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THE ORCBS > Biological Safety > Programs & Guidelines > Biosafety Manual >
The following is a brief summary of the regulatory authorities that either regulate or provide guidelines for the use of biological materials, infectious agents and recombinant DNA molecules. Copies of these documents are available from the ORCBS. 1. National Institute of Health (NIH): Guidelines for Research Involving Recombinant DNA Molecules . These guidelines address the safe conduct of research that involves construction and handling of recombinant DNA molecules and organisms containing them. In 1974, a recombinant DNA Advisory Committee (RAC) was established to determine appropriate biological and physical containment practices and procedures for experiments that potentially posed risks to human health and the environment. As a result of the committee's activity, the initial version of the NIH Guidelines was published in 1976. It has been amended and revised many times since then. Included in the Guidelines is a requirement for the institution to establish an Institutional Biosafety Committee (IBC) with authority to approve or disapprove proposed research using the NIH Guidelines as a minimum standard. For more information, please refer to the following section of this manual: Biosafety and Recombinant DNA Technology, the NIH Guidelines for Research Involving Recombinant DNA Molecules and the Biosafety in Research website (www.biosafety.msu.edu). 2. Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) Guidelines on: Biosafety in Microbiological and Biomedical Laboratories (BMBL) . In 1984, the CDC/NIH published the first edition of the BMBL. This document describes combinations of standard and special microbiological practices, safety equipment, and facilities that constitute Biosafety Levels 1-4, which are recommended for working with a variety of infectious agents in various laboratory settings. This document also outlines requirements for animal biosafety levels. The BMBL has been revised several times and is commonly seen as the standard for biosafety. MSU is using the BMBL as the basis for this biosafety manual. 3. Michigan Occupational Safety and Health Administration: Bloodborne Infectious Disease Standard . In 1992, the Occupational Safety and Health Administration (OSHA) promulgated a rule to deal with the occupational health risk caused by exposure to human blood and other potentially infectious materials. OSHA's rule includes a combination of engineering and work practice controls, personal protective clothing and equipment, training and medical follow-up of exposure incidents, vaccination, and other provisions. The Michigan Occupational Safety and Health Administration (MIOSHA) enforced its standard for Bloodborne Infectious Diseases in 1993. Consequently, MSU established an Exposure Control Plan to protect employees at MSU from exposure to HIV, Hepatitis B and other bloodborne pathogens. For more information, please refer to the MSU Exposure Control Plan. 4. Department of Health and Human Services (HHS): Possession, Use, and Transfer of Select Agents and Toxins . In 1996, HHS published a set of rules that require facilities and institutions to be registered and approved in order to transfer or receive certain biological agents and toxins. These rules have been revised several times since then. HHS requires MSU to comply with the BMBL (see above) and OSHA's Laboratory Safety Standard 29 CFR 1910.1450. A copy of the most current list of restricted agents and toxins covered under this rule is included in Appendix B. 5. United States Department of Agriculture (USDA): Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins . The USDA has also established a set of rules that require facilities and institutions to be registered and approved in order to transfer or receive certain biological agents and toxins. A copy of the most current list of restricted agents and toxins covered under this rule is included in Appendix B. 6. Michigan Department of Public Health: Michigan Medical Waste Regulatory Act (MMWRA). In 1990, the MMWRA was promulgated to establish a program regulating the handling and disposal of medical waste. The rule mandates how producing facilities (generators of medical waste) must handle medical waste from the point at which it becomes medical waste, to the point of its ultimate disposal. MSU's compliance with this Act is outlined in the MSU Biohazardous Waste Management Plan, which is used in conjunction with the MSU Hazardous Waste Disposal Guide. 7. Packaging, shipment and transportation requirements for infectious substances, diagnostic specimens, biological products and genetically modified organisms are addressed in the following rules and guidelines:
8. Importation permits are required for certain infectious agents, biological materials and animals as outlined in U.S. Public Health Service, 42 CFR Part 71, Foreign Quarantine. In addition, the Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) requires permits for importation and transportation of controlled materials, certain organisms or vectors. This includes animal and plant pathogens, certain tissue cultures and live animals. APHIS also regulates the importation, interstate movement, or environmental release of genetically engineered organisms as regulated under 7 CFR Part 340. |
Rules, Regulations & Guidelines
