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LAT Certification

Chapter 2

QuestionAnswer
What year was the Laboratory Animal Welfare Act established? 1966
When was the Animal Welfare Act enacted? 1970
What does the Animal Welfare Act cover? All warm-blooded animals, including animals sold as pets or used in exhibitions.
What animals are excluded from the Animal Welfare Act? Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, horses not used for research purposes, farm animals intended for use as food or breeding
What describes what a facility must do to comply with the Animal Welfare Act? Animal Welfare Regulations
What are some of the requirements found in the Animal Welfare Regulations? Registration of research institutions, oversight by an IACUC, research staff qualified for humane care, adequate vet. program, proper id of animals, adequate recordkeeping,
Who is APHIS? Animal and Plant Health Inspection Service-part of the USDA that is tasked with administering the Animal Welfare Act and the Animal Welfare Regulations
How often must nonfederal research facilities register with the USDA? Every 3 years
What information is included in the yearly report sent to the USDA? Institution must demonstrate it is following AWA, animal care meets standard, PIs consider alternatives, exceptions are approved by IACUC, location of animal facilities, how many animals were used in previous year in each pain category
Describe USDA Pain Category B Animals being bred or held for use in experiments, but not yet used for such purposes
Describe USDA Pain Category C Experiments conducted that cause no pain or distress and do not require use of pain-relieving drugs
Describe USDA Pain Category D Experiments causing pain or distress to animals, for which appropriate anesthetic, analgesic or tranquilizing drugs were used
Describe USDA Pain Category E Experiments causing pain or distress to animals, for which appropriate anesthetic, analgesic or tranquilizing drugs were not used because they would have adversely affected the procedures, results or interpretation.
Define a Class A dealer Raise and sell animals themselves; these animals are known as purpose-bred
Define a Class B dealer Purchase and resell animals; including random-source dogs and cats, import nonhuman primates and resell animals from research facilities
How long must an animal obtained from a shelter be held before it can be sold? 5 days
Which IACUC records must be kept on file? Meeting minutes, proposed animal use protocols and significant changes to those protocols, semiannual reports, any recommendations
What records are mandated by the USDA? Records for live dogs and cats and any offspring born of these animals at the research facility, as well as records of disposition for species covered by the USDA
What health records must be kept? Animal's identity, description and resolution of problems, dates and details of observations, examinations, tests, treatments and any treatment plan with a diagnosis and prognosis
What are some examples of procedures that should be documented in health records? Vaccinations, fecal examinations, radiographs, surgeries and necropsies
What does the Animal Welfare Assurance commit the institution to? Compliance with PHS Policy, the AVMA Guidelines for the Euthanasia of Animals, the Guide, and the AWA.
Who is responsible for monitoring compliance with the PHS Policy? Office of Laboratory Animal Welfare (OLAW)
How does the PHS Policy describe a program of animal care? The location, components, construction, management and operation of the facility where animals are housed, the physical and social environment of the animals, animal husbandry, animal ID, genetic monitoring, animal health records, daily obs of animals
What animals does the PHS Policy cover? All live vertebrate animals
How often are IACUC conducted inspections required by PHS Policy and the AWR? Every 6 months
What is the purpose of the Guide? To make recommendations regarding the humane care and use of laboratory animals based on performance standards
With regards to the Guide, what does "must" mean? Used to describe aspects of an animal care program that are considered essential or imperative to the proper humane care and use of lab animals
With regards to the Guide, what does "should" mean? Used to describe aspects of an animal care program that are strong recommendations for achieving a goal
What makes an effective occupational health and safety program? Having strategies for control and prevention, which begins with the identification of hazards and comprehensive risk assessments.
