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