The Realities of Animal Testing Facilities are Brought to Light by Whistle-blowers

The Ministers Answer at the Diet

The company that had made consignment contract with the Tokyo University of Science animal testing facility blew the whistle on the university’s unjust treatment of animals. Councilor Tani covered this issue to the Committees on Science Education and Health, Labour and Welfare. The following are abstracts from minutes of the Diet. Please follow the link below for full text.

The 159th Diet

May 11, 2004

http://kokkai.ndl.go.jp/SENTAKU/sangiin/159/0061/index.html

Sloppy Reality of Testing Facility

Hiroyuki Tani (Councilor)

 It is unnecessary to carry out animal testing as a part of nonclinical study in the field of pharmacy and medicine. I also believe that more accurate data could be gained by proper management of experimental animals.

 In February, an agency which had been receiving management commission from Tokyo University of Science blew the whistle on university’s animal testing facility. For five years, Research Institute for Biological Sciences at Tokyo University of Science has been raising genetically engineered animals outside the facility and transporting them in plastic bags from which the mouse could easily escape. They also failed to keep a breeding log. (The pharmacy department has done the above since last year.) Especially vicious Abe Laboratory was keeping 37 mice inside a cage designed for five. As a result, their tails were cut off, heads flew away, and some preyed on each other due to lack of food. In 1997, they were also enforcing administration of malaria parasites although it was prohibited by internal regulations.

 In addition, mouse which could have been infected or genetically engineered were seen at the dumpster right next to the laboratory twice. Moreover, guards and other personnel had witnessed a white mouse, which appeared to be an experimental one, running away from the school of pharmacy. Some citizens contacted the public health center when they found out about this matter. The health center did conduct on-site inspection; however, regrettably they failed to inspect the inside of the facility thoroughly.

 The agency must have reported such facts to the Ministry of Education. After the institute attempted to muzzle them, the agency ended the contract unilaterally. Have you heard any of these matters?

Takeo Kawamura (Minister of Education in Science)

 We have been trying to confirm the fact. Meanwhile, the university has admitted to some facts that were brought up. Although animal testing is indispensable to life science research, it is necessary to respect and take Cruelty to Animal Act and animal welfare into consideration. Ministry for Education in Science will urge each university to carry out animal testing appropriately.

Necessity of Boarding Inspection

Hiroyuki Tani (Councilor)

 Laws regulating the genetically engineered organisms became effective in this February. Its 31th article stipulates compulsive inspection. I think it is necessary to conduct boarding inspection immediately. It would also support university’s claim. What do you think?

Akira Ishikawa (Ministry of Education, Director of Research Promotion Bureau)

 We must take measures to prevent spreading of genetically engineered organisms. We had asked Tokyo University of Science for explanations, and they reported that appropriate steps based on the laws have already taken. Therefore, we do not think it is necessary to enforce inspection at this moment.

Hiroyuki Tani (Councilor)

 In reality, we must confirm the facts. Have you confirmed every single fact such as raising the animals outside the facility and transporting in plastic bags?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 Such facts will be investigated by school itself. School’s board of Investigation (including extramural people) has already started investigation. I believe the matter brought up today will be revealed through this investigation.

Hiroyuki Tani (Councilor)

 Neighboring residents of Tokyo University of Science and other research facilities cannot distinguish experimental animals from the non experimental ones. They probably do not know the existence of such facilities. We should think about making inspection by health center compulsory. What do you think about necessity of such efforts?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 Each university has set up its own Board of Experiment and is now following rules based on animal rights laws and reports of Science Council. I think it is also appropriate to respect school’s autonomy because of freedom of academic pursuits. Therefore, inspection in line with the law should be addressed carefully. In addition, I believe that it is desirable for the school to provide information such as the breeding log voluntarily. We would like to make positive efforts to appeal for such information.

Necessity of Qualification System

Hiroyuki Tani (Councilor)

 These management commissions are done by agencies in almost all schools. Though there are some labs which do these on their own, live animals should be handled by responsible management. Since there are only five such agencies in Japan , other companies (e.g. building maintenance) do management of the animals as a side business. Because not everyone is experts, it is doubtful whether appropriate management is taking place. I think it is the best course of action to mandate license, or at least notification procedure, for those agencies.

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 We are aware that certain research organizations are outsourcing operation of animals such as feeding. We believe it is important that we consign such operation to agencies that possess sufficient ability. On that basis, we also recognize that appropriate management should take place under universities or laboratories independently. Mandating license or notification procedure will likely to result in breeding of animals by both labs and private enterprise. We see necessity of broad discussion by related ministries and parties.

