
| Note: | BBP training MUST be taken annually; register for EHS-1600 - WEB through Axess - Stanford University. Completion of the course is required within the first month of work at Stanford University. Additionally, all personnel listed on grant applications must be shown to have completed the appropriate training. Additionally, the worker MUST complete an Exposure Control Plan in conjunction with their supervisor. Once the plan is completed, it is to be kept in the laboratory and reviewed annually. |
Location of the Occupational Health Center
Environmental Safety Facility (ESF)
480 Oak Road, Room B15
Stanford, CA 94305-8007
Phone: (650) 725-5308
Fax: (650) 725-9218
Hours:
Monday - Friday
8:00 am - 5:00 pm
SUHOC
For additional information on the above see Occupational Health Surveillance Program.
Hepatitis B Vaccination
University employees with potential for any exposure to blood or body fluids as a part of their work at Stanford University will be offered Hepatitis B vaccine at no cost to the employee. Contact the Stanford University Occupational Health Center (SUOHC) for additional information.
School of Medicine personnel, please use this information
For more information about the Hepatitis B vaccine and occupational exposure to the virus, see Occupational Exposure to Hepatitis B Virus (HBV) by the Stanford University Occupational Health Center.
Exposures
In case of accidental exposure (needle stick, splash, ingestion) or physical injury, see Stanford University Occupational Health Center.
- SU-17: Use the SU-17 to report any accident or exposure.
- Sharps Injury Log: Use the Sharps Injury Log if a sharp (needle, razor, glass, etc) was involved in any accidental exposure.
Research Animals
Approvals
Administrative Panel on Laboratory Animal Care (APLAC): All research and teaching activities involving live or dead vertebrate animals use must be reviewed and approved by the APLAC prior to activity commencement. See Administrative Panel on Laboratory Animal Care (APLAC) for additional information.
Use of biohazardous materials in animals requires both APB and APLAC approvals.
Training
The Veterinary Service Center (VSC), working with Biosafety, conducts specific training for animal biosafety projects at BSL-2 or above. The training, "Working Safely with Biohazardous Agents in Laboratory Animals" is required for anyone using biohazardous agents in laboratory animals at Stanford University. The course consists of two parts. The first part is a 20 minute web-based video reviewing general practices to follow when working at animal biosafety level 2. This is followed by a meeting with personnel from the Veterinary Service Center (VSC) and Environmental Health and Safety (EH&S) to review safe practices specific to particular studies or animal facilities.
For additional information see Veterinary Service Center Programs.
Medical Surveillance
Laboratory Animal Occupational Health Program: The purpose of the Laboratory Animal Occupational Health Program (LAOHP) is to:
- protect individuals from work-related risks associated with research on animals,
- protect the health of research animals from certain transmissible diseases.
The LAOHP is specific to the researchers' work and the species to which they are exposed while being minimally intrusive and cost-effective. This program is relevant to faculty, staff, visiting scholars, and students who use vertebrate animals in research or teaching activities.
University policy requires that all faculty, staff, visiting scholars, and students who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas must participate in the LAOHP below. Continuing authorization to use animals is contingent upon your participation in the program.
For additional information on LAOPH and how to enroll, see Laboratory Animal Occupational Health Program.
Lab Animals Zoonoses
Working with animals can exposure personnel to infectious agents capable of infecting humans. See Lab Animal Safety Data Sheets for specific information on zoonotic agents.
Emergency Procedures
Accidental Exposure
If an exposure or injury occurs during work hours and it is not a medical emergency, personnel should go to the SUOHC. After hours and on weekends personnel should go to the Stanford Hospital Emergency Department. Detailed information is available on the SUOHC web page.
For any Exposure Incident, the following steps shall be taken:
- Care for personnel -
- if medical attention is needed, go to the Stanford University Occupational Health Clinic (non-life threatening incidents) or to the Stanford Hospital Emergency Department for medical emergencies or after hours.
- if there has been a needlestick/puncture, wash the affected area with antiseptic soap and warm water for 15 minutes.
- For a mucous membrane exposure, flush the affected area for 15 minutes using an eyewash.
- If a spill has occurred, contain and initiate clean up (see below).
- Notify PI, manager or supervisor to initiate accident or exposure incident report.
- Notify Biosafety (725.1473) of incident. After hours call 723.0448 and leave a message.
