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What does the Public Service Policy on Humane Care and Use of Laboratory Animal (PHS Policy) implement? - ✔✔the Health Research Extension Act of 1985 The Health Research Extension Act of 1985 directs to establish guidelines for the proper care and treatment of animals used in research - ✔✔the Secretary of Health and Human Services In 1986 , the PHS Policy incorporated the by the Interagency Research Animal Committee and adopted by US Government agencies that use vertebrate animals - ✔✔U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training IACUC membership requirements for PHS Assurance - ✔✔ 5 members: One veterinarian (training/experience in lab animal medicine) One scientist (experience in research) One nonscientific member One not affiliated member PHS Policy mandates that animal care and use programs must operate in accordance with four specific laws and guidelines - ✔✔ 1. The Animal Welfare Act
- United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
- The Guide for the Care and Use of Laboratory Animals
- AVMA Guidelines for the Euthanasia of Animals Code of Federal Regulations, Title 9 , Chapter 1 , Subchapter A, Parts 1 , 2 , and 3 - ✔✔Animal Welfare Regulations that are implemented by the USDA/APHIS/AC
Clarified humane care, minimization of pain and distress, consideration of alternatives, institutional animal care and use committees, psychological well-being of primates, and exercise for dogs - ✔✔ 1985 amendments to the AWA Which term is defined in the Guide as "all measures to control known or unknown infections in laboratory animals." a. Biosecurity b. Stabilization c. Quarantine d. Biosafety - ✔✔a. Biosecurity Which of the following statements about multiple survival surgical procedures on a single animal is TRUE? a. The Guide's definition of "major" surgery is rigid, and does not provide for any interpretation by the veterinarian or the IACUC. b. When USDA-covered species are used, the Animal Welfare Regulations' definition of "major" surgery takes precedence. c. The Animal Welfare Regulations allow for the interpretation of "major" surgery to be evaluated on a case-by-case basis by the IACUC. d. The Guide's requirement that multiple major survival surgeries must be scientifically justified and included in the IACUC-approved protocol only applies to non-rodent mammals. - ✔✔b. When USDA- covered species are used, the Animal Welfare Regulations' definition of "major" surgery takes precedence. Animals using which type of thermoregulation depend mostly on environmental temperature to maintain their internal physiology? - ✔✔Poikilothermic Which should be provided in the environment of a semi-aquatic animal? a. porous substrate b. recirculating system c. a terrestrial area d. low humidity level - ✔✔c. a terrestrial area
Introduced specific guidelines concerning the humane care and handling of animals in research facilities, such as sanitation, housing and ventilation - ✔✔The Food Security Act of 1985 , also called "The Improved Standards for Laboratory Animals Act"
- Mandated that all personnel using animals in research are appropriately trained.
- Introduced and defined the role of the Institutional Animal Care and Use Committee or IACUC, and its responsibilities to the Animal and Plant Health Inspection Service (APHIS), a division of the USDA. One of an IACUC's responsibilities is to inspect the institutional animal facilities and all its study areas at least twice per year.
- Specified that consultation with a veterinarian is necessary in the planning of any procedure that could cause pain or distress to animals.
- Directed the Secretary of Agriculture to establish rules to provide exercise for dogs and an adequate physical environment for the psychological well-being of non-human primates.
- Specifies that no animal can be used in more than one major operative procedure from which it recovers unless it is scientifically justified. However, multiple major operative procedures are allowable in certain circumstances, as determined by the USDA, including the provision of veterinary medical care, such as for the health care of the animal.
- Established the National Agricultural Library's Animal Welfare Information Center (AWIC) to be an information resource on the humane care and use of animals and alternatives to procedures causing pain and distress. Mandated a minimum period of five days for pounds and shelters to hold dogs and cats before providing them to a dealer. - ✔✔the pet protection provision of the 1990 farm bill A breeder. Specifically, this dealer breeds and raises animals on the premises in a closed or stable colony. A dealer may acquire animals for the sole purpose of maintaining or enhancing the breeding colony. - ✔✔Class A dealer (AWA Act)
A person whose business includes the purchase and/or resale of any animal - ✔✔Class B dealer (AWA Act) Dogs and cats obtained from animal pounds or shelters, auction sales, or from any person who did not breed and raise them on his or her premises - ✔✔Random Source AWA required IACUC members - ✔✔ 1. Chairperson
- A Veterinarian (experience in lab animal science and medicine)
- Not affiliated Exemptions to the requirement for an USDA license for dealers/vendors are - ✔✔ 1. Persons who sell or negotiate the sale or purchase of animals other than wild or exotic animals, dogs, cats and who derive no more than $ 500 gross income annually from the sale of these other animals to research facilities, exhibitors, dealers, or pet stores.
