FINAL English Version China Presentations

7/27/2019 FINAL English Version China Presentations

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Welcome!Welcome! 2012 AAALAC International. All rights reserved.


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AAALACInternat ona

Y.Alex

Zhang,

Ph.D.

2012 AAALAC International. All rights reserved.


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What is AAALAC?

The Association for Assessment and Accreditation ofLaborator Animal Care International ...

Enhances life sciences by promoting the responsible

rea men o an ma s use n researc , eac ng antesting through voluntary accreditation andassessment ro rams.



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Established in 1965

Non-governmental

Non-profit Does not establish independent

standards/policies, but relies on scientific data



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Makes it Work

Council on Accreditation (56) scientists, veterinarians, program administrators

Ad Hoc Consultants/Specialists (>300) from 27 countries

9 from China

Board of Trustees 66 Member Organizations, including AFLAS

Executive Office Staff Frederick, Maryland (Headquarters)

,

Bangkok, Thailand



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wo programs

e n erna ona ccre a on rogram

Pro ram Status Evaluation PSE Pro ram

Optional

Often used prior to applying for accreditation Helps familiarize institutions with AAALAC

standards/processes

- , - Provides detailed recommendations



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nese em ers o e ounc onAccreditation

Dr. Y. Alex Zhang (Section Leader)

Dr. Jianfei Wang



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Chinese Ad Hoc

Dr. Fon Chang, AstraZeneca Pharmaceuticals LP

Dr. Yan Chan NCDSER Shan hai Innostar Bio-tech Co. Ltd.

Dr. Lijie Fu, Shin Nippon Biomedical Laboratories, Ltd.

Dr. John Zhaolong Gong, Beijing Labsolutions Pharmaceuticals CoLtd

Dr. Anthony E. James, Chinese University of Hong Kong

Dr. Hongxia Li, WestChina Frontier Pharma Tech Co., Ltd.

The National Chen du Center for Safet Evaluation of Dru s

Dr. Shengming Lu, Beijing Laboratory Animal Research Center

Dr. Wubin Pan, Crown Bioscience, Inc.

. ,



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Demographics Comparison Accredited and

Commercial = 41%

=

Commercial = 70%

Academic = 15%

Government = 14%

Non-Profit = 11%

Government = 9%

Non-Profit = 3%

Hospital = 5% Hospital = 3%



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Distribution of the 91 Accredited Units

n ac c m nc u es a a P.R. China (Mainland and Hong Kong) 38 + 3 new applications

Korea 13

India 11 + 1 new application

Japan 9 + 2 new applications Taiwan 8

Singapore 6

Thailand 2 + 1 new application

Indonesia 2 + 1 new application Philippines 2

Vietnam 1

Cambodia - 1

*As of August 2009



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*As of August 2009



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Number of Chinese Institutions

ee ng ccre a on ac ear 12

10

6No.Units

2

2005 2006 2007 2008 2009 2010 2011



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Cumulative Number of Accredited and

ar c pa ng ns u ons40

30

35

15

20CumulativeNo.Units

5

10

2005 2006 2007 2008 2009 2010 2011



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Examples of Animal Welfare Improvement

to animals

nsur ng a soun sys em o rev ew o an ma use

proposals and of the animal program

Prov ng enr c ment to an ma s Reference to the 3Rs



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Concerns Addressed Following an

Literature searches for alternatives topa n u or stress u proce ures

Re-reviewing protocols involving painful

proce ures

Intensifying consideration of analgesic use

ur ng protoco rev ew Intensifying consideration of humane

en po nts ur ng protoco rev ew



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In the face of increasin

globalization of animal-based,

care and use standards and practicesbecomes essential and the role

.



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Something to be

proud of.



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verv ew o anges n t everv ew o anges n t e

KathrynBayne,M.S.,Ph.D.,D.V.M.



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na ys s o e u e

Council Retreat July 2010 Intensive evaluation

100s topics were discussed

What does it mean?

How does it affect program function?

How does it affect the accreditation process

Must

Should

How will it be assessed?

What are AAALACs expectations?

pos on s a emen s requ re so ar 17 FAQs required (so far)

so rev ewe g u e an uropean rect ve



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ounc e rea

-

June Council held a 2-day Retreat in July:

our su comm ees were orme an eac ana yze

one chapter (Chapters 2-5)

- -

1996 Guide and the 2011 Guide

,added or deleted and their impact on the

accreditation rocess



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ounc e rea u e

na ys s a so nc u e every wr tten comment

provided to Council by:

Board of Trustees Member Organizations

Other scientific organizations



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ounc e rea u e

na ys s o eac top c a so nc u e :

1. Comparisons with the revised European

Directive and theAg Guide

2. Councils interpretation of meaning3. Councils expectations of units

4. How the issue will be evaluated on site visits and

ur ng Counc meet ngs



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ounc e rea u e

e erat ons an ana ys s y eac su comm ttee

culminated in a review by the full Council

ummary an scuss on con nue a su sequen

meetings

discussions

the Council



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e erm na ons o e ounc

121 separate topics were discussed and classified according to theirneed for clarification. 16 discussion items

Review team identified the topic as a new approach in the Guide which Council will needto evaluate during site visits and discuss further the possible ramifications

37 action items

Position Statement may be necessary

Consistent approach (model statement) taken by Council

68 FYI items Just a general heads-up that there was a new item or comment in the Guide

6 position statements required (so far) 18 FAQs required (so far)



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scuss on tem examp es:

The Guide applies to agricultural animals used in

biomedical research, including those maintained in

typical farm settings.

orr ors are no appropr a e s orage areas.



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ct on tem examp es:

Alcohol is neither a sterilant nor a high level

disinfectant, but may be acceptable for some

procedures, if prolonged contact times are used.

http://www.aaalac.org/accreditation/faq_landing.cfm#D

2



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examp es:

Entire Aquatics section

Council felt the new Guide merely reflected what is

considered standard practice for the care and use of

a uatic animals.



