Chapter 5 Managing Compliance

Question 1

which animals must have a written plan for psychological enrichment?

Answer 1

nonhuman primates

Question 2

how often must the IACUC conduct animal care and use program reviews?

Answer 2

semiannually

Question 3

per the Controlled Substances Act, controlled substances are classified into ____schedules, with schedule _____ being the least addictive.

Answer 3

five

V

Question 4

which agency controls the receipt, possession, use, transfer, and disposal of licensed nuclear material?

Answer 4

Nuclear Regulatory Commission

Question 5

blood-soaked bandages are an example of what type of waste?

Answer 5

medical waste

Question 6

how often is the research facility’s registration with the USDA updated?

Answer 6

every 3 years

Question 7

what Act regulates drugs that have the potential to be addictive?

Answer 7

Controlled Substances Act

Question 8

t or f: mice of the genera Mus that are bred for research are not covered by the Animal Welfare Act.

Answer 8

true

Question 9

t or f: if the procedure on an animal will be terminal, expired drugs may be used.

Answer 9

false. expired drugs may not be used in live animals.

Question 10

t or f: all staff may be questioned by USDA/IACUC/AAALAC inspectors.

Answer 10

true

Question 11

Which agency requires that every research facility must establish an Institutional Animal Care and Use
Committee?
a. United States Department of Agriculture
b. Food & Drug Administration
c. American Veterinary Medical Association
d. AAALAC International

Answer 11

a. United States Department of Agriculture

Question 12

How often should a research facility using regulated species update their USDA registration?

a. Every year
b. Every 2 years
c. Every 3 years
d. Every 5 years

Answer 12

c. Every 3 years

Question 13

Which publication provides additional clarifications and guidance in support of the Animal Welfare Act?
a. Animal Care Policy Manual
b. Guide for the Care and Use of Laboratory Animals
c. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training
d. AVMA Guidelines for the Euthanasia of Animals

Answer 13

a. Animal Care Policy Manual

Question 14

What is the minimum time period that all USDA reports and records must be kept after completion of
the study?
a. 1 year
b. 3 years
c. 5 years
d. As long as those animal species are present in the facility.

Answer 14

b. 3 years

Question 15

Which statement correctly describe the PHS assurance?

a. It must be approved by AAALAC before any research is conducted in the facility.
b. It must be renewed every year.
c. It must describe the essential components of an institution’s animal care and use program.
d. It is optional for institutions that house rodents only.

Answer 15

c. It must describe the essential components of an institution’s animal use and care program.

Question 16

To be compliant with OLAW, what document should be the basis of the IACUC review of the institution’s
program for the use and care of animals?
a. Guide for the Care and Use of Laboratory Animals
b. Guidelines for Ethical Conduct In the Care and Use of Animals
c. Animal Welfare Act
d. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training

Answer 16

a. Guide for the Care and Use of Laboratory Animals

Question 17

Which organization accredits research institutions that meet national laws and guidelines?

a. American Association for Laboratory Animal Science
b. AAALAC International
c. Office of Laboratory Animal Welfare
d. United States Department of Agriculture

Answer 17

b. AAALAC

Question 18

Semiannual inspections conducted by the IACUC should:

a. be limited to a physical inspection of areas where animals are housed.
b. use the Guide for the Care and Use of Laboratory Animals as the basis for the inspection.
c. inspect only those areas where NIH-supported research is conducted.
d. All of the above

Answer 18

b. use the Guide for the Care and Use of Laboratory Animals as the basis for the inspection.

Question 19

Which requirement is part of the IACUC inspection criteria?

a. All records required by the AWA and PHS must be available for review.
b. The institution’s Occupational Health and Safety office must be inspected for copies of all SOPs.
c. Breeding operations of vendors supplying animals for the research program must be inspected.
d. All of the above

Answer 19

a. All records required by the AWA and PHS must be available for review.

Question 20

According to PHS, all animals should be housed in a manner that ____________ and _____________.
a. provides them with companionship; allows them to interact with others of the same species
b. facilitates the expression of species-specific behavior; minimizes stress-induced behaviors
c. provides them with mental and physical stimulation; promotes the expression of colony
behaviors
d. mimics natural conditions; optimizes dominance-submission hierarchies

Answer 20

b. facilitates the expression of species-specific behavior; minimizes stress-induced behaviors

Question 21

Which of the following groups have regulatory authority to conduct unannounced inspections of the
animal facility?
a. IACUC and USDA personnel
b. AAALAC
c. Accredited members of the media
d. Any community group who submits a written request to perform an inspection

Answer 21

a. IACUC and USDA personnel

Question 22

How often do USDA APHIS personnel make unannounced inspections of a research facility?

a. At least every 6 months
b. At least once a year
c. Once every 3 years
d. Each time a new grant is funded

Answer 22

. b. At least once a year

Question 23

USDA APHIS inspectors have the authority to:
a. have an animal euthanized if they determine that the animal is suffering as a result of
noncompliance.
b. take photographs of areas of noncompliance.
c. make copies of required records in the facility.
d. All of the above

Answer 23

. d. All of the above

Question 24

Which step is recommended in managing inspections?

a. Develop an SOP outlining the process to follow for an inspection.
b. Identify the people on the staff who will be authorized to answer the inspectors’ questions.
c. Limit the amount of time inspectors spend in each area of the facility.
d. All of the above

Answer 24

a. Develop an SOP outlining the process to follow for an inspection.

