Chapter 5 Managing Compliance

Question 1

Which of the following is NOT a requirement that is found in the Animal Welfare Act and ts amendments?

Answer 1

Young animals may not be used in research before they are weaned.

Question 2

Birds bred for research are NOT presently covered under the Animal Welfare Act.

Answer 2

True

Question 3

The IACUC has an obligation to identify whistle blowers who report possible animal abuse or neglect so they can receive recognition from the institution.

Answer 3

False

Question 4

USDA does not require that IACUC meeting minutes be recorded.

Answer 4

False

Question 5

Which of the following are mandated by the Animal Welfare Act?

Answer 5

• Establishment of an IACUC
• Information on how to report deficiencies in animal care
• Training of all animal care personnel

Question 6

Amphibians, reptiles, and fish are exempt from coverage under th Animal Welfare Act.

Answer 6

True

Question 7

What needs to be specifically addressed in the required plan for environmental enhancement for nonhuman primate?

Answer 7

• Social grouping

- Restraint devices

Question 8

Research facilities using regulated species must register with USDA and the registration must be updated every year.

Answer 8

False

Question 9

Which agency is authorized to develop regulations based on the Animal Welfare Act?

Answer 9

Animal Plant and Health Inspection Service

Question 10

Which of the following applies to semiannual inspections conducted by the IACUC?

Answer 10

The IACUC can use the Guide as the basis for the inspeciton

Question 11

Rats and mice bred for research are covered under the PHS policy.

Answer 11

True

Question 12

OLAW requires that institutions submit an assurance document affirming that they will comply with all the PHS Policy requirements.

Answer 12

True

Question 13

The AWA Regulations and PHS Policy both require that the IACUC conduct semiannual inspection of all areas where live animals are housed or used.

Answer 13

True

Question 14

Freedom of Information Act information requests are sent to the institutions.

Answer 14

False

Question 15

Which of the following is an authority granted to USDA APHIS inspectors?

Answer 15

• To make copies of documents in the facility that are required by the regulations
• To require euthanizing an animal if it is determined that the animal is suffering as a result of noncompliance
• To take photographs of areas of noncompliance

Question 16

Which group(s) has/have a right to conduct unannounced inspections of the animal facility?

Answer 16

USDA APHIS personnel

-DEA personnel

Question 17

USDA APHIS inspectors are NOT allowed to take photographs while inspecting a facility.

Answer 17

False

Question 18

USDA APHIS inspectors have the authority to make copies of required records kept in the facility.

Answer 18

True

Question 19

Which statement is FALSE regarding staff responsibilities during a USDA inspection?

Answer 19

Inspectors should be provided as much information as possible

Question 20

USDA inspections may be conducted in response to public complaints

Answer 20

True

Question 21

All regulations regarding obtaining, storing, and disposing of controlled substances are federal statues.

Answer 21

False

Question 22

Many drugs used for analgesia and tranquilization are controlled substances.

Answer 22

True

Question 23

In addition to federal regulations, there are local and state regulations that need to be followed.

Answer 23

True

Question 24

GLPs describe the training requirements for personnel involved in covered studies

Answer 24

True

Question 25

Which group of compounds falls within the scope of GLPs.

Answer 25

Biological products Veterinary drugs Food and color additives

Question 26

Nonclinical studies of the effect of pesticides on the embryonic development of fish would fall under the GLPs regulations

Answer 26

True

Question 27

An intent of the GLPs is to ensure that studies can be reconstructed accurately if they need to be repeated.

Answer 27

True

Question 28

Which regulatory agency codifies GLPs for laboratory studies?

Answer 28

- Food and Drug Administration - Organization for Economic Co-operation and Development - Environmental Protection Agency

Question 29

The Centers for Disease Control is one of the agencies that regulates the care and welfare of research animals

Answer 29

False

Question 30

The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control

Answer 30

True

Question 31

Which agency has regulations or guideline that regulate the transportation of animals?

Answer 31

- US Department of Transportation - Food and Drug Administration - US Fish and Wildlife Service

Question 32

There are federal regulations that set limits on noise exposure in the animal facility

Answer 32

True

Question 33

Under no circumstances can a manufacturer withhold information about a potentially hazardous material

Answer 33

False

Question 34

The Nuclear Regulatory Commission regulates use of nuclear materials for medical and academic uses through regulations, licensing, and safety oversight.

Answer 34

True

Question 35

Where is low-level waste generally stored?

Answer 35

On site

Question 36

The Radiation Safety Officer must monitor the exposure level of all employees who work with low-level radiation sources

Answer 36

True

Question 37

Which office has regulations which relate to medical waste?

Answer 37

- Department of Transportation Office of Hazardous Materials Safey - US Postal Service - Food and Drug Administration

Question 38

All medical waste should be considered infectious.

Answer 38

False

Question 39

The Centers for Disease Control may perform biosafety and biosecurity inspections of registered facilities

Answer 39

True

Question 40

Which publication describes microbiological practices?

Answer 40

Biosafety in Microbiological and Biomedical Laboratories

Question 41

A post-approval monitoring (PAM) program provides review before a study has been started

Answer 41

False

Question 42

When responding to a reported noncompliance, the IACUC:

Answer 42

- can work with the researcher to establish a plan - may elect to suspend a protocol to protect animal welfare - should begin a process of information gathering

Question 43

The IACUC may be made aware of noncompliance through the post-approval monitoring program

Answer 43

True

Question 44

Noncompliance can lead to citations and major financial penalties against the institution through enforcement action by regulatory agencies.

Answer 44

True

Question 45

Which of the following is often referred to as the Worker Right-to-know legislation?

Answer 45

OSHA's Hazard Communication Standard

Question 46

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?

Answer 46

Schedules 2 through 5

Question 47

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?

Answer 47

The regulatory documents

Question 48

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?

Answer 48

Guide for the Care and Use of Laboratory Animals

Question 49

Which of the following statements best apply to Good Laboratory Practices regulations?

Answer 49

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

Question 50

Which statement is FALSE regarding post-approval monitoring programs?

Answer 50

There are many state regulations with specific requirements for post-approval monitoring programs.

Question 51

Which of the following is often referred to as the Worker Right-to-know legislation?

Answer 51

OSHA's Hazard Communication Standard

Question 52

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?

Answer 52

Schedules 2 through 5

Question 53

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?

Answer 53

The regulatory documents

Question 54

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?

Answer 54

Guide for the Care and Use of Laboratory Animals

Question 55

Which of the following statements best apply to Good Laboratory Practices regulations?

Answer 55

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

Question 56

Which statement is FALSE regarding post-approval monitoring programs?

Answer 56

There are many state regulations with specific requirements for post-approval monitoring programs.