This policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals The 6th Edition of the Guide was incorporated by reference into the PHS Policy in 1985. 2
Policy footnote 2
Self Monitoring, Self Reporting
It is far preferable to place primary responsibility
for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections. 3
Congressional Committee report
1985 Health Research Extension Act
1985 Guide for the Care and Use
of Laboratory Animals Proper care and humane treatment of animals used in research, testing, and educationrequire scientific and professional judgment, which is based on knowledge of the husbandry needs of each species and the special requirements of research, testing, and educational programs. 4
Guide, 6th Edition 1985
2011 Guide for the Care and Use
of Laboratory Animals Performance standard means a standard or guideline that, while describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC. The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals... Performance standards can be advantageous because they accommodate the consideration of many variables... so that implementation can be best tailored to meet the recommendations in the Guide. (See Guide pages 6-7.) http://grants.nih.gov/grants/olaw/positionstatement_guide.htm#performance 5
SCAW Conference 1997
June 1997 SCAW sponsored a conference in Baltimore and began a new initiative focused on how to translate theoretical performance standards into practical, easy-to-implement guidelines for the care and use of many species of research animals. Performance standards require professional judgment that is supported by real data, measurements and defined outcomes. Once performance standards have been defined, then different applications and methods for assessment of outcomes need to be developed. This meeting was a starting point to begin looking at these processes.
Performance Standards and Animal Welfare: Definition, Application and
Assessment Parts I & II 1998 (out of print) 6
2007 request to NIH
from ILAR Council Chair on behalf of ILAR Director regarding the process of updating the 7th Edition (1996) of the Guide.
Council members pointed
out the necessity of
preserving, and perhaps even increasing, the performance-based nature of the document.
2011Guide Statement of Task
Where scientifically warranted, the guidance and recommendations of the 1996 Guide will be changed to reflect new scientific evidence, while maintaining the performance standards of the 1996 Guide.
Guide Appendix C
NIH Position (1)
Performance standards are the most important component of the infrastructure of PHS oversight of animal programs at Assured institutions. IACUCs are able to meet their responsibility to ensure humane animal care and use while advancing quality scientific research through the use of performance standards in their oversight of institutional animal programs. http://grants.nih.gov/grants/olaw/positionstatement_guide.htm#performance
NIH Position (2)
OLAW encourages the cooperative application of diverse expertise to develop outcome-based performance standards that enhance the quality of animal care and use programs. OLAW expects Assured institutions to apply appropriate professional judgment and experience to the challenges inherent in developing policies and procedures to maintain a quality program that provides humane care to vertebrate animals. 10
NIH Position (3)
Implementation of the Guide is expected to have a minimal impact on institutions that are currently using policies and procedures based on well-developed performance standards. These policies and procedures may not need to be revised as part of the institution's implementation of the 8th Edition of the Guide. Institutions that do not currently have performance standards that meet the criteria stated in this document are expected to use the benchmarks provided by the 8th Edition of the Guide to develop performance-based policies and procedures. 11
NIH Performance Standard Criteria
A well-established performance standard meets the following criteria:
12
supports scientific objectives;
supports the health and welfare of the animal; includes a justified performance index; and has associated outcome criteria.
NIH Position Statement
OLAW Responds to Concerns Regarding Adoption of the Guide for the Care and Use of Laboratory Animals: Eighth Edition December 2, 2011 May 2012 Update
13
Guide Implementation Webinars
NIH Adopts 8th Edition of the Guide: A Discussion December 8, 2011 Use of Non-Pharmaceutical-Grade Chemicals and Other Substances in Research with Animals March 1, 2012 Performance Standards April 19, 2012 Housing Laboratory Rodents According to the 8th Edition of the Guide July 19, 2012
in Determining Rodent Housing Practices, Including Management of Rodent Breeding Colonies? Performance standards are to be applied to rodent housing issues. While the Guide's space recommendations are accepted reference points for addressing space needs, performance standards allow flexibility to improve animal welfare and scientific research. Adjustments to recommendations for primary enclosures may be made at the institutional level by the IACUC. OLAW FAQ F10 http://grants.nih.gov/grants/olaw/faqs.htm#674 See also Guide pages 56-58 15
OLAW FAQ F10 (2)
The IACUC should critically evaluate objective measures of outcome-based performance. The Guide identifies examples of performance indices to assess adequacy of housing including: health, reproduction, growth, behavior, activity, and use of space.
