Bluebook questions Ch 2.txt

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Bluebook questions Ch 2.txt
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Bluebook questions Ch 2
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  1. 1. Que. What was the original name of the U.S. Animal Welfare Act?
    Ans. Laboratory Animal Welfare Act
  2. 2. Que. What year did the first legislation protecting animals in research pass?
    Ans. 1966
  3. 3. Que. What year was the year that the Laboratory Animal Welfare Act amended to the Animal Welfare Act and its scope was broadened to include animals used for teaching, exhibitions, and the wholesale pet industry?
    Ans. 1970
  4. 4. Que. What year was that the Animal Welfare Act was amended to include regulation of common carriers and intermediate handlers and established transportation standards for animals?
    Ans. 1976
  5. 5. Que. What year the AWA amended to broaden the regulation to include specific requirements for research facilities that were related to the experimental use of animals?
    Ans. 1985
  6. 6. Que. What year was the AWA amended to establish a 5 day holding period for dogs and cats held at pounds, shelters and research facilities?
    Ans. 1990
  7. 7. Que. Within the USDA, the Animal Welfare Act is administered through which organization?
    Ans. Animal and Plant Health Inspection Service
  8. 8. Que. What is the required minimum number of days the USDA must publish any new regulations or changes in the Federal Register for public comment?
    Ans. 60
  9. 9. Que. Which animals, regardless of intended use, are specifically excluded from the AWA?
    Ans. Birds, rats of genus Rattus, mice of the genus Mus
  10. 10. Que. Any person operating or desiring to operate as a dealer, broker, or operator or an auction sale must be licensed by what agency?
    Ans. USDA
  11. 11. Que. Research facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons must also hold the animals for how many days?
    Ans. 5
  12. 12. Que. How often must research facilities, intermediate handlers, and common carriers of regulated species register with the USDA?
    Ans. 3 years
  13. 13. Que. How often must the IACUC review the research facility�s program for humane care and use of animals, based on USDA regulations?
    Ans. 6 months
  14. 14. Que. What is the minimum number of people that can be on an IACUC according to the AWA?
    Ans. 3
  15. 15. Que. Which healthcare professional must be a member of the IACUC according to the AWA?
    Ans. Doctor of Veterinary Medicine
  16. 16. Que. How often must the IACUC conduct an inspection of all animal study areas and animal facilities?
    Ans. 6 months
  17. 17. Que. Which type of deficiencies are defined as those that threaten animal health or safety, must be distinguished from minor deficiencies
    Ans. Significant
  18. 18. Que. IACUC may suspend an activity if it determines that the activity is not conducted in accordance with IACUC- approved procedures. Any suspended activities must be reported to which agency?
    Ans. USDA
  19. 19. Que According to the USDA, records that relate directly to activities approve by the IACUC must be maintained for how long?
    Ans. For the duration of the activity and for an additional 3 years after completion of the activity.
  20. 20. Each facility must submit an annual report to whom and when?
    Ans. Think just changed from fiscal to calendar year but BB says to �USDA on or before December 1 of each calendar year to provide information relevant to the immediately preceding fiscal year (October 1 � September 30).�
  21. 21. Que. According to the USDA, dogs over what age must be provided with the opportunity for exercise?
    ANS. 12 weeks
  22. 22. QUE. How often must veterinarians who exempt dogs from the opportunity for exercise document and review the exemptions?
    ANS. every 30 days.
  23. 23. QUE. In NHP protocols, which require more than 12 hours of continuous restraint, the NHP must be provided the daily opportunity for continuous unrestrained activity for a minimum of how long?
    ANS. 1hour
  24. 24. Que. What agency is responsible for the implementation, interpretation, and evaluation of compliance with the PHS Policy and for education of institutions and investigators receiving PHS support?
    Ans. Office of Laboratory Animal Welfare (OLAW)
  25. 25. Que. How often must a new assurance be submitted to the Office of Laboratory Animal Welfare?
