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 and Prion-like Proteins
• 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 and synthetic nucleic acid molecule use is also covered by the Biosafety program. This includes:

• Recombinant and synthetic nucleic acid molecules
• Transgenic animals
• Transgenic plants
• Human gene transfer/studies using recombinant and synthetic nucleic acid molecules

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).

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.

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.

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 recombinant and synthetic nucleic acid molecule 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, including all biohazardous materials listed under "Introduction", must have APB approval prior to commencing work. Any work using recombinant and synthetic nucleic acid molecules that are deemed by the NIH to be non-exempt from the Recombinant and Synthetic Nucleic Acid Molecule Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH Recombinant and Synthetic Nucleic Acid Molecule 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

Click here to see information about DOD Funded Research.

Training

Universal Precautions

Safety Sharps

Emergency Response

Reporting

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.

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.

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 recombinant and synthetic nucleic acid molecule 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, including all biohazardous materials listed under "Introduction", must have APB approval prior to commencing work. Any work using recombinant and synthetic nucleic acid molecules that are deemed by the NIH to be non-exempt from the Recombinant and Synthetic Nucleic Acid Molecule Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH Recombinant and Synthetic Nucleic Acid Molecule 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).

The NIH Guidelines for Research Involving Recombinant DNA have been revised and are now titled The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Synthetic nucleic acid research that includes the following now falls under the NIH Guidelines and is regulated by the APB:

1. 1. Synthetic nucleic acids that:
1.     a. Can replicate or generate nucleic acids that can replicate in a living cell and/or
2.     b. Are designed to integrate into DNA and/or
3.     c. Produce a toxin with a LD50<100ng/kg body weight.
2. 2. Synthetic nucleic acids that are deliberately transferred into one or more human subjects and:
1.     a. Are >100 nucleotides and/or
2.     b. Can integrate into the genome and/or
3.     c. Can replicate in a cell and/or
4.     d. Can be transcribed or translated.

For a broader overview of the New Guidelines, see the Update to the NIH Guidelines on Research Involving Recombinant and Synthetic Nucleic Acid Molecules

For further information, please see the following resources:

• NIH Guidelines
• NIH FAQs on Guidelines Exemptions
• NIH FAQs on Synthetic Nucleic Acids
• Working with Viral Vectors (Stanford)
• Overview of Covered Experiments (Yale)

Determining if recombinant and synthetic nucleic acid molecules are 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

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.

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/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

Animal Biosafety Levels (ABSL) refer to the use of rDNA or Biohazardous Agents in animals. All ABSLs are associated with detailed cage labeling requirements, biohazard carcass disposal, and personnel training; certain ABSLs require specific housing designations. For specific information on ABSL housing, see Animal Housing and Biosafety flow chart.

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).

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 Recombinant and Synthetic Nucleic Acid Molecule 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).

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.

APB approval: Any work using recombinant and synthetic nucleic acid molecules that are deemed by the NIH to be non-exempt from the Recombinant and Synthetic Nucleic Acid Molecule Guidelines must have APB approval prior to commencing work. To determine if your research requires APB approval, check the NIH Recombinant and Synthetic Nucleic Acid Molecule 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.

Prion and Prion-like Proteins: Any work with prion or prion-like proteins must have APB approval prior to commencing work. Prion and prion-like proteins are defined as proteins, human or animal, that are (1) associated with a proteinopathy, (2) have been shown to be transmissible cell-to-cell, or (3) have a fibrillar or aggregated form that has been shown to "seed" a pathology associated with a disease. Any in vitro or in vivo work that involves synthesis, use of highly concentrated protein, use of mutated proteins or use of fibrillar or misfolded forms of the protein requires an APB-approved protocol prior to commencing work. See here for further information.

The use of one's own or a fellow lab member's blood for experimental purposes is permitted provided the following conditions are satisfied.

