Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use Summary of a Workshop (2015) / Chapter Skim
Currently Skimming:
3 Regulatory and Advisory Perspectives
3 Regulatory and Advisory Perspectives
Pages 11-26
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 11... ...
Gilly Griffin, Director of Standards at the Canadian Council on Animal Care, discussed Canada's view of performance standards, and Judy MacArthur Clark, Head of the United Kingdom's Animals in Science Regulation Unit, spoke about the U.K. perspective and how it fits within the European regulatory system.
|
From page 12... ...
The Guide, Silk noted, is not an operations document, but rather a collection of experts' wisdom assembled "under the benevolent leadership of the National Academies and ILAR, which serves the interest of nonpartisan scientific integrity." She clarified a misunderstanding as to whether federal agencies strongly support the use of performance standards. "Performance standards are the most important component of the infrastructure of PHS oversight of animal programs, and OLAW stands behind this statement.
|
From page 13... ...
mix performance and engineering standards to show there is more than one way to achieve animal welfare goals, explained Carol Clarke. The regulations, for example, require the IACUC to review animal care and use programs and inspect animal facilities every six months, a prescriptive engineering approach with no exceptions and no special circumstances.
|
From page 14... ...
Some believe these regulations are based on specific engineering standards and have not yet incorporated performance standards. To show why this is not the case, Clarke cited the following example: regulations regarding operative procedures on nonͲrodents call for surgery to be performed only in facilities intended for that purpose and maintained under aseptic conditions.
|
From page 15... ...
Griffin said there is true public involvement in every aspect of its programs, including members of the public who serve on the Council and on CCAC animal care committees, the equivalent of U.S.
|
From page 16... ...
16 RE EGULATORY AN ADVISORY P ND PERSPECTIVES S anada's animal welfare guide FIGURE 3Ͳ1 Ca l elines developm ment process SOURCE: Griff slide 5 fin This last point is important, she said, beca use the guidelines are t writt for several audiences, inc ten l cluding: x Investigat tors, who write protocols and want to know how their e d w animals are going to be managed; x Animal ca committee members, wh o review those protocols are e and ensur they comply with CCAC gu re y uidelines and ppolicies; x Veterinar and animal care staff, who maintain the health and ry c o wellͲbeing of those anim g mals; and x Assessme panels, who use the guide ent o elines as their standards during asssessment visits and make rec s commendation based on ns the guidelines themselv ves. As with the Guide, Canada guidelines use "must" fo mandatory G a's or y requuirements and "should" to indicate an obligation fo which any d o or y exceeption must be justified and approved by an animal ca committee e d y are base on strong sc ed cientific justific cation for chan nging that requ uirement.
|
From page 17... ...
For example, the CCAC guideline on the care and use of farm animals in research, teaching, and testing includes a performance standard stating that flooring should provide a dry, comfortable lying surface, it should allow animals to go through their normal movements and postural changes without slipping, and it should not result in injuries. This performance standard does not specify the flooring material, allowing institutions to choose based on their local circumstances and the types of barns they have.
|
From page 18... ...
regulations for the protection of animals used for scientific purposes are stated in EU Directive 2010/63, Annex III (European Parliament, 2010) , which lists mandatory standards for application throughout EU member states, explained Judy MacArthur Clark.
|
From page 19... ...
International expert panels, run by the European Commission, help develop some understanding of performance outcomes, and MacArthur Clark's unit in the United Kingdom develops advisory notes and codes of practice. Often, there are diametrically opposed views on the need for these notes and codes of practice, but getting people with diverse views to talk about their differences and to better understand the role of these advisory documents results in advisories that have broad support.
|
From page 20... ...
In that respect, she said, guidance for performance standards describes what is normally considered appropriate or suitable for a particular species, but also allows for exceptions provided animal welfare standards are maintained. Guidance includes suggestions for enrichment for each species, suggested temperature and humidity ranges, typical species housing needs, typical social needs of a species including those for different sexes and ages, and speciesͲspecific dietary advice.
|
From page 21... ...
MacArthur Clark agreed with Kurtz's idea of sharing negative results and said that the field needs a mechanism by which investigators can freely exchange their experiences and get feedback from others in the field, perhaps in the form of a wikiͲtype environment. Paul Locke, from Johns Hopkins Bloomberg School of Public Health, asked Turner to clarify her use of the term practice standard.
|
From page 22... ...
regulatory agency supports a specific act of Congress, and her agency supports the Animal Welfare Act. Silk noted that USDA is a regulatory agency but NIH is a scientific agency and compliance with its guidelines is entirely optional.
|
From page 23... ...
Griffin noted the need to put more emphasis on developing good guidance for welfare assessment, something with which institutions often struggle. Another question submitted online asked MacArthur Clark to comment on the Stop Vivisection European Citizens' Initiative currently in front of the European Parliament and the impact it may have on performance standards in the European Union.
|
From page 24... ...
The assurance document describes how an institution's animal care program operates and achieves compliance with PHS policy, which incorporates by reference the standards of the Guide. Her division within OLAW also helps institutions with education and policy interpretation.
|
From page 25... ...
MacArthur Clark stressed the importance of the individuals who work in an institution. If the animal care staff is wellͲtrained, wellͲqualified, and empowered to speak up, there will be adequate protection of animal welfare.
|
From page 26... ...
Silk replied that the IACUC determines where performance standards are kept. Clarke added that when a USDA inspector comes and asks why there is a deviation from the regulations, they expect an answer.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.