7/27/2019 FINAL English Version China Presentations
1/371
Welcome!Welcome! 2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
2/371
AAALACInternat ona
Y.Alex
Zhang,
Ph.D.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
3/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
4/371
Established in 1965
Non-governmental
Non-profit Does not establish independent
standards/policies, but relies on scientific data
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
5/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
6/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
7/371
nese em ers o e ounc onAccreditation
Dr. Y. Alex Zhang (Section Leader)
Dr. Jianfei Wang
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
8/371
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.
. ,
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
9/371
Demographics Comparison Accredited and
Commercial = 41%
=
Commercial = 70%
Academic = 15%
Government = 14%
Non-Profit = 11%
Government = 9%
Non-Profit = 3%
Hospital = 5% Hospital = 3%
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
10/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
11/371
*As of August 2009
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
12/371
Number of Chinese Institutions
ee ng ccre a on ac ear 12
10
6No.Units
2
2005 2006 2007 2008 2009 2010 2011
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
13/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
14/371
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
15/371
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
16/371
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
17/371
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
18/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
19/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
20/371
In the face of increasin
globalization of animal-based,
care and use standards and practicesbecomes essential and the role
.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
21/371
Something to be
proud of.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
22/371
verv ew o anges n t everv ew o anges n t e
KathrynBayne,M.S.,Ph.D.,D.V.M.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
23/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
24/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
25/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
26/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
27/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
28/371
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)
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
29/371
e erm na ons o e ounc
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
30/371
e erm na ons o e ounc
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
31/371
e erm na ons o e ounc
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
32/371
e erm na ons o e ounc
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
33/371
or ose o oun
ew must statements ui e
Chapter 1: 1
Chapter 2: 11
Chapter 3: 4
Chapter 4: 10
Chapter 5: 11
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
34/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
35/371
us ou ay
Must = imperative and mandatory for humane
animal care and use
Should = stron recommendation May = suggestion to be considered
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
36/371
er ormance r er a
er ormance tan ar
Performance Criteria
Professional Judgment
Performance Approach - requires professional
, ,achieve specific goals.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
37/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
38/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
39/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
40/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
41/371
Cha ter 2: Animal Care and Use
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
Changes:MinimalChange,Expanded/ChangeofWording,
New
Sections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
42/371
Cha ter 2: Animal Care and Use
Program
rogram vers g
Post-Approval Monitoring
Disaster Planning and Emergency Preparedness
Changes:MinimalChange,Expanded/ChangeofWording,
New
Sections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
43/371
ew us s mpera ves ap er
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
44/371
ew us s mpera ves ap er
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
45/371
ew us s mpera ves ap er
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
.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
46/371
ew us s mpera ves ap er
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]
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
47/371
Cha ter 3: Animal Environment
Housing and Management
Terrestrial Environment
croenv ronmen an acroenv ronmen
Temperature and Humidity
Illumination
Noise and Vibration
Changes:MinimalChange,Expanded/ChangeofWording,
New
Sections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
48/371
Cha ter 3: Animal Environment
Housing and Management
Terrestrial Housing
croenv ronmen r mary nc osure
Environmental Enrichment
Naturalistic Environments
S ace
Changes:MinimalChange,Expanded/ChangeofWording,
New
Sections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
49/371
Cha ter 3: Animal Environment
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
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
50/371
Cha ter 3: Animal Environment
Housing and Management
erres r a n ma s
Terrestrial Management
Population Management
Identification
Record Kee in
Breeding, Genetics and Nomenclature
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
51/371
Cha ter 3: Animal Environment
Housing and Management
Aquatic Environment
Water Quality
Life Su ort S stem Temperature, Humidity and Ventilation
Illumination
Noise and Vibration
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
52/371
Cha ter 3: Animal Environment
Housing and Management
Aquatic Housing
Environmental Enrichment and Social Housing
Sheltered or Outdoor Housin Space
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
53/371
Cha ter 3: Animal Environment
Housing and Management
Aquatic Management
Husbandry
Food, Water, Substrate
Sanitation
Waste Disposal
Emergency, Weekend and Holiday Care
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
Ch 3 A i l i
7/27/2019 FINAL English Version China Presentations
54/371
Cha ter 3: Animal Environment
Housing and Management
qua c n ma s
Aquatic Management
Population Management
Identification
Record Kee in
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
55/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
56/371
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
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
57/371
ap er : e er nary are
Medical Management Emergency Care
Record Keeping
Surgery
Pre-surgical Planning
Surgical Facilities
Aseptic Technique Intraoperative Monitoring
-Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
58/371
ap er : e er nary are
a n an stress
Anesthesia and Analgesia
Euthanasia
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
59/371
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
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
60/371
ew us s mpera ves ap er
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
61/371
ew us s mpera ves ap er
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
62/371
ew us s mpera ves ap er
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
.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
63/371
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
Changes:MinimalChange,Expanded/ChangeofWording,NewSections
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
64/371
ew us s mpera ves ap er
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.
