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Policy and Procedures for Mandatory Biosafety Training

Institutional Policy

The privilege of conducting research with recombinant or synthetic nucleic acid molecules and/or infectious agents, human cell lines and other human materials used in research, toxins of biological origin, or Select Agents and Toxins at Tufts University and/or Tufts Medical Center depends on the institutions’ compliance with federal, state, and local regulations governing this research. To this end, the Institutional Biosafety Committees have been charged with enforcing a mandatory biosafety training policy to ensure that all personnel listed on an active IBC registration have been provided the training necessary to understand the risk associated with the use of the material and understand how to conduct research safely and with appropriate knowledge of the regulations that govern its use. All of the pertinent regulations are listed below. Please review each for additional information. Non-compliance with this policy will be followed up by the IBC regulatory office.

The Institutional Biosafety Committees of Tufts Cummings School of Veterinary Medicine and Tufts University/Tufts Medical Center recognize that much relevant training occurs within each laboratory and that many individuals have experience that qualifies them in certain aspects of the use of biohazardous agents. However, we believe attendance by all those involved in IBC-regulated research is essential. Principal Investigators must keep in mind that it is their responsibility to guarantee the appropriate training of their students, associates, and staff and to make sure that their research programs are in compliance with all pertinent regulations and institutional policies. The Environmental Health and Safety (EHS) staff members provide initial and refresher courses to help all those listed on an IBC registration understand how to comply and how to conduct their research while minimizing risk. It will be necessary for all individuals who have completed this training requirement to be documented as such by the IBCs.

All individuals listed on active IBC registrations at Tufts Cummings School of Veterinary Medicine, Tufts University, and Tufts Medical Center will be required to attend.

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Schedule and Types of Mandatory Training

  • Biosafety in the Research Laboratory
    New investigative staff will be expected to attend one of these seminars within the first 90 days of inclusion onto an active IBC registration. Additionally, attendance at this seminar must be renewed at least every 3 years. If any person would like training that goes beyond the information covered in the Basic Biosafety seminar, additional training is available upon request to the Biosafety Officers.
  • Principal Investigator Training on NIH Guidelines (Recombinant DNA and Synthetic Nucleic Acids)
    All new Principal Investigators are required to take this training once. There is no renewal required for this training. This is a requirement for all Principal Investigators regardless of whether or not they currently work with recombinant DNA and/or synthetic nucleic acids.

  • Specialized Training

    • Advanced Biosafety
      Use of some biohazardous agents will require additional training that is more specialized than what is offered in the Basic Biosafety seminar. Most of this training will be agent-specific and will be required by the IBC upon registration review. Thus, these trainings will be scheduled on an as needed basis. The staff listed on these registrations will be required to attend both the “Basic Biosafety” and the “Advanced Biosafety” seminars.

    • Shipping Infectious and Other Biological Materials-Compliance with Domestic and International Regulations
      All individuals that plan to ship infectious or other regulated biological materials are considered “HAZMAT” employees under the Department of Transportation Regulations and are required to have formal training before sending biological materials to recipients in the US or internationally. This course is offered regularly by the Environmental Health and Safety staff.

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Regulations Regarding Training

From the NIH Guidelines:

  • Section IV-B-1-a. Establish and implement policies that provide for the safe conduct of recombinant or synthetic nucleic acid molecule research and that ensure compliance with the NIH Guidelines.

  • Section IV-B-1-h. Ensure appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer and other containment experts (when applicable), Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines.

From the “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) (NIH) 5th ed.:

  • Laboratory personnel have specific training in handling pathogenic agents. This includes the precautions to prevent exposures (to pathogenic agents).

From the Bloodborne Pathogens 1910.1030 Occupational Safety and Health Administration (OSHA):

  • The employer (TU/TMC) shall train each employee with occupational exposure to bloodborne pathogens (including human cell lines and tissues) initially upon employment and annually thereafter.

From 42 CFR 73 Select Agents and Toxins:

  • An entity (TU/TMC) must provide training at the time of an individuals initial assignment to an area where Select Agents and Toxins are present and annual refresher training thereafter.

From Boston Public Health Commission (BPHC) “Regulating Recombinant DNA:”

  • Implement a training program of safeguards for personnel using recombinant DNA.

From 49 CFR 172.704 Shipping hazardous biological materials:

  • HAZMAT employees must receive general awareness and function specific training initially and every 3 years thereafter.

From Town of Grafton “Biomedical Research and Production By-Law:”

  • The IBC shall ensure that proper training and appropriate safeguards and procedures for minimizing potential environmental and personal exposure are followed.

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