Reporting form: if an accident involving a sharps occurs with potential exposure to blood borne pathogens, complete an SU-17
Sharps Injury log: If a sharps was involved, you will also need a Sharps Injury Log Form
Spill
The following procedures are provided as a guideline to biohazardous/rDNA spill cleanup. If the spill is considered too large or too dangerous for laboratory personnel to safely clean up, secure the entire laboratory and call EH&S (723.0448) immediately for assistance.
Bleach is recommended as a standard disinfectant, however, other disinfectants may be used provided they are effective against the particular agents, along with the appropriate dilution and contact time.
Inside the Biosafety Cabinet
- Wait at least five minutes to allow the BSC to contain aerosols.
- Wear laboratory coat, safety glasses and gloves during cleanup.
- Allow BSC to run during cleanup.
- Apply disinfectant and allow a minimum of 20 minutes contact time.
- Wipe up spillage with disposable disinfectant-soaked paper towels. Do not place your head in the cabinet to clean the spill; keep your face behind the viewscreen.
- Wipe the walls, work surfaces and any equipment in the cabinet with disinfectant-soaked paper towels.
- Discard contaminated disposable materials using appropriate biohazardous waste disposal procedures.
- Place contaminated reusable items in biohazard bags or autoclavable pans with lids before autoclaving.
- Expose non-autoclavable materials to disinfectant (20 minutes contact time) before removal from the BSC
- Remove protective clothing used during cleanup and place in a biohazard bag for removal
- Run BSC 10 minutes after cleanup before resuming work or turning BSC off.
If the spill overflows the drain pan/catch basin under the work surface into the interior of the BSC notify EH&S. A more extensive decontamination of the BSC may be required.
In the laboratory, outside of the Biosafety Cabinet
- Evacuate Room - insure all personnel are accounted for and that doors are closed. Put notice on door informing personnel of spill and not to enter. Allow spill to settle (30 min).
- Assemble clean-up materials (disinfectant, paper towels, biohazard bags and forceps.
- Put on appropriate PPE, including lab coat, shoe covers, gloves and eye/face protection.
- Initiate cleanup with disinfectant as follows:
- Place paper towels or other absorbent material over spill area
- Carefully pour disinfectant around the edges of the spill and then onto the paper towels. Avoid splashing or generating aerosol droplets.
- Allow disinfectant to remain in contact with spill for at least 20 minutes
- Apply more paper towels to wipe up spill
- Clean spill area with fresh towels soaked in disinfectant
- Dispose of all towels or absorbent materials using appropriate biohazardous waste disposal procedures. If any sharp objects are present, use forceps and discard in a sharps container.
- Remove protective clothing and segregate for disposal or cleaning.
- Wash hands with soap prior to leaving area.
Inside a centrifuge
- Clear area of all personnel.
- Wait 30 minutes for aerosol to settle before attempting to cleanup spill.
- If a spill is identified after the centrifuge lid is opened, carefully close the lid, evacuate the laboratory and close the laboratory door. Remain out of laboratory for at least 30 minutes. Put notice on door informing personnel of spill and not to enter.
- Wear a laboratory coat, safety glasses and gloves during cleanup.
- Remove rotors and buckets to nearest BSC for cleanup
- Thoroughly disinfect inside of centrifuge.
- Discard contaminated disposable materials using appropriate biohazardous waste disposal procedures.
Outside the laboratory
- To prevent a spill, transport labeled biohazardous material in an unbreakable, well-sealed primary container placed inside of a second unbreakable, lidded container (cooler, plastic pan or pail) labeled with the biohazard symbol.
- Should a spill occur in a public area, do not attempt to clean it up without appropriate PPE.
- Secure the area, keeping all people well clear of the spill.
- Call EHS at 724.0448 to assist in cleanup.
- Stand by during spill response and cleanup activity and provide assistance only as requested or as necessary.
Reporting
It is the responsibility of all Stanford personnel to report any exposures or unauthorized research using biohazardous agents and/or rDNA to the Biosafety Manager (esegal@stanford.edu, 725.1473). Initial reporting must be done at the earliest time possible, and within 24 hrs of the incident; a more detailed report is to be submitted within 10 days. See the rDNA Incident Reporting Template for additional information.
Select Agents
Oversight
Select Agents are pathogens or biological toxins which have been declared by the U.S. Department of Health and Human Serivices or by the U.S. Department of Agriculture to have the "potential to pose a severe threat to public health and safety". The Centers for Disease and Prevention (CDC) and the Department of Health and Human Services (HHS) provide oversight and regulation for select agents (for additional information go to National Select Agent Registry. Regulations specify requirements for the packaging, labeling, transport, shipping, and handling for facilities that transfer or receive agents listed in the rule.
