Bluebook questions Ch 2.txt

1. Que. What was the original name of the U.S. Animal Welfare Act?

2. Que. What year did the first legislation protecting animals in research pass?

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?

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?

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?

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?

7. Que. Within the USDA, the Animal Welfare Act is administered through which organization?

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?

9. Que. Which animals, regardless of intended use, are specifically excluded from the AWA?

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?

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?

12. Que. How often must research facilities, intermediate handlers, and common carriers of regulated species register with the USDA?

13. Que. How often must the IACUC review the research facility�s program for humane care and use of animals, based on USDA regulations?

14. Que. What is the minimum number of people that can be on an IACUC according to the AWA?

15. Que. Which healthcare professional must be a member of the IACUC according to the AWA?

16. Que. How often must the IACUC conduct an inspection of all animal study areas and animal facilities?

17. Que. Which type of deficiencies are defined as those that threaten animal health or safety, must be distinguished from minor deficiencies

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?

19. Que According to the USDA, records that relate directly to activities approve by the IACUC must be maintained for how long?

20. Each facility must submit an annual report to whom and when?

21. Que. According to the USDA, dogs over what age must be provided with the opportunity for exercise?

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?

25. Que. How often must a new assurance be submitted to the Office of Laboratory Animal Welfare?

26. Que. The PHS Policy requires that euthanasia of animals be conducted in accordance with which �report�?

27. Que. How many IACUC members are required by PHS ppolicy?

28. Que. PHS Policy requires that records of IACUC activities (e.g. meeting minutes, semiannual program reports, etc) must be maintained for how long?

29. Que. PHS Policy requires that records of IACUC-approved activities (protocols, etc) be maintained for how long?

30. Que. How often must the IO (institute Official), acting on behalf of the IACUC, report to OLAW according to PHS policy?

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?

32. Que. In 1995, authorized representatives of what three governmental organizations signed a Memorandum of Agreement concerning Laboratory Animal Welfare?

33. Que. What governmental agency is responsible for the registration and control of pesticides?

34. Que. What specific legislative Act, enacted in 1947, authorizes the administrator of the EPA to register and control the use of pesticides?

35. Que. What specific legislative Act governs the use of GLP standards for conducting GLP-regulated chemical studies?

36. Que. What does ILAR stand for?

37. Que. Who is the publisher of �The Guide�?

38. Which 2 major organizations recognize The Guide as the standard reference on laboratory animal care and use programs?

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.

40. Que. What does AAALAC International stand for?

41. Que. What publication is used to help assure the ethical and humane treatment of farm animals used in agricultural research?

42. Que. What international organization, in 1985, was responsible for developing the �International Guiding Principles for Biomedical Research Involving Animals�?

43. Que. What governmental agency regulates the importation of all animals and

44. Why do horses require a 60 day quarantine upon importation?

45. Que. Which APHIS agency regulates the importation of plants and other vegetable matter?

46. Which government agency and office regulates the importation of nonhuman primates?

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?

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?

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?

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?

51. Que. What agency provides workers with protection against illnesses or injury resulting from unsafe or unsanitary working conditions?

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?

53. Which act authorizes the Environmental Protection Agency to require testing of chemical substances entering the environment and to regulate them as necessary?

54. What chemicals are exclusively exempt from the Toxic Substance Control Act (TCSA) but regulated elsewhere?

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)?

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?

57. Que. What is CITES?

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.

2. Que. The law requires USDA to inspect each research facility at least once each _____.

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.

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.

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 ___________________________.

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.

7. Que. A new assurance must be submitted to the Office of Laboratory Animal Welfare at least every ____ years.

8. Que. The PHS Policy implements the ________________________________, developed by the Interagency Research Animal Committee.

9. Que. The PHS Policy requires that euthanasia of animals be conducted in accordance with the _________________________________________.

10. Que. What policy implements the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training?

11. Que. How many �US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training� are there?

12. Que. Unlike the Animal Welfare Act, the PHS Policy requires that the IACUC consist of ___________ members.

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 ___________.

14. Que. PHS Policy requires that records of IACUC activities (e.g. meeting minutes, semiannual program reports, etc) must be maintained for ____________.

15. Que. PHS Policy requires that records of IACUC-approved activities (protocols, etc) be maintained for _____________.

16. Que. PHS Policy requires that the IACUC report to OLAW, through the Institutional Official, _______________.

17. Que. Good Laboratory Practice regulations became effective _________and were amended ___________.

18. Que. What four types of studies are not covered by GLP regulations?

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.

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.

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.

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?

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?

24. Que. In 1995, authorized representatives of what three governmental organizations signed a Memorandum of Agreement concerning Laboratory Animal Welfare?

25. Que. What governmental agency is responsible for the registration and control of pesticides?

26. Que. What specific legislative Act, enacted in 1947, authorizes the administrator of the EPA to register and control the use of pesticides?

27. Que. What specific legislative Act governs the use of GLP standards for conducting GLP-regulated chemical studies?

28. Que. What does ILAR stand for?

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 ______________.

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?

31. Que. The NRC has eight major program units or offices, including the _____________ (CLS), under which ILAR is located.

32. Que. ILAR is governed by a ____________ (number)-member council of experts in laboratory animal medicine, other science disciplines, and ethics.

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 �__________.�

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.

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.

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?

37. Que. Which organization maintains a large database of commercial and investigator-held unique animal models?

38. Que. Which organization maintains an international registry of laboratory registration codes on behalf of the International Committee on Standardized Genetic Nomenclature for Mice?

39. Que. What does AAALAC International stand for?

40. Que. True or False: AAALAC is a funded principally by government research monies.

50. Que. What are AAALAC�s primary roles?

51. Que. What publication is used to help assure the ethical and humane treatment of farm animals used in agricultural research?

52. Que. True or False: AAALAC wrote and continually revises the Ag Guide.

53. Que. What international organization, in 1985, was responsible for developing the �International Guiding Principles for Biomedical Research Involving Animals�.

54. Que. What governmental agency regulates the importation of all animals and animal derived materials that could represent a disease risk to United States

55. Que. List the 3 main facts of information that a health certificate designates.

56. Que. Which of the following species requires a 60-day quarantine ? Why ?

57. Que. Which APHIS agency regulates the importation of plants and other vegetable matter ?

58. Que. Which government agency and office regulates the importation of nonhuman primates?

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?

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?

61. Que. What species are protected under the Endangered Species Act? Is a permit required to use these species for scientific research?

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?

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?

64. Que. ___________ enacted in 1970 is administered and enforced by the Department of Labor, Occupational Safety and Health Administration (OSHA).

65. Que. ___________ within the Center for Disease Control was established by the Occupational Safety and Health Act.

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.

67. Que. What chemicals are exclusively exempt from the Toxic Substance Control Act (TCSA) but regulated elsewhere?

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)?

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.

70. Que. In 1974, the Nuclear Regulatory Commission (NRC) became an independent regulatory agency under the provision of ___________ .

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.

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 ___________.

73. Que. Experiments involving recombinant DNA have been divided in to _____ classes

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.

75. Que. The institution must appoint a Biosafety Officer (BSO) if it engages in research at the Biosafety Level _____ or Biosafety Level _____ containment level.

76. Que. What is CITES?.

77. Que. With regard to the Institutional Biosafety Committee (IBC), the Biosafety Officer (BSO) is responsible for __________ and the principal investigator is responsible for __________.