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ui e, y apter po nts o c ar cat on

required)

Chapter 2: 39 topics

Chapter 3: 29 topics Chapter 4: 25 topics

Chapter 5: 28 topics



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or ose o oun

ew must statements ui e

Chapter 1: 1

Chapter 2: 11

Chapter 3: 4

Chapter 4: 10

Chapter 5: 11



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ap er : ey oncep s Applicability and Goals

Intended Audiences and Use of the Guide Ethics and Animal Use

The Three Rs

Key Terms Used in the Guideumane are

Animal Care and Use Program

Engineering and Performance Standards

ract ce tan ar s

Policies, Principles and Procedures

,Changes:MinimalChange,Expanded/ChangeofWording,NewSections



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us ou ay

Must = imperative and mandatory for humane

animal care and use

Should = stron recommendation May = suggestion to be considered



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er ormance r er a

er ormance tan ar

Performance Criteria

Professional Judgment

Performance Approach - requires professional

, ,achieve specific goals.



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er ormance an ar s

Focused on results rather than the process Allows flexibilit to fit different situations

Requires a detailed definition of the outcome

Must provide specific criteria for assessing theoutcome

Must know where performance standards can and cannot be a lied

Requires professional judgment/input



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ew us s mpera ves ap er

eter nary consu tat on must occur w en pa n

or distress is beyond the level anticipated in

t e protoco escr pt on or w en ntervent ona

control is not possible.



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Cha ter 2: Animal Care and Use

Program

egu at ons, o c es an r nc p es

Program Management

Program Management Responsibility

Institutional Official, Attending Veterinarian, IACUC

Personnel Management

Training and Education

Occupational Health and Safety

Personnel Security

Changes:MinimalChange,Expanded/ChangeofWording,

New

Sections



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ersonne anagemen Training and Education

Veterinary Care personnel

The Research Team

The IACUC

Occupational Health and Safety Control and Prevention Strategies

Facilities and Monitoring

Personnel Training

Personal H iene

Animal Experimentation Involving Hazards

Personal Protection

Medical Evaluation and Preventive Medicine for Personnel

Changes:MinimalChange,Expanded/ChangeofWording,NewSections



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Program

The Role of the IACUC IACUC Constitution and Function

ro oco ev ew

Special Considerations for IACUC Review

Experimental and Humane Endpoints

Physical Restraint

Multiple Survival Surgical Procedures

Food and FluidRe ulation

Use of Non-Pharmaceutical-Grade Chemicals and Other Substances

Field Investigations

Agricultural Animals


New

Sections



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Program

rogram vers g

Post-Approval Monitoring

Disaster Planning and Emergency Preparedness


New

Sections



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e tten ng eter nar an s respons e

for the health and well-being of all laboratory.

The institution mustprovide the AV with

,animals, and resources to manage the programof veterinar care. The AV should oversee

other aspects of animal care and use to ensurethat the Program complies with the Guide.



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a u t me veter nar an s not ava a e on

site, visits by a consulting or part-time

veter nar an s ou e at nterva s appropr ate

to programmatic needs. In such instances,

t ere must e an n v ua w t ass gne

responsibility for daily animal care and use

an ac ty management.



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e ns u on mus eve op me o s or repor ng an

investigating animal welfare concerns. IACUC members named in rotocols or have other

conflicts must recuse themselves from decisionsregarding these protocols.

e ent cat on o umane en po nts s o tenchallenging because multiple factors mustbe weighed,includin the model s ecies and sometimes strain or

stock), animal health status, study objectives,institutional policy, regulatory requirements, and

.



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es ra n ev ces s ou no e cons ere a

normal method of housing, andmustbe justified.

Veterinary care mustbe provided if lesions or

illnesses associated with restraint are observed.[in Restraint section]

Facilities must have a disaster plan.

Animals that cannot be recoveredmustbehumanely euthanized. [in Disaster Planningsect on]



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Cha ter 3: Animal Environment

Housing and Management

Terrestrial Environment

croenv ronmen an acroenv ronmen

Temperature and Humidity

Illumination

Noise and Vibration


New

Sections



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Terrestrial Housing

croenv ronmen r mary nc osure

Environmental Enrichment

Naturalistic Environments

S ace


New

Sections



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Housing and Management Terrestrial Animals

Terrestrial Management Behavioral and Social Management

Activit Social Environment

Procedural Habituation and Training of Animals

Husbandry Food, Water, Bedding and Nesting Materials

an a on

Bedding/Substrate Change

Cleaning & Disinfection of the Microenvironment

Cleaning & Disinfection of the Macroenvironment

Assessing the effectiveness of Sanitation

Waste Disposal

Pest Control

Emergency, Weekend and Holiday Care




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erres r a n ma s

Terrestrial Management

Population Management

Identification

Record Kee in

Breeding, Genetics and Nomenclature




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Aquatic Environment

Water Quality

Life Su ort S stem Temperature, Humidity and Ventilation

Illumination

Noise and Vibration




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Aquatic Housing

Environmental Enrichment and Social Housing

Sheltered or Outdoor Housin Space




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Aquatic Management

Husbandry

Food, Water, Substrate

Sanitation

Waste Disposal

Emergency, Weekend and Holiday Care



Ch 3 A i l i


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qua c n ma s

Aquatic Management

Population Management

Identification

Record Kee in




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ew us s mpera ves ap er Emergency veterinary care mustbe available after work hours,

, .

Chlorine and chloramines utilized to disinfect water for humanconsum tion or to disinfect e ui ment are toxic to fish and

amphibians andmustbe removed or neutralized prior to use in

aquatic systems.

e o er mus e o su c en s ze .e., con a n a su c en

quantity of bacteria) to be capable of processing the bioload

(level of nitrogenous waste) entering the system.

When utilized to disinfect an entire system or systemcomponents, extreme care mustbe taken to ensure that

, ,

removed.



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ap er : e er nary are

n ma rocuremen an ranspor a on

Animal Procurement

ranspor a on o n ma s

Preventive Medicine

n ma osecur ty

Quarantine and Stabilization

epara on y ea a us an pec es

Surveillance, Diagnosis, Treatment and Control of




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Medical Management Emergency Care

Record Keeping

Surgery

Pre-surgical Planning

Surgical Facilities

Aseptic Technique Intraoperative Monitoring

-Changes:MinimalChange,Expanded/ChangeofWording,NewSections



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a n an stress

Anesthesia and Analgesia

Euthanasia




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ap er : ys ca an Functional Areas

Corridors

Animal-Room Doors

Exterior Windows

Floors, Drainage

Walls and Ceilings

Heating, Ventilation and Air-condition (HVAC)

Power and Lighting

Storage Areas

Noise Control

Vi ration Contro

Facilities for Sanitizing Materials

Environmental Monitoring




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e num er, spec es, an use o an ma s ouse n an

institution may influence the complexity of the veterinary careprogram; however, an acceptable veterinary program that

offers high quality of care and ethical standards mustbe

provided, regardless of the number of animals or species being

. Procedures mustbe in place to provide for emergency

veterinary care both during and outside of regularly scheduled

hours. Such procedures must enable timely reporting of animal

injury, illness, or death by animal care and research staff.



