The main concern is the containment of the hazard and animal located within the transport device in order to prevent inadvertent release, including escape, of the animal or the agent. A number of transport devices have been utilized, from filtered rodent microisolator caging to transport small animals to specialized mobile HEPA filtered enclosures for multiple cages of rodents and larger animals. The primary containment transport device should be a durable, leak proof container that can be secured for transport, allows sufficient air exchange to support the physiological needs of the animal s , and the interior and exterior of the containment device should be easily disinfected.
As stated earlier, the facility provides secondary containment of the hazard and incorporates barriers into the design and construction of the facility that may include features such as autoclaves, specialized ventilation that provides directional airflow, air filtration, controlled access zones, or airlocks located at laboratory entrances.
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The determination of the appropriate animal biosafety level requires experience and professional judgment and should be made in consultation with a biosafety professional and based on a thorough risk assessment of the agent and how it is going to be used. Even different projects involving the same microorganism or toxin might have a different level of risk because of the animal species involved, the route of exposure, and the activities or procedures being performed.
An important facility consideration is the heating, ventilation, and air conditioning HVAC system. For biocontainment facilities, the HVAC system is considered a means of secondary containment and must be able to maintain the facility under negative pressure, thereby containing the hazardous agents and preventing any accidental release into the environment. This is usually accomplished with HVAC systems that have automated controls on the intake and exhaust valves creating directional airflow from areas that do not have pathogens to areas that do.
HVAC systems require careful monitoring, periodic maintenance to sustain operational integrity, and routine verification to ensure proper directional air flow. Loss of directional airflow compromises safe laboratory operation and HVAC systems should be redundant and designed to prevent inadvertent positive pressurization from occurring during an HVAC failure. While engineering controls provide a barrier between the individual and a hazard, the use of personal protective equipment PPE is the final physical barrier used to prevent exposures to hazardous materials and should not be used in lieu of appropriate engineering controls.
Requirements for PPE should be clearly identified, consistent with the hazard and the required level of containment, and posted, so that personnel entering the room or area are aware. While PPE comes in many forms and each item serves an important purpose, working with animals, sharps, and infectious agents and toxins together make gloves and respiratory protection critical considerations.
People subject to a risk of an aerosol exposure to infectious agents or toxins must be provided appropriate respiratory protection. When the use of a respirator is required, the institution must implement a respiratory protection program and have a dedicated program administrator. A common hazard working with animals is the need for sharps, such as syringe needles, scalpels, surgical instruments, etc.
Good sharps handling practices, demonstrated proficiency, and having an awareness of the risks associated with handling sharps in a biocontainment environment that may be contaminated with infectious material are important considerations. A standard practice is that needles should not be recapped.
Waste streams must be clearly identified to ensure the proper decontamination and disposal of all types of waste generated in animal rooms and support areas within a containment facility. The types of waste streams can vary based on the activities being performed; therefore, each institution should identify and define their waste streams and implement appropriate decontamination and disposal procedures for each stream. Knowledge of the multiple national, state and local regulations that apply to the identification of waste streams, decontamination, handling, transportation and disposal of biohazard waste is critical to ensure compliance.
The use of commercial hazardous waste disposal companies to help with navigating the myriad of regulatory requirements for waste disposal has become a common practice. These companies can be an excellent resource for obtaining training on identifying waste streams and for help with developing internal waste handling procedures that meet regulatory requirements. Maintenance of those conditions involves activities such as changing cages and bedding, as well as routine sanitation of animal caging, racks, and the secondary environment. Cleaning and disinfection are important aspects of any sanitation program and the difference between the 2 methods should be understood in a biocontainment environment.
These activities in biocontainment may be slightly different than in a conventional area. For example in most biocontainment facilities, the cage wash is located outside of the biocontainment area, so caging and waste must be sterilized prior to removal from the containment area. Some caging, such as biocontainment caging for larger, nonrodent species, may have to be partially disassembled to allow for adequate cleaning. Cleaning in biocontainment is usually performed by hand without the use of a mechanical washer. Caging should be adequately rinsed after cleaning to prevent exposure of the animals to residual chemicals.
Disinfection of primary and secondary enclosures in containment usually involves the use of chemical disinfectants during the conduct of the study and chemical, gas or vapor disinfectants between studies.
