Kensuke Nakajima Division of International Collaboration, National Institute of Infectious Diseases (Tuberculosis and Infectious Diseases Control Division, Health Service Bureau, Ministry of Health, Labour and Welfare) Since implementation of the Law Concerning the Prevention of Infectious Diseases and Medical Care for Patients of Infections (the Infectious Diseases Control Law), the first-ever recently revised law revision (Infectious Diseases Control Law, No. 145, October 16, 2003) has substantially enhanced control measures by (i) strengthening infectious disease control in times of emergencies, particularly the role of the national government, (ii) organizing and strengthening measures against zoonotic infectious diseases, and (iii) as a law involving both the revision of targeted infectious diseases and its classification (http://idsc.nih.go.jp/iasr/25/287/tpc287.html), Animal Importation establishing an Notification System especially for zoonotic infectious disease control.  This revised law is considered essential toward promoting infectious disease control in Japan, based on subsequent occurrences of domestic outbreaks of avian influenza and human infection, and spread of diseases such as avian influenza, West Nile fever, Nipah virus infection within endemic areas and to humans in countries abroad. After the law revision, the Ministry of Health, Labour and Welfare (MHLW), based on opinions of the Health Sciences Council Infectious Disease Committee (June 4, 2004), implemented necessary revisions of government ordinances, ministerial ordinances, and announcements, and has proceeded with administrative reorganization policies, in order to carry out new zoonotic infectious disease control measures as stipulated by law. This article summarizes these revisions. Strengthening of 1. animal importation measures (see http://www.mhlw.go.jp/english/topics/importanimal/index.html) (1) Implementation of a notification system for importation of animals (Infectious Diseases Control Law, Article 56 Part 2) The intent of this new legal requirement is to implement public health control measures for imported animals as a way of preventing the introduction of infectious diseases into Japan. In addition to import restrictions, quarantine and inspections of animals, submission of import notification forms and accompanying health certificates 1 issued by government agencies of exporting countries are required, thereby authorizing importations on condition that animals capable of infecting humans do not develop disease and cause subsequent spread. The required provisions toward execution of the newly established notification system have been stipulated by the MHLW ordinance (MHLW Ordinance No. 128, September 15, 2004) as follows (however, certain additional revisions are scheduled for experimental animals by the time the new system is implemented) (see figure in page 6): 1) Implementation of the notification system: September 1, 2005. 2) Notifiable animals: Terrestrial mammals, rodents including carcasses, lagomorphs (e.g. rabbits) including carcasses, birds. In other words, all animals that fall under the categories mentioned above are imported for any purpose (e.g. exhibition, sales, individual pet) are subject to notification. Animals previously subject to import restrictions or quarantine have been excluded from this new system (Ministerial Ordinance No. 28, Appendix No. 1, Column No. 1). 3) Targeted infectious diseases: Defined in accordance with the corresponding targeted animals (Ministerial Ordinance No. 28, Appendix No. 1, Column No. 2). 4)   Notification forms: Documentation of 15 items, including intended use and country of origin of animals (Ministerial Ordinance No. 29, Form No. 3). 5)  Health certificate: Documentation of 8 items, including animal species/quantity, and certificate-issuing agency (Ministerial Ordinances Nos. 30 & 31). 6) Necessary accompanying documents: Documents allowing verification of submitting individuals or corporations, airline consignment notes, etc. (Ministerial Ordinance No. 29, Announcement No. 337). 7) Notification receiving agencies: 27 quarantine stations and substations, MHLW (Ministerial Ordinance No. 29). 8) Other: New ministerial announcements required for implementation of the system will be prescribed by MHLW, including Criteria for Animal Holding Facilities for Rodents, Areas Free of Rabies, and Areas Free of Highly Pathogenic Avian Influenza (Announcements Nos. 338, 339 & 340, respectively). (2) Expansion of animals subject to importation restrictions (Infectious Diseases
Control Law, Article 54)
New legal requirements stipulate that animals specified by government ordinance as highly capable of infecting humans with zoonotic infectious diseases, and that are shipped from designated areas (as defined by the MHLW and the Ministry of Agriculture, Forestry and Fisheries [MAFF]) or pass through these areas, are prohibited from being imported. Based on the law revision, bats and African soft-furred rats have been added to the list of animals previously subject to import restrictions, which includes ferret badgers, monkeys, raccoons, civet cats, and prairie dogs (Government Ordinance No. 459, October 22, 2003). In addition, for the above-designated animals other than monkeys, all areas are defined as designated areas by the MHLW and MAFF (MHLW/ MAFF Ordinance No. 6, October 30, 2003). (3) Enhancement of safety measures for imported monkeys (Infectious Diseases
Control Law, Article 54)
Because monkeys are likely to carry infectious diseases common to humans, regulations were introduced on July 1, 2005 that, in compliance with World Organization for Animal Health (Office International des Epizooties: OIE) standards, limit importation of monkeys to those utilized for work in research institutes or zoos (both types of facilities limited to those designated by MHLW and MAFF), while disallowing imports of monkeys as pets (MHLW/MAFF Ordinance No. 3, March 30, 2005).
