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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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7

SHARING ACCEPTABLE PERFORMANCE STANDARDS
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According to Steven Niemi, Roundtable member and Liaison to the American College of Laboratory Animal Medicine and Director of the Office of Animal Resources for the Harvard University Faculty of Arts and Sciences, this workshop represented the first serious and in-depth discussion of performance standards among the research community. He began his talk by focusing on funds that are available for the U.S. biomedical discovery enterprise. The pharmaceutical industry’s contribution to research and development expenditures, while substantial, began flat-lining just prior to the last economic downturn and has not yet begun to rise again (Figure 7-1). At the same time, NIH funding in constant dollars has fallen by 6.2 percent since fiscal year 2000. Together, these numbers translate into fewer investigators getting funded (Figure 7-2).

_________________________

1 This section is based on the presentation by Steven Niemi, and the statements are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine.

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

In the last fiscal year, NIH awarded about $26 billion in extramural grants, including RO1, RO1-equivalent and large, collaborative research program grants. There were 14,404 awards, with an average of $1.8 million per year per award. Niemi estimated that 1.67 percent of an institution’s life science research budget is devoted to animal care. He further estimated that about $430 million was invested by NIH in animal care expenses, including husbandry, veterinary medicine, management, and training for staff, the next generation of animal care providers, and investigators. Up to 30 percent of that, he calculated, is unnecessarily spent trying to meet engineering standards, so a conservative estimate of 20 percent waste would translate into $86 million dollars that could be spent funding 48 additional average-size awards.

Even more distressing, said Niemi, are the generational changes underway. In 1980, investigators under 35 years of age were far more likely than investigators age 66 or older to receive NIH funding. Today, the opposite is true (Figure 7-3), and he expressed his concern about the graying of academic science (Figure 7-4). In another what-if exercise, he calculated that the $86 million wasted on meeting engineering standards could support 215 additional new investigator awards at an average $250,000 per year above the current level of 144. These financial considerations, Niemi explained, lead him to label this problem of wasted resources as vitally important.

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

Performance standards can be valued, he said, in terms of liberating funds for academic science and for shareholders in the for-profit sector. Savings could also result from compliance relief, which, Niemi explained, was discussed in a paper published in the FASEB Journal in May 2014 (Thulin et al., 2014) and was one of the foci of the 2015 Public Responsibility in Medicine and Research (PRIM&R) IACUC conference. Niemi said the discussions at this conference highlighted the idea that more regulation is not always better regulation.

The challenge is how to scale back over-regulation. He presented four questions to be used in any program:

  1. Are we doing things right?
  2. If so, what would be even better, faster, easier, more humane, cheaper, safer, and less prone to mistakes even if animal welfare remains unchanged?
  3. Are we doing the right things?
  4. If not, what would be even better, including faster, easier, more humane, cheaper, safer, and less prone to mistakes even if animal welfare remains unchanged.

Niemi said that when he meets with the animal care staff or supervisors, he often asks them to point out things that do not make sense to them. These discussions have empowered staff to be vigilant about ways to improve operations and the welfare of the animals. For example, before Niemi arrived at Harvard, typically animal technicians took three 30-second air showers a day, which equaled about $1,500 in labor costs annually. While this may not seem a large amount, it would be enough for two to three people to attend a national meeting or three to four technicians to attend a regional or local one. Harvard has now stopped using these air showers.

Another example concerned the use of full personal protective equipment (PPE), including head cover, face mask, gloves, Tyvek jumpsuit, and shoe covers. Given that Harvard’s animal facilities use ventilated cages, laminar flow, purified air, and hoods for animal work, Niemi copied procedures established at the University of Michigan and the University of Houston that require only personnel working with rodents or handling animal-contaminated products to wear gloves and a paper gown. A paper published last year in the Journal of the American Association of Laboratory Animal Science by researchers from Columbia University (Baker et al., 2014) showed that eliminating full PPE had no negative impact on the virus-naïve status of animals as long as personnel used gloves, gowns, and proper technique. The authors calculated that these

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

procedures, which are based on experiences with micro-isolator cages accumulated over 25 years, would result in savings of $150,000.

Research conducted by Donna Matthews Jarrell and her colleagues at Massachusetts General Hospital and presented at the 2009 American Association of Laboratory Animal Science annual meeting showed possible savings from changing cage-cleaning cycles based on research data. Investigators viewed a series of photographs depicting a variety of caging situations and voted on when a cage appeared to need bedding change. Jarrell and her colleagues also measured ammonia levels and assessed animal welfare. Based on the data collected approximately 30 percent of cages did not need changing at the scheduled times. For the facility Niemi was managing at the time, which had 27,000 mouse cages, 85 percent of which are ventilated and 15 percent of which are not, such a reduction would translate into saving over 8,000 hours of labor, require over 242,000 fewer changes, and disturb the mice less often.

Niemi explained his facility had piloted spot changing immediately prior to an AAALAC site visit, but the study was not completed before the AAALAC review. He noted current standard practice at most institutions is to spot change before two weeks based on decisions made by animal care technicians, but he does not believe this policy is based on rigorous scientific criteria. Genentech, said Niemi, has instituted a system of scheduling changes not by calendar but by occupancy rate, and he has been told this change reduced inefficiency by 37 percent.