- Persons who annually sell fewer than 25 dogs and/or cats which were born and raised on their premises for research, testing, or education. Indoor housing temperature ranges for dogs and cats (AWA) - ✔✔The ambient temperature must not fall below 45 °F or rise above 85 °F for more than four consecutive hours when animals are present. Indoor housing temperature ranges for guinea pigs and hamsters (AWA) - ✔✔Ambient temperature for indoor housing facilities must not be allowed to fall below 60 °F or to exceed 85 °F. Indoor housing temperature ranges for primates (AWA) - ✔✔The facility's ambient temperature must not fall below 45 °F ( 7. 2 °C) and must not rise above 8 5°F ( 29. 5 °C) for more than four consecutive hours Which of the following information need not be present on an official tag? a. Date of birth b. Numbers identifying the animal c. Numbers identifying the dealer
Can a U.S. supplier be exempt from USDA licensing for DoD studies? - ✔✔Yes. They must meet exemption criteria AND the Component shall conduct a program review/facility inspection (by a DoD Veterinarian) to confirm standards. May be waived if AAALACi What is the exception for a DoD institution to not have AAALACi accreditation? - ✔✔Using or housing animals for RDT&E or training for less than 8 continuous calendar days (still inspected by DoD vets). DoD requirements for IACUC Committee members - ✔✔Federal Employees or considered experts/consultants 5 members Veterinarian Non-affiliated community member and an alternate Non-scientific member Who must attend DoD IACUC meetings - ✔✔Veterinarian and one community member must be present All RDT&E and training approved by an IACUC must be reviewed by the IACUC - ✔✔At least annually DoD Component Headquarters Approval and Oversight perform what 3 reviews? - ✔✔ 1. Review all protocols of nonhuman primates, dogs, cats, or marine mammals and all medical training annually
- Review and approve significant changes to protocols
- Review the program review conducted by the IACUC and oversee any corrective actions When an institution is under USDA investigation, lost AAALACi accreditation, or any other adverse events the institution shall notify their Component Headquarters within business days. - ✔✔ 5 DoD supported research: All protocols must by reviewed how often by the IACUC? - ✔✔Annually
True/False? DoD funded studies not conducted at DoD facilities do not have to report to DoD Component Headquarters. - ✔✔False. DoD Component Headquarters administratively review and approve all DoD supported research prior to start and ensure annual review are completed. USDA inspection reports (when applicable) are also submitted annually. How often are on-site inspections conducted by a DoD veterinarian for DoD funded research (contract location)? - ✔✔Must pass an on-site evaluation within 30 days of signed agreement and will repeated annually. AAALACi accreditation may waive the requirement A systematic investigation of a scientific question employing a hypothesis, structured methodology, and controlled study design (e.g., a manipulation of variables, an assessment of differences in outcome due to variables) for the purpose of contributing to the generalized body of knowledge. - ✔✔Research A systematic investigation, structured methodology, or controlled study designed for the purpose of further refining the product and demonstrating its intended use. - ✔✔Development A systematic analysis of the product to ensure that it meets it intended goals. - ✔✔Test An analysis of the product's suitability and readiness to be produced and fielded. - ✔✔Evaluation Ag Guide requirements for IACUC Committee members - ✔✔ 5 members:
- A scientist with Ag research experience
- A scientist with training/experience in management of Ag animals
The agency (within the USDA) that ensures compliance with the Humane Methods of Slaughter Act? - ✔✔Food Safety and Inspection Service The range of environmental temperatures over which animals use the minimum amount of metabolizable dietary energy to control body temperature - ✔✔Thermoneutral zone The ventilation rate for Ag animals should be high enough to prevent indoor temperature from exceeding outdoor temperature by more than. - ✔✔ 3 degrees C 5 degrees F National and local policies and procedures that address the protection of food and water supplies from intentional contamination and used to define measures required to maintain security and accountability of select agents and toxins. - ✔✔Biosecurity "It is often more imperative to perform research or testing on animals before subjecting humans to new procedures, pharmacologics, or devices." - ✔✔Principle # 3 of the Nuremberg Code of 1947 The basic principles governing animal research in VA - ✔✔U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training ACORP - ✔✔Animal Component of Research Protocol - official VA animal protocol form CRADO - ✔✔Chief Research and Development Officer (VA) True/False: The VA Policy requires compliance with PHS Policy even if PHS funds are not received. - ✔✔True Research and Development (R&D) Committee (VHA) - ✔✔Overseeing and approving all research projects at the VA medical facility. The IACUC/IBC/IRB is a subcommittee of the R&D.
Subcommittee for Research Safety (SRS) - ✔✔IBC for the VHA Has the authority to suspend or terminate research involving animals or a VA animal research program. - ✔✔The Under Secretary for Health or the Office of Research Oversight Who does the CVMO report directly to in the VA system? - ✔✔CRADO A VA medical facility contracts a veterinarian rather than a VMO, how often must the facility be visited? - ✔✔VA medical facility with an ongoing animal research program must be visited less frequent than monthly to ensure adequate veterinary care VHA: To test the ability of facilities management personnel to properly detect and respond to elevations in animal room temperatures, personnel must purposely overheat a temperature sensor how often? - ✔✔At least once every fiscal year (recorded in IACUC minutes) Who and how often are animal facility SOPs reviewed for the VHA? - ✔✔Reviewed and approved by the IACUC annually after reviewed by the VMO True/False: All VA facilities or affiliates must be accredited by AAALAC. - ✔✔True True/False: The VA IACUC may serve as the IACUC of record for a non-VA institution. - ✔✔False Who appoints the IACUC members, including a specific length of time, for the VHA? - ✔✔The medical facility Director Nominations provided by the IACUC and R&D Committee Required VA IACUC members - ✔✔ 5 members: Chairperson (appointed annually) AV Scientist Non-affiliated
VA facilities must submit USDA to report to by each year - ✔✔CVMO's office or ORD by November 15 th (who then sends to USDA) VA facilities submit copies of all AAALAC correspondence and annual reports to the no later than - ✔✔CVMO and ORO no later than 30 days after submission Annual VA VMU Report - ✔✔Completed by January 15 th for the previous fiscal year and includes all species VA facilities PHS Assurances and Annual Reports must be forwarded to with in - ✔✔CVMO's office within 30 days of submission to PHS A copy of all correspondence between OLAW, USDA, AAALAC and VA facilities must be forwarded to the within - ✔✔CVMO and ORO within 15 business days of receipt