2012 AAALAC International. All rights reserved.
Three Primary Standards
7/27/2019 FINAL English Version China Presentations
65/371
y
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
66/371
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)
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
67/371
Snapshot 2011 Guide
25
30
Environment,Housing,
20
F
indings
OccHealth
10
15
%ofT
otal
VetCare
0
5 PhysicalPlant
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
68/371
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
69/371
2011 Guide Webinars Available...
- -
http://www.aaalac-outreach.org/
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
70/371
C apter2:An ma Carean UseY. Alex Zhang, Ph.D.Y. Alex Zhang, Ph.D.
2012 AAALAC International. All rights reserved.
Topics
7/27/2019 FINAL English Version China Presentations
71/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
72/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 12
7/27/2019 FINAL English Version China Presentations
73/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
74/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 12-13
7/27/2019 FINAL English Version China Presentations
75/371
Remaining current
ounc s nterpretat on:
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
76/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 12-13
7/27/2019 FINAL English Version China Presentations
77/371
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,
.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
78/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 15
7/27/2019 FINAL English Version China Presentations
79/371
Collaborations
ounc s nterpretat on:
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
80/371
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.
2012 AAALAC International. All rights reserved.
Chapter 2: pages 15-17
7/27/2019 FINAL English Version China Presentations
81/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 15-17
7/27/2019 FINAL English Version China Presentations
82/371
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
2012 AAALAC International. All rights reserved.
Chapter 2: pages 15-17
7/27/2019 FINAL English Version China Presentations
83/371
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
84/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 18
7/27/2019 FINAL English Version China Presentations
85/371
Prevention and control strategies
Councils Interpretation:
This new section sim l clarifies the
longstanding hallmarks of:
Job-related risk assessment Prevention and control
2012 AAALAC International. All rights reserved.
Chapter 2: pages 18-19
7/27/2019 FINAL English Version China Presentations
86/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 18-19H d id ifi i d i k
7/27/2019 FINAL English Version China Presentations
87/371
Hazard identification and risk assessment
Councils Interpretation:
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
88/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 19F iliti i t d it i
7/27/2019 FINAL English Version China Presentations
89/371
Facilities, equipment and monitoring
Councils Interpretation:
No chan e in the accreditation rocess
Council endorses the concept of engineering
protection
reference resource for the accreditation process
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
90/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 22P l t ti
7/27/2019 FINAL English Version China Presentations
91/371
Personnel protection
Councils Interpretation:
Council ex ects that when ersonnel are
required to wear respirators, respiratory fit
testin and trainin mustbe rovided
2012 AAALAC International. All rights reserved.
Chapter 2: pages 22-23
Medical evaluation and preventive medicine for personnel
7/27/2019 FINAL English Version China Presentations
92/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 22-23Medical evaluation/ preventative medicine
7/27/2019 FINAL English Version China Presentations
93/371
Medical evaluation/ preventative medicine
ounc s n erpre a on:
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
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
94/371
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
2012 AAALAC International. All rights reserved.
Chapter 2: page 23
Medical evaluation/ preventative medicine
7/27/2019 FINAL English Version China Presentations
95/371
Medical evaluation/ preventative medicine
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
2012 AAALAC International. All rights reserved.
ap er : pages
7/27/2019 FINAL English Version China Presentations
96/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 23-24Reporting concerns
7/27/2019 FINAL English Version China Presentations
97/371
Reporting concerns
ounc s nterpretat on:
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
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
98/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 24
IACUC constitution and function
7/27/2019 FINAL English Version China Presentations
99/371
IACUC constitution and function
ounc s nterpretat on:
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).
