Biological Safety Program

A Biological Safety Program should provide the necessary information, training, work practices and procedures to ensure the health and safety of individuals exposed to biohazardous agents in the workplace. Work areas that use infectious agents or biological materials, such as specimens or cultures, in research or clinical labs, or engage in activities involving human or animal specimens are responsible for implementing and maintaining a Biological Safety Program. EHS has developed a Biological Safety Manual that contains guidance and information necessary to establish a formal program. Failure to comply with instructions found in the manual may result in a violation of the General Duty Clause of the Iowa Occupational Safety and Health Administration. This law states that employers must furnish employees a place of employment that is free from recognized hazards likely to cause death or serious physical harm. Paramount to a safe workplace is the establishment of a program that defines and details the necessary practices that guide the handling and use of biohazardous agents.

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Application

Each Principal Investigator should determine the safety requirements for their staff through consideration of the types of organisms handled and procedures performed in their laboratory.  In this respect, a laboratory can develop a comprehensive Biosafety Program that suits its specific requirements.  The Biosafety Office in EHS has developed program material in several areas that will assist the Principal Investigator to fulfill the needs of his/her laboratory, in addition to meeting the requirements set forth by the Federal government.

If you work with:

  • Biohazardous agents: please refer to EHS’s Biological Safety Manual.
  • Blood and blood products, human tissues or cell lines, certain body fluids: please refer to EHS’s Bloodborne Pathogens Program as additional Occupational Safety and Health Administration regulations will apply. 
  • Recombinant DNA: please refer to EHS’s Recombinant DNA Program as additional Federal regulations established by the National Institutes of Health will apply to your research.
  • Select Agents or Toxins: please refer to EHS’s Select Agent Program as additional Federal regulations established by the Centers for Disease Control and Prevention or United States Department of Agriculture will apply to your research.
  • Exempt quantities of Select Agent Toxins: please refer to the UI Requirements for Possession of Exempt Quantities of CDC Select Agent Toxins.
  • Any of the above materials: please refer to the Biohazard Waste Guide.  (This guide was created using Adobe Acrobat Writer.  Please download Adobe Acrobat Reader now if you do not have it.)

Program Elements

Responsibilities

Laboratory supervisors and principal investigators are responsible for biological safety in their laboratories.
Principal Investigators/supervisors must:

  • possess a thorough knowledge of current biological safety requirements;
  • determine required levels of personal protective equipment and ensure adequacy of facilities and equipment;
  • ensure that workers know and follow proper biological safety procedures and complete appropriate training
  • ensure accidents or hazardous conditions are promptly reported; and
  • perform regular biosafety inspections of their facilities and equipment.

Written Program

A written biological safety program must be developed, maintained and made available to affected employees. EHS has developed a Biological Safety Manual to serve this purpose. Area specific concerns should be added to the manual.

Training

Employee training must include:

  • location and availability of the written Biological Safety Manual and associated reference material;
  • health hazards, signs and symptoms associated with exposures to the biohazardous agents used in the work area; and
  • measures employees must take to protect themselves from these hazards (work practices, emergency procedures, and personal protective equipment).

Medical Surveillance

Departments must provide all employees who work with biohazardous agents an opportunity to receive medical attention upon exposure to such agents, including any follow-up examinations which the examining physician deems necessary.  In addition, departments are required to offer CDC recommended vaccinations, when appropriate, to potentially exposed staff (e.g., vaccinia and hepatitis B vaccinations).
Medical surveillance, vaccinations, and examinations must be performed by, or under the supervision of a licensed physician, and be provided without cost to the employee and without loss of pay. Call University Employee Health Clinic (UEHC) at 356-3631 to receive information about these services.

Documentation

Maintain accurate records of:

  • The written biosafety program.
  • Training, including who was trained, content of the training, who provided the training, and date.
  • Medical surveillance.
  • Actual medical records and vaccination declination forms are confidential and kept by UEHC or the attending physician.
  • Exposure evaluations.

Reference