Animal experimentation in Japan: Regulatory processes and application for microbiological studies

Comparative Immunology, Microbiology and Infectious Diseases

Volumn 30, Issue 4, 2007, Pages 225-246

  Takahashi Omoe, H ^a   Omoe, K ^b  

^a NATIONAL INSTITUTE OF SCIENCE AND TECHNOLOGY POLICY   (Japan)

^b IWATE UNIVERSITY   (Japan)

Author keywords

Animal experimentation; Biologics; Laboratory animals; Management system; Microbiological research and development

Indexed keywords

ANIMAL EXPERIMENT; ANIMAL RIGHTS; ARTICLE; EXPERIMENTAL ANIMAL; GOVERNMENT; JAPAN; LAW; MANAGEMENT; MICROBIOLOGICAL EXAMINATION; NONHUMAN; PRACTICE GUIDELINE; PROFESSIONAL PRACTICE;

ANIMAL EXPERIMENTATION; ANIMAL WELFARE; ANIMALS; ANIMALS, LABORATORY; BIOMEDICAL RESEARCH; JAPAN;

ANIMALIA;

EID: 34249716733     PISSN: 01479571     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cimid.2007.02.001     Document Type: Article

References (50)

1. European Convention. 〈http://www.uku.fi/vkek/Sopimus/convention.html〉. For the protection of vertebrate animals use for experimental and other scientific purposes (European Agreement).
2. The Council of the European Communities. 〈http://europa.eu.int/comm/food/fs/aw/aw_legislation/scientific/86- 609-eec_en.pdf〉. EU Directive 86/609/EEC.
3. Canadian Council on Animal Care (CCAC). 〈http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Gu idelis.htm〉. List of CCAC guidelines.
4. US Department of Agriculture. 〈http://www.nal.usda.gov/awic/legislat/awa.htm〉. Animal welfare act as amended, 7 USC. p. 2131-56.
5. 〈http://www.nap.edu/readingroom/books/labrats/index.html〉. Guide for the care and use of laboratory animals, 1996.
6. National Institutes of Health. 〈http://grants.nih.gov/grants/olaw/references/phspol.htm〉. Public health service policy on humane care and use of laboratory animals. Office of Laboratory Animal Welfare. Amended August 2002.
7. Omoe H. Recent trends in animal experimentation in Japan-on the revision and implementation of the law for the humane treatment and management of animals. Sci Technol Trends Q Rev 21 (2006) 13-31
8. Ministry of the Environment, Japan. 〈http://www.env.go.jp/nature/dobutsu/aigo/law_series/law_index.html 〉. Law for the humane treatment and management of animals.
9. Yamanouchi K. Regulatory considerations in the development and application of biotechnology in Japan. Rev Sci Technol 24 1 (2005) 109-115
10. Ministry of Education, Culture, Sports, Science and Technology (MEXT) Life Science Portal Site. 〈http://www.lifescience-mext.jp/policies/shingikai.html〉. Kenkyuu kikan ni okeru doubutsu jikken tou ni kansuru kihonshishin' (Japanese) (The proposed basic guidelines on animal experimentation in research laboratories).
11. Kouseiroudoushou ni okeru doubutsu jikken tou no jisshi ni kansuru kihonshishin (an) ni tsuite (Japanese) (The proposed basic guidelines on the carrying out of animal experimentation within Ministry of Health, Labour and Welfare (MHLW)). In: 31st Science and Technology Committee, Health Sciences Council, MHLW, May 2006.
12. Ministry of Agriculture, Forestry and Fisher (MAFF). 〈http://www.maff.go.jp/www/press/2006/20060601press_2.html〉. Nourinsuisannshou no shokan suru kenkyuu kikan tou ni okeru doubutsu jikken tou no jisshi ni kansuru kihonshishin (Japanese) (The proposed basic guidelines on carrying out of animal experimentation in research laboratories).
13. Japan Biosafety Clearing-House (J-BCH). 〈http://www.bch.biodic.go.jp/english/law.html〉. Domestic law and regulations.
14. Ministry of Education, Culture, Sports, Science and Technology (MEXT). 〈http://www.mext.go.jp/a_menu/shinkou/seimei/kumikae.htm〉. Law concerning the conservation and sustainable use of biological diversity through regulations on the use of living modified organisms.
15. Japan Biosafety Clearing-House (J-BCH). 〈http://www.bch.biodic.go.jp/download/en_law/Research%20and%20Devel opment.doc〉. The ministerial ordinance providing containment measures to be taken in type 2 use of living modified organisms for research and development.
16. Kurata T. Current situation of biosafety in Japan. Biosafety in Asian Pacific. In: The international symposium of biosafety, November 2006.
17. Regulation on the Safety Control of Laboratories Handling Pathogenic Agents (Japanese). Japan National Institute of Infectious Diseases, July 2006.
18. Ministry of the Environment (MOE). 〈http://www.env.go.jp/nature/yasei/hozonho/index.html〉. Explanation of the Law for the Conservation of Endangered Species of Wild Fauna and Flora (Japanese).
19. Ministry of the Environment (MOE). 〈http://www.env.go.jp/en/nature/as/040427.pdf〉. Invasive Alien Species Act. Law No.78 (Japanese).
20. 〈http://www.env.go.jp/nature/yasei/choju_ho/index.html〉. Enforcement of the Wildlife Protection and Hunting Law (Japanese). Ministry of the Environment (MOE).