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
100/371
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.
2012 AAALAC International. All rights reserved.
Chapter 2: page 25
rogram rev ew an ac es nspec on
7/27/2019 FINAL English Version China Presentations
101/371
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
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
102/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 25-26Protocol review
7/27/2019 FINAL English Version China Presentations
103/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 25-26Protocol review
7/27/2019 FINAL English Version China Presentations
104/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 25-26Protocol review
7/27/2019 FINAL English Version China Presentations
105/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
106/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 27
Harm-Benefit analysis
7/27/2019 FINAL English Version China Presentations
107/371
y
ounc s nterpretat on:
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
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
108/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 27-28
Humane endpoints
7/27/2019 FINAL English Version China Presentations
109/371
ounc s n erpre a on:
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 .
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
110/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 28-29 &77
Unexpected outcomes
7/27/2019 FINAL English Version China Presentations
111/371
ounc s nterpretat on:
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)
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
112/371
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?
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 29
Physical Restraint
7/27/2019 FINAL English Version China Presentations
113/371
ounc s n erpre a on:
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
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
114/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 30
Multiple survival surgeries
7/27/2019 FINAL English Version China Presentations
115/371
ounc s nterpretat on:
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)
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
116/371
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
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 30-31
Food and fluid regulation
7/27/2019 FINAL English Version China Presentations
117/371
ounc s nterpretat on:
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, , ,
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
118/371
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,
- , .
2012 AAALAC International. All rights reserved.
Cha ter 2: a e 31
Non-pharmaceutical grade substances
7/27/2019 FINAL English Version China Presentations
119/371
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,,
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
120/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 32-33
Agricultural animals
7/27/2019 FINAL English Version China Presentations
121/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages -
7/27/2019 FINAL English Version China Presentations
122/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 2: a es 33-34
Postapproval monitoring
7/27/2019 FINAL English Version China Presentations
123/371
: 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
2012 AAALAC International. All rights reserved.
ap er : page
7/27/2019 FINAL English Version China Presentations
124/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
125/371
PP
7/27/2019 FINAL English Version China Presentations
126/371
apter Pract cumapter Pract cum
Y. Alex Zhang, Ph.D.Y. Alex Zhang, Ph.D.
2012 AAALAC International. All rights reserved.
Case StudyFindin :
7/27/2019 FINAL English Version China Presentations
127/371
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.
2012 AAALAC International. All rights reserved.
Case StudyFindin :
7/27/2019 FINAL English Version China Presentations
128/371
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
2012 AAALAC International. All rights reserved.
Case StudyFindin :
7/27/2019 FINAL English Version China Presentations
129/371
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.
2012 AAALAC International. All rights reserved.
Case Stud
Finding:
7/27/2019 FINAL English Version China Presentations
130/371
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.
2012 AAALAC International. All rights reserved.
Case StudyFinding:
I
7/27/2019 FINAL English Version China Presentations
131/371
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.
2012 AAALAC International. All rights reserved.
Case Study
Finding:
ou o serve a gra ua e
7/27/2019 FINAL English Version China Presentations
132/371
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.
2012 AAALAC International. All rights reserved.
Finding:
7/27/2019 FINAL English Version China Presentations
133/371
A bench top in a
had this appearance.
conducted in this
.
issues?
2012 AAALAC International. All rights reserved.
C apter 3: Env ronment Hous ng
7/27/2019 FINAL English Version China Presentations
134/371
C apter3:Env ronment,Hous ngJianfei Wang, D.V.M., Ph.D.Jianfei Wang, D.V.M., Ph.D.
2012 AAALAC International. All rights reserved.
Topics
Invertebrates
Temperature guidelines
Outdoor housing
Habituation/ training
Relative humidity Feeding
7/27/2019 FINAL English Version China Presentations
135/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 41
Invertebrate species
ounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
136/371
ounc s nterpretat on:
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.
