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Proceedings for Pain Management and Humane Endpoints

Multinational Agreements/International Harmonization

J.G. Miller, DVM
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)

Current efforts to harmonize laboratory animal welfare standards are focused principally in Europe. Important multinational agreements reflecting these efforts include the European Union's (EU's) Directive 86/609 and the Council of Europe's (CoE's) treaty ETS 123. At the same time, the 1996 Guide for the Care and Use of Laboratory Animals (Guide) is gaining wide acceptance as an extremely useful set of standards that can be applied internationally. All three of these multinational documents recognize that the use of animals will continue to be necessary for the foreseeable future to answer scientific questions. All three also have as a principal focus the avoidance, minimization and alleviation of pain and distress. Through a high degree of cooperation among those who developed these multinational standards, these documents are consistent in their recommendations and requirements. Thus, there appears to be agreement on both the importance of minimizing pain and distress, and on the general standards that should be applied. However, uniform implementation of these standards may be problematic. In the US, federal requirements (USDA Animal Welfare Regulations and the Public Health Service's Policy on Humane Care and Use of Laboratory Animals) are closely aligned with the recommendations of the Guide. The EU requires that member states enact national legislation that implements the provisions of its Directives. The CoE expects the same of its treaty signatories. The translation of these requirements and standards into legislation, and the implementation and oversight of such legislation, can lead to inconsistencies in the application of specific standards. Although the consideration of pain and distress is consistently addressed in each of the aforementioned multinational documents, it is still susceptible to inconsistent application at the local level. Harmonizing the application of agreed-upon standards will be a priority for multinational bodies, national governments, other interested groups (e.g., the Federation of Laboratory Animal Science Associations, the International Conference on Harmonisation, the European Centre for the Validation of Alternative Methods) and independent accreditation and assessment bodies such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

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