The Guide (8th edition)

What are the three primary reference for AAALAC accreditation?

the Guide, Ag guide and European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS123)

What are the 9 U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

1. transportation 2. animal procedure design 3. species selection 4. proper animal use 5. analgesic, anesthesia 6. euthanasia 7. living condition 8. personnel training 9. exception/deviations

A veterinary care program is the responsibility of the _________________

attending veterinarian

Can animals be obtained from pet stores for scientific research?

Animals should not be obtained from pet stores for scientific research

Which entity updates the Live Animals Regulations annually

International Air Transport Association

Which entity set standards for interstate and export/import transportation of regulated species

Animal Welfare Regulations

Who enforce regulations to prevent the introduction, transmission, or spread of communicable diseases and regulate the importation of any animal or animal product capable of carrying a zoonotic disease

CDC and USDA

Who regulates movement of CITES-listed species that are captive bred, including nonhuman primates?

US Fish and Wildlife Service

African and Asian NHP species should be in separate room because which two pathogens?

Simian hemorrhagic fever virus and Simian Immunodeficiency Virus - subclinical in African NHP species, cause disease in Asian NHP species.

Squirrel monkeys should not be housed with owl monkeys because of which pathogen?

Squirrel monkeys and tamarins can have latent herpesvirus infection that can cause fatal disease in owl monkeys

Definition for Major survival surgery

penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement, and limb amputation) or involves extensive tissue dissection or transection.

Definition for Minor survival surgery

does not expose a body cavity and causes little or no physical impairment

What kind of surgical cleanliness is needed for Non-survival surgery?

at a minimum, surgical site should be clipped, surgeon should wear gloves, and the instruments and surrounding area should be clean

What do aseptic techniques include?

-Preparation of the patient (hair/feather removal , disinfection of the operative site)

-Preparation of the surgeon (appropriate surgical attire, face masks, and sterile gloves)

-Sterilization of instruments, supplies, and implanted materials

-The use of operative techniques to reduce the likelihood of infection.

Euthanasia

the act of humanely killing animals by methods that induce rapid unconsciousness and death without pain and distress.

Rooms with MR scanners or in which cryogen gasses are stored must be equipped with oxygen sensors and a method for increasing room ventilation, why?

Because cryogen boil-off can lead to asphyxiation of both personnel and animals,

What are the disadvantages of Decentralized facility?

-Costs more to construct because environmental controls --required at various locations and duplicate equipment needed

-Opportunity for exposure to disease agents is much greater

What is the purpose of terminated stop of the door frame?

A terminated stop is a modification to a door frame, where the stop is terminated above the floor - usually at 4 inches, 6 inches, or 8 inches from the bottom of the frame. This frame is great for allowing floors to be cleaned with ease; there are no stops at the floor to trap debris

What is the suggested width of corridor?

6-8 feet wide (wide enough to facilitate movement of people/equip)

What is the minimal drainpipe diameter? what is the drain pipe diameter for dog/ ag animal facilities?

Drainpipes at least 4 in (10.2 cm)

Drain pipes at least 6 in diameter in dog/agricultural animal facilities

Surgery, clean equipment storage should have __________ (negative, positive) room pressure

Positive pressure

Quarantine, NHP housing, hazmat exposed animals should have __________ (negative, positive) room pressure

Negative pressure

ABSL1

-1 agents not known to cause human disease

ABSL2

-2 moderate risk of human infection by ingestion, percutaneous, mucus membrane.

ABSL3

-3 serious, potentially lethal infection, aerosol transmission

ABSL4

-4 Exotic agents, high individual risk of life-threatening disease, no vaccine or treatment

What year was The Animal Care Panel created?

year 1959

What year was Guide for the Care and Use of Laboratory Animals first published? name changed?

year 1963; year 1972

Guide- Definition of animals

Any vertebrate animal (e.g., traditional laboratory animals, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching.

AWA- Definition of animals

any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research teaching, testing.

Veterinary consultation ______ (must, should, may) occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible.

MUST

Replacement

Methods that avoid or replace using animals

(absolute or relative)

Refinement

Methods which improve animal well-being and minimize or eliminate pain and distress

Reduction

Methods which minimize the number of animals used per experiment

LAL (limulus amebocyte lysate)testing

An in vitro assay utilizing blood cells (amebocytes) from horseshoe crabs to detect the presence and concentration of bacterial endotoxins in drugs and biological products.

example of replacement of pyrogenicity test

Definition of Engineering standard

specifies in detail a method, technology or technique for achieving a specific outcome.

-A defined measurable parameter.

