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Purpose

The purpose of the ÍƼöÐÓ°ÉÔ­´´ Biosafety Manual is to define policies and procedures that when implemented, will minimize risks to personnel, facilities, and the environment resulting from the use of biological agents during teaching, research, and clinical activities at University.  The work practices, procedures and policies specified in this manual are based on current regulatory requirements and accepted good biosafety practices.  Implementation of these measures will reduce the likelihood that an incident involving a biological agent will occur, and will fulfill regulatory biosafety expectations.  Laboratory microbiological work usually involves exposure not only to biological hazards, but to chemical and radiological hazards as well.  Consequently, this manual should be used in conjunction with the University Chemical Hygiene Plan and the University Radiation Safety Manual, as appropriate.

Scope

This manual applies to all University activities involving biological agents. All University faculty, staff, students, visitors, and employees of industry partners when working on University sponsored projects or at University facilities, are included in the scope of this manual. For purposes of this manual the term biological agents includes the following:

1. Microorganisms (bacteria, chlamydiae, rickettsiae, fungi, and parasites)
2. Viruses
3. Prions and other infectious agents
4. Cultured cells
5. Human blood, unfixed tissues, and potentially infectious body fluids
6. Recombinant and synthetic nucleic acid molecules and toxic products
7. Biological toxins
8. Animals infected with human pathogens, and animals as sources of zoonotic diseases
9. Insects

Responsibilities

The responsibility for biosafety at University is a team effort requiring the direct involvement of the University Institutional Biosafety Committee, the University Biosafety Officer and Environmental Health and Safety Department (EH&S), Principal Investigators (PIs), and laboratory workers.

University Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) approves biological agent use protocols (MOUAs), develops biosafety policies, and provides administrative oversight of the university biosafety program, with the goal of reducing laboratory biosafety risks to the University community. The IBC is composed of at least five members that collectively represent experience and expertise in a wide range of biosafety areas applicable to University activities. At least two members of the IBC must be from outside the University community (community members not otherwise affiliated with University). Non-committee faculty or staff with special expertise may be asked to advise the IBC as appropriate. Additional information on the IBC can be found at the IBC web page

Responsibilities of the IBC include:

1. Developing biosafety policies applicable to University activities, including work practices, biohazardous waste, and medical surveillance of personnel.
2. Reviewing and approving new research proposals in accordance with CDC/NIH guidelines.
3. Setting required containment levels for research projects. Generally, the biosafety levels (BSLs) established by the CDC and NIH will be used as the level of containment; however, the IBC can increase or decrease the level of containment according to the specific circumstances of the project.
4. Developing design specifications and criteria for containment facilities.
5. Investigating significant violations of University biosafety procedures or policies, and significant accidents or illnesses involving biological agents. If appropriate, the IBC will recommend disciplinary action to the proper University officials.
6. Notifying the NIH Office of Biotechnology Activities of reportable incidents as specified in the latest edition of the NIH Guidelines.

University Biosafety Officer

The University Biosafety Officer (BSO) is responsible for providing guidance on safe handling of biological agents and overall management of the Biosafety program. The BSO is a member of the IBC. Specific responsibilities of the BSO include:

1. Providing technical advice to the IBC and PIs on biosafety protocols.
2. Developing emergency response plans for accidental spills and personnel contamination, and investigating incidents involving biological agents.
3. Making periodic inspections of laboratories to assess biosafety issues.
4. Keeping the IBC informed of pertinent biosafety issues and program status.
5. Providing general biosafety training for University personnel on a regular basis.
6. Informing the IBC Chair of biosafety incidents involving personnel exposures, releases outside of containment, non-compliance with local, State, or federal regulations or NIH Guidelines, or other biosafety issues.

Principal Investigators

Principal Investigators (PIs) are responsible for the health and safety of all personnel in their laboratory. Specific responsibilities of the PI include:

1. Ensuring that specific laboratory hazards are effectively communicated to laboratory personnel, and that controls are in place to minimize risks associated with these hazards.
   1. Developing laboratory-specific standard operating procedures (SOPs) that cover the hazards and activities (both routine activities and unusual events) relevant to the laboratory.
   2. Ensuring that engineering controls are available, are in good working order, and are used appropriately to minimize exposure to biohazardous agents.
   3. Ensuring that appropriate personal protective equipment is available and used by laboratory personnel.
2. Ensuring that all laboratory personnel receive general biosafety training conducted by EH&S (or equivalent), as well as laboratory-specific training on the hazards, procedures, and practices relevant to the laboratory they are working in. All training must be documented and records maintained.
3. Notifying the IBC and obtaining prior IBC approval for work involving biohazardous material as specified in this manual (see Chapter 2).
4. Ensuring that laboratory workers are provided immunizations and medical surveillance prior to exposure to biohazardous agents as appropriate (based on current recommendations of the Centers for Disease Control and Prevention, and IBC recommendations).
5. Notifying the BSO of any spills or incidents involving biological agents that result in exposure to laboratory personnel or the public, or release to the environment (including laboratory spills).
6. Ensuring that biological agents are disposed of as outlined in this manual.
7. Ensuring that biohazardous materials to be transported are packaged and shipped in accordance with regulations, and that persons performing these duties have appropriate and current training.
8. Ensuring that an accurate inventory of biological agents is maintained.
9. Ensuring that periodic assessments of the laboratory are conducted to self-identify health and safety weaknesses, and that identified weaknesses are remedied in a timely manner.

Laboratory Workers

Laboratory workers are the most important element in developing and maintaining a safe laboratory environment. Laboratory workers are responsible for their own health and safety, as well as that of their coworkers. An incident caused by one laboratory worker can have a widespread effect on others. Specific responsibilities include:

1. Following procedures and practices established by the University and the laboratory.
2. Knowing how to access the Biosafety Manual (this document) and being knowledgeable of requirements and procedures contained in the Manual.
3. Using practices and procedures specified in this manual, presented in training, and other accepted good laboratory practices to minimize exposures to biological agents, and to avoid other incidents (such as fire, explosion, etc.).
4. Attend biosafety and other laboratory safety training as required.
5. Report unsafe laboratory conditions, incidents or near incidents involving personnel exposure, releases outside of containment, or other biosafety issues to the PI, EH&S, or other responsible party.
6. Utilize control measures such as biological safety cabinets and personal protective equipment to prevent exposure to biological agents, and contamination of personnel and facilities.

EH&S biosafety contact information

Biosafety Officer, Keith Kikawa at 775-327-5046, kkikawa@unr.edu

Responsible Official, Cheston Carpenter at 775-784-4342, chestonc@unr.edu

Chapter 2: Approval of Research Projects