Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use Summary of a Workshop (2015) / Chapter Skim
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4 End-User Perspectives
4 End-User Perspectives
Pages 27-52
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From page 27... ...
, gave a wildlife biologist's perspective. In the second session, Bart Carter, Director of Animal Resources and Attending Veterinarian for the University of Texas Southwestern Medical Center, provided an agricultural perspective; Kenneth Litwak, Laboratory Animal Advisor to the Animal Welfare Institute, spoke from a public interest perspective; and John Bradfield, Senior Director at the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
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From page 28... ...
They can be tailored to an individual situation or institution, and they can refine and improve engineering standards. Despite these characteristics, performance standards are expensive to properly develop, a challenge for resourceͲlimited Animal Care and Use Programs.
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From page 29... ...
indicated that toeͲclipping may be the preferred method for neonatal mice up to age 7 days based on physiological and behavioral observations. These publications were referenced in the 8th edition of the Guide, which, Lipman believes, established a de facto engineering standard that warranted further study to create a new performance standard to minimize pain and distress; limit shortͲ and longͲ term physiologic and behavioral effects; be safe for both animal and operator; be fast, easy, and permanent; and be costͲeffective.
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From page 30... ...
30 ENDͲUSER P PERSPECTIVES phal lanx. When toe clipping and tail biop t a psy are both needed, the proc cedure should be done betwe PND 14 an PND 17.
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From page 31... ...
" said Lipman. The CCMP team compared its performance with the AVMA Guidelines recommendation and showed that the CCMP system produced significantly lower distress levels in both mice and rats.
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From page 32... ...
To answer some of the larger questions, such as those about cage space, it will be necessary to create multiͲinstitutional consortia to secure the funds to pay for these large studies, he added. THE PHARMACEUTICAL INDUSTRY PERSPECTIVE2 A unique feature of the pharmaceutical industry, said Mary Ann Vasbinder, is its obligation to answer to multiple regulatory organizations worldwide, creating a dynamic working environment, particularly given that views on animal welfare differ across the globe.
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From page 33... ...
Social interaction, both between dogs and between dogs and humans, the opportunity to exercise, and the ability to have environmental enrichment were perceived to be more important than cage size. Using the experts' recommendations, the team built cages that would increase visibility for the dogs, optimize interactions with staff, and have a softer look than with standard cages.
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From page 34... ...
THE WILDLIFE PERSPECTIVE3 Most wildlife research, John Bryan noted, is done for the sake of the wildlife and is not about using animals as a model for human biology. As a result, the methodology used to develop performance standards in the wildlife setting is different than in the laboratory setting.
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From page 35... ...
The point of the design process is to achieve the desired outcome of the highest possible standards of animal care in the context of compliance and regardless of circumstance, Bryan explained. The traditional resources an investigator can draw upon when designing a performance standard are the Animal Welfare Act and the Guide.
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From page 36... ...
In those cases, a wildlife IACUC would pull out a performance standard and suggest changes to the investigator. A big challenge for wildlife IACUCs, said Bryan, is that since the wildlife field is so large there will be many projects it needs to review for which none of the members have any experience relevant to those projects.
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From page 37... ...
The key, said Bryan, was the IACUC was staffed with wildlife researchers who knew wildlife research can be chaotic, and so when the IACUC created its standard operating procedures for this project it built in flexibility to respond to dynamic change while also achieving compliance and following existing rules. Rigid standards, he said, would have resulted in catastrophe.
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From page 38... ...
Typically, this type of facility can house animals at a reduced cost compared to a biomedical facility, but it frequently has floors and other surfaces that are not easily sanitized. Most often, they are located remotely from the rest of the 4 This section is based on the presentation by Bart Carter, and the statements are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine.
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From page 39... ...
The reverse situation – moving animals from a biomedical facility to a more traditional farm setting – might seem easier, but these animals may not have been housed in that manner for some time, if ever, so it is important to consider what steps will be necessary to acclimate them to a less structured environment. An acceptable performance standard for agricultural animals, said Carter, allows the animals to remain dry, be at a comfortable temperature, and remain free of urine and fecal contamination, and it also allows for appropriate data collection by the research staff.