    Ans. every five years
  26. 26. Que. The PHS Policy requires that euthanasia of animals be conducted in accordance with which �report�?
    Ans. �Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia�
  27. 27. Que. How many IACUC members are required by PHS ppolicy?
    Ans. At least five
  28. 28. Que. PHS Policy requires that records of IACUC activities (e.g. meeting minutes, semiannual program reports, etc) must be maintained for how long?
    Ans. At least three years
  29. 29. Que. PHS Policy requires that records of IACUC-approved activities (protocols, etc) be maintained for how long?
    Ans. Three years beyond the completion of the activity.
  30. 30. Que. How often must the IO (institute Official), acting on behalf of the IACUC, report to OLAW according to PHS policy?
    Ans. At least once every 12 months.
  31. 31. Que. What agency checks for compliance with the GLP regulations, by conducting periodic, routine surveillance inspections and data audits of public, private, and government nonclinical laboratories that perform tests on GLP-regulated products?
    Ans. Food & Drug Administration (FDA)
  32. 32. Que. In 1995, authorized representatives of what three governmental organizations signed a Memorandum of Agreement concerning Laboratory Animal Welfare?
    Ans. USDA, NIH, and FDA
  33. 33. Que. What governmental agency is responsible for the registration and control of pesticides?
    Ans. Environmental Protection Agency (EPA)
  34. 34. Que. What specific legislative Act, enacted in 1947, authorizes the administrator of the EPA to register and control the use of pesticides?
    Ans. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
  35. 35. Que. What specific legislative Act governs the use of GLP standards for conducting GLP-regulated chemical studies?
    Ans. The Toxic Substances Control Act (TSCA)
  36. 36. Que. What does ILAR stand for?
    Ans. Institute for Laboratory Animal Research
  37. 37. Que. Who is the publisher of �The Guide�?
    Ans. ILAR
  38. 38. Which 2 major organizations recognize The Guide as the standard reference on laboratory animal care and use programs?
    Ans. Public Health Service (PHS) and AAALAC
  39. 39. Que. In addition to The Guide, ILAR publishes two other standard references that are used to establish and maintain optimal animal care and use programs. List these two other references.
    Ans. �Occupational Health and Safety in the Care and Use of Research Animals� and �The Psychological Well-being of Non-human Primates�
  40. 40. Que. What does AAALAC International stand for?
    Ans. The Association for Assessment and Accreditation of Laboratory Animal Care International.
  41. 41. Que. What publication is used to help assure the ethical and humane treatment of farm animals used in agricultural research?
    Ans. �The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching� (aka �Ag Guide�)
  42. 42. Que. What international organization, in 1985, was responsible for developing the �International Guiding Principles for Biomedical Research Involving Animals�?
    Ans. Council for International Organizations of Medical Sciences (CIOMS).
  43. 43. Que. What governmental agency regulates the importation of all animals and
    • animal derived materials that could represent a disease risk to United States
    • livestock?
    • Ans. US Department of Agriculture (USDA), APHIS, Veterinary Services (VS),
    • Import-Export Products Staff.
  44. 44. Why do horses require a 60 day quarantine upon importation?
    Ans. African horsesickness
  45. 45. Que. Which APHIS agency regulates the importation of plants and other vegetable matter?
    Ans. PPQ (Plant Protection and Quarantine)
  46. 46. Which government agency and office regulates the importation of nonhuman primates?
    Ans. CDC, Office of Health and Safety
  47. 47. What is the minimum CDC-imposed quarantine period for receipt of imported nonhuman primates shipped to an institution or registered organization on arrival in the United States?
    Ans. 31 days
  48. 48. Que. Which agency enforces the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)? To what species does it apply?
    Ans. Department of the Interior, US Fish and Wildlife Service (FWS)- applies to all designated vertebrate and invertebrate animal or plant species, dead or alive, and any recognizable part of a designated animal.
