Guidelines on genetically engineered animalsGuidelines on: transgenic animals (1997) temporary document Revision needed for Animal welfare implications of advancements in genetic engineering
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Guidelines on geneticallyengineered animals
CCAC National Workshop 2012
Gilly Griffin, PhDCCAC Guidelines and Three Rs Programs Director
Why was this Guidelines DocumentDeveloped?
Guidelines on: transgenic animals(1997) temporary document
Revision needed for
Animal welfare implications ofadvancements in genetic engineering
Problems associated with assigningCategories of Invasiveness
How was this Guidelines DocumentDeveloped?
Volunteer subcommittee
Dr. Bruce Murphy Université de Montréal S
Dr. Garth Fletcher Memorial University of Newfoundland S
Mr. Darren Grandel Ontario SPCA C
Dr. Gary Halbert Canadian Food Inspection Agency S/V
Dr. Hélène Héon CHUM research centre V
Dr. Eike-Henner Kluge University of Victoria E
Dr. Lauryl Nutter Toronto Centre for Phenogenomics S
Dr. Sui-Pok Yee University of Connecticut Health Center S
Draft Reviews
Four external reviews2006 – peer review, 21 experts
2008 – widespread review,35 responses
2010 – ‘final’ review,32 responses
2011 – additional widespreadreview, 21 responses
Impact analysis2009-2010 – 5 group discussions
Why Single Out Genetically EngineeredAnimals?
Welfare concerns for many GEAs same as forconventional animals
Identify welfare concerns related to genetic modificationearly
Particular challengesNumbers of animals and procedures
Additional public concern
Genetically Engineered Animals HaveBeen Around for a Long Time
Good practices exist for generation, care and use
Guidelines don’t detract from good programs
Some institutions, investigators and ACCmembers are less experienced in implementationof the Three Rs in this area
Guidelines assist in ensuring necessary elementsin place
Why is the Guidelines DocumentInclusive of all Species?
Focus on general principles
Difference between institutions andtypes of research requires flexibility
More specific information inimplementation tools
best practices for procedures
assessment of welfare
documentation
Assessment of Welfare of GEAs
Procedures should be determined byinvestigator and approved by ACC
Initial assessment may be sufficient if welfare isnot compromised
If welfare concerns, may need more frequentmonitoring and mitigation
Benefits animals, science and addresses publictrust issues
Welfare Status
Refers to the animal itself (CIs refer to theprocedures)
Welfare statuses:
Standard
Mild to moderate
Severe
Any difference from standard should be reflectedin CIs when considering the impact of procedures
Nomenclature
Enables investigators toproperly identify GEA lines
Essential in accuratelyinterpreting findings and inpublication
Critical to maintainingfunctional databases andavoiding duplication ofmodels
Additional Reporting
Good record keeping should be standard, ifgood systems in place then should be fewchanges
Guidelines provide a framework, gives leewayfor ACCs to use their own procedures
Examples of how information could be capturedand shared will be provided
Are Animal Passports Required?
Term “animal passport” has been replaced byrequirement to document animal information
Passport is an example and may be a useful reference ifdocumentation practices not in place
Emphasis on ensuring an effective system is in place
Archiving/Cryopreservation
Investigators should usethese technologies
Risk assessment forcatastrophic loss of line,genetic drift, fertilityproblems etc.
can the line be retrievedelsewhere
are controls in place toprevent loss
costs associated withmaintaining frozen stockversus live animals
Counting Animals
Requirement to count GEAs separately fromnon-GEAs in 1997 guidelines
Assigning CI D to new lines created impressionof GEAs with a high potential for pain anddistress
Reclassification did not occur in many cases
Reporting Animals
For generation and use:
numbers of geneticallyengineered animals andwildtype animals reportedto CCAC on AUDF
For breeding colonies:
numbers of animals &welfare concerns reportedannually to ACC
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