-Easy verification of compliance

-Prescriptive with limited flexibility

e.g. Cage size, temperature range, photoperiod, perch length

Definition of Performance standard

describes an outcome, and provides flexibility in achieving that outcome.

-An outcomes-based parameter

-Accommodate the consideration of many variables

-Provides flexibility in achieving the desired outcome

e.g. Walls and floors shall be surfaced with a material resistant to heavy wear and tear, cage will allow for normal posture

Definition of Practice standard

application of professional judgment from time-proven experiences to a task or process.

Definition of Policies

commonly derive from a public agency or private entity. Practical statements of collective wisdom, convention or management direction that are internal to the entity.

Definition of Principles

are broader in scope (than policies) and intended application, and are accepted generalizations about a topic that are frequently endorsed by many diverse organizations.

Definition of Procedures

are typically detailed, step-by-step processes meant to ensure the consistent application of institutional practices. SOPs help institutions to comply with policies, regulations and principles.

Must

Must is used to describe aspects of an animal care program that are considered mandatory or imperative to providing humane animal care and use.

Should

is used to describe aspects of an animal care program that are strong recommendations for achieving a goal.

May

is used to indicate a suggestion for consideration

Institutional Official (IO)

individual who, as a representative of senior administration, bears ultimate responsibility for the Program and is responsible for resource planning and ensuring alignment of Program goals with the institution's mission.

Attending Veterinarian (AV)

veterinarian responsible for the health and well-being of all laboratory animals used at the institution.

IACUC

responsible for assessment and oversight of the institution's Program components and facilities, and should have sufficient authority and resources to fulfill this responsibility.

_________ are responsible for providing appropriate resources to support personnel training

Institutions

__________ is responsible for providing oversight and for evaluating the effectiveness of the training program

IACUC

AWIC

animal welfare information center

LAWTE

laboratory animal welfare and training exchange

In the order of most important to the least important: PPE, engineering controls, SOP**

engineering controls> SOP >PPE

Facilities that handle agents of unknown risk ________ (must, should or may) consult with _______ (which organization) about hazard control and medical surveillance.

Should, CDC

No more than ______ voting members from any administrative unit on IACUC committee

3

Guide- how many roles for IACUC committee? What are they?

1. Veterinarian: with training and experience in laboratory animal science and medicine or in the use of the species at the institution.

2. Scientist: practicing scientist experienced in research involving animals

3. Nonscientist: nonscientific background, drawn from inside or outside the institution

4. Public Member: represent general community interests in the proper care and use of animals

Public Member should not be ? can they accept compensation?

Should NOT be a lab animal user

Should NOT be affiliated with the institution in any way

Should NOT be an immediate family of an affiliated person

May receive modest compensation

Guide- How often should IACUC perform Program review and inspections?

at least annually

AWA and PHS policy- How often should IACUC perform Program review and inspections?

Every 6 months

Whether a procedure is major or minor is determined by the ________ and ________.

veterinarian and IACUC.

Multiple major survival surgeries on one animal only acceptable if

1. Included in one IACUC-approved protocol

2. Scientifically justified

3. Necessary for clinical reasons

______ MUST submit request to USDA/APHIS to allow multiple survival surgeries on a regulated species in separate protocols

IO

How often should the body weights be taken in water restricted animals?

Body weights should be taken and recorded at least weekly

Animal facilities _______ have a disaster plan

MUST

According to the Guide, responsibility for review and investigation of animal welfare concerns in the U.S. rests with the ___?

a) Attending veterinarian

b) Institutional official and IACUC

c)IACUC Chair

d)CEO or Vice President of Research

Institutional official and IACUC

Which of the following statements is most consistent regarding laboratory animal allergies? **

a) Urine proteins are the main source of allergenic proteins in mice and rats

b) Saliva proteins are the main source of allergenic proteins in mice and rats

c) Personal protective equipment should be the major protective mechanism for allergies

d) Laboratory animal allergies are not a concern of the institutional health and safety programs

a) Urine proteins are the main source of allergenic proteins in mice and rats

According to the Guide, who is responsible for determining that personnel performing surgical procedures are appropriately qualified and trained in surgical procedures?

a) Attending Veterinarian (AV)

b) IACUC

c) PI

d) IACUC with the AV

e) PI with the IACUC

d) IACUC with the AV

What is the definition of Microenvironment?

the immediate surroundings/primary enclosure

-Terrestrial: cage, pen, stall

-Aquatic: tank, raceway, or pond

What is the definition of Macroenvironment?

physical environment of the secondary enclosure

-Terrestrial: room, barn, outdoor habitat

-Aquatic: the room the tank is in

Thermoneutral zone (TNZ)

the ambient temperature range in which thermoregulation occurs without the need to increase metabolic heat production or activate evaporative heat loss mechanisms

Bounded by the Lower and upper critical temperatures

High Relative Humidity often associate with high _______ (an important parameter at cage level)

high ammonia

Recycled air Should be at minimum filtered with ______% ASHRAE efficient filters to remove airborne particles before it is recycled

85-95% ASHRAE efficient filters

ASHRAE - American Society of Heating, Refrigerating and Air Conditioning Engineers

What is the air changes rate in the room?