  49. 49. Que. What regulation is responsible for spelling out the conditions of transport and package and container labeling for live wildlife when transported in interstate and foreign commerce?
    Ans. The Lacey Act
  50. 50. Que. What government agency is responsible for licensing, distribution and sale of pesticides requiring registration of users and certification of applicators? What legislation does this agency enforce?
    Ans. Environmental Protection Agency; the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
  51. 51. Que. What agency provides workers with protection against illnesses or injury resulting from unsafe or unsanitary working conditions?
    Ans. Occupational Safety and Health Administration (OSHA)
  52. 52. Que. What organization plans, directs, and coordinates national programs to develop and establish recommended occupational safety and health standards and to conduct research, training, and related activities to assure safe and healthful working conditions?
    Ans. National Institute for Occupational Safety and Health (NIOSH)
  53. 53. Which act authorizes the Environmental Protection Agency to require testing of chemical substances entering the environment and to regulate them as necessary?
    Ans. Toxic Substances Control Act (TSCA)
  54. 54. What chemicals are exclusively exempt from the Toxic Substance Control Act (TCSA) but regulated elsewhere?
    Ans. pesticides, food, food additives, drugs, and cosmetics
  55. 55. Que. Who is responsible for enforcement of the Drug Enforcement Act (This law requires appropriate security and record management of controlled substances that are considered to be potentially addictive or habituating for human and animal use)?
    Ans. Drug Enforcement Administration of the Department of Justice
  56. 56. Que. Which act authorizes the Nuclear Regulatory Commission (NRC) to help assure that the civilian use of radioactive materials is conducted in a manner consistent with public health and safety, environmental quality, national security, and antitrust laws?
    Ans. Atomic Energy Act
  57. 57. Que. What is CITES?
    Ans. Convention on International Trade in Endangered Species
  58. 1. Que. The _______ _____ section of the USDA�s Animal and Plant Health Inspection Service (APHIS) is responsible for assuring compliance of transportation, sale, and handling of animals used in laboratory research.
    Ans. Animal Care
  59. 2. Que. The law requires USDA to inspect each research facility at least once each _____.
    Ans. year
  60. 3. Que. Animals may be ________ or ________ by the authority of an APHIS official, if the animal is suffering as a result of the research facility�s failure to comply with any provision of the regulations or standards.
    Ans. confiscated, euthanatized
  61. 4. Que. The ________________________________ mandated the Secretary of Health and Human Services, acting through the director of the National Institutes of Health, to establish guidelines for the proper care and treatment of animals used in biomedical and behavioral research.
    Ans. Health Research Extension Act of 1985 (Pub. L. 99-158), Section 495, Animals in Research
  62. 5. Que. Any institution receiving support through the U. S. Public Health Service (PHS) for animal research, training, biological testing, or animal-related activities, must provide extensive written assurance of their compliance with ___________________________.
    Ans. PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)
  63. 6. Que. The ____________________________, National Institutes of Health (NIH), is responsible for the implementation, interpretation, and evaluation of compliance with the PHS Policy and for education of institutions and investigators receiving PHS support.
    Ans. Office of Laboratory Animal Welfare (OLAW)
  64. 7. Que. A new assurance must be submitted to the Office of Laboratory Animal Welfare at least every ____ years.
    Ans. five
  65. 8. Que. The PHS Policy implements the ________________________________, developed by the Interagency Research Animal Committee.
    Ans. �U. S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training�
  66. 9. Que. The PHS Policy requires that euthanasia of animals be conducted in accordance with the _________________________________________.
    Ans. �Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia�
  67. 10. Que. What policy implements the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training?
    Ans. PHS Animal Welfare Policy
  68. 11. Que. How many �US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training� are there?
    Ans. 9
  69. 12. Que. Unlike the Animal Welfare Act, the PHS Policy requires that the IACUC consist of ___________ members.