Necessity of Animal Welfare

Hiroyuki Tani (Councilor)

 Based on matters that have been brought up (e.g. breeding outside the facilities, overcrowded breeding, and inaccurate breeding log), I believe fruition of their studies is almost impossible to improve. I also worry whether an international evaluation is fulfilled.

 The word “welfare” is used as “human welfare”, but in general, animals also have welfare. As they are living creature, it is fundamental to think how to lower the number of experimental animals, how not to inflict pain, and whether to use the precious lives for clinical purpose. We should start making a strong effort to apply alternative method or curriculum on bioethical issues. It seems that there will be enough time for such curriculum if the pharmacy becomes a six-year program.

Yoshiaki Harada (Vice Minister of Ministry of Education)

 I think that very important points have just been brought up. As for pharmacy education, “model/core curriculum of pharmacology education” was developed at Pharmaceutical Society of Japan in August, 2002. We went to the trouble of adding the chapter on the ways to handle animals carefully and appropriately.

 The Ministry of Education would like to direct each university to educate students concerting this problem.

House of Councilors, Committee of Ministry of Health, Labor and Welfare

May 13, 2004

http://kokkai.ndl.go.jp/SENTAKU/sangiin/159/0062/index.html

Hiroyuki Tani (Councilor)

To begin with, the legislation degree concerning the animal experiment is not being maintained in our country at the moment. As a result, appropriate treatment has been basically entrusted to the experimenter's own restriction and effort. We are in the situation where we are utterly ignorant about types and location of animal testing that are carried out in Japan .

In other words, people living in the neighborhood of testing facility don’t quite understand the types of studies being carried out. Some people are very disturbed about infected animals escaping from the facilities.

Chikara Sakaguchi (Minister of Health, Labor and Welfare)

 We revised the infections disease method last October, and we have just specified the animals to be covered by epidemiological investigation. As for four kinds of infectious diseases in which the animal are the medium, we have decided to take necessary actions such as using disinfectant or exterminating animals.

 As it was indicated, there are diseases that are shared by both men and animals. I also believe that the management of the animals becomes a very important issue when we breed them for experimental purpose. This does not only refer to the pharmacy department, but also to school of medicine and other laboratories. Many hospitals take great care in management of the experimental animals. They are highly concerned about hereditary, breeding, and infectious problems. I also think that problems do exist between neighboring residents and the laboratories. We would like to give adequate care from now on.

Hiroyuki Tani (Councilor)

Laws regulating the genetically engineered organisms became effective in this February, and its 31th article stipulates boarding inspection. Do you think it is necessary to rethink about conducting the inspection when the school announces the truth?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 The school’s Board of Experiment is currently investigating the matter. We have been informed that they are now taking appropriate measures based on the laws. Therefore, Ministry of Education does not think it is necessary to conduct boarding inspection. The school should begin with establishing better maintenance so these problems will not return. If new problems are to be revealed by school’s reports, then I would like to correspond appropriately according to the contents.

Infectious Experiment and Disclosure of Information

Hiroyuki Tani (Councilor)

 The agency which had been managing breeding of animals blew the whistles on detailed facts that took place inside the school for the past ten years. I think this is a very serious problem.

 Animals also have the rights and welfare. They are being sacrificed to produce medications and to maintain human’s lives. I would like everyone to take a good look at the university’s report.

With last year’s SARS as a turning point, infectious disease preventive laws were revised. The locations of the infected animals are not clearly understood. As truths are revealed gradually, residents become very anxious and the first thing they would do is to visit the public health center.

On the ground of animal protection laws, which are managed by Ministry of Environment, the health center went to the university last September. However, regrettably, there were no facts which violated the protection laws. There is a limit to these laws.

Chikara Sakaguchi (Minister of Health, Labor and Welfare)

 I believe that local health centers need to play such a role and be ready for future incidents. If local residents were to become infected or become anxious of the possibility of infection, the centers need to provide information such as symptom and treatment. I think that the health centers are obligated to report possibility of infection to citizen.

 When it is possible for the infection to spread, we can conduct boarding inspection of the facility. In any case, this issue is pertinent to residents’ health; therefore, we would like all the health centers in the country to be better prepared to deal with future cases.