Other options for reducing waste in animal care, which may not have risen to the level of a performance standard, include:

  • Sterilize the incoming bedding rather than the rodent barrier cages and racks.
  • Allow 20 percent relative humidity in rodent barrier rooms during frigid weather because humidity within the animals’ primary enclosure remains at the engineering standard of 30 percent.
  • Maintain non-human primate rooms at six or more air changes per hour compared to the standard engineering level of 10 to 15 air changes per hour.
  • Use routine care for animals not receiving toxic substances or that are receiving drugs at such low levels that metabolite levels secreted into bedding will be too low to be toxic.
  • Allow human cell line xenografts to be handled in Animal Biosafety Level 1 facilities instead of Level 2 as long as the cell lines can be tested for and are free from common pathogens of concern.
Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

For compliance with veterinary medicine issues, Niemi presented the following list established at his facility:

  • Replace sentinel rodents with polymerase chain reaction swabs of inanimate surfaces such as the exhaust plena of ventilated racks. While this procedure is not more cost-efficient, it reduces numbers of animals used.
  • Eliminate annual reviews of non-USDA, non-Department of Defense research protocols.

Turning to the assigned topic of his talk – how to share and promote performance standards – Niemi first discussed his thoughts on the process to enable the dissemination of a performance standard, which should be based on standards that are evidence-based, accompanied by many examples of local adoption deposited in one or more public repositories and have been approved by an IACUC. For performance standards to displace engineering standards, a repository for performance standards populated almost immediately by at least 500 examples is crucial. Such a repository, Niemi suggested, should be hosted on a reliable and secure server, be accessible and searchable via a user-friendly website, and list entries by specific categories, such as species, date of entry, and institution. Entries should be linked to pertinent sections of the Guide or the Animal Welfare Act, and perhaps even EU, UK, and Japanese regulations and should indicate the name of the USDA inspector who allowed the modification. He was unsure if access to the repository should be restricted. Just as important, he said, would be to invite contributions or suggestions from the public.

Niemi stated that someone or some organization would have to manage the repository and act as a primary filter to keep useless data from publication. There should also be a second, in-depth review provided by a panel of expert peers – including members of the animal welfare community. The community, he said, would ultimately decide on the utility of a given performance standard. The repository should also invite commentary and discussion that would go through the same primary and secondary filters, perhaps along the lines of a Wikipedia model. One possible outcome is that the repository could serve as the mechanism for making the Guide a living document. The animal care community has talked about this possibility given it was 14 years between the release of the 7th and 8th editions of the Guide.

In Niemi’s opinion, an obvious host for the repository would be the ILAR roundtable. Operation costs could be supported by dues, subscriptions, donations, and grants. If the roundtable chooses not to

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

support this idea, any one of a number of other non-governmental organizations could be enlisted to host it.

DISCUSSION

Joseph Newsome asked if NIH could be a source of funding. Niemi replied that his preference would be to seek support from other sources first. Clarke and Jarrell seconded

Niemi’s suggestion of the roundtable driving the creation of a repository, and Clarke hoped the repository would contain examples of performance standards that did not work. MacArthur Clark urged that the repository be international in nature as the issues addressed in the United States are the same she and her colleagues face in Europe and other parts of the world. Having the repository as an international initiative would also create more opportunities for international collaborations, MacArthur Clark added, and she cautioned against having a regulator such as NIH managing it. She also voiced support for ILAR taking a leading role in creating and managing the repository. Niemi said he hoped that in time, the repository would be translated into other languages so it could be used globally. Peterson suggested that the repository be augmented by a feature to post questions and engage in discussion, as well as to link it to the CompMed listserv to notify the community when a new performance standard is entered into the repository.

Regarding the idea of reducing the use of PPE, Clarke suggested that National Institute of Environmental Health and Safety and the Environmental Protection Agency, which are similarly interested in lower levels of PPE in biological facilities, could be a source of funding for studies in this area. Dysko then noted that, although Niemi used his facility as an example of an institution that had reduced the use of PPE, he has received comments that staff are not protected from allergies because they no longer wear face masks. As a result, an additional performance standard evaluating the human safety aspect of reduced PPE use may be necessary. Niemi responded that at Harvard, this change was approved by the biosafety office, the environmental health and safety office, and the occupational health physician.

Neil Lipman pointed to a European study showing that rodent allergens accumulate in human hair and can be traced to a person’s home and bedding (Krop et al., 2007). He said this finding suggests the need to be careful about reducing PPE use and eliminating air showers and changing stations.

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

Kennedy asked if technology exists for measuring ammonia levels and if it could be used to establish an engineering standard for cage-changing frequency. Niemi replied it is difficult to measure ammonia reliably and even more difficult to set a threshold below which ammonia levels are safe and above which they are deleterious. At his facility, the standard procedure is to observe every animal at least once daily without disturbing them. Niemi envisions a day where smart cages will monitor animals for activity and send out an alarm when activity does not fall within some predetermined range.

Jarrell reemphasized the importance of talking with the people who are directly working with the animals and asking them where they see opportunities for improvement, including reallocating time to activities that benefit the welfare of the animals. Her staff, for example, did not like disturbing animals in clean cages and were excited to participate in the spot cleaning study. The biggest challenge in instituting spot cleaning is the need to also move to a seven-day-a-week workforce to ensure spot changing is consistent, therefore some facilities in her institution are pursuing this idea.

Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
Page 88
Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
Page 89
Suggested Citation:"7 Sharing Acceptable Performance Standards." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×
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In order to better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the Institute for Laboratory Animal Research Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop on April 20-21, 2015. The purpose of the workshop was to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion and collaboration, and to help build transparency and trust among stakeholders. Participants addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure "optimal practices, management, and operations." This report summarizes the presentations and discussions from the workshop.

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