    Ans. At least five
  70. 13. Que. According to USDA regulations, the IACUC required to review ongoing research activities ___________ whereas the PHS Policy requires a complete review of ongoing activities ___________.
    Ans. Annually, at least every 3 years
  71. 14. Que. PHS Policy requires that records of IACUC activities (e.g. meeting minutes, semiannual program reports, etc) must be maintained for ____________.
    Ans. At least three years
  72. 15. Que. PHS Policy requires that records of IACUC-approved activities (protocols, etc) be maintained for _____________.
    Ans. Three years beyond the completion of the activity.
  73. 16. Que. PHS Policy requires that the IACUC report to OLAW, through the Institutional Official, _______________.
    Ans. At least once every 12 months.
  74. 17. Que. Good Laboratory Practice regulations became effective _________and were amended ___________.
    Ans. June 1979, 1987
  75. 18. Que. What four types of studies are not covered by GLP regulations?
    Ans. Basic research studies, clinical trials or field trials in animals, human subject trials
  76. 19. Que. For GLP studies, the FDA relies heavily on documented adherence to ___________ and __________ in judging the acceptability of safety data submitted in support of marketing or clinical research permits.
    Ans. Written protocols, SOPs
  77. 20. Que. Every study conducted under GLP regulations must have a _____________, who is ultimately responsible for the implementation of the protocol and conduct of the study.
    Ans. Study director
  78. 21. Que. Under GLP regulations, ___________ is required to monitor the conduct of studies to assure that the protocol is being followed and the records are properly maintained.
    Ans. A quality assurance unit
  79. 22. Que. To help assure compliance with the GLP regulations, who conducts periodic, routine surveillance inspections and data audits of public, private, and government nonclinical laboratories that may be performing tests on GLP-regulated products?
    Ans. Food & Drug Administration (FDA)
  80. 23. Que. Initial inspections by the FDA, on university and government laboratories that are performing tests on GLP-regulated products, are initiated only after the facility has been informed in a letter from whom?
    Ans. The Bioresearch Monitoring Program coordinator, Division of Compliance Policy, Office of Enforcement, FDA.
  81. 24. Que. In 1995, authorized representatives of what three governmental organizations signed a Memorandum of Agreement concerning Laboratory Animal Welfare?
    Ans. USDA, NIH, and FDA
  82. 25. Que. What governmental agency is responsible for the registration and control of pesticides?
    Ans. Environmental Protection Agency (EPA)
  83. 26. Que. What specific legislative Act, enacted in 1947, authorizes the administrator of the EPA to register and control the use of pesticides?
    Ans. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
  84. 27. Que. What specific legislative Act governs the use of GLP standards for conducting GLP-regulated chemical studies?
    Ans. The Toxic Substances Control Act (TSCA)
  85. 28. Que. What does ILAR stand for?
    Ans. Institute for Laboratory Animal Research
  86. 29. Que. The National Academies serve as advisors to the nation on issues of science, engineering, and medicine. The three Academies are the National Academy of Engineering (NAE), the Institute of Medicine (IOM), and the ______________.
    Ans. National Academy of Science (NAS)
  87. 30. Que. Although the NRC is part of the organization of the NAE and the IOM, it is the working arm of the National Academy of Science (NAS). What does NRC stand for?
    Ans. National Research Council
  88. 31. Que. The NRC has eight major program units or offices, including the _____________ (CLS), under which ILAR is located.
    • Ans. Commission on Life Sciences
    • Note: CLS was consolidated on January 1, 2001 and is now a part of the Division of Earth and Life Sciences (DELS), one of the offices of the NRC. ILAR falls under DELS. Also, the NRC has more than eight program offices now. See http://www.nationalacademies.org/directories/nrc_p.htm for an organizational chart of the NRC.
  89. 32. Que. ILAR is governed by a ____________ (number)-member council of experts in laboratory animal medicine, other science disciplines, and ethics.