The Realities of Animal Testing Facilities are Brought to Light by Whistle-blowers

The Ministers Answer at the Diet

 The company that had made consignment contract with the Tokyo University of Science animal testing facility blew the whistle on the university’s unjust treatment of animals. Councilor Tani covered this issue to the Committees on Science Education and Health, Labour and Welfare. The following are abstracts from minutes of the Diet. Please follow the link below for full text.

The 159th Diet

May 11, 2004

http://kokkai.ndl.go.jp/SENTAKU/sangiin/159/0061/index.html

Sloppy Reality of Testing Facility

Hiroyuki Tani (Councilor)

 It is unnecessary to carry out animal testing as a part of nonclinical study in the field of pharmacy and medicine. I also believe that more accurate data could be gained by proper management of experimental animals.

 In February, an agency which had been receiving management commission from Tokyo University of Science blew the whistle on university’s animal testing facility. For five years, Research Institute for Biological Sciences at Tokyo University of Science has been raising genetically engineered animals outside the facility and transporting them in plastic bags from which the mouse could easily escape. They also failed to keep a breeding log. (The pharmacy department has done the above since last year.) Especially vicious Abe Laboratory was keeping 37 mice inside a cage designed for five. As a result, their tails were cut off, heads flew away, and some preyed on each other due to lack of food. In 1997, they were also enforcing administration of malaria parasites although it was prohibited by internal regulations.

 In addition, mouse which could have been infected or genetically engineered were seen at the dumpster right next to the laboratory twice. Moreover, guards and other personnel had witnessed a white mouse, which appeared to be an experimental one, running away from the school of pharmacy. Some citizens contacted the public health center when they found out about this matter. The health center did conduct on-site inspection; however, regrettably they failed to inspect the inside of the facility thoroughly.

 The agency must have reported such facts to the Ministry of Education. After the institute attempted to muzzle them, the agency ended the contract unilaterally. Have you heard any of these matters?

Takeo Kawamura (Minister of Education in Science)

 We have been trying to confirm the fact. Meanwhile, the university has admitted to some facts that were brought up. Although animal testing is indispensable to life science research, it is necessary to respect and take Cruelty to Animal Act and animal welfare into consideration. Ministry for Education in Science will urge each university to carry out animal testing appropriately.

Necessity of Boarding Inspection

Hiroyuki Tani (Councilor)

 Laws regulating the genetically engineered organisms became effective in this February. Its 31th article stipulates compulsive inspection. I think it is necessary to conduct boarding inspection immediately. It would also support university’s claim. What do you think?

Akira Ishikawa (Ministry of Education, Director of Research Promotion Bureau)

 We must take measures to prevent spreading of genetically engineered organisms. We had asked Tokyo University of Science for explanations, and they reported that appropriate steps based on the laws have already taken. Therefore, we do not think it is necessary to enforce inspection at this moment.

Hiroyuki Tani (Councilor)

 In reality, we must confirm the facts. Have you confirmed every single fact such as raising the animals outside the facility and transporting in plastic bags?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 Such facts will be investigated by school itself. School’s board of Investigation (including extramural people) has already started investigation. I believe the matter brought up today will be revealed through this investigation.

Hiroyuki Tani (Councilor)

 Neighboring residents of Tokyo University of Science and other research facilities cannot distinguish experimental animals from the non experimental ones. They probably do not know the existence of such facilities. We should think about making inspection by health center compulsory. What do you think about necessity of such efforts?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 Each university has set up its own Board of Experiment and is now following rules based on animal rights laws and reports of Science Council. I think it is also appropriate to respect school’s autonomy because of freedom of academic pursuits. Therefore, inspection in line with the law should be addressed carefully. In addition, I believe that it is desirable for the school to provide information such as the breeding log voluntarily. We would like to make positive efforts to appeal for such information.

Necessity of Qualification System

Hiroyuki Tani (Councilor)

 These management commissions are done by agencies in almost all schools. Though there are some labs which do these on their own, live animals should be handled by responsible management. Since there are only five such agencies in Japan , other companies (e.g. building maintenance) do management of the animals as a side business. Because not everyone is experts, it is doubtful whether appropriate management is taking place. I think it is the best course of action to mandate license, or at least notification procedure, for those agencies.

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 We are aware that certain research organizations are outsourcing operation of animals such as feeding. We believe it is important that we consign such operation to agencies that possess sufficient ability. On that basis, we also recognize that appropriate management should take place under universities or laboratories independently. Mandating license or notification procedure will likely to result in breeding of animals by both labs and private enterprise. We see necessity of broad discussion by related ministries and parties.