• Procedures utilizing these blood samples must be a terminal experiment. Examples would include harvesting genomic DNA for genetic characterization or harvesting Peripheral Blood Mononuclear Cells (PBMCs) for protein harvest to use as a control in western blotting.
• Blood cells must not be cultured, transformed, immortalized or inoculated with an infectious agent. Self-inoculation of these cells could result in cells having the ability to evade host immune systems, thus increasing the risk of disease.
• Blood collection must be performed by experienced personnel e.g., physician, medical fellow/resident or a certified phlebotomist).
• Researchers and the individual drawing blood must complete Bloodborne pathogens Training (EHS-1600) and complete an Exposure Control Plan in conjunction with their Principal Investigator or supervisor.
• Institutional Review Board (IRB) approval is required if this experiment is part of a human research study. For more information please see http://researchcompliance.stanford.edu/hs/index.html.

If you have any questions, please contact EH&S Biosafety at 723-0448.

Universal Precautions is the concept of treating all human/primate blood and other body fluids, tissues and cells (including cell lines) as if they were known to be infectious for bloodborne pathogens. In addition to frequent hand washing, 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 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 or face shields must be selected and used as appropriate. Areas subject to Universal Precautions must have appropriate signs posted on doors and equipment; these signs can be obtained from EH&S (723.0448). See Universal Precautions handout for additional information.

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.

The use of one's own or a fellow lab member's blood for experimental purposes is permitted provided the following conditions are satisfied.

• Procedures utilizing these blood samples must be a terminal experiment. Examples would include harvesting genomic DNA for genetic characterization or harvesting Peripheral Blood Mononuclear Cells (PBMCs) for protein harvest to use as a control in western blotting.
• Blood cells must not be cultured, transformed, immortalized or inoculated with an infectious agent. Self-inoculation of these cells could result in cells having the ability to evade host immune systems, thus increasing the risk of disease.
• Blood collection must be performed by experienced personnel e.g., physician, medical fellow/resident or a certified phlebotomist).
• Researchers and the individual drawing blood must complete Bloodborne pathogens Training (EHS-1600) and complete an Exposure Control Plan in conjunction with their Principal Investigator or supervisor.
• Institutional Review Board (IRB) approval is required if this experiment is part of a human research study. For more information please see http://researchcompliance.stanford.edu/hs/index.html.

If you have any questions, please contact EH&S Biosafety at 723-0448.

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.

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.

For additional information on the above see Occupational Health Surveillance Program.

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.

For personnel working in laboratories and clinical workers

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).
• 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.

For personnel not working in laboratories

Stanford University Non-Laboratory Environments: Who is covered by the CA-OSHA Bloodborne Pathogens (5193) standard?

http://www.dir.ca.gov/dosh/BloodborneFAQ.html

The Bloodborne Pathogen Standard (BBP) applies to all occupational exposure to blood or other potentially infectious materials (OPIM), Occupational exposure is "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties."

The following categories will help you determine if your work is covered by the BBP.

Covered under BBP:

• Employees working in blood banks, hospitals
• Emergency first aid providers
• Police and fire services
• Healthcare laundries
• Plumbers working on hospital/healthcare facilities
• Athletic trainers/coaches, lifeguards

Not covered:

• Plumbers not working on hospital/healthcare facilities
• Housing and Dinning
• Gardeners
• Custodians not working on hospital/healthcare facilities

If the job description is listed under covered the worker is considered to be at occupational risk of contracting Bloodborne pathogens and must take the Bloodborne Pathogen Training (EHS-1600).

• Complete BBP training (EHS-1600)
  BBP training must be done annually
• Working with supervisor, complete a BBP Local Exposure Control Plan - Non Laboratory (Local ECP-NL)
  The Plan shall be reviewed/updated on an annual basis or if there are changes to job position or procedures, whichever comes first

The Stanford University Institutional Exposure Control Plan (Institutional ECP) is designed to comply with the California OSHA Bloodborne Pathogens Standard (8 CCR • 5193). The Institutional ECP addresses issues related to the elimination or minimization of Stanford University personnel to human blood/bloodborne pathogens (BBPs)/other potentially infectious materials (OPIM). Principal Investigators (PIs) and supervisors should refer to the Institutional ECP as a resource for exposure control background, issues and regulatory procedures.

