LATG Ch. 5 Managing Compliance Flashcards
Managing Compliance
Animal Welfare Act
-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
USDA and APHIS (Animal and plant health inspection service)
Administers the AWA Regulations and standards based on AWA
-published animals care policy
1985 Amendment to AWA
Require research facility to establish a IACUC
- Dog exercise
- Enrichment for NHPs
USDA/ APHIS
- Publishes animal care policy manual with 18 policies;
- Update USDA registration for regulated species every 3 years
- Maintain records for 3 years
Veterinary care
all care for animals, SX, Pharmacy
NX
USDA may require a facility perform nx
NHP brackiating
Adequate enclosures and space to meet needs of species
Activities requiring a license
Clarification on licensing of producers of antibodies, sera, genetically modified
IACUC
Institutional official
IACUC chairperson
Vet
Nonaffiliate member
Health certificates
Higher species: issued 10 days before shipment
PHS policy on humane care and use of lab animals
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
OLAW (Office of lab animal welfare) at NIH
Enforces PHS policy
-NIH office that oversees compliance with the PHS policy
PHS requires conformity to
The guide; US gov. principles for the utilization and care of vertebrate species
AWRegu.
AVMA on euth.
Document reports required by OLAW
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)
OLAW records
Maintained for 3 years and retained for 3 years
IACUC inspections
Every 6 months
USDA; DEA
Unannounced visits yearly
AAALAC
Association for Assessment and Accreditation of Laboratory Animal Care; accreditation is good for 3 years
USDA APHIS inspectors have the authority to make copies of required records kept in the facility.
True Agencies do not copy or remove the materials from the research facilities’ premises unless there is an alleged violation under investigation or enforcement.
CDC
does not regulate animal welfare; monitors importation of animals
animal care policy manual
USDA publication clarified the intent of AWA
Class of controlled substance
Most additive class I > class II > Class III> Class IV > Class V
US Fish and wildlife
Issues permits for import and export of animals
Agreement state
Administers licensees of nuclear material
PHS assurance resubmitted
every 5 years
Animal and physical plant chapt of semiannual program and facility review must file with OLAW how
A semiannual inspection
Not accessible through FOIA
Husbandry logs
FOIA
freedom of information act
Which step is recommended in managing inspections?
Develop an SOP outlining the process to follow for an inspection