21. Ministry of Health, Labour and Welfare (MHLW). 〈http://www.forth.go.jp/mhlw/animal/page_b/b04-14.html〉. Law concerning the prevention of infectious diseases and medical care for patients of infectious diseases (Japanese).
22. 〈http://www.mhlw.go.jp/english/topics/importanimal/index.html〉 . New notification system for the importation of animals (Japanese).
23. Ministry of Agriculture, Forestry and Fisher (MAFF). 〈http://www.maff-aqs.go.jp/hou/57.htm〉. Explanation of the Infectious Diseases Control Law (Japanese).
24. e-Government (e-GOV). 〈http://law.e-gov.go.jp/htmldata/S35/S35HO145.html〉. The Pharmaceutical Affairs Law (Japanese).
25. The Standards of Non-clinical Safety Tests on Drugs (Japanese). Ministry of Health, Labour and Welfare (MHLW) Ordinance No. 21, March 1997.
26. The Guidelines for Toxicity Studies of Drugs (Japanese). Ministry of Health, Labour and Welfare (MHLW) Notification No. 24, September 1989.
27. The partial amendments to 'Handling of Clerical Works Related to Drugs for Animals' (Japanese). Ministry of Agriculture, Forestry and Fisher (MAFF) Notification No. 1702, June 2002.
28. International conference on harmonization of technical requirement for registration of pharmaceuticals for human use (ICH). 〈http://www.ich.org/cache/compo/276-254-1.html〉.
29. International cooperation on harmonization of technical requirements for registration of veterinary medicinal products (VICH). 〈http://vich.eudra.org/〉.
30. National Institute of Infectious Diseases (NIID). 〈http://www.nih.go.jp/niid/index-e.html〉.
31. National Veterinary Assay Laboratory (NVAL). 〈http://www.nval.go.jp/info/intoroE.htm〉.
32. The Science Council of Japan. 〈http://wwwsoc.nii.ac.jp/jalas/law_guide/060601gakujyutu.pdf〉. Guidelines toward an appropriate implementation of animal experimentation (Japanese).
33. Japanese Association for Laboratory Animal Science. 〈http://wwwsoc.nii.ac.jp/jalas/law_guide/law_04.html〉. Guidelines for animal experimentation formulated by JALAS (Japanese).
34. 〈http://www.archive.official-documents.co.uk/document/hoc/321/321.h tm〉. Guidance on the Operation of the Animals. Animals (Scientific Procedures) Act 1986.
35. The survey of laboratory animals sold in 1995. Report of the Japanese Society for Laboratory Animal Resources, 1997.
36. The survey of laboratory animals sold in 1998. Report of the Japanese Society for Laboratory Animal Resources, 1999.
37. The survey of laboratory animals sold in 2001. Report of the Japanese Society for Laboratory Animal Resources, 2002.
38. The number of live animals used in experiments in 1995-results of a survey. Lab Anim News 1998;47(1):55-67.
39. The number of live animals used in experiments in 1998-results of a survey. Lab Anim News 2001;50(5):55-63.
40. The number of live animals used in experiments in 2001-results of a survey. Lab Anim News 2003;52(5):141-58.
41. Koike S., Taya C., Kurata T., et al. Transgenic mice susceptible to poliovirus. Proc Natl Acad Sci USA 88 (1991) 951-955
42. Wakita T., Pietschmann T., Kato T., et al. Production of infectious hepatitis C virus in tissue culture from a cloned viral genome. Nat Med 11 (2005) 791-796
43. Hamaguchi K, Imai J, Momose. Trying to establishment of new safety assessment of vaccines using gene expression analysis. In: Collection of summaries, 10th Japanese Society for Vaccinology, 2006. p. 81.
44. Miyamura K., Tajiri E., Ito A., Murata R., and Kono R. Micro cell culture methods for determination of diphtheria toxin and antitoxin titers using Vero cells. Part II. Comparison with the rabbit skin methods and practical application for seroepidemiological studies. J Biol Stand 2 (1974) 203-209
45. Miyamura K., Nishino S., Ito A., Murata R., and Kono R. Micro cell culture method for determination of diphtheria toxin and antitoxin titers using Vero cells. Part I. Studies on factors affecting the toxin and antitoxin titration. J Biol Stand 2 (1974) 189-201
46. Chino F. The views and policy of the Japanese control authorities on the three R's. In: Brown F, Cussler K, Hendriksen C, editors. Replacement, reduction and refinement of animal experiments in the development and control of biological products. Dev Biol Stand 1996;86:53-62.
47. Hamamoto H., Kurokawa K., Kaito C., et al. Quantitative evaluation of the therapeutic effects of antibiotics using silkworms infected with human pathogenic microorganisms. Antimicrob Agents Chemother 48 (2004) 774-779
48. Mase M., Tanimura N., Imada T., et al. Recent H5N1 avian Influenza A virus increases rapidly in virulence to mice after a single passage in mice. J Gen Virol 87 (2006) 3655-3659
49. Japan International Center for Occupational Safety and Health. 〈http://www.jicosh.gr.jp/japanese/oshlaw/IndustrialSafetyHealth_Law /indexjp.html〉. Industrial Safety and Health Law (Tentative translation).
50. Sakara E. The plan on labor safety and hygiene in animal experimentation. In: 53rd annual meeting of the Japanese Association of Laboratory Animal Science, 2006.