The Local Bloodborne Pathogen Exposure Control Plan (Local ECP, Local ECP-NL) is designed to aid the PI/Supervisor in completing requirements for the BBP Standard. It is the responsibility of the PI/Supervisor to review the Local ECP with input from employees covered by the Bloodborne Pathogen Standard, with the goal of minimizing personnel exposure to bloodborne pathogens (BBPs) in blood or other potentially infectious materials (OPIMs).

For personnel working in laboratories and clinical workers

Use the Local ECP to:

• Guide identification of procedures and materials in the laboratory that have the possibility of exposing personnel to BBPs (Appendix A)
• Review methods of compliance to ensure a safe work environment, document training (Appendix B)
• Determine appropriate engineering and work practice controls, including appropriate use of safety sharps (Appendix C)
• Review requirements for reporting and documenting sharps injuries
• Ensure participation in the Stanford University Medical Surveillance Program

The Local ECP shall be completed and reviewed by the PIs/Supervisor and personnel annually and/or as needed by job changes. Upon review, complete Appendixes A and B; complete Appendix C as needed. The completed Local ECP shall be located in the laboratory for reference and documentation of compliance.

The Local Bloodborne Pathogen Exposure Control Plan can be downloaded as a single document or individual sections can be accessed here:

1. 1. Local ECP Overview
2. 2. Purpose, Regulatory Driver and Scope of Local ECP
3. 3. Responsibilities
4. 4. Local ECP Engineering, Work Practices and PPE
5. 5. Reporting and Documenting Incidents and Sharps Injuries, Medical Surveillance
6. 6. Local ECP Instructions and Completion
7. 7. Appendixes A, B and C
8. 8. Local ECP Check Sheet

This document is provided to assist in recording and documenting personnel names, positions, dates and information during completion of required ECP segments. Attach filled Check Sheet to appendixes. The use of this sheet is optional.

Reference information:

• Stanford University Incident Report
• Sharps Injury Report
• Hepatitis B Declaration
• Definitions
• Contact Information
• Spills
• Local ECP Check Sheet

For personnel not working in laboratories

A separate Local ECP, the Local Exposure Control Plan Non-Laboratory (Local ECP-NL), is specifically tailored for use by personnel. Some examples of potential occupational exposure issues are:

• Law enforcement officers may face the risk of exposure to blood during the conduct of their duties. For example, at the crime scene or during the processing of suspects, law enforcement officers may encounter blood-contaminated hypodermic needles or weapons, or be called upon to render emergency aid. Therefore law enforcement personnel are covered under the ECP for bloodborne pathogens and are offered hepatitis B immunization and will receive appropriate training.
• Fire and emergency response personnel often provide emergency medical services and, therefore, encounter exposures common to those experienced by paramedics and emergency medical technicians. Job duties may be performed hurriedly in the pre-hospital setting under uncontrolled conditions. Fire and emergency response personnel are, therefore, covered under the ECP for bloodborne pathogens and are offered HBV immunization and will receive appropriate training.

The Local ECP-NL shall be completed and reviewed by the Supervisor and personnel annually and/or as needed by job changes. Upon review, complete Appendix A ECP-NL and Appendix B ECP-NL; complete Appendix C ECP-NL as needed. The completed Local ECP-NL shall be located in the workplace for reference and documentation of compliance.

Reference information:

• Stanford University Incident Report
• Sharps Injury Report
• Hepatitis B Declaration
• Definitions
• Contact Information
• Spills
• Local ECP Check Sheet

This document is provided to assist in recording and documenting personnel names, positions, dates and information during completion of required ECP segments. Attach filled Check Sheet to appendixes. The use of this sheet is optional.

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.

The Stanford University Institutional Aerosol Transmissible Disease Program (Institutional ATD) is designed to comply with the California OSHA Aerosol Transmissible Disease Standard (Title 8, Section 5199). The Institutional ATD addresses issues related to the elimination, minimization and protection of Stanford University personnel to airborne transmissible diseases from both humans and animals (zoonotic diseases). Principal Investigators (PIs) and supervisors should refer to the Institutional ATD as a resource for exposure control background, issues and regulatory procedures.