Stanford University Program
For use of any Select Agent biological, contact the Biosafety Program (esegal@stanford.edu).
To obtain additional information about the use of Select Toxins at Stanford University, go to Select Toxins Program webpage
Training
Requirements
There are three 'tiers' of training at Stanford applicable to Biosafety:
- Tier I: general training for laboratory workers.
- Tier II: training that is specified according to job-specific issues.
- Tier III: specific, job and project related training that is provided by the PI, supervisor or other appropriate personnel. Documentation of training is to be recorded by the PI.
Training required for Biosafety is listed here
Support for determining overall training needs can be found at Training
On-line training is obtained through Axess - Stanford University.
Shipping
Completing FedEx Labels
Oversight
Federal (FAA, 49 CFR) and international agencies (ICAO, the branch of the United Nations that governs all international civil aviation matters), and IATA (International Air Transport Association) have in place numerous regulations for shipping of dangerous goods by surface or air. According to regulations, Biological Dangerous Goods "are articles or substances which are capable of posing a significant risk to health, safety or to property when transported". For Biological material, the flow chart shown below indicates which materials are regulated and which are not.
Note: Dry Ice is considered a Dangerous Good. Training and certification is required, and the package must be labeled and shipped accordingly!
Transport of biohazardous goods off Stanford University requires training and certification prior to shipping. Training is mandatory for shippers (the person sending out the package or signing the air bill) and handlers (the people who transport the package) and is based on these regulations. Non-conformance of these regulations can result in a fine to the department found lacking.
Training
Training to become certified can be done by completing the Biological Shipping Training Course--EHS-2700, DOT: Shipping Biological Goods or Dry Ice; these are available through the STARS system via http://axess.stanford.edu.
Note that training certification is only valid for two years or until regulatory changes and MUST be re-taken at that time if needed.
Links Related to Shipping
- IATA - for Declaration forms
- QICSTAT - for useful information
- Saf-T-Pak Inc. - information and supplies
- FedEx - information and supplies
- Berlin Packaging - supplies
Export Controls Related to Biologicals and Toxins
The Commerce Department, along with other federal agencies, regulates shipping of biologicals and toxins outside the U.S. All select agents and many biological agents and toxins are controlled for export and require US government authorization in the form of an export license before they may be shipped internationally. Stanford University's Export Controls Website identifies those agents and toxins requiring a license for export.
Stanford's Export Control Officer must be contacted before any export controlled biological or toxin is shipped abroad so that an export license can be obtained (Note: the export licensing process can take up to two months so plan well in advance). All other exports of biologicals need to be documented with the appropriate export certification signed by the responsible PI or researcher. An Export Controls Decision Tree is available to assist PIs and researchers with selecting the appropriate certification, as is Stanford's Export Control Officer.
See Stanford's University Export Control website for additional details.
Shipping with Dry Ice
Equipment
Biosafety Cabinets
Types
Biological safety cabinets (BSC), also known as Tissue Culture Hoods, are designed to provide three types of protection:
- Personnel protection from material inside the cabinet
- Protection for the material inside of the cabinet
- Protection for the environment from the material inside of the cabinet
There are three types of BSCs, Class I, II, and III. Class I are designed to provide personnel and environmental protection only. The material (research experiment) inside the cabinet is not protected and thus subject to contamination. The use of Class I BSC is not advised at Stanford; talk to Biosafety if you feel you need to purchase one.
Selection of a Cabinet Through Risk Assessment
| Biological Risk Assessed |
Protection Provided | BCS Class |
||
| Personnel | Product | Environmental | ||
| BSL 1-3 | YES | NO | YES | I |
| BSL 1-3 | YES | YES | YES | II (A, B1, B2, B3) |
| BSL 4 | YES | YES | YES | III B1, B2 |
Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, CDC/NIH, 2nd edition.
For additional information on the selection of Biosafety Cabinets, see the Stanford University Biosafety Manual, Chapter 7.
Installation, Maintenance and Certification
Installation of cabinets must be done by certified professionals. Stanford University has a contract with a certified company for installation, cabinet certification (MUST be done annually), decontamination and any other needs that may arise. Arrangements and payment for any of the above work must be schedualed by the PI or the Department.
TSS, Inc. is Stanford University's designated vendor for Biosafety cabinet service. They can be reached at (510) 845-5591.
Use
"Biosafety Cabinet Use and Safety"
Use this document to provide training on the understanding, safety and use of Biosafety Cabinets. It is suggested that this document be used along with the below videos to provide BSC training.