Air changes

10-15 per hour

What is the appropriate light level? 1m above the floor, at cage level?

325 lux (30-ft candles) approximately 1 m (3.3 ft) above the floor

If susceptible, light should be between 130 and 325 lux at cage level

Exposure of sound >____ dB can have both auditory and nonauditory effects i mice**

85

Exposure of sound >85dB can have both auditory and nonauditory effects

-Eosinopenia

-Increased adrenal gland weights

-Reduced rodent fertility

-Increased BP in NHPs

What is the housing temperature range for Mouse, rat, hamster, gerbil, guinea pig?

Mouse, rat, hamster, gerbil, guinea pig: 68-79° F

What is the housing temperature range for Rabbit?

Rabbit: 61-72° F

What is the housing temperature range for Cat, dog, nonhuman primate?

Cat, dog, nonhuman primate: 64-84° F

What is the housing temperature range for Farm animals and poultry?

Farm animals and poultry: 61-81° F

What housing enrichments are recommended in cats or rabbits ?

cats, rabbits - elevated shelves

What four things should not be considered part of the floor space?**

Food bowls, water containers, litter boxes, and enrichment devices should not be considered part of the floor space

At minimum, animals MUST have enough space to express their natural postures and postural adjustments-

Without touching the enclosures walls or ceilings

Be able to turn around

Have ready access to food and water

There MUST be sufficient space to comfortably rest away from soiled areas

Natural-ingredient diets; storage condition?

are formulated with agricultural products and byproducts and are commercially available for all species commonly used in the laboratory.

The nutrient composition of ingredients varies, and natural ingredients may contain low levels of naturally occurring or artificial contaminants.

Contaminants such as pesticide residues, heavy metals, toxins, carcinogens, and phytoestrogens may be at levels that induce few or no health sequelae yet may have subtle effects on experimental results.

< 21°C (70°F)

Below 50% humidity

Certified diets

have been assayed for contaminants are commercially available for use in select studies, such as preclinical toxicology, conducted in compliance with FDA Good Laboratory Practice standards (CFR 2009).

Purified diets ; storage condition?

are refined such that each ingredient contains a single nutrient or nutrient class; they have less nutrient concentration variability and the potential for chemical contamination is lower.

≤ 4°C (39°F)

Chemically defined diets ; storage condition?

contain the most elemental ingredients available, such as individual amino acids and specific sugars.

≤ 4°C (39°F)

Purified & chemically defined diets

are more likely to be used for specific types of studies in rodents but are not commonly used because of cost, lower palatability, and a reduced shelf life

Palatable, uncontaminated diets that meet nutritional & behavioral needs at least daily

≤ 4°C (39°F)

Cedar shavings are not recommended because?

they emit aromatic hydrocarbons that induce hepatic microsomal enzymes and cytotoxicity and increased the incidence of cancer.

Cleaning

removes excessive amounts of excrement, dirt, and debri

Disinfection

reduces or eliminates unacceptable concentrations of microorganisms

Disinfection by washing and rinsing at _______°F

Wash and rinse water at 143-180°F

Toe clipping in small rodents (up to what age?) should be used only when no other method is feasible

7 days

What is the functio of biofilter in aquatic water system?

ammonia to nitrite (< 0.75ppm) and nitrate (<40ppm)

How often should enclosure and accessories (like tops) be sanitized?

once every 2 weeks

How often do solid-bottom caging, bottles, and sipper tubes usually require sanitation?

at least once a week

This edition of the Guide for the Care and Use of Laboratory Animals (the Guide) strongly affirms the principle that ________ must assume responsibility for their well-being.

all who care for, use, or produce animals for research, testing, or teaching

Veterinary consultation must occur ______ or when interventional control is not possible

when pain or distress is beyond the level anticipated in the protocol description

The institution must provide the ______ with sufficient authority, including access to all animals, and resources to manage the program of veterinary care.

AV

If a full-time veterinarian is not available on site, a _______ should be available in visits at intervals appropriate to programmatic needs.

consulting or part-time veterinarian

In such instances where a part time or consulting vet is available for the program, there must be what?

an individual with assigned responsibility for daily animal care and use and facility management