Research Laboratories
The Stanford University Local Aerosol Transmissible Disease Biosafety Plan- Laboratories (Local ATD-Labs) is specifically directed towards research laboratory workers.

The ATD requires laboratories to adopt standard biosafety practices to protect laboratory workers when handling materials containing pathogens that may be spread through aerosols and which can cause serious disease. In addition, the employer is required to develop, implement, and annually review, a written ATD Biosafety Plan (Plan).

The Stanford University Administrative Panel on Biosafety (APB) includes, as part of its charge and following the Biosafety in Microbiological and Biomedical Laboratories (BMBL), oversight of issues covered within the California OSHA Aerosol Transmissible Disease (ATD) standard. As such, an approved APB protocol shall cover requirements for laboratories.

Complete the following:

1. Go to Appendix A, which contains a list of biological agents that are covered by the ATD standard with regards to research laboratories.
• If your lab uses on any of the listed agents, go to #2.
• If your lab does NOT use any of the listed agents no further action is required. If, in the future, your research will include any of the listed agents, you are required at that time to comply with the standard.
2. Download a copy of the Stanford University Local Aerosol Transmissible Disease Biosafety Plan- Laboratories
3. Review the Plan (use information and training materials associated with your approved APB protocol(s)) with all applicable members of your laboratory.
4. Review the Plan annually or when changes are made (new personnel, agents, SOPs, etc).

The completed Plan includes the Local ATD document along with approved APB protocol(s). The Plan shall be filed in a central location within the laboratory/work place for all personnel to access and to be made readily available to authorities in event of a regulatory inspection of the facility.

Department of Public Safety

The Stanford University Local Aerosol Transmissible Disease Biosafety Plan - Department of Public Safety (Local ATD - DPS) supplements the Stanford University Institutional Aerosol Transmissible Disease Program for the DPS. The Local ATD-DPS addresses how to eliminate or minimize exposure to materials containing pathogens that may be spread through aerosols and which can cause serious disease. The Local ATD-DPS addresses health and safety issues specific to the jobs and procedures being used by personnel and constitutes a Tier III training for these topics.

The ATD Standard requires the use of feasible engineering and work practice controls to limit exposure to aerosols, and, when necessary, the provision of personal protective equipment and respirators. The Local ATD - DPS constitutes a written Biosafety Plan (BSP), which shall be implemented and reviewed annually.

Complete the following:

1. Download a copy of the Stanford University Local Aerosol Transmissible Disease Plan - Department of Public Safety.
2. Complete and review the Plan (use information and training materials provided with the Plan) with all applicable members of the DPS; document training on sheet provided.
3. Review the Plan annually or when changes are made (new personnel, procedures, etc).

The Plan, including training documentation, shall be filed in a central location within the work place for all personnel to access and to be made readily available to authorities in event of a regulatory inspection of the facility.

Zoonotic

The Stanford University Local Transmissible Diseases Plan - Zoonotic (Local ATD - Zoonotic) supplements the Stanford University Institutional Aerosol Transmissible Disease Program for employees with exposure to animals. The Local ATD-Zoonotic addresses how to eliminate or minimize exposure to materials containing pathogens that may be spread through aerosols and which can cause serious disease. The Local ATD- Zoonotic addresses health and safety issues specific to the jobs and procedures being used by personnel and constitutes a Tier III training for these topics. The ATD Standard requires the use of feasible engineering and work practice controls to limit exposure to aerosols, and, when necessary, the provision of personal protective equipment and respirators. The Local ATD - Zoonotic constitutes a written Biosafety Plan (BSP), which shall be implemented and reviewed annually.

Research

The Stanford University Administrative Panel on Biosafety (APB) includes, as part of its charge and following the Biosafety in Microbiological and Biomedical Laboratories (BMBL), oversight of issues covered within the California OSHA Aerosol Transmissible Disease (ATD) standard. As such, an approved APB protocol shall cover requirements for researchers with potential exposure to Zoonotic diseases (ABSL-2 or above).

