Chapter 3: List of Regulations and Guidelines

Federal, State, and Local Agency Regulations

The following is a summary of federal, state, and local agency regulations and guidelines that either regulate or provide guidelines covering the use of biological agents:

Centers for Disease Controls and Prevention and the National Institutes of Health: Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition, 2020. This document contains guidelines for microbiological 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.

National Institutes of Health: Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). This document provides guidelines for constructing and handling recombinant or synthetic nucleic acid molecules and organisms containing those molecules. Although these guidelines are not subject to regulatory enforcement, 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 IBC with the authority to approve proposed research involving recombinant or synthetic nucleic acid molecules using the NIH guidelines as the minimum standard.

Occupational Safety and Health Administration: Bloodborne Pathogens. This regulation covers occupational exposure to human blood and other potentially infectious materials, 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 hepatitis B and receive annual training. Personnel who work with HIV or hepatitis B in a research laboratory must receive additional training and demonstrate proficiency in working with human pathogens.

BPHC: Biological Laboratory Regulation (passed January 16, 2019) and Biological Laboratory Regulations Implementation & Enforcement Guidelines (passed October 15, 2019). These regulations require that all institutions in the City of Boston that work with recombinant DNA molecules or that operates BSL3 or BSL4 laboratories be licensed by BPHC. These regulations require strict adherence to the CDC/NIH guidelines, as well as other regulations that the BPHC’s Board of Health and Hospitals may apply. Disease Surveillance and Reporting Regulation (passed in 2019) requires all institutions in the City of Boston that engage in research with select agents, Risk Group 4 agents, and other agents named by BPHC as high-risk agents to be registered and maintain disease surveillance and reporting programs in effect to minimize potential exposures to these high-risk agents.

Commonwealth of Massachusetts Department of Public Health: The Center for Environmental Health regulates the storage and disposal of potentially infectious material, and includes requirements for labeling and recordkeeping.

Select Agent Rule

Department of Health and Human Services (HHS) 42 CFR Part 73 and United States Department of Agriculture (USDA) 7 CFR Part 331 and 9 CFR Part 121 Possession, Use, and Transfer of Select Agents and Toxins Final Rule, effective December 4, 2012.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. Specific requirements are described in Chapter 10. Additionally, a subset of select agents and toxins have been designated as Tier 1 because they pose the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, public and the environment.

Other Regulatory Requirements

U.S. Department of Transportation and the International Air Transportation Authority: These organizations have strict requirements governing the packaging, shipment and transportation of hazardous materials, including biological agents. Chapter 11 provides information on shipping regulations.

Centers for Disease Control and Prevention: 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. The federal regulation governing the importation of etiologic agents is USPHS 42 CFR – Part 71 Foreign Quarantine. Part 71.54, Etiologic agents, hosts, and vectors.

U.S. Department of Agriculture, Animal and Plant Health Inspection Service, and Veterinary Services: USDA, APHIS, and VS 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. Exceptions to this requirement are human and non-human primate tissues, serum, and blood.

U.S. Department of Commerce, Bureau of Industry and Security: The DOC has specific regulatory requirements for exportation of biological materials. These regulations are both agent and country specific and must be followed strictly. Link here for a basic overview of U.S. Export Controls for Biological Materials.

Massachusetts Department of Public Health (MADPH): The MADPH regulates the management of biological wastes in the state (105 CMR 480) and also inspects BSL3 laboratory spaces on a regular basis.

United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC): The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

IBC: The IBC has promulgated a number of specific policies and procedures that are incorporated into this manual as requirements or have been included as appendices.