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ve er nar an or e ve er nar an s es gnee mus e ava a e

to expeditiously assess the animals condition, treat the animal,investigate an unexpected death, or advise on euthanasia.

If the animal user cannot be reached in the case of a pressing

health problem, or if consensus between the investigator and

,veterinarian must have the authority, delegated by senior

administration and the IACUC, to treat, remove from the

experiment, institute appropriate measures to relieve severe

pain or distress or euthanize the animal if necessary.



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esearc ers con uc ng surg ca proce ures mus ave appropr a e

training to ensure that good surgical technique is practiced, that is,asepsis, gentle tissue handling, minimal dissection of tissue,

appropr ate use o nstruments, e ect ve emostas s, an correct use

of suture materials and patterns.

Antinociception occurs at a surgical plane of anesthesia, and prior tosurgery, adequate antinociception mustbe ascertained.

Agents used to provide anesthesia and analgesia mustbe used before

and disposed of legally and safely. Death mustbe confirmed by personnel who have been trained to

.



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ap er : ys ca an Special Facilities

Surgery

Barrier Facilities

Imaging

Whole Body Irradiation

Hazardous Agent Containment

Behavioral Studies

quat c pec es ous ng

Security and Access Control




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ooms w t scanners or n w c cryogen s

storedmustbe equipped with oxygen sensors and a

inert gases during cryogen filling.

,which pose a threat to animal and plant health or

public health and safety, are usedmust adhere to

applicable federal, state or local regulations.


Three Primary Standards


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y



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op cs o ar cu ar n eres - ,

height)oc a ous ng as e au me o

Acceptability of Non-Pharmaceutical-Grade

su stances

Food/ fluid regulation (documentation)

IACUC function (protocol review, documentation,unexpected outcomes, humane endpoints, harm-benefit, etc)



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Snapshot 2011 Guide

25

30

Environment,Housing,

20

F

indings

OccHealth

10

15

%ofT

otal

VetCare

0

5 PhysicalPlant



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2011 Guide Webinars Available...

- -

http://www.aaalac-outreach.org/



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C apter2:An ma Carean UseY. Alex Zhang, Ph.D.Y. Alex Zhang, Ph.D.


Topics


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Reviewing written procedures

Remaining current IACUC constitution

Program review/inspections

Collaborations

Training

Protoco Rev ew

Harm-benefit analysis Humane endpoints

con ro preven on

OHSP Hazard ID/ riskassessment

Unexpected outcomes

Physical restraint

Multiple survival surgery , ,

monitoring

OHSP personnel protection

Food/ fluid regulation

Pharmaceutical grade substances

Agricultural animals

preventive medicine Reporting concerns

PAM

Disaster plans



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ap er : page

ev ew o wr tten proce ures

Also, institutions are encouraged to establish

and periodically review written procedures to

ensure consistent application of Guide

standards.


Cha ter 2: a e 12


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Cha ter 2: a e 12Review of written procedures

ounc s nterpretat on:

Council expects periodic review of written

procedures

The breadth and sco e of the writtenprocedures should be defined by the institution

and a mechanism for their eriodic review

established.



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ap er : pages -

equ r ng rograms to rema n current

The body of literature related to animal

science and use of animals is constantly

evolving, requiring Programs to remain

current with the information and best

practices.


Cha ter 2: a es 12-13


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Remaining current


Council does expect Programs to keep

apprised of the evolving best practices of

animal use and related fields of science.

Site visitors will use a performance-based

a roach to assess this as ect of the Pro ram



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ap er : pages -

rogram anagement nst tut ona

Official (IO)

This section specifies the responsibilities of the

IO

There is new language which describes the

interrelationshi of the IO IACUC and AV

Collaborative approach to Program oversight




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Program management - IO

ounc s n erpre a on:

Overall, the role of the IO is not significantlyc ange

There is now a charge for the IACUC and AV

o regu ar y commun ca e rogram nee s othe IO

ore o a co a ora ve e or , w essdistinction of responsibilities among the IO,

.



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ap er : page

o a orat ons

Interinstitutional collaboration has the potential to create.

cases of such collaboration between institutions that involves

animal use (beyond animal transport), the participating

institutions should have a formal written understanding

(e.g., a contract, memorandum of understanding or

a reement that addresses the res onsibilit or o site animal

care and use, animal ownership, and IACUC review andoversight.


Cha ter 2: a e 15


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Collaborations


When inter-institutional collaborations exist,(i.e. animals owned by one institution that are housed

and used at another institution) - the Council

expects that there be a formal written

agreement which describes the responsibilities

and oversight of animal care and use



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ap er : pages -

ra n ng

All personnel involved with the care and use ofanimalsmust be adequately educated, trained and/or

qualified in basic principles of laboratory animal

-animal well-being.


Chapter 2: pages 15-17


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ra n ng op csVeterinary staffmust have experience, training and expertise necessary to evaluate the

Veterinary or other professional staff should havetraining/experience:

Laboratory animal facility administration and management,

May need expertise in: facility design and renovation,, human resourcemanagement, pathology of laboratory animals, comparative genomics, facility

an equ pment ma ntenance, agnost c a oratory operat ons, an e av oramanagement.

Animal care staff

..shouldreceive training and/or have the experience to complete the tasks forwhich they are responsible

Animal husbandry; Administration; Veterinary medical technology




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Research team(Before the IACUC (Formal orientation)

Training topics

study)

Animal care and use legislation

Relevant legislation,

regulations, guidelines andpolicies

Ethics of animal use/ concepts ofthe 3-Rs

Animal facilities andlaboratories

Process for rotocol andOHS

Handling

program review

Ongoing opportunities toenhance understandin

Aseptic technique

Anesthesia/ analgesia

Euthanasia




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Councils Interpretation:ra n ng

Depending on the institutions current training

program, this training requirement may, or may not,necess a e c anges

All training should be documented



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ap er : page Control and prevention strategies (new)and prevention strategies that begins with the identification of

hazards and theassessment of risk associated with thosehazards.