2012 AAALAC International. All rights reserved.
ap er : page
New tem erature uidelines
I l d b lb i i l h ld b
7/27/2019 FINAL English Version China Presentations
137/371
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
2012 AAALAC International. All rights reserved.
ap er : page
TABLE 3 1 R d d D B lb M i t l
7/27/2019 FINAL English Version China Presentations
138/371
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
2012 AAALAC International. All rights reserved.
New temperature guidelines
7/27/2019 FINAL English Version China Presentations
139/371
Councils Interpretation:
guidelines
2012 AAALAC International. All rights reserved.
Relative Humidity
R l i h idi h ld l b ll d b
7/27/2019 FINAL English Version China Presentations
140/371
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.
2012 AAALAC International. All rights reserved.
7/27/2019 FINAL English Version China Presentations
141/371
Chapter 3: page 46 (Chapter 5: page 139)
VAV systems
7/27/2019 FINAL English Version China Presentations
142/371
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.
2012 AAALAC International. All rights reserved.
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
7/27/2019 FINAL English Version China Presentations
143/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 47
Rec cled air
The use of recycled air to ventilate animal rooms may save
7/27/2019 FINAL English Version China Presentations
144/371
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.
2012 AAALAC International. All rights reserved.
Chapter 3:page47
Council Inter retation: continue to use the
Recyc e air
guidelines outlined in the 1996 Guide (FAQ)
7/27/2019 FINAL English Version China Presentations
145/371
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.
2012 AAALAC International. All rights reserved.
ap er : page
a os an soun generators
7/27/2019 FINAL English Version China Presentations
146/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 50
Radios and sound generators
ounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
147/371
Although this is a new recommendation, this islikely not a significant change for most
programs
2012 AAALAC International. All rights reserved.
ap er : page
rat on
7/27/2019 FINAL English Version China Presentations
148/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 50
Vibration
ounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
149/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages - an Social Housing
space as well as supplementary structures and resources required tomeet physical physiologic and behavioral needs
7/27/2019 FINAL English Version China Presentations
150/371
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.
2012 AAALAC International. All rights reserved.
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-
7/27/2019 FINAL English Version China Presentations
151/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages -
Flooring should be solid perforated or slatted with
7/27/2019 FINAL English Version China Presentations
152/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 51-52
Wire bottom cages
Councils Interpretation:
7/27/2019 FINAL English Version China Presentations
153/371
Continue to encoura e the use of solid-bottomcages
should be provided.
2012 AAALAC International. All rights reserved.
ap er : page
e ng
7/27/2019 FINAL English Version China Presentations
154/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 52
Bedding
ounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
155/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages -
Enrichment programs should be reviewedby the
7/27/2019 FINAL English Version China Presentations
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.
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 53-54
Environmental enrichment :
Important method of improving well-being
7/27/2019 FINAL English Version China Presentations
157/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 53-54
Environmental enrichment
AAALAC site visitors will focus their attention on
7/27/2019 FINAL English Version China Presentations
158/371
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.
2012 AAALAC International. All rights reserved.
ap er : pages -
age an pen space
There is new language in the 2011 Guide
7/27/2019 FINAL English Version China Presentations
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)
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 55-63
Cage and pen space : pos on s a emen
Comply with all national or regional regulations,
7/27/2019 FINAL English Version China Presentations
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).
2012 AAALAC International. All rights reserved.
Chapter 3: pages 55-63
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
7/27/2019 FINAL English Version China Presentations
161/371
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.
2012 AAALAC International. All rights reserved.
Chapter 3: pages 55-63
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
7/27/2019 FINAL English Version China Presentations
162/371
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
2012 AAALAC International. All rights reserved.
ap er : page
e tere or out oor ous ng
Animals maintained in outdoor runs, pens, or other
7/27/2019 FINAL English Version China Presentations
163/371
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).
2012 AAALAC International. All rights reserved.
Sheltered or outdoor housing
7/27/2019 FINAL English Version China Presentations
164/371
Councils Interpretation: No real change in requirements for outdoor
housin areas
2012 AAALAC International. All rights reserved.
ap er : pages -
Habituating animals to routine husbandry or
7/27/2019 FINAL English Version China Presentations
165/371
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
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 64-65
Habituation and training
ounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
166/371
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)
2012 AAALAC International. All rights reserved.
ap er : page
ee ng
In some species (e.g. nonhuman primates) and on
7/27/2019 FINAL English Version China Presentations
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.