Biological Safety Cabinet videos:
| Effective Use of Class II Biological Safety Cabinets |
|
| The Bad Laboratorian (a short video showing what not to do when working in a biological safety cabinet) |
|
| Smoke and Particle Counter Demonstrations |
|
Additional information on the proper use of a BSC can be found in the CDC publication on Biosafety Cabinets.
Open Flames
Gas burners or alcohol flames must not be used in BSCs due to safety issues. For additional information see BSC Open Flames.
Ultraviolet (UV) Lamp usage
UV lamps are not required or recommended in BSCs. There is a potential for exposure to UV radiation above recommended limits if working in or near a BSC with a UV light in use. In addition, the germicidal activity of UV lights is limited by a number of factors, many of which are difficult to control. These include the ability of the light to penetrate the cabinet air flow, relative humidity levels >70%, ambient temperature < 77° F and > 80° F, cleanliness of the bulb, and age of the bulb (should be measured every 6 months for intensity).
Biosafety Cabinet (BSC) General Use Procedures
Start-Up
- Turn off UV light if in use. Ensure that the sash is set in the correct operating position.
- Segregate all clean and contaminated materials in the work area and arrange materials to minimize the movement of contaminated materials into clean areas.
- Check the return air grilles for obstructions, and note the pressure gauge reading.
- Allow the cabinet to operate unobstructed for at least five to ten minutes.
- Wash hands and arms thoroughly with soap.
- Wear a long sleeved lab coat with knit cuffs and over-the-cuff gloves.
Surface Decontamination - Before Work
- Wipe down the interior surfaces of the cabinet with 10% bleach, followed in 5 to 10 minutes with 70% ethanol to prevent pitting of the stainless steel, and allow to dry.
Loading Materials and Equipment
- Only load the materials required for the procedure. Do not overload the cabinet.
- Do not obstruct the front, side, or rear return air grilles.
- Large objects should not be placed close together. After loading the cabinet, wait two to three minutes to purge airborne contaminants from the work area.
Work Techniques
- Keep all materials off the sash
- Segregate all clean and contaminated materials in the work area and arrange materials to minimize the movement of contaminated materials into clean areas.
- Keep all discarded, contaminated material to the rear of the cabinet.
- Avoid moving materials or excessive motion of the operator’s hands and arms through the front access opening during use.
- Open flames SHOULD NOT be used.
- Use proper aseptic technique.
- Avoid using techniques or procedures that disrupt the air flow pattern of the cabinet.
- If there is a spill or splatter during use, all objects in the cabinet should be surface decontaminated before removal. Thoroughly disinfect the working area of the cabinet WHILE IT IS STILL IN OPERATION. This will prevent the release of contaminants from the cabinet.
Final Purging
- Upon completion of work, the cabinet should be allowed to operate for three to five minutes undisturbed, to purge airborne contaminants from the work area.
Unloading Materials and Equipment
- Disposable contaminated objects, including gloves, should be placed in appropriate waste stream bags after use.
- Reusable objects in contact with contaminated material should be surface decontaminated before removal from the cabinet.
- All open trays or containers should be covered before being removed from the cabinet.
Surface Decontamination - After Work
- Wipe down the interior surfaces of the cabinet with 10% bleach, followed in 5 to 10 minutes with 70% ethanol to prevent pitting of the stainless steel, and allow to dry.
Shutdown (Optional)
- Turn off the florescent light and cabinet blower.
Autoclaves
Overview
A steam autoclave is a device designed to sterilize cultures, meida, surgical instruments and medical waste. Autoclaves will sterilize off the bases of:
- length of time in the cycle
- temperature
- contact
- pressure
- steam
An autoclave is suitable for the treatment of certain types of medical waste but not all types. The following items of medical waste must not be autoclaved:
- Items of medical waste which are mixed with volatile chemical solvents or radioactive materials (this waste must be handled as either chemical waste or radioactive waste).
- Pathological waste (pathological waste is handled as follows: animal carcasses are placed in a red bag and taken to the pathological waste freezers in the Research Animal Facility; human body parts are placed in a red bag and disposed of as medical waste without autoclaving).
Unless otherwise stated, at Stanford University autoclaving materials prior to medical waste disposal is not necessary. Exceptions to this are users of BSL-3 biohazardous agents.
Use and Safety
Centrifuges
If using centrifuges with biohazardous agents see Centrifuge use.
FACS
Guidelines
Use of a FACS machine for unfixed cells and/or infectious agents creates a droplet hazard to users. For information on this procedure see Standard Safety Practices for Sorting of Unfixed Cells.