Laboratory Animal Medicine
The type of chemical disinfectant used must be carefully considered as it must be effective against both naturally occurring microorganisms in the environment and those that are used experimentally. Validation studies may be required to verify the effectiveness of the disinfectant against the microorganism and the appropriate contact time.
Animals exposed to infectious diseases present a concern to individuals handling the animal due to the risk of transmission of the agent from the animal to the handler. Transmission could occur by a variety of methods, to include bites, scratches, needle sticks, mucous membrane exposure, or aerosol transmission.
The use of physical restraint devices squeeze cages or restraint boxes , chemical restraint, additional PPE as previously described, and practices that reduce the risk of exposure during animal manipulations should be used whenever possible. According to the BMBL, all procedures involving the manipulation of infectious materials either the infectious agent or tissues from infected animals , handling of infected animals or the generation of aerosols must be conducted within BSCs or other physical containment devices when practical.
BSCs are commonly used with small rodents, but present a challenge when handling larger laboratory animal species and are impractical for agricultural animals. When a procedure cannot be performed within a biosafety cabinet, a combination of personal protective equipment and other containment devices or methods must be used. Research involving hazardous agents, including pathogenic organisms, toxins, and biological materials from infected animals, requires careful consideration during the review process.
To ensure compliance with all applicable laws and regulations, research involving hazardous agents may be reviewed and approval granted by a number of different groups prior to the conduct of the study. Additional regulatory approval may be required based on national or state requirements for the work being conducted.
The ultimate responsibility for review and approval of animal use protocols lies with the IACUC 2 p25 , 14 , 15 or similar ethical review committee. It is important that there are members of the IACUC that have the background and experience to adequately review protocols involving biohazards or the committee should have access to a biosafety professional who is knowledgeable about the biohazards that will be used.
Many institutions have someone from the institutional biosafety program to serve as a member of the IACUC. Alternatively, an appropriate biosafety professional could serve as an ad hoc reviewer for the committee. During the review process, it is important to have adequate information about the biohazard and protective measures. Many institutions have adopted the use of a biohazard appendix to the protocol form to assist in the review process. The biohazard appendix is tailored to the needs of the institution. Institutions have safety offices and committees that review the use of hazardous agents, including chemicals, biological agents, and radioactive materials.
A requirement of these guidelines is the establishment of an institutional biosafety committee IBC that includes individuals with experience and expertise in recombinant or synthetic nucleic acid technology, biosafety and physical containment. The committee must also have a biological safety officer if work is being conducted at ABSL3 or ABSL4 and a member with expertise in animal containment if experiments with animals are being performed.
The NIH Guidelines provide guidance on physical and biological containment practices for recombinant or synthetic nucleic acid molecule research involving etiological agents and animals. Experiments with recombinant or synthetic nucleic acid molecules and animals could include the creation of transgenic animals as well as the use of manipulated biological agents in animals. Either situation makes the risk assessment and review more difficult because the disease process and pathogenesis in the animal may be altered, thereby requiring additional containment measures.
Institutions have a responsibility for ensuring worker safety. An essential part of an institution's safety program is an occupational health and safety program OHSP that is consistent with national, state, and local regulations and focuses on maintaining a safe and healthy workplace.
- Safety considerations for working with animal models involving human health hazards.
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An effective OHSP takes into consideration all facets of the research program including facilities, personnel, research activities, biohazards, and animal species, and includes careful coordination with members of the research, animal care and use, occupational health, safety, and administration groups. Optimally, there should be ready access to an infectious disease physician with understanding of the hazards presented by the agents used within the facility. As part of the medical evaluation, the healthcare provider should review any previous and ongoing medical problems, current medications, allergies, and prior immunizations in order to determine an individual's medical fitness to perform the duties of a specific position and what medical services are needed to permit the individual to safely assume the duties of the position.
Commercial vaccines should be made available to workers to provide protection against infectious agents to which they may be occupationally exposed. Routine, periodic medical evaluations may be a part of an OHSP for personnel working with hazardous agents, and medical clearances may be required for specific circumstances eg, respirator usage.