Question 25

The US Drug Enforcement Administration has how many schedules of controlled substances? a. Two b. Three c. Four d. Five

Answer 25

d. Five

Question 26

``` A substance that is classified as a Schedule I controlled substance has _____ potential for addiction than one that is in Schedule III. a. a greater b. a lesser c. an equal d. no difference in ```

Answer 26

a. a greater

Question 27

What is a good reference for those who are responsible for managing controlled substances? a. Guide for the Care and Use of Laboratory Animals b. DEA’s Practitioner’s Manual c. PHS Policy d. Animal Welfare Act

Answer 27

. b. DEA’s Practitioner’s Manual

Question 28

Which statement best applies to Good Laboratory Practices regulations? a. They apply to studies of the effect of inorganic compounds on animal subjects. b. They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment. c. They apply to studies that are done on nonhuman primates that have the potential to cause pain and distress. d. They must be applied only under supervised conditions in registered institutions.

Answer 28

b. They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.

Question 29

Which group of compounds falls within the scope of the Good Laboratory Practices regulations? a. Veterinary drugs b. Food and color additives c. Biological products d. All of the above

Answer 29

. d. All of the above

Question 30

Providing each staff member with specific training regarding Good Laboratory Practices is the responsibility of the institution’s: a. biosafety office. b. quality assurance unit. c. human resources office. d. occupational health and safety office.

Answer 30

b. quality assurance unit.

Question 31

Which of these agencies have regulations or guidelines that regulate the transportation of animals? a. Food & Drug Administration b. US Department of Transportation c. US Fish and Wildlife Service d. All of the above

Answer 31

. d. All of the above

Question 32

Which of these international organizations has developed standards and guidelines to help prevent the transmission of zoonoses via the importation of animals? a. International Air Transportation Association b. Convention on International Trade in Endangered Species c. World Organisation for Animal Health d. European Union

Answer 32

c. World Organisation for Animal Health

Question 33

Which of the following is NOT part of the Hazard Communication Standard guidelines and requirements? a. All chemicals in the workplace must be labeled. b. Employers must maintain a list of all hazardous chemicals used in the workplace. c. The amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less. d. Employees must receive training in the handling of hazardous materials and the interpretation of MSDS.

Answer 33

. c. The amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less.

Question 34

What agency has regulations that control the receipt, possession, use, transfer, and disposal of nuclear materials? a. National Radiation Control Office b. Nuclear Regulatory Commission c. Occupational Health and Safety Administration d. Office of Hazardous Materials Safety

Answer 34

. b. Nuclear Regulatory Commission

Question 35

Where is low-level radioactive waste generally stored? a. On site in the institution b. In state-controlled waste holding facilities c. In regional military facilities d. None of the above

Answer 35

a. On site in the institution

Question 36

Medical waste does NOT include which of the items listed below? a. Blood-soaked bandages b. Swabs used to inoculate cultures c. Organs of animals used in research d. Mops used to wash floors in quarantine rooms

Answer 36

d. Mops used to wash floors in quarantine rooms

Question 37

Most regulated medical waste is generally regulated at the _______ level. a. facility b. institutional c. state and local d. federal

Answer 37

c. state and local

Question 38

Which agency has some regulations that relate to medical waste? a. Department of Transportation Office of Hazardous Materials Safety b. Food and Drug Administration c. The US Postal Service d. All of the above

Answer 38

d. All of the above

Question 39

What method of disposal is most generally used for medical waste? a. Burial in landfills b. Incineration c. Disinfection in autoclaves followed by disposal as regular waste d. Long-term storage in sealed containers until all living organisms have been killed

Answer 39

b. Incineration

Question 40

The USDA, through _____ is required to inspect animal facilities _____. a. FDA; semi-annually b. APHIS; annually c. NIH; semi-annually d. PHS; annually

Answer 40

b. APHIS; annually

Question 41

Which of the following is a requirement included in the 1985 amendment to the Animal Welfare Act? a. Dogs must have at least one chew toy in each pen. b. Dogs must be bathed once a week. c. Dogs must be given the opportunity to exercise. d. Dogs must have a regular opportunity for socialization with people.

Answer 41

c. Dogs must be given the opportunity to exercise.

Question 42

What addition was made to the Animal Welfare Act in the 1985 amendments regarding the care of nonhuman primates? a. They must have an adequate environment for psychological well-being. b. Lights must be kept on at least 14 hours per day for maintaining physiological cycles. c. They must be given 2 fruits per day for nutritional and environmental enrichment. d. They must have regular one-to-one interaction with humans for social adjustment.

Answer 42

a. They must have an adequate environment for psychological well-being.

Question 43

What type of training is NOT required by the Animal Welfare Act? a. Training in how to report animal care deficiencies b. AALAS certification training c. Training in humane animal restraint d. Training in research or testing methods that minimize or eliminate the use of animals

Answer 43

b. AALAS certification training

Question 44

Which standard reflects what USDA inspectors look for during an inspection? a. That professionally accepted standards of care are followed in the facility. b. That compliance is maintained with the PHS Policy. c. That scientific standards are used in the conduct of animal studies. d. That facility staffing levels correspond with the workload in animal care.

Answer 44

a. That professionally accepted standards of care are followed in the facility.

Question 45

``` 5. During their inspection, IACUC members will want to see documentation showing that warm-blooded animals are observed how often? a. Every day b. Twice a day c. At least weekly d. Twice a week ```

Answer 45

a. Every day

Question 46

During USDA inspections, facilities must demonstrate compliance with provisions of which federal regulations? a. Good Laboratory Practice regulations b. Animal Welfare Act c. Guide for the Care and Use of Laboratory Animals d. PHS Policy

Answer 46

. b. Animal Welfare Act

Question 47

The AWA amendments of 1985 require that enrichment be provided to promote psychological wellbeing of which of the following species? a. Primates b. Rodents c. Aquatic species d. Horses

Answer 47

a. Primates