Necessity of Animal Welfare

Hiroyuki Tani (Councilor)

 Based on matters that have been brought up (e.g. breeding outside the facilities, overcrowded breeding, and inaccurate breeding log), I believe fruition of their studies is almost impossible to improve. I also worry whether an international evaluation is fulfilled.

 The word “welfare” is used as “human welfare”, but in general, animals also have welfare. As they are living creature, it is fundamental to think how to lower the number of experimental animals, how not to inflict pain, and whether to use the precious lives for clinical purpose. We should start making a strong effort to apply alternative method or curriculum on bioethical issues. It seems that there will be enough time for such curriculum if the pharmacy becomes a six-year program.

Yoshiaki Harada (Vice Minister of Ministry of Education)

 I think that very important points have just been brought up. As for pharmacy education, “model/core curriculum of pharmacology education” was developed at Pharmaceutical Society of Japan in August, 2002. We went to the trouble of adding the chapter on the ways to handle animals carefully and appropriately.

 The Ministry of Education would like to direct each university to educate students concerting this problem.

House of Councilors, Committee of Ministry of Health, Labor and Welfare

May 13, 2004

http://kokkai.ndl.go.jp/SENTAKU/sangiin/159/0062/index.html

Hiroyuki Tani (Councilor)

 To begin with, the legislation degree concerning the animal experiment is not being maintained in our country at the moment. As a result, appropriate treatment has been basically entrusted to the experimenter's own restriction and effort. We are in the situation where we are utterly ignorant about types and location of animal testing that are carried out in Japan .

 In other words, people living in the neighborhood of testing facility don’t quite understand the types of studies being carried out. Some people are very disturbed about infected animals escaping from the facilities.

Chikara Sakaguchi (Minister of Health, Labor and Welfare)

 We revised the infections disease method last October, and we have just specified the animals to be covered by epidemiological investigation. As for four kinds of infectious diseases in which the animal are the medium, we have decided to take necessary actions such as using disinfectant or exterminating animals.

 As it was indicated, there are diseases that are shared by both men and animals. I also believe that the management of the animals becomes a very important issue when we breed them for experimental purpose. This does not only refer to the pharmacy department, but also to school of medicine and other laboratories. Many hospitals take great care in management of the experimental animals. They are highly concerned about hereditary, breeding, and infectious problems. I also think that problems do exist between neighboring residents and the laboratories. We would like to give adequate care from now on.

Hiroyuki Tani (Councilor)

 Laws regulating the genetically engineered organisms became effective in this February, and its 31th article stipulates boarding inspection. Do you think it is necessary to rethink about conducting the inspection when the school announces the truth?

Akira Ishikawa (Ministry of Education, director of Research Promotion Bureau)

 The school’s Board of Experiment is currently investigating the matter. We have been informed that they are now taking appropriate measures based on the laws. Therefore, Ministry of Education does not think it is necessary to conduct boarding inspection. The school should begin with establishing better maintenance so these problems will not return. If new problems are to be revealed by school’s reports, then I would like to correspond appropriately according to the contents.

Infectious Experiment and Disclosure of Information

Hiroyuki Tani (Councilor)

 The agency which had been managing breeding of animals blew the whistles on detailed facts that took place inside the school for the past ten years. I think this is a very serious problem.

 Animals also have the rights and welfare. They are being sacrificed to produce medications and to maintain human’s lives. I would like everyone to take a good look at the university’s report.

 With last year’s SARS as a turning point, infectious disease preventive laws were revised. The locations of the infected animals are not clearly understood. As truths are revealed gradually, residents become very anxious and the first thing they would do is to visit the public health center.

On the ground of animal protection laws, which are managed by Ministry of Environment, the health center went to the university last September. However, regrettably, there were no facts which violated the protection laws. There is a limit to these laws.

Chikara Sakaguchi (Minister of Health, Labor and Welfare)

 I believe that local health centers need to play such a role and be ready for future incidents. If local residents were to become infected or become anxious of the possibility of infection, the centers need to provide information such as symptom and treatment. I think that the health centers are obligated to report possibility of infection to citizen.

 When it is possible for the infection to spread, we can conduct boarding inspection of the facility. In any case, this issue is pertinent to residents’ health; therefore, we would like all the health centers in the country to be better prepared to deal with future cases.