The University must comply with local, state and federal regulations that apply to biological research and its residuals.
- Federal Guidelines: Certain research is subject to federal guidelines and regulations prescribed by the NIH, the US Department of Agriculture, the Environmental Protection Agency, and the Food and Drug Administration.
- State Law Regarding rDNA Field Studies: The State of Wisconsin has enacted a law requiring that the Wisconsin Department of Natural Resources (DNR) or Department of Agriculture, Trade and Consumer Protection be notified of intended field studies of genetically engineered organisms.
- DNR Guidelines for Waste Disposal: The DNR has established regulations (Medical Waste-Oct.1994) for the decontamination and elimination of infectious and medical wastes. Appropriate disposal of these wastes is an important aspect of a comprehensive safety program.
- D Comm Regulations/OSHA Bloodborne Pathogens Standard: As a public institution, the University must also comply with regulations prescribed by the Wisconsin Department of Commerce (D Comm), including the Bloodborne Pathogens Standard mandated by the Occupational Safety and Health Administration (OSHA).
Investigators utilizing human blood and other potentially infectious human materials must meet certain requirements. The Occupational Health Program (263-2177) can assist you in this area.
Faculty and Staff of UW-Madison
Faculty and staff are responsible for observing safe practices when handling hazardous biological materials in teaching, research and clinical laboratories. These materials include pathogenic microorganisms; toxins; experimental, biologically active chemicals (carcinogens, mutagens, and teratogens); human blood, body fluids and tissues; and supplies and equipment used with such substances. In addition, all sharps and hazardous glass and plastic, whether contaminated or not, require careful handling and appropriate disposal.
Principal Investigators, faculty and others who supervise people are responsible for the use of proper safety practices by the people they supervise. Everyone is responsible for their own use of safe work practices and for following safety related instructions from their supervisors. Principal Investigators, instructors and laboratory supervisors have a special obligation to instill in their students and laboratory assistants a proactive philosophy concerning safety principles and practices.
An investigator applying for intra- or extramural research support or receiving unsolicited gifts or grants for research involving any potentially hazardous biological material and/or recombinant DNA work that is subject to the NIH Guidelines must obtain clearance for the proposed research. This is done by submitting a biosafety protocol, Biological Materials and Recombinant DNA Protocol to the OBS. The first page of the form provides administrative information, including a list of grants associated with the protocol. Once registered and assigned a safety committee number (SC#), the protocol is valid for three years. Please note that the signature of the Principal Investigator is always required. The form is available on the Biological Safety Website.
Risk assessments of planned experiments should be done prior to initiation. The investigator’s biosafety protocol can be used for safety training of staff. The criteria for submission of a protocol to the Office of Biological Safety, outlined below in Section II, encompass pathogens (human, plant, and animal), exotic organisms, harmful chemicals administered in vivo or in vitro, select agents and rDNA. Although some rDNA techniques are exempt from the Guidelines, many low-risk experiments are still subject to the Guidelines and must therefore be reported for compliance purposes. Investigators must obtain preinitiation approval from the IBC for rDNA experiments involving genetically engineered products of potential virulence and toxicity or altered drug resistance. In some cases they must also obtain approval from the NIH Recombinant DNA Advisory Committee, or other federal agencies having jurisdiction. However, registration with the IBC is sufficient for proposals of lesser hazard potential.
Investigators contemplating proposals involving rDNA are responsible for familiarizing themselves with the current Guidelines, determining which sections pertain to their experiments, and assessing the appropriate containment levels. The current NIH Guidelines is available electronically as a link from the Biological Safety Website. Contact OBS for assistance in interpreting the Guidelines.
The investigator is asked to describe the research protocol, with emphasis on practices and engineering controls employed to contain potentially biohazardous materials. For research involving recombinant DNA techniques, required information includes the source and nature of the DNA and host/vector system(s), and any other relevant details of the experimental protocol. It is important that the investigator identifies potential hazards and describes mitigating procedures or circumstances in sufficient detail such that the OBS and IBC can independently evaluate whether adequate safety measures will be taken.