Managing risk involves the following steps: first, theappropriate design and operation of facilities and use ofappropriate safety equipment (engineering controls); second,t e eve opment o processes an stan ar operat ngprocedures (SOPs; administrative controls); and finally, theprovision of appropriate personal protective equipment (PPE)

.

combination with appropriate management and safetypractices


Cha ter 2: a e 18


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Prevention and control strategies

Councils Interpretation:

This new section sim l clarifies the

longstanding hallmarks of:

Job-related risk assessment Prevention and control




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Hazard Identification and risk assessment

environment and conduct a criticalassessment of the associated risks.

Hazard identification and risk assessment areongoing processes thatinvolve individuals uali iedto assess dan ers associated with theProgram and implement commensurate safeguards.

Once potential hazards have been identified, acritical ongoing

assessment o the associated risks should be conductedto determineappropriate strategies to minimize or manage the risks.

The extent and level of participation of personnel in the OHSP shouldbe based on thehazards posed by the animals and materials used(theseverity or seriousness of the hazard); the exposure intensity, duration,

and frequency (prevalence of the hazard); to some extent, thesusceptibility (e.g., immune status) of the personnel; and thehistory ofoccu ational illness and in ur in the articular work lace


Cha ter 2: a es 18-19H d id ifi i d i k


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Hazard identification and risk assessment


Medical evaluation of ersonnel is a ke

aspect ofpersonal risk assessment.

Expect periodic review of identified hazards &

Key institutional safety personnel should be

nvo ve



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ap er : page,

The facilities required to support the OHSP will varydepending on the scope and activities of the Program.T eir esign s ou pre erent a y use eng neer ngcontrols and equipment to minimize exposure toanticipated hazards (see also Chapter 5).

Where biological agents are used, the Centers forDisease Control and Prevention (CDC) and NationalInstitutes of Health (NIH) publicationBiosafety inMicrobiological and Biomedical Laboratories (BMBL;

DHHS 2009) and the USDA standards (USDA 2002)should be consulted for appropriate facility design andsa ety proce ures.


Cha ter 2: a e 19F iliti i t d it i


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Facilities, equipment and monitoring


No chan e in the accreditation rocess

Council endorses the concept of engineering

protection

reference resource for the accreditation process



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ap er : page ersonne protect on

Personnel working in areas where they might beexposed to contaminated airborne particulate

material or vaporsshouldhave suitable respiratory

...the proper use and maintenance of the respirator.


Cha ter 2: a e 22P l t ti


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Personnel protection


Council ex ects that when ersonnel are

required to wear respirators, respiratory fit

testin and trainin mustbe rovided



Medical evaluation and preventive medicine for personnel


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Medical evaluation and preventive medicine for personnel Apre-employment health evaluation and/or a health-history

evaluation be ore work assi nment is advisable to assesspotential risks for individual employees. Periodic medical

evaluations are advisable for personnel in specific riskcategories.

Laboratory animalallergy has become a significant issueforindividuals in contact with laboratory animals The medicalsurveillance program should promote the early diagnosis of

a erg es an nc u e eva ua on o an n v ua s me cahistory for preexisting allergies. Personneltraining shouldinclude information on laboratory animal allergies, preventive

,symptoms, and proper techniques for working with animals.

PPE should be used to supplement, not replace, engineering or


Cha ter 2: a es 22-23Medical evaluation/ preventative medicine


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Medical evaluation/ preventative medicine


The medical surveillance program should addressr s s assoc a e w a ora ory an ma a ergy(LAA) by appropriate evaluations that promote

Engineering and process controls should be therimar means of rotectin ersonnel.

Personal protective equipment should be used asan adjunct to engineering controls, not as the solemeans of protection



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ap er : pageMedical evaluation and preventive medicine for personnel

Because of the potential for exposure to Macacine

herpesvirus 1 (formerly Cercopithecine herpesvirus 1 or,

handle biological samples (blood and tissues) frommacaquesshouldhave access to and be instructed in the use

- ...Injuries associated with macaques, their tissues or bodyfluids, or caging and equipment with which the animals have

,

appropriate post-exposure treatment and follow-upimplemented


Chapter 2: page 23



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Council endorses these concepts but considers them

macaques, their biological samples, or their cages

and e ui ment These elements of theMacacine herpesvirus 1

revention and ex osure ro ram are considered to

be essential No chan e to the accreditation rocess


ap er : pages


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ap er : pages -

The institutionmust develop methods for reporting and investigating

animal welfare concerns and employees should be aware of the importanceof and mechanisms for reporting animal welfare concerns.

Mechanisms for reporting concernsshould be postedin prominentlocations in the facility and on applicable institutional website(s) withinstructions on how to report the concern and to whom.

Multiple points of contact, including senior management, the IO, IACUCChair and AV are recommended.

The processshouldinclude amechanism for anonymity, compliancewith applicable whistleblower policies, non-discrimination against the

concerned/reporting party and protection from reprisals.


Cha ter 2: a es 23-24Reporting concerns


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Reporting concerns


Not a new requirement, but there are newlydescribed aspects of animal concern reporting:

A mechanism must be in place

Signage with instructions in the facility(s)

Multi le oints of contact

Anonymity

Whistleblower rotection


ap er : page


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ap er : page

Committee membership includes the following: Doctor o Veterinar Medicine certi ied e. . ACLAM

ECLAM, JCLAM, KCLAM) or with training and experiencein laboratory animal science and medicine or in the use ofthe species at the institution.

t least one practicing scientist experienced in researchinvolving animals.

At least one member from a nonscientific background,drawn from inside or outside the institution.

At least one public member to represent general communityinterests in the proper care and use of animals.


Cha ter 2: a e 24

IACUC constitution and function


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IACUC constitution and function


No significant change Council has alwaysexpected a non-scientist member

The Guide no lon er states that the IO should

appoint the committee members. The Council

ex ects that IACUC members be a ointed b

a senior institutional official (CEO, IO).


ap er : page


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ap er : page rogram rev ew an ac t es nspect on

Program review and facilities inspections shouldoccur at least annually or more often as required

(e.g., Animal Welfare Act and PHS Policy). After

,minority views) should be made to the IO on the

status o the Pro ram.


