What is a biohazard?
- An agent of biological origin that has the capacity to produce deleterious effects on humans, animals, plants and insects. These include microorganisms, toxins and allergens derived from those organisms; all allergens and toxins derived from insects, animals and plants.
Hazardous and potentially hazardous biological agents include the following:
- Microorganisms which may cause disease in humans, including bacterial, fungal, parasitic, chlamydial, rickettsia, viral, and prion disease agents;
- Microorganisms in human or non-human primate body fluids, tissues, or wastes (e.g. bloodborne pathogens), including non-human cell culture (primary or continuous)
- Microorganisms in animals (e.g. zoonotic diseases)
- Items contaminated with animal or human body fluids, tissues, or wastes;
- Plant and animal toxins
- Plant and animal allergens
- Recombinant DNA (rDNA)
- Genetically engineered organisms and products
- CDC List of Select Agents
Recombinant DNA (rDNA)
- rDNA molecules are defined as:
- molecules that are constructed outside lving cells by joining natural or synthetic DNA segments to DNA molecules that can replicate a living cell
- molecules that result from the replication of those described above
- Research involving recombinant deoxyribonucleic acid (rDNA) shall comply with the National Institute of Health’s Guidelines for Research Involving Recombinant DNA Molecules” and outlined in the federal register.
- The purpose of the NIH Guidelines is to specify practices for constructing and handling:
- rDNA molecules
- organisms and viruses contains rDNA molecules
- The rDNA guidelines are applicable to all rDNA research within the United States or its territories, which is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH.
- An Institutional Biosafety Committee (IBC)
- IBCs were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing rDNA.
- The IBC must consist of at least 5 members. Collectively, the membership should include:
- Expertise in rDNA Technology and Biosafety and physical containment
- Knowledge of : institutional commitments & policies; applicable laws; standards of professional conduct & practice; community attitudes; environmental considerations
- Capability to: assess the safety of rDNA research; identify potential risks to public health & safety
- The committee must include two external members not affiliated with the institution
- Depending on the type of research conducted, the IBC may also need to include a Biological Safety Officer (BSO), a Plant Expert and/or an Animal Expert
Select Agents / Toxins
What is a select agent?
- “Select agents” is a euphemism for viable organisms, biological toxins that might be used by bioterrorists. Two laws regulate their use. The first, passed in 1996, restricts the shipment of select agents. The second, enacted in 2001, extends the restrictions to the possession of these agents.
- The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-Terrorism Act (1989) and other earlier Anti-Terrorism legislation.
- In response to the terrorist attacks of September 11, 2001, Congress passed and President Bush signed into law, three pieces of legislation that expanded restrictions on the possession, use, and access to biological agents and toxins (select agents). Failure to comply with the requirements and restrictions contained in the new laws expose Principal Investigators to large fines and imprisonment up to 5-years
Centers for Disease Control (CDC)
- The CDC oversees the implementation of federal laws pertaining to the use of select agents. For details consult the National Select Agent Registry
- This legislation directed the Department of Health and Human Services to develop and maintain a list of biological agents that could pose a threat to the public health and to regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes
- The CDC developed a list of infectious agents and biological toxins with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms.
- The CDC developed regulations on the transfer and transport of the select agents
- Facilities receiving select agents must be registered with the federal government, certifying that they fulfill the proper biosafety level requirements for handling, containment, and disposal
- Records retention: all research related data/records must be maintained for at least 7 years after project completion
Radiation in Research
- Radioisotopes and radiation producing machines may have beneficial uses in research and medical applications.
- Radioactive materials include any material that spontaneously emits ionizing radiation
- Ionizing radiation is electromagnetic radiation (x-ray and gamma-ray photons) or particulate radiation (beta particles, electronics, positrons, neutrons, and alpha particles) capable of producing ions by direct or secondary processes
- ALARA (As Low As Reasonably Achievable) – a level to which radiation protection aims to reduce occupational exposures. ALARA is achieved through good radiation protection planning and practice, backed my management commitment.
Concerns about Radiation in Research
- When not properly controlled, ionizing radiation can present a hazard to individual users and others in the immediate environment. The heath of an individual and the possibility of genetic effects to future generations depend on the amount of radiation exposure an individual receives.
- Maximum radiation dose limits and radiation protection license guidelines have been established through state and federal regulations.
Radiation Safety Offices
- Charge: typically, radiation safety offices are established to help minimize occupationally related exposures to radiation, and to ensure that all radio active materials are used in compliance with federal, state and local rules and regulations.
- Radiation Safety Committee (RSC)
- The RSC is a committee responsible for development and administration of the radiation safety program at an Institution. It establishes policies and enforces regulatory requirements. The RSC has the authority and responsibility for approval of all proposals for radionuclide use and x-ray users. The RSC reviews and approves protocols prior to the use of radioactive material
- Radiation Safety Officer (RSO)
- The RSO is an individual responsible for the daily implementation of the radiation safety program in accordance with the directives from a RSC
- All individuals who wish to independently use radioactive material must apply to the RSC for a license. The license evaluations take into consideration the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures.
- All individuals who wish to work with ionizing radiation must receive appropriate instruction in radiation safety.
- All awards over $2,000 for construction
- All awards over $2,500 for other activities
- Notification to employees
- Preparation and submission of a material safety data sheet