LAT 02: Policies and Guidelines and Regulations in Animal Research (2021

LAT

Animal Welfare Regulations (AWR)

Rules established by the USDA to enforce the AWA

What does APHIS stand for?

Animal and Plant Health Inspection Service, a branch of the USDA that administers the AWR.

What are Class A Dealers?

Animal dealers who raise and sell their own animals, known as purpose-bred.

What are Class B Dealers?

Dealers who purchase and resell animals, including random-source dogs and cats.

How many categories are there in the United States Department of Agriculture (USDA) pain descriptions?

4

USDA permits routine vaccinations of a group of animals to be documented in herd health records.

True / False?

True

A research institution is required to confer full authority to the attending veterinarian to ensure appropriate veterinary care.

True / False?

True

An IACUC's semiannual review of the research program's policies and procedures includes which of the following?

A. Husbandry practices

B. Issues raised during the timeframe of the report

C. Occupational health requirements

D. Personnel training

E. All of the Above

E. All of the Above

Which mandate includes the full text of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training?

A. Animal Welfare Regulations

B. Animal Welfare Act

C. Guide for The Care and Use of laboratory Animals

D. PHS Policy on Humane Care and Use of Laboratory Animals

E. All of the Above

E. All of the Above

The AWA and the PHS Policy cover the exact same species of animals.

True / False?

False

AWA COVERS - Warm-blooded vertebrate animals, live or dead, excluding birds, rats, and mice bred for research; horses not used to research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber.

PHS COVERS - All live vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

Although not a regulation, the Guide for the Care and Use of Laboratory Animals must be followed for research with animals covered by which mandate?

Public Health Service (PHS)

The Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide) is a required mandate for which entities?

USDA for enforcement of the AWA and AAALAC International for accreditation

In the Guide, which word is defined as indicating essential or imperative aspects for the proper humane care and use of lab animals?

Must

In the Guide, which word is used to describe aspects of an animal care program that are strong recommendations for achieving a goal?

Should

In the Guide, which word is used to indicate a suggestion to be considered?

May

What does AVMA stand for?

American Veterinary Medical Association

What describes an ideal euthanasia agent?

A. Rapidly induces loss of consciousness.

B. Lacks hazards for the personnel administering it.

C. Induces death quickly.

D. All of the Above

D. All of the Above

Permits may be necessary from which of the following agencies to import or ship animals for research, depending on the animals’ species and their health status?

A. USDA Animal and Plant Health Inspection Service

B. Centers for Disease Control and Prevention

C. US Fish and Wildlife

D. All of the Above

D. All of the Above

What are the import requirements for laboratory rodents?

1. The necessary export documents and proper identification are provided.

2. Animals are shipped from the country of origin.

3. The animals enter the United States through designated ports of entry.

4. The animals appear healthy.

Dogs, cats, and nonhuman primates must be accompanied by a health certificate stating that the animals have been recently examined by a veterinarian and are healthy?

True / False?

True

What does CITES stand for?

Convention on International Trade in Endangered Species of Wild Fauna and Flora

Why was CITES implemented?

CITES was implemented to prevent the endangerment / extinction of species due to international trade of animals and their tissues.

What is CITES?

CITES is an agreement between countries which provides a framework for the member countries to create legislation within the individual countries.

What does ESA stand for?

Endangered Species Act

Who is responsible for enforcing the Endangered Species Act (ESA)?

United States Fish and Wildlife Service (FWS)

What does FWS stand for?

United States Fish and Wildlife Service

Who is responsible for overseeing the importation of animals and animal tissues capable of causing human disease into the United States? Centers for Disease Control and Prevention (CDC)

Centers for Disease Control and Prevention (CDC)

What does CDC stand for?

Centers for Disease Control and Prevention

What gives guidance on creating and implementing an institutional occupational health and safety program?

Occupational Health and Safety in the Care and Use of Research Animals (Occ Health)

What has recommendations for the safe handling and containment of infectious microorganisms and potentially hazardous biological materials in a laboratory setting.

Biosafety in Microbiological and Biomedical Laboratories (BMBL)²² and published by the CDC in partnership with the NIH.

What does BMBL stand for?

Biosafety in Microbiological and Biomedical Laboratories

In the context of biosafety, biosecurity means the protection of what?

Microbial agents from loss, theft, diversion, or intentional misuse

What identifies the four categories of risk associated with infectious agents used in laboratories(BSL-1 to BSL-4) as well as describes a similar set of categories for Animal Biosafety (ABSL-1 to ABSL-4) ?

The BMBL

In the context of the laboratory animal field, biosecurity means the protection of what?

An animal colony from microbial contamination

Which two federal entities enforce Good Laboratory Practice regulations?

1. Food and Drug Administration(FDA)

2. Environmental Protection Agency(EPA)

How often does the Guide specify that IACUC must review the entire animal care and use program?

at least once a year

What is the agreement from a research institute outlining how it complies with the PHS policy?

Animal Welfare Assurance

What does OLAW stand for?

Office of Laboratory Animal Welfare

What organization is responsible for monitoring compliance with the PHS policy?

OLAW

What animal is covered under the AWA and AWR?

A. Birds

B. Horses not used for research

C. Mice bred for use in research

D. Wild mice

D. Wild mice

What feature is required to be provided for dogs by the AWA?

an exercise program

Who can restrict or withdraw approval of the AWA if an institute fails at its responsibilities?

Office of Laboratory Animal Welfare (OLAW)

Guidance for controlling laboratory animal allergy can be found in which document?

Occupational Health and Safety in the Care and Use of Research Animals

Which statement is TRUE about a biological risk assessment?

A. Laboratory usage of the hazard does not affect its potential for risk.

B. The risk assessment should be conducted only for known infectious agents and materials.

C. Biosafety professionals determine the risk level for an agent according to the BMBL.

D. The risk assessment aims to identify the best equipment and methods for protection.

D. The risk assessment aims to identify the best equipment and methods for protection.

How does the AVMA guidelines categorize methods of euthanasia?

Acceptable, acceptable with conditions, and unacceptable

Inspectors from the USDA who inspect animal facilities are known as what?

Veterinary Medical Officers

Which feature is required to be provided for nonhuman primates by the Animal Welfare Act (AWA)?

Psychological enrichment

According to the GLPs, a _______ includes the animals or other entity that is administered a substance.

Test system

If an animal with a health condition such as diabetes is needed for a study, who can grant an exception to the requirement for a health certificate?

USDA

What determines how long GLP archives of data must be stored?

Research or marketing permit

Who developed the Animal Welfare Regulations?

USDA

Which regulatory mandate includes the full text of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training?

A. PHS Policy

B. Animal Welfare Act/Regulations

C. Animal Care Inspection Guide

D. All of the Above

D. All of the Above

Which person has the responsibility of ensuring the institution complies with the Animal Welfare Act?

A. Director of facility operations

B. IACUC Chair

C. Attending veterinarian

D. Chief executive officer

E. None of the Above

D. Chief executive officer

Who regulates the AWA for the USDA?

APHIS

How often is the USDA required to inspect registered research facilities?

Unscheduled/once a year

What is the holding period for impounded animals?

minimum of 5 days

What organization publishes the Guide?

ILAR

What does ILAR stand for?

Institute of Laboratory Animal Resources

What are the five categories for infectious agents?

BSL-1

BSL-2

BSL-3

BSL-4

BSL3-Ag

What species are covered under federal regulations?

Dogs, cats, and NHPs

What entities require facilities to follow the AVMA Guidelines of Euthanasia?

The Guide, PHS Policy, and AAALAC International