Chapter 3: Biosafety Regulations and Guidelines

There are several local, state, and federal agencies that either regulate or provide guidelines covering the use of biological agents. A summary of these regulations and guidelines is provided below. Copies of these documents can be obtained from EH&S.

  1. Centers for Disease Controls and Prevention (CDC) and the National Institutes of Health (NIH): Biosafety in Microbiological and Biomedical Laboratories (BMBL). This document contains guidelines for microbiological safe work practices, safety equipment, and facilities that constitute the four established biosafety levels. The BMBL is generally considered the standard for biosafety and is the basis for this manual. Compliance with the BMBL is a regulatory requirement for work involving select agents and toxins.
  2. National Institutes of Health (NIH): Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). This document provides guidelines for constructing and handling recombinant and synthetic nucleic acid molecules, and organisms containing such nucleic acid. Although these guidelines are not subject to regulatory enforcement (with the exception of work involving select agents and toxins), institutions that receive any NIH funding for research involving recombinant or synthetic nucleic acid molecules are required to comply with these guidelines as a condition of funding. This document requires that each institution establish an Institutional Biosafety Committee with the authority to approve proposed research involving recombinant or synthetic nucleic acid molecules, using the NIH Guidelines as a minimum standard.
  3. Occupational Safety and Health Administration (OSHA): Bloodborne Pathogens. This regulation covers occupational exposure to human blood and other potentially infectious material, including human tissue and cells. OSHA specifies a combination of engineering controls, work practices, and training to reduce the risk of infection. Personnel potentially exposed to human blood and other potentially infectious material must be offered immunization against the Hepatitis B virus and receive annual training. Personnel who work with HIV or Hepatitis B virus in a research laboratory must receive additional training and demonstrate proficiency in working with human pathogens
  4. Department of Health and Human Services (CDC) and Department of Agriculture (APHIS): Select Agent and Toxin Regulations. These regulations cover the possession, use, and transfer of biological agents and toxins that affect humans, animals, and plants and which have been determined to be potential bioterrorism agents (known as select agents). Entities and personnel who wish to work with select agents must be registered with the CDC or APHIS before acquiring or having access to select agents. Individuals who require access to select agents require a FBI background check and submittal of fingerprints, and must be approved by the Select Agent Program. These regulations mandate strict requirements for biosafety, emergency planning, and security of select agents and toxins, and requires that laboratories that possess select agents comply with the BMBL (see above) and the OSHA Laboratory Standard (see the University Chemical Hygiene Plan) if select agent toxins are used. Each transfer of a Select Agent must have prior approval of the Select Agent Program through completion of APHIS/CDC Form 2, which requires signature by the Select Agent Responsible Official (University Biosafety Officer) or designated alternate. Accurate inventory records of Select Agents, including transfers, must be maintained. See Chapter 14 of this manual for additional information.
  5. Washoe County: Regulations of the Washoe County District Board of Health Governing Solid Waste Management (see Section 080 “Biohazardous Waste”). These regulations include requirements for biohazardous waste storage, treatment, and disposal, including specific requirements for decontamination of biohazardous wastes by autoclaving or treatment with chemical disinfectants.

Chapter 4: Biosafety Principles