The frequency and methods of medical evaluation may vary and are based on the needs of the program. Routine medical evaluations may be done through the use of questionnaires or through physical evaluations, depending on the level of risk present in the workplace and the health of the individual. It is also important to note that in special circumstances, it may be appropriate to offer periodic laboratory testing to workers with substantial risk of exposure to infectious agents to detect preclinical or subclinical evidence for an occupationally acquired infection. As part of the OHSP, plans for addressing potential exposures to hazardous agents should be in place.
Workers should be encouraged to seek medical evaluation for symptoms that can be associated with infectious agents in their work area. Proactive reporting of clinical signs is important because infections are more difficult to treat and have greater morbidity and mortality if treatment is delayed. Fatal occupational infections have resulted from apparently unknown exposures. The ability to work safely with animal models exposed to biohazards depends on multiple factors, several of which are presented in this article for consideration.
Working in or managing an animal biocontainment program requires a thorough understanding of the basic principles of containment, including both the engineering and procedural controls necessary to protect both personnel and the animals with which they work.
Animal Care and Use Policies | University of Maryland Center for Environmental Science
Personnel must be fully aware of the highly regulated environment that accompanies this type of work and they must have a profound appreciation for the serious consequences of noncompliance. Working with animals exposed to biohazardous agents requires a high level of skill and awareness to overcome some of the challenges of the biocontainment environment, but the positive impact on society and one's own professional fulfillment can be great. While this article is not a comprehensive review of all the aspects of working with animals exposed to biohazards, it provides a basis for understanding the complexity of the environment and provides additional reference materials for anyone working in this area or considering it as a career path.
Volume 1 , Issue 2. If you do not receive an email within 10 minutes, your email address may not be registered, and you may need to create a new Wiley Online Library account. If the address matches an existing account you will receive an email with instructions to retrieve your username. Calvin B. Carpenter Corresponding Author E-mail address: carpenterdvm gmail. Tools Request permission Export citation Add to favorites Track citation.
Share Give access Share full text access. Share full text access. Please review our Terms and Conditions of Use and check box below to share full-text version of article. Abstract A human health hazard may constitute a variety of hazards that are encountered in an animal facility. Biosafety in Microbiological and Biomedical Laboratories. The table below illustrates several organisms and toxins of fish origin and exposure routes that have been reported or have the potential to infect humans. This table is not all-inclusive see M. Stoskopf et. The major exposure routes include ingestion and introduction of organisms through open wounds or abrasions.
More specifically, ingestion includes consumption of raw or under-cooked infected fish tissue, ingestion of fish tissue contaminated with feces from infected fish, and ingestion of water harboring infectious organisms. Dermal exposure includes introduction of infectious agents into open wounds or abrasions through handling infected fish or infected water. Section 4. Investigators submitting research proposals to their Laboratory Director must indicate whether vertebrate animals limited to fish, amphibians, and reptiles in laboratory research will be used in the proposed research.
Initiation of federal agency funding is contingent on having proposed research protocols approved BEFORE research funds are awarded. See Section 5. This form should be filled out, electronically signed by the applicant, principal investigator if different , and Laboratory Director, and submitted to the IACUC office lstepp umces.
The following information should be considered in filling out the application. Protocol review is based upon the summary document, Principles for the Use of Animals in Research, Teaching, and Testing developed by the U. Interagency Research Animal Committee. According to these principles protocols need to:. Animal use may not begin until the research protocol is approved. All approved applications are assigned a protocol number.
This number should be used in all correspondence and used on experimental tanks for identification purposes. Please note that according to federal regulations, Animal Use Protocols may only be approved for up to three years. If you continue your project beyond three years, you will be out of compliance with public Health Service policy on Humane Care and Use of Laboratory Animals. Principal Investigators are responsible for insuring, at least two months before an approved protocol expires on a continuing grant that a new De Novo application is submitted for review.
The IACUC reviews annually all existing protocols and should be made aware if there are any significant changes that would affect the approved care and use of vertebrate animals. Please ensure that you and your laboratory director have signed the form prior to submission. Electronic signatures are acceptable. Section 5. Skip to main content. Home Animal Care and Use Policies. Hoogland Ph. Change in principal investigator. Change of species. Addition of USDA-regulated species. Large increase in animal numbers. Addition of survival surgery. Addition of painful procedure. Unanticipated marked increase in clinical signs or proportion of animal deaths.
Substitution of a qualified student or technician. Addition of a faculty collaborator. Change in sex of animal to be used.
Small increase in animal numbers.