16
OLAW FAQ F10 (3)
Rodent cages of the size commonly used in the US may be appropriate for pair or trio breeding. The Guide does not add specific, additional engineering standards for breeding configurations. This empowers institutions to determine appropriate housing. The IACUC must consider relevant factors when assessing the adequacy of cage space according to performance standards. Examples of these factors may include:
17
OLAW FAQ F10 (4)
18
average litter size of the strain(s) of rodents;
whether multiple litters are present in the cage; difference in the age of the pups of different litters; growth rate; need for cross-fostering; cage dimensions; and overall management and husbandry practices such as cage sanitation or bedding change.
OLAW FAQ F10 (5)
Blanket, program-wide departures from the Guide for reasons of convenience, cost, or other non-animal welfare considerations are not acceptable. Cages that might be acceptable when litters are born may have insufficient space as pups grow. Whatever parameters are used to establish breeding configurations and weaning procedures, the IACUC must ensure that cage population does not negatively impact animal well-being and overcrowding does not occur.
19
May Performance Standards
Determine Housing Issues? Performance standards are to be applied to housing issues. Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. While the Guide's space recommendations are accepted reference points for addressing space needs performance standards allow flexibility to improve animal welfare and scientific research. OLAW FAQ F16 http://grants.nih.gov/grants/olaw/faqs.htm#3285 See also Guide pages 50 63 and 6 - 7. 20
FAQ F16 (2)
An institutions animal housing practices must be speciesspecific, appropriate for the animals, and in compliance with all applicable federal and local regulatory requirements. Compliance with the applicable regulations (9 CFR Subchapter A) issued by the U.S. Department of Agriculture under the Animal Welfare Act are an absolute requirement of the PHS Policy Footnote 2, page 9.
21
May Performance Standards
Determine Environmental Issues? An institutions environmental enrichment practices must be species-specific and appropriate for the animals. Devices that animals climb on or through, perch on, or nest in contribute to, rather than detract from, the animals living space and need not be subtracted from the floor dimensions. Some species are upset by the introduction of novel items. Animals should not be subjected to the presence of items that they find distressing. OLAW FAQ F17 http://grants.nih.gov/grants/olaw/faqs.htm#3286 See also Guide pages 52 - 54 22
FAQ F17 (2)
Compliance with the applicable regulations (9 CFR Subchapter A) issued by the US Department of Agriculture under the Animal Welfare Act are an absolute requirement of the PHS Policy (Footnote 2, page 9).
23
Can Performance Standards be Used
in Determining Rabbit Housing Practices? OLAW concurs with the Guide that animals should be housed under conditions that provide sufficient space to meet physical, physiologic, and behavioral needs. The height of an enclosure can be important to allow for expression of species-specific behaviors and postural adjustments. Cage height should take into account the animals typical posture and provide adequate clearance for the animal from cage structures, such as feeders and water devices. OLAW FAQ F18 http://grants.nih.gov/grants/olaw/faqs.htm See also Guide pages 50 51 and 56 24
FAQ F18 (2)
IACUCs may consider the use of a rabbit cage that is 14 inches in height, if appropriate for specific animals. The IACUC should establish, through performance indices related to animal well-being, that the cage provides sufficient space to meet the physical, physiologic and behavioral needs of the animal. For example, the rabbit must be able to hold its ears in an upright position (if this is natural for the breed) and ears must not be forced to fold over by contact with the cage ceiling. 25