The completed Plan includes the Local ATD-Zoonotic document along with approved APB protocol(s). The Plan shall be filed in a central location within the laboratory/work place for all personnel to access and to be made readily available to authorities in event of a regulatory inspection of the facility.

Field Studies

For work with wildlife likely containing zoonotic Aerosol Transmissible Pathogens, such as:

• Capture, sampling, transportation or disposal of wild birds or other wildlife for research purposes.
• Disposal of such wildlife remains or waste by employees.

The Local ATD-Zoonotic includes how to establish, implement, and maintain effective procedures for preventing employee exposure to zoonotic aerosol transmissible pathogens; once complete, this shall be kept, along with updates and training records, in a location available for reference by personnel and regulators.

Complete the following:

1. Download a copy of The Stanford University Local Transmissible Diseases Plan - Zoonotic, Appendix A, B and C.
2. Complete and review the Plan (use information and training materials provided with the Plan) with all applicable employees; document training on sheet provided.
3. Review the Plan annually or when changes are made (new personnel, procedures, etc).

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.

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.

Animal Biosafety Levels (ABSL) refer to the use of rDNA or Biohazardous Agents in animals. All ABSLs are associated with detailed cage labeling requirements, biohazard carcass disposal, and personnel training; certain ABSLs require specific housing designations. For specific information on ABSL housing, see Animal Housing and Biosafety flow chart.

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.

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.

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.

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:

1. 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.
2. If a spill has occurred, contain and initiate clean up (see below).
3. Notify PI, manager or supervisor to initiate accident or exposure incident report.
4. 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

The following procedures are provided as a guideline to biohazardous/recombinant and synthetic nucleic acid molecule 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.

It is the responsibility of all Stanford personnel to report any exposures or unauthorized research using biohazardous agents and/or recombinant and synthetic nucleic acid material 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 Recombinant and Synthetic Nucleic Acid Molecule Incident Reporting Template for additional information.

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.

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

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 Dangerous Materials by FedEx, Domestically, Completing Labels Online
• • Shipping Dangerous Materials by FedEx, Domestic or International, Completing Printed FedEx Labels

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 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.

• IATA - for Declaration forms
• QICSTAT - for useful information
• Saf-T-Pak Inc. - information and supplies
• FedEx - information and supplies
• Berlin Packaging - supplies

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.

Directions for packing dry ice with non-hazardous materials

Types

Installation, Maintenance and Certification

Use

Open Flames

Ultraviolet (UV) Lamp usage

Biosafety Cabinet (BSC) General Use Procedures

Overview

Use and Safety

If using centrifuges with biohazardous agents see Centrifuge use.

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.

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 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.

Disinfection of prion and prion-like proteins must follow established WHO and CDC guidelines found at http://www.who.int/csr/resources/publications/bse/WHO_CDS_CSR_APH_2000_3/en/ and http://www.cdc.gov/ncidod/dvrd/cjd/qa_cjd_infection_control.htm.

Overview

Use

OBA - Recombinant and Synthetic Nucleic Acid Molecule Program

http://www.cdc.gov/

CDC - Office of Health and Safety - Biosafety Information

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition

Prions and Prion-like proteins:

http://www.cdc.gov/ncidod/dvrd/prions/index.htm

http://www.cdc.gov/ncidod/dvrd/cjd/qa_cjd_infection_control.htm

http://www.who.int/csr/resources/publications/bse/WHO_CDS_CSR_APH_2000_3/en/

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 American Society of Gene & Cell Therapy (ASGCT)
ASGT - American Society of Gene Therapy

Journal of Gene Medicine
http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1521-2254

Gene Therapy Net - News, Clinical Trials, Guidelines, Regulation, Articles, Education, Societies, Companies and More Gene Therapy Information

ABSA

AIHA - Biosafety

CDC import permit applications

USDA Veterinary Services National Center for Import and Export

APHIS import and shipment permits for animal, plant pathogens and biotechnology

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

MMWR
http://www.cdc.gov/mmwr/

CDC: Emerging Infectious Diseases
http://www.cdc.gov/ncidod/EID/index.htm

Addgene
http://www.addgene.org/pgvec1