LATG Ch. 5 Managing Compliance

Question 1

Animal Welfare Act

Answer 1

-Passed congress in 1966;
-amended 8 times
-Authorizes USDA to develop regulations
-Requires facilities to submit a report with pain categories
-Whistleblower concerns
-Standards for humane transport of animals.
Establish an IACUC

Question 2

USDA and APHIS (Animal and plant health inspection service)

Answer 2

Administers the AWA Regulations and standards based on AWA

-published animals care policy

Question 3

1985 Amendment to AWA

Answer 3

Require research facility to establish a IACUC

• Dog exercise
• Enrichment for NHPs

Question 4

USDA/ APHIS

Answer 4

• Publishes animal care policy manual with 18 policies;
• Update USDA registration for regulated species every 3 years
• Maintain records for 3 years

Question 5

Veterinary care

Answer 5

all care for animals, SX, Pharmacy

Question 6

NX

Answer 6

USDA may require a facility perform nx

Question 7

NHP brackiating

Answer 7

Adequate enclosures and space to meet needs of species

Question 8

Activities requiring a license

Answer 8

Clarification on licensing of producers of antibodies, sera, genetically modified

Question 9

IACUC

Answer 9

Institutional official
IACUC chairperson
Vet
Nonaffiliate member

Question 10

Health certificates

Answer 10

Higher species: issued 10 days before shipment

Question 11

PHS policy on humane care and use of lab animals

Answer 11

applies to all research, testing, and educational activities supported or conducted by PHS agency with NIH and CDC.
-standards for the species (mice, rats, and birds) that are excluded by the AWA

Question 12

OLAW (Office of lab animal welfare) at NIH

Answer 12

Enforces PHS policy

-NIH office that oversees compliance with the PHS policy

Question 13

PHS requires conformity to

Answer 13

The guide; US gov. principles for the utilization and care of vertebrate species
AWRegu.
AVMA on euth.

Question 14

Document reports required by OLAW

Answer 14

Animal welfare assurance: insitutions animal care and use program and that it complies with PHS; must be approved by OLAW before animal use; Valid for up to 5 years
Semiannual program and facility report: AICUC mandated to review at leave every 6months (inspections)

Question 15

OLAW records

Answer 15

Maintained for 3 years and retained for 3 years

Question 16

IACUC inspections

Answer 16

Every 6 months

Question 17

USDA; DEA

Answer 17

Unannounced visits yearly

Question 18

AAALAC

Answer 18

Association for Assessment and Accreditation of Laboratory Animal Care; accreditation is good for 3 years

Question 19

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

Answer 19

True Agencies do not copy or remove the materials from the research facilities’ premises unless there is an alleged violation under investigation or enforcement.

Question 20

CDC

Answer 20

does not regulate animal welfare; monitors importation of animals

Question 21

animal care policy manual

Answer 21

USDA publication clarified the intent of AWA

Question 22

Class of controlled substance

Answer 22

Most additive class I > class II > Class III> Class IV > Class V

Question 23

US Fish and wildlife

Answer 23

Issues permits for import and export of animals

Question 24

Agreement state

Answer 24

Administers licensees of nuclear material

Question 25

PHS assurance resubmitted

Answer 25

every 5 years

Question 26

Animal and physical plant chapt of semiannual program and facility review must file with OLAW how

Answer 26

A semiannual inspection

Question 27

Not accessible through FOIA

Answer 27

Husbandry logs

Question 28

FOIA

Answer 28

freedom of information act

Question 29

Which step is recommended in managing inspections?

Answer 29

Develop an SOP outlining the process to follow for an inspection