AAALAC International’s review and implementation
of the revised guidelines
December 14, 2010
The AAALAC International Council on Accreditation has been working tirelessly over the last several months to prepare for the publication of updates to three important guidance documents: the update of ILAR’s Guide for the Care and Use of Laboratory Animals (the Guide, NRC); the new European Directive 2010/63/EU on the Protection of Animals used for Scientific Purposes which contains accommodation and care standards from the European Treaty Series 123 (ETS 123); and the newly updated and released Guide for the Care and Use of Agricultural Animals in Research and Teaching (the Ag Guide, FASS 2010).
The following is an overview of how this review has progressed throughout 2010:
Review of the updated Guide (NRC 2010)
- In preparation for an intense two-day retreat in July, Council formed four subcommittees, each one charged with reviewing one of Chapters 2-5 in the prepublication release of the new ILAR Guide.
- The analysis performed by the subcommittees included a line-by-line comparison of the 1996 Guide and the 2010 Guide. The committees looked at all topics that were revised, added or deleted, and their potential impact on the AAALAC International accreditation process.
- The analysis also included every written comment provided to the Council by member organizations represented on AAALAC’s Board of Trustees, as well as comments received from other scientific organizations.
- As a result of the many changes that were discussed, 121 were classified according to their need for clarification. Some of these changes were significant with great potential impact on the accreditation process, while others were issues that will simply require communication within the research community regarding Council’s interpretation of the change.
- 16 issues were identified as very important and needing in-depth discussion by the full Council. These issues range from Institutional Animal Care and Use Committee function, institutional responsibilities, cage space, occupational health and safety, and physical plant.
- 13 issues were identified as requiring some type of “formal” clarification or interpretation by the Council ,either through a new Position Statement (AAALAC’s current Position Statements can be viewed at http://www.aaalac.org/accreditation/positionstatements.cfm), or by developing new Frequently Asked Questions (AAALAC’s current FAQs can be viewed at http://www.aaalac.org/accreditation/faq_landing.cfm). It is anticipated that the FAQs and proposed Position Statements will be disseminated in February 2011.
Review of the updated Ag Guide (FASS 2010)
- Concurrent with the review of the 2010 Guide, the AAALAC Council on Accreditation created a committee comprised of both Council and Board members to review the updated Ag Guide.
- The Ag Guide review committee determined that there is extensive harmonization between the Ag Guide and the revised ILAR Guide, but some key differences were identified. (Additional details on the differences between the two documents and Council’s interpretation of those differences will be communicated in the months ahead.) The review committee and the Council (unanimously) recommended to the Board of Trustees that the Ag Guide be “upgraded” from a Reference Resource (see http://www.aaalac.org/accreditation/resources.cfm for a complete list of Reference Resources) to a primary standard for conducting assessments.
- The review committee and the Council determined that a new Position Statement will be crafted which will provide clarification in determining when to use the Ag Guide and when to follow the ILAR Guide.
Review of the European Directive and ETS 123
- The AAALAC Council has used ETS 123 as a basis for reviewing programs in Europe for several years, in addition to the applicable legislation (i.e., European Directive 86-609). With the final draft of the new European Directive complete, Council conducted a review of the Directive to determine the impact its finalization will have on the accreditation process in Europe.
- In early July, the European Section of Council met to conduct a preliminary assessment of the revised European Directive compared with the 2010 ILAR Guide. The comparison was made mainly with the text of the Directive because it will be a mandatory document to follow within the European Union. The results of and conclusions from that discussion were incorporated into the review process of the ILAR Guide to determine the parallels between the two documents.
- Council paid special attention to the fact that the Directive contains the accommodation and care standards of the ETS 123 Appendix A that were revised in 2006. The ETS 123 was issued by the Council of Europe which consists of 47 countries (including the 27 countries of the European Union which are subjected to the Directive).
- The full Council determined that there is extensive harmonization between the principles of the updated European guidelines and the ILAR Guide, with some differences identified in engineering standards. Guidance from AAALAC will be forthcoming to clarify these differences as well as AAALAC’s expectations for accredited institutions.
Summary: “Three Primary Standards”
The intense work of the Council continues. When it is concluded and the new Guide is published in final format, AAALAC will release a complete package of information for accredited institutions that includes proposed new Position Statements which will be made available for a 30-day public comment period; new FAQs; a revised Program Description that reflects the content of the updated Guide, which will be used for the Fall trimester (September through November) 2011 site visits; and details on AAALAC’s expectations for implementing the updated guidelines (including timeframes for adoption, as AAALAC plans to allow for reasonable transition periods for all institutions subject to the new standards).
During the Fall 2011 trimester, AAALAC International will begin to use Three Primary Standards to evaluate animal care and use programs: the ILAR Guide, the FASS Ag Guide, and the ETS 123. (This is a change from simply recognizing the ILAR Guide as the sole primary standard. Until that time, the 1996 version of the Guide will continue to be the main standard used by AAALAC to evaluate animal care and use programs.
We will continue to post updates on this ongoing implementation process for the entire animal care and use committee, and believe that this process will ultimately allow AAALAC International to better harmonize and implement global performance-based standards for animal care and use.
For more details…
Click here to download a copy of AAALAC’s presentation at the 2010 National AALAS: “Implementing the New Guide” for more details. (pdf file)
A special thanks to the Council on Accreditation
AAALAC wishes to recognize the tremendous work of the Council during this time of transition. In addition to continuing to conduct hundreds of accreditation site visits this year, members of the Council are investing substantial amounts of time, thought and intense consideration as they review and distill these new guidelines and determine how they should be clarified and implemented. We are grateful for their service to AAALAC International and the animal care and use community.
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