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What Every IACUC Should Know About AAALAC International

Christian E. Newcomer, VMD, DACLAM Executive Director

OLAW On-Line Seminar, June 11, 2009

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AAALAC Mission AAALAC International is a voluntary

accrediting organization that enhances the quality of research, teaching, and testing by promoting humane, responsible animal careand use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards. Revised 1996

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ILAR Newsletter – October 1965 The AAALAC has been organized “to promote a program for the accreditation of laboratory animal care facilities which will encourage, promote and facilitate scientific research which includes the use of experimental animals.”

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Oversight Organization Comparison Animal

Welfare Act Public Health Service Policy AAALAC International

Responsible Agency USDA/APHIS NIH/OLAW Private Corporation

Applicability Required of all Users Required of PHS Awardees Voluntary

Species Covered Warm-blooded Vertebrates All

Standards Regulations PHS Policy & Guide Guide & Reference

Resources

Enforcement Unannounced Inspections Written “Assurance” Confidential Peer Reviews

Sanctions Legal/Fines Withdrawal of Assurance Approval

Revocation of Accreditation

Link to Funding None Direct Nearly None

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AAALAC Accreditation Process Organization prepares Program Description AAALAC conducts on-site assessment Council on Accreditation considers findings Organization notified of accreditation status Appeal process for revocation or withhold

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Accreditation Standards National requirements as baseline

Animal Welfare Act Health Research Extension Act of 1985

Guide is principal standard AAALAC Reference Resources as applicable AAALAC Policy Statements

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The “AAALAC Standard” Not a single document Encompasses the entire animal program Based on internationally recognized standards

Most are science-based Collective professional judgment of experts

Science-driven Applied through in-depth peer review process

Science-based

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Peer Review Process Program Description (PD) = organization’s experts PD Review = AAALAC staff experts Site Visit = Council and organization’s experts Council on Accreditation

Multiple member review of site visit report Full Council review at triannual meetings Committees on Consistency and Continuing Education

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Who is Accredited? Over 770 programs in 31 countries Top 100 NIH awardees All major pharmaceutical companies All commercial laboratory animal producers Government laboratories (NIH, DoD, VA, et al.) Large biotechnology companies Large contract research organizations

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Growth in Accredited Programs Total Number of Accredited Units

616626

636 641649

655

673

692

710

746

500

550

600

650

700

750

800

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

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Countries With Accredited Programs Austria Indonesia Singapore Belgium Israel South Africa Canada Italy Spain China/Hong Kong Japan Switzerland Denmark Korea Taiwan Egypt Mauritius Thailand France Netherlands United Kingdom Germany Norway England Hungary Peru Scotland India Philippines USA

Russia

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6%11%

17%

37%

29%Academic

Commercial

Government

Non-Profit

Hospital

Proportion of Accredited Unitsby Industry Sector

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What People Value Most About Accreditation ...

“It assures the credibility of ourprogram among funding sources” From a 1998

survey ofaccredited

“It provides the public withprograms a positive image”

“It helps convince management ofthe need to commit resources to maintain a high-quality program”

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What People Value Most About Accreditation ...

“Application of AAALACstandards ensures high-qualityFrom a 1998

survey of research and animal care,accredited resulting in better science” programs

“It conveys a high level ofprofessionalism to the scientificcommunity”

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Accreditation Outcomes Provisional Status Full Accreditation Deferred Accreditation Probation Withhold/Revoke Accreditation

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Mandatory Item vs.Suggestion for Improvement

Mandatory Item = a deficiency which must becorrected for Full Accreditation to be awarded or continued

Suggestion for Improvement (SFI) = item which the Council feels is desirable to upgrade an alreadyacceptable or even commendable program

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2020

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0

50

100

150

200

1996 1998 2000 2002 2004 2006 2008

# Mandatory

Deficiencies

Total Number of MandatoryDeficiencies Per Year

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0%

20%

40%

60%

80%

Institutional

Policies

Laboratory

Animal

Management

Veterinary

Care

Physical

Plant

Mandatory Items SFIs

Percent Mandatory Items & SFIs for the Period 2003-2008

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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1999 2001 2003 2005 2007

Institutional Policies

Laboratory Animal

Mgmt

Veterinary Care

Physical Plant

Percent Mandatory Deficiencies byCategory (1999-2008)

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Top Three Mandatory DeficienciesIdentified During Site Visits Occupational Health and Safety Issues Institutional Animal Care and Use Committee Issues Heating, Ventilation and Air Conditioning System

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010

20

30

4050

60

70

8090

100

1998 2000 2002 2004 2006 2008 2010

Mandatory

SFI

Trendline (Mandatory)

Trendline (SFI)

Occupational Health & Safety

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OHSP of Total Mandatory Items &SFIs-Percent and Rank Order

0

5

10

15

20

25

30

35

40

1998 2000 2002 2004 2006 2008 2010

Percent

Mandatory

Percent SFIs

Trendline

(Mandatory)

Trendline

(SFIs)

ProgramAdministration

Hazard Identification/RiskAssessment

Animal ExperimentationInvolving Hazards

Facilities,Procedures,Monitoring

Medical Evaluation & Preventive Medicine for Personnel

Personal Protection Personnel Training

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0

20

40

60

80

100

120

1990 1995 2000 2005 2010

Mandatory

SFI's

Trendline (Mandatory)

Trendline (SFI's)

IACUC (or Comparable Review Function)

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IACUC (or Comparable Review Function)

0

20

40

60

80

100

120

1993 1995 1997 1999 2001 2003 2005 2007

Mandatory

SFI's

Problem Areas Protocol Review Policies Composition and

Participation Semiannual

Evaluations Documentation Training

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0%

20%

40%

60%

80%

100%

% Mandatory % SFI

Ceilings, Floors, Walls,Doors

Facilities for AsepticSurgery

Facilities for SanitizingMaterials

Functional Areas

HVAC

Power and Lighting

Percent Physical Plant Findings (2003-2008)

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0%

20%

40%

60%

80%

100%

2003 2004 2005 2006 2007 2008

Mandatory SFIs

Percent Heating, Ventilation, & Air Conditioning(HVAC) of Total Physical Plant Deficiencies

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0

5

10

15

20

25

30

35

40

45

50

Percentage

Behavioral Management

Emergency, Weekend &Holiday Care

Housing

Husbandry

Illumination

Noise

Population Management -Identification & Records

Sanitation/Maintenance

Space Recommendations

Percent Animal Environment, Housing andManagement Mandatory Findings (2003 – 2008)

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Percent Program of AdequateVeterinary Care Findings

0%

10%

20%

30%

40%

50%

2003 2004 2005 2006 2007 2008

Mandatory Suggestions

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“Mission Creep” Reality

Guide is over 12 years old State-of-the-art practices have evolved “Mandatory” items always based on existing standards “Suggestions for Improvement” are just that AAALAC’s BOT representatives are continuously engaged

on this topic Perceptions

AAALAC over-interprets standards AAALAC imposes new standards “Suggestions for Improvement” must be followed

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Judgments Differ/No Clear Standard AAALAC looks to science

Published data Scientific principles Expert opinion Experience with proven methods/practices

Example: alcohol as a disinfectant

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Your Questions and Comments Please

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