Chapter 2: page 25

rogram rev ew an ac es nspec on


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Councils Inter retation: FArogram rev ew an ac es nspec on

Review at a frequency and intensity that ensures

correction of identified deficiencies.

Highly engaged Committee that conducts thorough

eva ua ons o e program an ac es,Program and facilities adequately support the research,

testin and teachin ob ectives of the institution.

An effective component of overall monitoring andoversight


ap er : pages -


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ap er : pages -

This section has been revised with threea ona e emen s o rev ew nc u e . ere

are also additional phrases which highlight

review


Cha ter 2: a es 25-26Protocol review


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Protocol review

: Rationale and purpose of the proposed use of animals.

A clear and concise sequential description of the proceduresnvo v ng e use o an ma s a s eas y un ers oo y a mem ers

of the committee.

Availability or appropriateness of the use of less-invasive procedures,

, , ,computer simulation (see Appendix A, Alternatives).

Justification of the species and number of animals proposed;whenever possible, the number of animals and experimental groupsizes should be statistically justified (e.g., provision of a power

analysis, see Appendix A, Experimental Design and Statistics). Unnecessary duplication of experiments.

on-stan ar ous ng an us an ry requ rements.




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Impact of the proposed procedures on the animals well-being.

Appropriate sedation, analgesia, and anesthesia (indices ofpain or invasiveness might aid in the preparation and reviewof protocols; see Appendix A, Anesthesia, Pain and Surgery)

Conduct ofsurgical procedures including multiple operativeprocedures.

Post- rocedural care and observation e. . inclusion of ost-treatment or postsurgical animal assessment forms).

Description and rationale for anticipated or selectedend oints.




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Criteria and process for timely intervention, removal of

animals from a stud , or euthanasia if ainful or stressfuloutcomes are anticipated.

Method of euthanasia or disposition of animal, including

-completion.

Adequacy of training and experience of personnel in the,

personnel involved. Use of hazardous materials and provision of a safe

wor ng env ronment.


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ap er : pages arm- ene t ana ys s

With regard to protocol review, the IACUCshould consider - Impact of the proposed

procedures on the animals well-being.

.the IACUC is obliged to weigh the

objectives of the study against potential animal

welfare concerns.


Cha ter 2: a e 27

Harm-Benefit analysis


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y


Although the term may be new, the concept isnot

AAALAC International ex ects that IACUCs

(or other oversight body) as part of the

rotocol review rocess will wei h the

potential adverse effects of the study againstthe otential benefits


ap er : pages -


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ap er : pages

Determination of humane endpointsshouldinvolve thePI, the veterinarian, and the IACUC, and should be

e ine w en possi epr or to t e start o t e stu y

Information that is critical to the IACUCs assessment of

precise definition of the humane endpoint (includingassessment criteria); the frequency of animal

assessment and recognition of the humane endpoint, andthe response required upon reaching the humaneend oint.



Humane endpoints


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Experimental and humane endpoints should be clearlydefined in the animal care & use rotocol and be reviewedand approved by the IACUC. Humane endpointdetermination should involve PI, veterinarian and IACUCrior to start of the stud .

When establishing humane endpoints, 4 critical criteria areessential for consideration:

2) frequency of observations3) training of personnel

requ re response w en e en po n s reac e .


ap er : pages -


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ap e : pages

Because of the potential for unexpected outcomes that may affect

animal well-being when highly novel variables are introduced, morere uent monitorin o animals ma be re uired. With their inherentpotential for unanticipated phenotypes, GMAs are an example of whenincreased monitoring for unexpected outcomes could beimplemented.

Regardless of whether genetic manipulation is targeted or random,thephenotype that initially results is often unpredictable and may leadto expected or unexpected outcomes that impact the animals wellbeing

When the initial characterization of a GMA reveals a condition thatnegatively impacts animal well-being,this should be reported to theIACUC and more extensive anal sis ma be re uired to better de inethe phenotype


Cha ter 2: a es 28-29 &77

Unexpected outcomes


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Develop a program to increase awareness ofthe need to report, and a mechanism for

reporting back to the IACUC

Important for unexpected outcomes in pilot

studies & other s ecial ex erimental

considerations (e.g., GMAs)


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p p g ys ca estra nt

The section discusses the guidelines and criticalelements to consider for studies that involve physical

restraint

re ere new e emen s o cons er ur ng rev ew othese studies?


Cha ter 2: a e 29

Physical Restraint


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The guidelines and critical elements of physical

Removal - when failure to adapt

Not as normal housing or for convenience, and minimized

Consideration of alternatives Justification and rationale

Positive reinforcement

Appropriate observations

Vet care must be provided for animal with illness or injury

ersonne ra n ng purpose, ura on, e c


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p p g u t p e urv va urg ca roce ures

Whether a procedure is major or minorshould be evaluated on a case-by-case basis,

as determined by the veterinarian and

IACUC.


Cha ter 2: a e 30

Multiple survival surgeries


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The IACUC should classify - a veterinarianshould be involved in the evaluation of

multiple survival surgeries

Multiple surgeries may be within a single

rotocol or associated with more than one

protocol(in US the latter requires an exemption from the USDA for coveredspecies)


ap er : pages -


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p p g oo an u regu at on

Significantly expanded and details importantconsiderations for studies involving feed or

water regulation.

Additional aspects of monitoring and

recordkee in described



Food and fluid regulation


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3 fundamental factors are essential whenevaluating these protocols:

The necessary level of regulation

The potential adverse consequences of regulation

Methods for assessing the health and well-being of the

Increased requirements for documentation (body, , ,


ap er : page


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se o non-p armaceut ca -gra e c em ca s

and other substancesThe use of pharmaceutical grade chemicals and

other substances ensures that toxic or unwanted side

e ec s are no n ro uce n o s u es con uc e wexperimental animals. They should therefore be used,

- , .


Cha ter 2: a e 31

Non-pharmaceutical grade substances


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Pharmaceutical grade substances should be used whenever

they are available Non-pharmaceutical grade substances may be acceptable

when: There are no equivalent pharmaceutical grade compounds

ava a e Approved by the IACUC

There is a schedule of monitoring, that allows the detection ofa verse even s re a e o e use o non-p armaceu ca gra ecompounds.

Issues related to quality assurance such as proper preparation,,


ap er : pages -


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With some studies, differences in research goals may

lead to a clear distinction between biomedical andagr cu tura researc .

