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CIEA/NCRR/NIH Genetic and Microbiological Monitoring of Mouse and Rat Resources: Directions for the Future Tatsuji Nomura Director, Central Institute for Experimental Animals Kawasaki, Japan During the US/Japan Meeting about 15 years ago, we decided to select specific microbiological items based on criteria that determine minimum require- ments. As Dr. Itoh explained, these requirements correspond to those of the International Council for Laboratory Animal Science (ICLAS). The ICLAS concept of microbiological monitoring is the same as that for genetic monitoring, that is, monitoring of animals that have been genetically controlled (such as inbred, hybrid, or congenic animals). Microbiological quality monitoring is applied only to microbiologically controlled animals that are bar- rier sustained, such as gnotobiotes and SPF animals. DIFFERENCES BETWEEN COUNTRIES In the United States and Europe, there is no microbiological monitoring; however, there is health monitoring. I can understand this concept because, from a practical standpoint, disease is the most important in those countries. However, health monitoring does not cover the microbiological quality of the animals. In addition, we have had recent experiences with new usersâmolecular geneti- cistsâwho have asked for more sophisticated high-quality mice for analysis of the expression of the introduced gene. For these users, we believe that it is important to monitor the microbiological quality of the animals. It is our desire to reach a consensus regarding worldwide minimum require- ments for genetic and microbiological monitoring. Each country has its own requirements for microbiological monitoring, which can be added as options; but we should at least establish minimum requirements. 76
TATSUJI NOMURA 77 QUESTIONS AND ANSWERS T. GILL: I believe the critical point in monitoring is not with people who understand (such as with all of us, who agree), but with the political process. Unless a lot of people make a lot of noise, nothing is going to happen. If you publish a set of standards, the microbiological and genetic standards must be checked. If you promulgate the standards among the scientific community, then when scientists ask for animals they will ask the suppliers, âDo you fulfill these criteria? If you donât, we wonât buy animals from you.â Therefore, I think that a relatively simple list of microbiological requirements and a simple list of genetic requirements that correspond with each animal should be developed, and the scientific community should be encouraged not to buy from suppliers who do not provide this information. T. NOMURA: What you describe is happening in Japan. The pharmaceu- tical industry will never buy from a breeder who has no test results from the ICLAS Monitoring Center. This has made the quality of breeders very high. As I mentioned, the United States should have a reliable, neutral, authorized moni- toring center for microbiology and genetics on which everyone can depend. T. GILL: The key point is that an institution independent of the animal suppliers has the authority to apply pressure from the pharmaceutical users to maintain these standards. That is why assigning the implementation of standards to the suppliers will never work because increasing profit is the basic drive of the suppliers. Sometimes high quality and increasing profits do not exactly mesh. Consequently, an outside group has to apply this pressure, and I think the users are the outside group that has to do this. T. NOMURA: ICLAS is the only neutral organization that can do that. T. ALLEN: You bring up a problem that is a real issue at NIH. Even though there were rules everywhere that you could not do what I am going to describe, it still happened. Within 6 months after we were finished with the ectromelia outbreak in 1979 to 1980, one of my colleagues on an airplane sat next to a man who had in his pocket a mouse that he was bringing in from the same institution where the outbreak originated to get around the rules and regulations. Asking staff to spend $1000 for a map test when they are on a budget is really a major problem. T. NOMURA: I would like to mention again that the microbiological moni- toring requirements that we selected are based on the contamination map of Japan. We have checked and know what agents are currently spreading. In addition, the standards for selection have to be decided by the users, not by the breeders. In Japan, we try to focus on the most critical usersâindustry. This focus is especially important when they are conducting long-term 2-year toxicol- ogy studies and they ask us to check certain items, especially pathogens causing inapparent infections. We base our selection in this way.