    Ans. 15
  90. 33. Que. ILAR publishes several reports that provide a framework for governmental and institutional animal welfare. The most widely distributed publication from ILAR is ____________________________, also known simply as �__________.�
    Ans. The Guide for the Care and Use of Laboratory Animals; �The Guide�
  91. 34. Que. The Guide is recognized by two other major organizations as the standard reference on laboratory animal care and use programs. Name these two organizations.
    Ans. Public Health Service (PHS) and AAALAC
  92. 35. Que. In addition to The Guide, ILAR publishes two other standard references that are used to establish and maintain optimal animal care and use programs. List these two other references.
    Ans. �Occupational Health and Safety in the Care and Use of Research Animals� and �The Psychological Well-being of Non-human Primates�
  93. 36. Que. ILAR publishes a series of books that provide specific recommendations for many laboratory animal species. What is the name of this collective of books?
    Ans. The Laboratory Animal Management Series
  94. 37. Que. Which organization maintains a large database of commercial and investigator-held unique animal models?
    Ans. ILAR
  95. 38. Que. Which organization maintains an international registry of laboratory registration codes on behalf of the International Committee on Standardized Genetic Nomenclature for Mice?
    Ans. ILAR
  96. 39. Que. What does AAALAC International stand for?
    Ans. The Association for Assessment and Accreditation of Laboratory Animal Care International.
  97. 40. Que. True or False: AAALAC is a funded principally by government research monies.
    Ans. False. AAALAC is a non-profit organization.
  98. 50. Que. What are AAALAC�s primary roles?
    Ans. AAALAC conducts voluntary peer review and accreditation of animal care and use programs. It stresses application of performance standards and professional judgment, rather than inspection and engineering standards.
  99. 51. Que. What publication is used to help assure the ethical and humane treatment of farm animals used in agricultural research?
    Ans. �The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching� (aka �Ag Guide�)
  100. 52. Que. True or False: AAALAC wrote and continually revises the Ag Guide.
    Ans. False. The Federation of Animal Science Societies oversees the writing and revision of the Ag Guide. AAALAC uses the Ag Guide for relevant program assessment and accreditation purposes.
  101. 53. Que. What international organization, in 1985, was responsible for developing the �International Guiding Principles for Biomedical Research Involving Animals�.
    Ans: Council for International Organizations of Medical Sciences (CIOMS).
  102. 54. Que. What governmental agency regulates the importation of all animals and animal derived materials that could represent a disease risk to United States
    • livestock.
    • Ans. US Department of Agriculture (USDA), APHIS, Veterinary Services (VS), Import-Export Products Staff.
  103. 55. Que. List the 3 main facts of information that a health certificate designates.
    Ans. (1) clinical health; (2) exposure to or inoculation with infectious agents; and (3) virus-free origin
  104. 56. Que. Which of the following species requires a 60-day quarantine ? Why ?
    Ans. horses; African horsesickness
  105. 57. Que. Which APHIS agency regulates the importation of plants and other vegetable matter ?
    Ans. PPQ (Plant Protection and Quarantine)
  106. 58. Que. Which government agency and office regulates the importation of nonhuman primates?
    Ans. CDC, Office of Health and Safety
  107. 59. Que. What is the minimum CDC-imposed quarantine period for receipt of imported nonhuman primates shipped to an institution or registered organization on arrival in the United States?
    Ans. 31 days
  108. 60. Que. Which agency enforces the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)? To what species does it apply?
    Ans. Department of the Interior, US Fish and Wildlife Service (FWS )- applies to all designated vertebrate and invertebrate animal or plant species, dead or alive, and any recognizable part of a designated animal.
  109. 61. Que. What species are protected under the Endangered Species Act? Is a permit required to use these species for scientific research?
    Ans. Birds, insects, fish, reptiles, mammals, crustaceans, flowers, grasses and trees. Yes, a permit is required to use these species for research.
