Chapter 3: Regulatory Guidelines
Federal, State, and Local Agency Regulations and Guidelines
The following is a summary of regulations and guidelines that cover the use of biological agents:
- Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH): Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition. This document contains guidelines for microbiological practices, safety equipment, and facilities that constitute the four established biosafety levels. The BMBL is considered the standard for biosafety and is the basis for this manual.
- 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/synthetic nucleic acid molecules (e.g., rDNA) and organisms containing these materials. Although these guidelines are not subject to regulatory enforcement, institutions that receive any NIH funding for recombinant/synthetic nucleic acid molecules research are required to comply with these guidelines as a condition of funding. The NIH Guidelines requires that each institution establish an Institutional Biosafety Committee (IBC) with the authority to approve proposed recombinant/synthetic nucleic acid molecules research using the NIH guidelines as the minimum standard.
- Occupational Safety and Health Administration (OSHA): Bloodborne Pathogen Standard. This regulation covers occupational exposure to human blood and other potentially infectious materials, including human tissues, body fluids, 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 or other potentially infectious materials must be offered immunization against hepatitis B virus (HBV) and receive annual training. Personnel who work with HIV or HBV in a research laboratory must receive additional training and demonstrate proficiency in working with human pathogens.
Select Agent Rule
US Department of Health and Human Services (HHS): 42 CFR Part 73 – Select Agents and Toxins; and the Department of Agriculture’s Animal and Plant Health Inspection Service: 7 CFR Part 331 and 9 CFR Part 121, Possession, Use, and Transfer of Biological Agents and Toxins. These regulations require institutions that possess, use, or transfer certain biological agents and toxins (“select agents”) to be registered and approved by DHHS and/or APHIS.
Other Regulatory Requirements
U.S. Department of Transportation (USDOT) and the International Air Transportation Authority (IATA)
These organizations have strict requirements governing the shipment and transportation of hazardous materials, including biological agents. Chapter 11 provides information on shipping regulations.
Centers for Disease Control and Prevention (CDC)
The CDC has established specific regulatory requirements for importation or transportation of etiologic agents, which include a permit application that must be submitted and approved prior to any such importations. Title 42 CFR Part 71 outlines the regulations governing the importation of etiologic agents. See Appendix A for more information.
U.S. Department of Agriculture (USDA), Animal & Plant Health Inspection Service (APHIS), & Veterinary Services (VS)
These agencies regulate the import, export, movement, and release of plants, plant pests, soil, genetically engineered organisms, and biofilms.
These agencies also regulate the importation of animals and animal-derived materials to ensure that exotic animal and poultry diseases are not introduced into the United States. Generally, a USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials. Materials that require a permit include animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for in vivo use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms, including bacteria, viruses, protozoa, and fungi.
Principal Investigators must apply for permits and receive the approved permit or letter of no jurisdiction prior to working with or transporting any of the above listed materials.
U.S. Department of Commerce
The DOC has specific regulatory requirements for exportation of biological materials. These regulations are both agent and country specific and must be followed strictly.
Institutional Biosafety Committee
The federal role of an Institutional Biosafety Committee (IBC) is to ensure compliance with the NIH Guidelines for research involving biohazardous materials, including genetically modified organisms (GMOs), recombinant DNA (rDNA), pathogens, and other potentially dangerous biological agents. The IBC has the authority to approve, require modifications to secure approval, disapprove, suspend, or terminate research activities as required to assure compliance with applicable regulations and guidelines.
The IBC has approved several specific policies and procedures that are incorporated into this document as requirements or have been included as appendices.