Waste
Disposal Guidance
Biohazardous waste includes all laboratory waste that may contain any biohazardous material or were in contact with said material. Additionally, any blood or components of blood or body fluids are to be disposed of as biohazardous waste.
Disposal of Medical and Biohazardous waste is regulated by Santa Clara County. To determine the proper waste stream for your materials see the poster labeled Medical and Biohazardous Waste. If this poster is not available in your laboratory, you can print it or call 5-3468 for a hard copy.
Disinfectants
Disinfectants have varying efficancies, contact times and dilutions for varying biological agents. For an overview of classes of disinfectants and their uses, see Disinfection.
- Chlorine compounds such as bleach are commonly used in the lab because of the relative ease in accessibility and low cost. Chlorine (hypochlorite) compounds are effective in inactivating vegetative bacteria, fungi, lipid and non-lipid viruses, Coxiella burnetii and TB.
- Chlorine compounds have some effect in inactivating bacterial spores.
- Recommended contact time: 10 minutes
- Recommended Working Dilution: 500 ppm (1:10 dilution of household bleach, 5% hypochlorite ion)
- Recommended for: floors, spills (inactivating liquid specimens), bench tops and contaminated clothing. Undiluted bleach and other disinfectants must not go down the drain.
Autoclaves
Overview
A steam autoclave is a device designed to sterilize cultures, media, surgical instruments and medical waste. Autoclaves will sterilize on the basis of:
- length of time in the cycle
- temperature
- contact
- pressure
- steam
An autoclave is suitable for the treatment of certain types of medical waste but not all types. The following items of medical waste must not be autoclaved:
- Items of medical waste which are mixed with volatile chemical solvents or radioactive materials (this waste must be handled as either chemical waste or radioactive waste).
- Pathological waste (pathological waste is handled as follows: animal carcasses are placed in a red bag and taken to the pathological waste freezers in the Research Animal Facility; human body parts are placed in a red bag and disposed of as medical waste without autoclaving).
Unless otherwise stated, at Stanford University autoclaving materials prior to medical waste disposal is not necessary. Exceptions to this are users of BSL-3 biohazardous agents.
Use
Each department is responsible for training personnel on autoclave use. For general information, see the Stanford University Biosafety Manual, Chapter 9.
Links
OBA (Office of Biotechnology Activities, NIH)
CDC (Centers for Disease Control and Prevention)
CDC - Office of Health and Safety - Biosafety Information
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Biosafety Levels
http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_B.htm
Material Safety Data Sheets (MSDS) for Infectious Substances - Public Health Agency of Canada
Gene Transfer
The American Society of Gene & Cell Therapy (ASGCT)
ASGT - American Society of Gene Therapy
Journal of Gene Medicine
http://www.wiley.co.uk/genetherapy/clinical/
Biosafety Sites on the Web
Shipping Permits
CDC import permit applications
USDA Veterinary Services National Center for Import and Export
APHIS import and shipment permits for animal, plant pathogens and biotechnology
Assorted
FDA: (Food and Drug Administration)
http://www.fda.gov
U.S. Department of Health & Human Services
http://www.hhs.gov/
OSHA Home Page
http://www.osha.gov/
WHO Home Page
http://www.who.int/
Zoonotic Fact Sheet
http://www.absa.org/pdf/ZoonoticFactSheet.pdf
ATCC
ATCC: The Global Bioresource Center
CDC: Emerging Infectious Diseases
http://www.cdc.gov/ncidod/EID/index.htm
Contacts
Stanford University Contact Information
| Biosafety Personnel | Phone | |
| Ellyn Segal, Ph.D. Manager | 725.1473 | esegal@stanford.edu |
| Dolores Cunanan Specialist | 724.0986 | dcunanan@stanford.edu |
| Brett Haltiwanger, Ph.D. Specialist | 724.7818 | bretth1@stanford.edu |
| Biological Waste (University) | 725.7529 | |
| Biological Waste (Med School/Hosp) | 723.6896 | |
| Health Physics | 723.3201 | |
| Radioactive Waste | 725.1408 | |
| Chemical Safety | 725.1474 | |
| Chemical Waste Program | 725.7520 | |
| EH&S Main Line | 723.0448 | |
| EH&S Emergency Line | 725.9999 | |
| SU Occupational Health Clinic | 725.5308 | |
| Research Compliance Office | 723.4697 | |
| School of Medicine Health & Safety | 723.6336 | |
| Animal Care & Use | 723.4550 | |