But when the distinction is unclear, as in the case of

, ,regulators and IACUCs face a dilemma in decidinghow to handle such studies.

The Guide applies to agricultural animals used in

biomedical research, including those maintained int ical arm settin s.



Agricultural animals


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ounc s n erpre a on: pos on s a emen

The research, testing or teaching objectives as well as

application of the recommendations of the Ag Guide,ILAR Guide, or ETS 123 is most appropriate.

Collective professional judgment of the responsibleoversight body (i.e., IACUC, Ethics Committee), PI

applies best

The rationale for making this determination should bedocumented.


ap er : pages -


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ostapprova mon tor ng

Continuing IACUC oversight of animalactivities is required by federal laws,

regulations and policies.

PAM helps ensure the well-being of the

animals and ma also rovide o ortunities to

refine research procedures.



Postapproval monitoring


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: Mechanism in place to help ensure that animal procedures

are conducted in accordance with the a roved rotocol.

PAM programs can vary from reliance on existingactivities performed by the oversight body (IACUC,

extensive supplemental audits of protocols and the entireprogram conducted by compliance staff.

the broadest sense - namely that there will be a system forensuring animal procedures conform with the approved


ap er : page


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saster p an

Facilitiesmust therefore have a disasterplan.

The lanshouldde ine the actions necessar

to prevent animal pain, distress, and deaths

due to loss o s stems such as those that

control ventilation, cooling, heating, orrovision o otable water.



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PP


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apter Pract cumapter Pract cum

Y. Alex Zhang, Ph.D.Y. Alex Zhang, Ph.D.


Case StudyFindin :


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While reviewing protocols during a site visit to XYZ

n vers y you rea a escr p on o s u y nvo v ng a

surgically induced leg fracture in rats. The rats recover

an are s u e or vary ng eng s o me o assess onehealing. Administration of pain medications and

.

that the IACUC considered the objectives of the study.


Case StudyFindin :


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While conducting visits to investigator laboratories atABC, Inc., you visit a multi-use laboratory where mice

undergo surgery to remove a kidney. Surgery is

conducted on a lab bench in one corner of the laboratorywhile other activities in the lab continue as usual. The

ui e states t at t e a oratory s ou e e cate

to surgery when surgery is underway. Is the scenario in

t s a oratory n con ct w t t e u e


Case StudyFindin :


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Animal care technicians at Great Eastern College were

cages in the staging area of the cagewash room. Some of

others in the area were not wearing any personal

face mask were required for this task, the technicians

gloves and a mask was up to the individual.


Case Stud

Finding:


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described in Protocol #XYZ123 stated

that butorphanol would be given every2-4 hours for 2 days. However, when

visiting the laboratories the

investi ator stated that one dose

butorphanol was given after recoveryfrom surgery and then additional doses

of pain.


Case StudyFinding:

I


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In one mouse room,

you see several

identified like this.

You ask to see the

approve pro oco ,but only a single

implant surgery is

described.


Case Study

Finding:

ou o serve a gra ua e


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ou o serve a gra ua e

student in the lab performing

this procedure. The surgeon iswearing non-sterile gloves,

and is using the same set of

the same procedure performed

earlier on 2 other animals

w ou su sequen

sterilization.


Finding:


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A bench top in a

had this appearance.

conducted in this

.

issues?


C apter 3: Env ronment Hous ng


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C apter3:Env ronment,Hous ngJianfei Wang, D.V.M., Ph.D.Jianfei Wang, D.V.M., Ph.D.


Topics

Invertebrates

Temperature guidelines

Outdoor housing

Habituation/ training

Relative humidity Feeding


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Relative humidity

VAV systems

Feeding

Watering devices

Radios/sound generators

Vibration

IVC microenvironment

Monitoring sanitation

Social housing Wire bottom cages

Waste disposal Emergency/ weekend/

Environmental enrichment Cage and pen space

Identification

Unexpected outcomes

Aquatics


Cha ter 3: a e 41

Invertebrate species



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No Change

AAALAC International does evaluate

ro rams involvin invertebrate s ecies when

they are relevant to the institutions mission

and recommends that the standards of the

Guidebe applied to their care and use.


ap er : page

New tem erature uidelines

I l d b lb i i l h ld b


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In general, dry-bulb temperatures in animal roomsshouldbe set

below the animals LCT to avoid heat stress. This, in turn, means that

thermoregulation (nesting material, shelter) to avoid cold stress.

mice 26-34 C (TNZ)

rats 26-30 Cgerbils 28-32 C

-

dogs/ cats 20-25 C


ap er : page

TABLE 3 1 R d d D B lb M i t l


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TABLE 3.1 Recommended Dry-Bulb Macroenvironmental

Temperatures for Common Laboratory AnimalsAnimal Dry-Bulb Temperature

C F

, , , , - -Rabbit 16-22 61-72

- -, ,

Farm animals and poultry 16-27 61-81


New temperature guidelines


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guidelines


Relative Humidity

R l i h idi h ld l b ll d b


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Relative humidityshouldalso be controlled, but not

nearl as narrowl as tem erature or man mammalsthe acceptable range of relative humidity is considered

to be 30 to 70% for most mammalian species.

Ideally relative humidityshouldbe maintained within

+/- 10% o set oint; however, this ma not be

achievable under some circumstances.



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Chapter 3: page 46 (Chapter 5: page 139)

VAV systems


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VAV systems

These s stems o er considerable advanta es with res ect toflexibility and energy conservation, but should always provide a

minimum amount of air exchange, as recommended for general

but variable-volume (VAV) systems may offer design and

,

set in accordance with heat load and other variables.


Cha ter 3: a e 46 Cha ter 5: a e 139

VAV systems

M ll f i h t b l th i id li f


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May allow for an air exchange rate below the previous guideline of

10-15 ach. Council will asses overall air quality and air exchange rate using

performance based criteria that will take into account a variety ofcircumstances such as: cage type (ventilated cages vs static), whether

the building exhaust system), filtration of animal cage exhaust air (ifany), animal density, husbandry practices and the overall needs of the

.

Assessments will be made via the HVAC reports and on-site

evaluations


Cha ter 3: a e 47

Rec cled air

The use of recycled air to ventilate animal rooms may save


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The use of recycled air to ventilate animal rooms may save

energy but entails risks. Because many animal pathogens can beairborne or travel on fomites (e.g., dust), exhaust air recycled into

heating, ventilation, and air conditioning (HVAC) systems that

serve multi le rooms resents a risk o cross contamination.

