Regulations and Resources

PI Responsibilities

Principal Investigators (PI) who conduct recombinant DNA research are responsible for full compliance with the NIH Guidelines. These responsibilities include:

Be adequately trained in good microbiological techniques.
Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents.
Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
Correct work errors and conditions that may result in the release of recombinant DNA materials.
Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., purity and genotypic and phenotypic characteristics).
Comply with permit and shipping requirements for recombinant DNA molecules.
Adhere to Institutional Biosafety Committee (IBC)-approved emergency plans for handling accidental spills and personnel contamination, found on the Environmental Health and Safety website.

Before initiating research subject to the NIH Guidelines, the PI must:

Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines.
Propose appropriate microbiological practices and laboratory techniques to be used for the research.
Submit a completed Memorandum of Understanding and Agreement (MUA) to the IBC for review and approval.
Seek NIH Office of Biotechnology Activities (OBA)'s determination of containment for experiments that require case-by-case review.
Petition OBA, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
Obtain IBC approval before initiating research subject to the NIH Guidelines.
Seek NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Guidelines.

While conducting research subject to the NIH Guidelines, the PI must:

Determine the need for IBC review before modifying recombinant DNA research already approved by the IBC.
Submit any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval.
Remain in communication with the IBC throughout the duration of the project.
Report any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer or IBC Chairperson.

University-specific Guidance on Safe and Responsible Research with Biohazards

Office of Environmental Health and Safety's Biological Safety

Federal Regulations

The National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) specify practices for constructing and handling: (i) recombinant deoxyribonucleic acid (DNA) molecules, and (ii) organisms and viruses containing recombinant DNA molecules. In addition, these guidelines mandate the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of biological research and outline roles and responsibilities for biosafety.

Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention is the code of practice for biosafety -- the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials. The principles of biosafety introduced in 1984 in the first edition of BMBL1 and carried through in the fifth edition remain steadfast. These principles are containment and risk assessment. The fundamentals of containment include the microbiological practices, safety equipment, and facility safeguards that protect laboratory workers, the environment, and the public from exposure to infectious microorganisms that are handled and stored in the laboratory.

The Centers for Disease Control and Prevention (CDC)’s Office of Safety, Health, and Environment publishes biosafety guidelines in partnership with the NIH for protecting workers and preventing exposures in biological laboratories; serves as the World Health Organization’s Center for Applied Biosafety Programs and Training; and provides online training and biosafety resource materials.

The NIH Office of Science Policy (OSP) promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. OBA accomplishes its mission through analysis, deliberation, and communication of scientific, medical, ethical, legal, and social issues.

NIH Guidelines FAQs of Interest to the Institutional Biosafety Committee

NIH OSP - Animal experiments covered under the NIH Guidelines for Research Involving Recombinant DNA Molecules provides a table for determining whether proposed breeding or creation of transgenic animals requires IBC review.

The Occupational Safety and Health Administration (OSHA) has established regulations for work with human blood and body fluids and tissue, primary cell lines and established cell lines that have not been proven to be free of bloodborne pathogens.

The National Select Agents Registry Program (NSAR) oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The NSAR currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities that possess, use or transfer biological agents and toxins.

The U.S. Departments of Health and Human Services (DHHS) and Agriculture (USDA) implemented the provisions of Public Law 107-188, the "Public Health Security and Bioterrorism Preparedness Response Act of 2002" through a series of regulations. These regulations culminated with the publication of the final Select Agents Regulations (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) in the Federal Register on March 18, 2005. The Final Rules were published in the Federal Register on March 18, 2005 and became effective on April 18, 2005.

The "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (Public Law 107-188) requires that all persons possessing select biological agents or toxins deemed a threat to public health, animal or plant health, or animal or plant products register with the appropriate federal agency.

If you anticipate using Select Agents, you must contact the University Biosafety Officer (Meagan Fitzpatrick at 8-6258, [email protected]) regardless of the planned quantity. You should be aware that if registration is required for your work, the CDC registration process and security risk assessment through the FBI will take an estimated 8 weeks and possibly longer. Furthermore, sources of research funds to cover the costs of facility security improvements associated with compliance will need to be identified.

Anyone contemplating Select Agent use should understand that a decision to do so means accepting a significant level of personal responsibility for meeting all aspects of the requirements mandated by the federal rules. Non-compliance carries with it the potential for significant civil and criminal penalties for violations.