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Purpose of Policy

1. To ensure all teaching and research activities involving the use of potentially hazardous microbial agents and/or their products are conducted in a safe and secure environment 51¸£ÀûÉç Michigan University (51¸£ÀûÉç).

   NOTE:  Recombinant DNA biosafety is under the auspices of the Institutional Biosafety Committee (IBC).

   NOTE: Blood-borne pathogen occupational exposure control is under the auspices of the Division of Environmental Health and Safety.

2. Stakeholders Most Impacted by the Policy

   This policy applies to all individuals involved in the use and/or storage of potentially hazardous microbial agents and/or their products.

3. Key Definitions
   • 3.1. Microbial Agent: Any potentially pathogenic microorganism and/or its products that do contain genetically-engineered or synthetic DNA molecules.
   • 3.2. Visiting Scientist: Any person, not a 51¸£ÀûÉç employee or student, who requires access to a laboratory and is engaged in work covered by the microbiological safety and security policy.
   • 3.3. Visitor: Any person, not a 51¸£ÀûÉç employee or student, who requires access to a posted microbiological safety laboratory, but is NOT engaged in work covered by the microbiological safety and security policy.
4. Full Policy Details
   • 4.1. Duties of those responsible for the Microbiological Safety and Security Program
     • 4.1.1. Vice President for Research (VPR)
       • 4.1.1.1. Ensure compliance with the rules, regulations, and procedures governing the use, storage, transportation, and security of microbial agents.
       • 4.1.1.2. Take prompt and decisive action when dealing with individuals who fail to comply with the rules, regulations, and procedures governing the use, storage, transportation, or security of microbial agents.
       • 4.1.1.3. Delegate the resources and the authority to conduct oversight of the day-to-day compliance with the rules, regulations, and procedures governing the use, storage, transportation, and security of microbial agents.
     • 4.1.2. Institutional Biosafety Committee (IBC)
       • 4.1.2.1. Advise the VPR on matters of biosafety and biosecurity.
       • 4.1.2.2. Provide oversight of microbiological safety program in conjunction with the biosafety officer and/or other staff designated by the VPR.
       • 4.1.2.3. Provide guidance and assistance to 51¸£ÀûÉç employees, researchers, students, and visitors involved in the development and implementation of procedures and practices used to ensure compliance with the rules and regulations governing the use and security of microbial agents.
       • 4.1.2.4. Disseminate information associated with the use of microbial agents, such as changes in rules, regulations, procedures, or policies that govern their use, storage, transportation, or security.
       • 4.1.2.5. Recommend to VPR the temporary or permanent suspension of any activity conducted with microbial agents which is deemed to pose a significant danger to health, safety, or security.
     • 4.1.3. Biosafety Officer (BSO)
       • 4.1.3.1. The BSO reports to the Associate VPR and is responsible for the development, maintenance, and enforcement of the University’s Microbiological Safety and Security Program.
       • 4.1.3.2. Shall have access to all buildings and research where microbiological agents or products are used or stored.
       • 4.1.3.3. Serve as a liaison between 51¸£ÀûÉç and regulatory agencies on matters pertaining to microbiological safety or security.
       • 4.1.3.4. Advise the IBC, laboratory directors, supervisors, and workers as necessary on biosafety issues and compliance questions.
     • 4.1.4. Laboratory Directors
       • 4.1.4.1. Responsible for complying with all rules, regulations, procedures, and policies that govern the use and security of microbial agents.
       • 4.1.4.2. Responsible for the compliance of students, workers, visiting scientists, or visitors conducting or observing policy activities within their labs or on their behalf.
       • 4.1.4.3. Develop and implement written laboratory-specific biosafety and biosecurity procedures that are consistent with the nature of current and planned activities and make available copies of the specific biosafety and biosecurity procedures in his/her laboratory.
       • 4.1.4.4. Report to the BSO and/or the IBC any microbiological related accidents. NOTE: This is in addition to any reports required by 51¸£ÀûÉç, state, or federal agencies.
5. Accountability and Consequences of non-compliance
   • 5.1. Legal Consequences
     • 5.1.1. The University is the responsible facility and could be held accountable in civil or criminal lawsuits for a failure to provide adequate measures to ensure the safety and well-being of its stakeholders and the general public.
   • 5.2. Local Consequences
     • 5.2.1. Because of the serious consequences to the general public, the VPR and BSO shall take prompt and decisive action when dealing with individuals who do not demonstrate the meticulous attention to detail and high standard of compliance expected of them.
     • 5.2.2. The BSO will document violations and deviations of the rules, regulations, procedures, and policies that govern the use of microbial agents.
     • 5.2.3. Sanctions that may be given in the order of severity, least to most:
       • 5.2.3.1. Meeting with the BSO, the laboratory director, and the individual; may also include the AVPR/VPR
       • 5.2.3.2. Require retraining of the individual.
       • 5.2.3.3. Restrict use of microbial agents or their products.
       • 5.2.3.4. Terminate the privilege to use microbial agents or their products.
     • 5.2.4. Could be subject to disciplinary action, up to and including dismissal from employment by the University.
6. Review Process
   • 6.1. This policy shall be reviewed no less than every three years.
   • 6.2. Reasons to review/revise earlier include changes in legal, technological, or program requirements.
7. Related Procedures and Guidelines that comprise the Microbiological Safety and Security Policy
   • 7.1. Microbiological Safety and Security Procedures and Guidelines

Related policies

• Western Michigan University’s Policy for Recombinant or Synthetic DNA Biosafety
• Western Michigan University’s Dual Use of Research Concern Policy

References

• Centers for Disease Control and Prevention/National Institutes of Health (CDC/NIH) Biosafety in Microbiological and Biomedical Laboratories 5th ed. (BMBL) published by the U.S. Government Printing Office, December 2009.