Recycling air from non-animal use areas (e.g., some humanoccupancy areas and food, bedding, and supply storage areas)

risk of infection.


Chapter 3:page47

Council Inter retation: continue to use the

Recyc e air

guidelines outlined in the 1996 Guide (FAQ)


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guidelines outlined in the 1996 Guide (FAQ)

owever, e use o nonrecyc e a r s pre erre or

ventilation of animal use holding areas.

,

the supply air does not exceed 50% recycled air).

Recycled air is returned only to the room or area from

which it was generated, except if it comes from other than

animal-housing areas.


ap er : page

a os an soun generators


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Radios, alarms, and other sound generators shouldnot be used in animal rooms unless they are parts of

an approved protocol or an enrichment program. Any

off at the end of the working day to minimize

associated adverse h siolo ic chan es


Cha ter 3: a e 50

Radios and sound generators



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Although this is a new recommendation, this islikely not a significant change for most

programs


ap er : page

rat on


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A variety of techniques may be used to isolategroundborne (see Chapter 5) and equipment

generated vibration Attempts should be made to

,

humans, and excessive vibration should be avoided.


Cha ter 3: a e 50

Vibration



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Not a significant change in expectations or theaccreditation process

Will ex ect that institutions will have iven the

issue appropriate consideration informationwill be re uested in the revised Pro ram

Description outline.


ap er : pages - an Social Housing

space as well as supplementary structures and resources required tomeet physical physiologic and behavioral needs


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meet physical, physiologic, andbehavioral needs.

An a ro riate housin s ace or enclosure should also account or theanimalssocial needs.

Social animals should be housed in stable pairs or groups ofcompatible individuals unless they must be housed alone for

exper men a reasons or ecause o soc a ncompa y

Appropriate social interactions among members of the samespecies(conspecifics) are essential to normal development and well-

Single housing of social species should be the exception and should

be justified based on experimental requirements or veterinary-relatedconcerns regarding animal well-being.


Chapter 3: pages 50-1 and 64

Councils Interpretation: (position statement) Social housing considered the default method of housing unless

ot erw se ust e ase on soc a ncompat ty resu t ng rominappropriate behavior, veterinary concerns regarding animal well-


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being or scientific necessity approved by the IACUC (or comparable

Single housing of social animals should be limited to the minimumperiod necessary, and where possible, visual, auditory, olfactory andtactile contact with compatible conspecifics should be provided.

In the absence of other animals, additional enrichment should beoffered, such as safe and positive interaction with the animal carestaff, as appropriate to the species of concern; periodic release into

addition of a companion animal in the room or housing area.

The need forsingle housing should be reviewed on a regular basisand a roved b the IACUC or other oversi ht bod and/orveterinarian.


ap er : pages -

Flooring should be solid perforated or slatted with


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Flooring should be solid, perforated or slatted with

a sli -resistant sur ace.If wire mesh flooring is used, a solid resting areamay be beneficial, as this floor type can induce foot

.

The size and weight of the animal as well as theduration of housing on wire-mesh floors may also

p ay a ro e n t e eve opment o t s con t on...

When given the choice, rodents prefer solid floorswith beddin to rid or wire-mesh loorin



Wire bottom cages



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Continue to encoura e the use of solid-bottomcages

should be provided.


ap er : page

e ng


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Animals should have adequate bedding substrateand/or structures for resting and sleeping. For many

animals, (e.g., rodents) contact bedding expands the

-

foraging, digging, burrowing, nest building


Cha ter 3: a e 52

Bedding



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Bedding should be provided according to theneeds of the animals and the study

Breedin animals should be rovided with

adequate nesting materials, substrate orstructures based on s ecies-s ecific behavior.


ap er : pages -

Enrichment programs should be reviewedby the


156/371

p g y

IACUC, researchers and veterinarian on a re ularbasis to ensure that they are beneficial to animal well-being and consistent with the goals of animal use.

reflect current knowledge.Personnel responsible for animal care and husbandry

species they work with to appropriately monitor the

effects of enrichment, as well as identify the.



Environmental enrichment :

Important method of improving well-being


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p p g g

-behaviors.

Should be provided in a consistent manner across the,

animal safety. Personnel should be made aware of the enrichment

program as one aspect o t e overa tra n ngprogram

Implementation of environmental enrichment shouldtake into account the scientific oals of the stud



Environmental enrichment

AAALAC site visitors will focus their attention on


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documentation of the review, andimplementationof the program.

AAALAC expects that the enrichment program willbe reviewed regularly by the IACUC, and that the

a equa e y represen s e researc

community and veterinarian(s) at the institution in.


ap er : pages -

age an pen space

There is new language in the 2011 Guide


159/371

There is new language in the 2011 Guide

space

with litters, some categories of NHPs and rabbits.

movement and postures (able to comfortably

stand erect, move without touching the sides,brachiation, etc)



Cage and pen space : pos on s a emen

Comply with all national or regional regulations,


160/371

p y g g

olicies and uidelines as well as conditions offunding.

AAALAC International considers performance

pens for housing animals used for research, testing orteaching.

Performance criteria described in the ILARGuide,

Ag Guide andETS 123 are used by AAALAC inassessin the ade uac of ca e or en s ace availableto the animal(s).



Some examples of performance criteria: (+ many species-specificcriteria)

age an pen space

At a minimum, animals must have enough space to express theirnatural postures and postural adjustments without touching the enclosurewalls or ceiling be able to turn around and have ready access to food


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walls or ceiling, be able to turn around, and have ready access to food. ,

away from areas soiled by urine and feces.

socially housed, animals should have sufficient space and structuralcomplexity to allow them to escape aggression or hide from otheranimals in the pair or group.

Cage height should take into account typical posture and provideadequate clearance for the animal from cage structures, such as feeders

.

Sufficient space should be allocated for mothers with litters to allow

the pups to develop to weaning without detrimental effects to the motheror the litter.



Trio-breeding (FAQ)

age an pen space

2011 Guide - postural adjustments, rest away from soiled areas, free

access to food and water, sufficient space for mothers with litters to


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allow the u s to develo to weanin without detrimental effects tothe mother or the litter.

ETS 123 - 51 in2 is acceptable for a monogamous pair (outbred/

In re or a tr o n re .