  110. 62. Que. What regulation is responsible for spelling out the conditions of transport and package and container labeling for live wildlife when transported in interstate and foreign commerce?
    Ans. The Lacey Act
  111. 63. Que. What government agency is responsible for licensing, distribution and sale of pesticides requiring registration of users and certification of applicators? What legislation does this agency enforce?
    Ans. Environmental Protection Agency; the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
  112. 64. Que. ___________ enacted in 1970 is administered and enforced by the Department of Labor, Occupational Safety and Health Administration (OSHA).
    Ans. Occupational Safety and Health Act-provides workers with protection against illnesses or injury resulting from unsafe or unsanitary working conditions.
  113. 65. Que. ___________ within the Center for Disease Control was established by the Occupational Safety and Health Act.
    Ans. National Institute for Occupational Safety and Health (NIOSH)-plans, directs, and coordinates national programs to develop and establish recommended occupational safety and health standards and to conduct research, training, and related activities to assure safe and healthful working conditions.
  114. 66. Que. ___________ enacted in 1976, authorizes the Environmental Protection Agency to require testing of chemical substances entering the environment and to regulate them as necessary.
    Ans. Toxic Substances Control Act (TSCA)
  115. 67. Que. What chemicals are exclusively exempt from the Toxic Substance Control Act (TCSA) but regulated elsewhere?
    Ans. pesticides, food, food additives, drugs, and cosmetics
  116. 68. Que. Who is responsible for enforcement of the Drug Enforcement Act (This law requires appropriate security and record management of controlled substances that are considered to be potentially addictive or habituating for human and animal use)?
    Ans. Drug Enforcement Administration of the Department of Justice
  117. 69. Que. ___________ enacted in 1954, authorizes the Nuclear Regulatory Commission (NRC) to help assure that the civilian use of radioactive materials is conducted in a manner consistent with public health and safety, environmental quality, national security, and antitrust laws.
    Ans. Atomic Energy Act
  118. 70. Que. In 1974, the Nuclear Regulatory Commission (NRC) became an independent regulatory agency under the provision of ___________ .
    Ans. Energy Reorganization Act
  119. 71. Que. The Radiation Control for Health and Safety Act, enacted in 1968, authorizes the ___________, through the Food and Drug Administration, to regulate the use of products that produce radiation, such as medical diagnostic imaging equipment, irradiators, and electron microscopes.
    Ans. Secretary of Health and Human Services
  120. 72. Que. According to the �Guidelines for Research Involving Recombinant DNA Molecules� in the Federal Register, the Department of Health and Human Services defines Recombinant DNA as ___________.
    Ans. (1) molecules that are constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate inside a living cell or (2) DNA molecules that result from the replication of these altered molecules.
  121. 73. Que. Experiments involving recombinant DNA have been divided in to _____ classes
    Ans. 4
  122. 74. Que. The institution must appoint an Institutional Biosafety Committee (IBC) that must have and least _____ members who have experience in recombinant DNA technology, biosafety, and physical containment, with at least _____ members not affiliated with the institution representing the general interest of the surrounding community.
    Ans. 5, 2
  123. 75. Que. The institution must appoint a Biosafety Officer (BSO) if it engages in research at the Biosafety Level _____ or Biosafety Level _____ containment level.
    Ans. 3, 4
  124. 76. Que. What is CITES?.
    Ans. Convention on International Trade in Endangered Species (of Wild Fauna and Flora) http://international.fws.gov/cites/cites.html
  125. 77. Que. With regard to the Institutional Biosafety Committee (IBC), the Biosafety Officer (BSO) is responsible for __________ and the principal investigator is responsible for __________.
    • Ans. BSO-responsible for monitoring the facilities and practices to assure compliance and for reporting to and serving on the IBC.
    • PI- responsible for assuring compliance with the guidelines and must request approval of the research and report any problems to he IBC.

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