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From page 40... ...
One question that arises, given there will be a farrowing crate in the middle of a biomedical facility, is how to deal with sanitation needs that differ from those of the more traditional biomedical research animals also housed in the facility. In the farm setting, Carter said often there are agricultural pigs in one area of a large facility and biomedical pigs in another area, raising the question of whether the one group of animals negatively impacts the other if they are being treated differently.
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From page 41... ...
For example, the thermal comfort zone for cattle is Ͳ15°C to 25°C, which is the range in the Ag Guide and in the Animal Welfare Act. For animals adapted to life outside and brought into a facility in winter, however, heat stress can develop at temperatures as low as 10°C, suggesting that a performance standard may be needed for this situation.
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From page 42... ...
He noted, too, when developing a performance standard for agricultural animals outside of a traditional biomedical facility, the animals may require vaccinations and deworming, and they may be exposed to infectious diseases. THE PUBLIC INTEREST PERSPECTIVE5 The Animal Welfare Institute, said Kenneth Litwak, was founded in 1951 to take the middle ground between researchers and antiͲ vivisectionists.
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From page 43... ...
Three volumes of discussions from this forum have been published, with a fourth coming out shortly. The history of the Animal Welfare Institute's involvement with performance standards started in 1985 with the Improved Standards for Laboratory Animals Act, which laid out the minimum requirements for canine exercise and promoted the psychological wellͲbeing of primates.
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From page 44... ...
The engineering standard says floor space should be 4.3 square feet, but a monkey of that size would not be able to make a normal postural adjustment in a cage of that size, begging the question of which standard applies, particularly when the definition of a normal postural adjustment is unstated. The ideal situation from the Animal Welfare Institute's perspective would be the 1999 USDA draft policy on environmental enhancement to promote psychological wellͲbeing of nonͲhuman primates.
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From page 45... ...
because it codified the concept of performanceͲbased assessments and standards in the management and operation of research animal facilities and provided flexibility on how to establish and operate Animal Care and Use Programs. This made AAALAC's job more difficult as there is no single right answer for how to promote animal welfare.
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From page 46... ...
If the cleaning interval was longer than one but less than two weeks, which for ventilated rodent cage racks is a practice standard, the IACUC would need to be aware of the situation and consider what the potential impacts might be on the microenvironment and the animals, but the IACUC review need not be rigorous. However, if the cleaning interval was longer than two weeks, the IACUC needs to conduct a more rigorous evaluation validating the cage microenvironment is satisfactory, preferably including an objective, dataͲ based analysis to show why the practice does not negatively impact animal health and wellͲbeing.
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From page 47... ...
At the end of one year, the IACUC, the attending veterinarians, and the investigators analyzed the data and found the performanceͲbased strategy produced a greater number of socially compatible groups, fewer stereotypic behaviors, a higher rate of producing litters, and less variable scientific data while using fewer dogs. As a result of the effort these investigators and facility staff put into
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From page 48... ...
These situations, said Locke, require an approach based on collecting evidence and constantly evaluating it with no clear hypothesis to test. While these are unique situations all of these speakers clearly pointed out the goal is to ensure that animal welfare is held to the highest standards and the best science is done with the fewest number of animals.
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From page 49... ...
" with no answer in mind except that AAALAC does anticipate some periodicity in evaluations. At his former institution, for example, the IACUC reviewed standards monthly for one particular study involving infectious diseases, but a performance standard that was more innocuous and for which the conditions did not change would require far less frequent reevaluations.
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From page 50... ...
The wildlife area, said Bryan, is one in which each and every project is judged on its own, and it is the norm with wildlife IACUCs to require investigators to come up with sufficient justification for any variances from existing engineering standards. He also said he did not think engineering standards have a big future in the wildlife area.
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From page 51... ...
Bradfield's example involving dog housing made Vasbinder wonder what would have happened if the IACUC had approved the request to keep litters together without further research based on a 3Rs rationale. Bradfield acknowledged that was an interesting scenario but guessed the AAALAC Council would have found that to be a less compelling case, albeit a valid rationale.
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