Trio-breeding may be acceptable when:

- ,

whethermultiple litters are present in the cage, difference in the age of the

pups of different litters, growth rate, need forcross-fostering, cagedimensions overall mana ement andhusbandr ractices such as ca e

sanitation, etc


ap er : page

e tere or out oor ous ng

Animals maintained in outdoor runs, pens, or other


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Animals maintained in outdoor runs, pens, or other

large enclosures, theremust have protection from

extremes in temperature or other harsh weather

retreat (for subordinate animals).


Sheltered or outdoor housing


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Councils Interpretation: No real change in requirements for outdoor

housin areas


ap er : pages -

Habituating animals to routine husbandry or


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experimental procedures should be encouraged,w enever possi e, as it may assist t e anima to ettercope with a captive environment by reducing stressassociated with novel procedures or people.

Thetype and duration of habituation needed will bedetermined by the complexity of the procedure. In mostcases rinci les o o erant conditionin ma beemployed during training sessions, using progressive

behavioral shaping, to induce voluntary cooperationwith rocedures



Habituation and training



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No real change in the accreditation process Animal training and habituation for specific

rocedures ma be warranted to reduce animal

stress and facilitate husbandry operations(e.g. training for NHPs or large animals to facilitate cage

changing procedures, or basic handling)


ap er : page

ee ng

In some species (e.g. nonhuman primates) and on


167/371

,and providing treats, including fresh fruit andvegetables, can be appropriate and improve well-

being. Scattering food in the bedding or presentingpart of the diet in ways that require the animals to. .,

primates) gives the animals the opportunity to forage,

which, in nature, normally takes up a largeproport on o t e r a y act v ty.


Cha ter 3: a e 67

Feedingounc s nterpretat on:


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Providing feed on the floor of the cage (e.g.foraging for NHPs, or to make feed more

accessible for post weanling rodents) is

considered acceptable as long as there are noproblems associated with contamination


ap er : page

ater ng ev ces

Watering devices, such as drinking tubes and


169/371

automated water delivery systems, should be checked

frequently to ensure appropriate maintenance,

, .


Cha ter 3: a e 68

Watering devicesounc s nterpretat on:


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No change in assessment/ accreditation


ap er : pages -

e ng an nest ng mater a s

h i i l h b dd d


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The term nesting materials has been addedand the use of appropriate materials is

emphasized



Bedding and nesting materialsounc s nterpretat on:

N h i h di i


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No change in the accreditation process


croenv ronmenta con t ons

With regard to IVCs - Verification of


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microenvironmental conditions may include

measurement of pollutants such as ammonia and

2 ,

animals behavior and appearance, and condition of

beddin and ca e sur aces.


Cha ter 3: a e 71

Microenvironmental conditionsounc s nterpretat on:

N h i th dit ti


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No change in the accreditation process


ap er : page

on or ng e ec veness o san a onMechanical washer function should be evaluated regularly and include

examination of mechanical components such as spray arms and moving


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examination of mechanical components such asspray arms and movingea ers as we asspray nozz es to ensure t ey are unct on ngappropriately. If sanitation is temperature dependent, the use oftemperature sensing devices (e.g., thermometers, probes, or temperaturesensitive indicator stri s is recommended to ensure that the e ui ment

being sanitized is exposed to the desired conditions.Whether the sanitation process is automated or manual,regularevaluation of sanitation effectiveness is recommended. This can be

performed by evaluating processed materials bymicrobiologic culture orthe use of organic material detection systems (e.g.,ATP bioluminescence)

and/or by confirming the removal of artificial soil applied to equipment.


Cha ter 3: a e 73

Monitoring sanitation effectiveness

Routine temperature monitoring during the wash

+


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+inspections as described.

Additional methods of assessing sanitatione ect veness are a so expecte

The frequency and type of monitoring should be,

practices (promote animal health and well-being,

avoid potential for disease transmission, and support


ap er : page

aste sposa

Sharps and glass should be disposed of in a


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Sharps and glass should be disposed of in amanner that will prevent injury to waste

handlers.


Cha ter 3: a e 74

Waste disposalounc s nterpretat on:

Not a new concept no change in the


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Not a new concept no change in theaccreditation process


ap er : page

mergency, wee en an o ay care

Animalsshouldbe cared for by qualified personnel

every day including weekends and holidays both to


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every day, including weekends and holidays, both to

safeguard their well-being and to satisfy research

.

available after work hours, on weekends, and onholida s.


Chapter 3: page 74

Emergency, wee en an o ay care

Not a new concept but one that is strengthened

mergency ve er nary care s now s e as a mus


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mergency ve er nary care s now s e as a mus

Emergency veterinary care is dependent upon daily

an ma care


ap er : page

ent cat on

As a method of identification of small rodents, toe-

clipping should be used only when no other


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clipping should be used only when no other

individual identification method is feasible. It may be

of age as it appears to have few adverse effects onbehavior and well-bein at this a e....es eciall i

toe-clipping and genotyping can be combined.


Cha ter 3: a e 75

Identification/ toe-clippingounc s nterpretat on:

While generally discouraged it is consideredt bl i i 7 d f l


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While generally discouraged, it is consideredacceptable in mice 7 days of age or less.

Combining toe-clipping with genotyping is

encouraged.


-

nexpecte outcomes

Newl enerated enot es should be care ulli d d h t th t ti l ff t


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Newl enerated enot es should be care ullmonitored andnew phenotypes that negatively affect

well-being should be reported to the IACUCand

manage n a manner o ensure e an ma s ea an

well being.

condition that negatively impacts animal well-being,this

should be reported to the IACUC, and more extensiveana ysis may e require to etter e ine t e p enotype


Cha ter 3: a e 77 & 28-29

Unexpected outcomesounc s nterpretat on:

Develop a program to increase awareness of

the need to report and a mechanism for


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the need to report, and a mechanism for

reporting back to IACUC

Important for unexpected outcomes in pilotstudies & other s ecial ex erimental

considerations (e.g. GMAs)



A uatics entire new section

New statements regarding imperative practices

must statementsR i hl i / hl i


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must statements Removing chlorine/chloramine

Appropriately sized biofilters

Careful use of disinfectants

Man new recommendations but most arenot new practices)


apter Pract cumapter Pract cum


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Jianfei Wang, D.V.M., Ph.D.Jianfei Wang, D.V.M., Ph.D.


Cas

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