Who is responsible for the veterinary oversight of the research program? The attending veterinarian (AV)
Who publishes guidelines on euthanasia? The American Veterinary Medical Association (AVMA)
Define euthanasia Method of killing that minimizes pain, distress and anxiety experienced by the animal prior to loss of consciousness and causes rapid loss of consciousness followed by death
What are the categories of known methods of euthanasia described by the AVMA Guidelines? Acceptable, Acceptable with Conditions, Unacceptable
What factors go into selecting the most appropriate euthanasia method? Animal species and age, available means of animal restraint, skill of personnel, personnel safety risks, and the number of animal to be euthanized
Why are there laws around the importation and shipment of animals? To ensure the welfare of transported animals and to protect human beings and the environment from the potential harmful effects of disease-carrying animals
What are common import regulations for laboratory animals? Animals must be shipped from the country of origin, necessary export documents and proper identification are provided, animals appear healthy, enter the US through designated ports of entry
What is CITES and what is the purpose? The Convention on International Trade in Endangered Species of Wild Fauna and Flora; implemented to prevent the endangerment or extinction of species due to international trade
What are the CITES Appendices Appendix I-contains species that are the most endangered Appendix II-contains species that are likely to become endangered Appendix III-contains species that are protected by a member country that requests cooperation to prevent exploitation
What was passed in the US to implement CITES? The US Endangered Species Act
Overseeing the importation of animals and animal products capable of causing human disease is the responsibility of? The Centers for Disease Control and Prevention (CDC)
What are key components to an occupational health and safety program? Training and experience levels among employees, possibility of exposure across different areas of the facility, types of research and animal species
What is the Biosafety in Microbiological and Biomedical Laboratories (BMBL)? A set of guidelines established by the CDC and the NIH for safe handling and containment of biological agents in a laboratory setting
How many categories of risk are associated with infectious agents used in laboratories? 4: BSL1, BSL2, BSL3, BSL4
What is the goal of a biosafety program? To ensure that personnel understand the standards and practices for each biosafety level and follow the appropriate protective measures.
What are some strategies involved in containment of potential pathogens? -Facility is designed in a manner appropriate to intended use -Risk assessment performed; biosafety level assigned accordingly -staff are trained appropriately -staff are consistent in use of safety equipment
What are Good Laboratory Practice (GLP) Regulations? A set of controls for research laboratories to ensure the consistency of procedures and the reliability of data.
Who mandates GLP? The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA)
What are some organizational requirements needed for conducting GLP-compliant studies? A study director must be appointed and is the single point of control for the study.; A quality assurance unit must audit all GLP-compliant studies; qualified personnel conducting studies; periodic internal evaluations; records maintained
What are some regulations about a facility that conducts GLP-compliant studies? Ensure separation of species, isolation of projects and isolation of quarantine areas; storage areas for feed, bedding, supplies and equipment separate from housing areas, environmental conditions regulated
According to GLP, what is a test system? Comprehensive term for the animals or any other entity that is administered a substance in a GLP study.
What are some of the GLP requirements involving animal care? -New animals must be quarantined and health status evaluated -Animals must be identified accurately -Housing areas must be kept clean and sanitized regularly -Contaminant levels of feed and water should be analyzed -compounds must be labeled
What are Standard Operating Procedures (SOPs)? Detailed documents that describe all procedures to be performed and are easily accessible to employees.
What are some areas in an animal facility where SOPs and documentation are required? -Animal room construction -Environmental conditions -Animal rooms and caging -Common areas and storage -Cage wash areas
What is included in raw data? Facility logs, Laboratory work sheets, Notes, Equipment or instrument output, Computer printouts, Biological specimens
What must be archived during or at the close of a GLP study? All protocols, raw data, specimens, documentation, and final reports
How often are AAALAC site visists? Every 3 years
What are typical institutional IACUC policies? Related to reporting matters such as animal welfare issues, euthanasia, pain and distress, training, veterinary care and survival surgery
How often should the IACUC review the animal care and use program, according to OLAW and the USDA? Every 6 months
Who must be notified if an animal use protocol is suspended by the IACUC? USDA, OLAW, and AAALAC
Created by: CarrieAngeles