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 67
Feedingounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
168/371
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
2012 AAALAC International. All rights reserved.
ap er : page
ater ng ev ces
Watering devices, such as drinking tubes and
7/27/2019 FINAL English Version China Presentations
169/371
automated water delivery systems, should be checked
frequently to ensure appropriate maintenance,
, .
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 68
Watering devicesounc s nterpretat on:
7/27/2019 FINAL English Version China Presentations
170/371
No change in assessment/ accreditation
2012 AAALAC International. All rights reserved.
ap er : pages -
e ng an nest ng mater a s
h i i l h b dd d
7/27/2019 FINAL English Version China Presentations
171/371
The term nesting materials has been addedand the use of appropriate materials is
emphasized
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 68-69
Bedding and nesting materialsounc s nterpretat on:
N h i h di i
7/27/2019 FINAL English Version China Presentations
172/371
No change in the accreditation process
2012 AAALAC International. All rights reserved.
croenv ronmenta con t ons
With regard to IVCs - Verification of
7/27/2019 FINAL English Version China Presentations
173/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 71
Microenvironmental conditionsounc s nterpretat on:
N h i th dit ti
7/27/2019 FINAL English Version China Presentations
174/371
No change in the accreditation process
2012 AAALAC International. All rights reserved.
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
7/27/2019 FINAL English Version China Presentations
175/371
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.
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 73
Monitoring sanitation effectiveness
Routine temperature monitoring during the wash
+
7/27/2019 FINAL English Version China Presentations
176/371
+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
2012 AAALAC International. All rights reserved.
ap er : page
aste sposa
Sharps and glass should be disposed of in a
7/27/2019 FINAL English Version China Presentations
177/371
Sharps and glass should be disposed of in amanner that will prevent injury to waste
handlers.
2012 AAALAC International. All rights reserved.
Cha ter 3: a e 74
Waste disposalounc s nterpretat on:
Not a new concept no change in the
7/27/2019 FINAL English Version China Presentations
178/371
Not a new concept no change in theaccreditation process
2012 AAALAC International. All rights reserved.
ap er : page
mergency, wee en an o ay care
Animalsshouldbe cared for by qualified personnel
every day including weekends and holidays both to
7/27/2019 FINAL English Version China Presentations
179/371
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.
2012 AAALAC International. All rights reserved.
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
7/27/2019 FINAL English Version China Presentations
180/371
mergency ve er nary care s now s e as a mus
Emergency veterinary care is dependent upon daily
an ma care
2012 AAALAC International. All rights reserved.
ap er : page
ent cat on
As a method of identification of small rodents, toe-
clipping should be used only when no other
7/27/2019 FINAL English Version China Presentations
181/371
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.
2012 AAALAC International. All rights reserved.
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
7/27/2019 FINAL English Version China Presentations
182/371
While generally discouraged, it is consideredacceptable in mice 7 days of age or less.
Combining toe-clipping with genotyping is
encouraged.
2012 AAALAC International. All rights reserved.
-
nexpecte outcomes
Newl enerated enot es should be care ulli d d h t th t ti l ff t
7/27/2019 FINAL English Version China Presentations
183/371
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
2012 AAALAC International. All rights reserved.
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
7/27/2019 FINAL English Version China Presentations
184/371
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)
2012 AAALAC International. All rights reserved.
Cha ter 3: a es 77-88
A uatics entire new section
New statements regarding imperative practices
must statementsR i hl i / hl i
7/27/2019 FINAL English Version China Presentations
185/371
must statements Removing chlorine/chloramine
Appropriately sized biofilters
Careful use of disinfectants
Man new recommendations but most arenot new practices)
2012 AAALAC International. All rights reserved.
apter Pract cumapter Pract cum
7/27/2019 FINAL English Version China Presentations
186/371
Jianfei Wang, D.V.M., Ph.D.Jianfei Wang, D.V.M., Ph.D.
2012 AAALAC International. All rights reserved.
Cas
Top Related