2. Strengthening of domestic animal measures
(1) Expansion of investigations of animals identified as sources of infection (Infectious Diseases Control Law, Article 15, Article 63 Part 2) Under the revised law, new articles clearly stipulate that, in the event of an occurrence or outbreak of Category I to IV infectious diseases, (i) prefectural governors (implementers: municipal employees engaged in infectious disease control) have the authority to question animal owners, administrators, and other concerned parties or conduct required active epidemiological investigations (Article 15, Section 1), (ii) the national government can order prefectures to conduct necessary investigations if there is potential for spread of the infectious disease beyond the affected prefectures and an urgent need to take action (Article 63 Part 2), and (iii) the national government can also conduct independent investigations (Article 15, Section 2). Based on these stipulations, new rules for active epidemiological investigations have been added to one of the MHLW ordinances and applied to epidemiological investigations of zoonotic infectious diseases (Ministerial Ordinance No. 128, Article No. 8, September 15, 2004), summarized as follows: 1) Situations in which active epidemiological investigations are to be conducted: (i) occurrence of a case or suspected case of a Category I to IV infectious disease, (ii) suspicion that an infectious disease, not previously recognized in Japan but endemic abroad, has occurred, or (iii) occurrence of an infectious disease capable of being transmitted from animals to humans, or suspicion of such an occurrence. 2) Response during the conduct of active epidemiological investigations: Investigators are requested to submit collected samples, documents with test results, information on occurrences of other infectious diseases, and necessary items that may help identify the cause and trends of the implicated disease. 3) Reports to prefectural governors (e.g. animal owners): For the purpose of rapid and accurate conduct of active epidemiological investigations, situations in which animals have contracted or may have contracted an infectious disease should be immediately reported to the nearest public health center, with items mentioned in 2) attached if available. 4) Reports from prefectural governors to MHLW: In the event that reports from 3) are considered important for infectious disease control, MHLW should be notified with necessary items attached. (2) Addition of veterinary reportable diseases and animals, and expansion of notification requirements (Infectious Diseases Control Law, Article 13) Under the revised law, Category IV infectious diseases have been added to the list of veterinary reportable diseases.   This addition has led to government ordinance revisions of criteria for selecting reportable diseases, with a disease considered reportable if it (i) potentially has a significant impact upon introduction into Japan and (ii) necessitates immediate consideration of preventive measures for humans. The following infectious diseases and susceptible animals have been added to the list of reportable entities: (i) bacillary dysentery, monkeys, (ii) West Nile fever, birds, and (iii) echinococcosis, dogs (Government Ordinance No. 231, July 9, 2004). In conjunction with this ordinance revision, a ministerial ordinance amendment has resulted in the expansion of notification items from 4 to 14 in order to increase information collection from veterinarians (MHLW Ordinance No. 128, September 15, 2004). Furthermore, Reporting Criteria for Veterinarians have been established for targeted notifiable diseases (Tuberculosis and Infectious Diseases Control Division notification No. 062002, June 20, 2005). The strengthening of zoonotic infectious disease control by involving veterinarians is interconnected with the establishment of a code of accountability under the revised law (Infectious Diseases Control Law No. 5, Part 2), calling for greater contributions of veterinarians toward public health action.
(3) Other
Based on law, government ordinance, and ministerial ordinance revisions, the following announcement revisions and guidelines have been developed. 1) The announcement "Basic Guidelines for Comprehensive Promotion of Infectious Disease Prevention " has been revised (MHLW Announcement No. 438, December 19, 2003) with new items for zoonotic infectious disease control (No. 11, Part 4, etc.) created and included. Guidelines development: Diagnostic and response guidelines have been established for 2) bacillary dysentery in monkeys, West Nile fever in birds, and echinococcosis in dogs, to accompany the addition of these diseases and animals as veterinary reportable entities under the government ordinance revision.
3. Administrative reorganization
Based on enhancement of zoonotic infectious disease control under the revision of the Infectious Diseases Control Law, Tuberculosis and Infectious Diseases Control Division, Health Service Bureau, MHLW, responsible for zoonotic infectious disease control, underwent a structural reorganization (after April 1, 2004).  Specifically, staffing of the zoonotic infectious diseases section has expanded from two (1 assistant director and 1 veterinary health subsection chief) to four (1 assistant director, 1 expert, 2 subsection chiefs − 1 advisor and 1 administrator) to further promote operations and services.   Moreover, in preparation for the implementation of the animal import notification system, a new department called the Animal Import Control Office has been set up in each of the quarantine stations at international airports in Eastern and Western Japan (Narita Airport Quarantine Station and Kansai Airport Quarantine Station). Figure Animal import notification system summary (effective September 1, 2005) Notifiable animals: mammals, birds, and rodents, lagomorphs (e.g. rabbits) including carcasses Submission of notification form & health certificate (submission to MHLW* quarantine station) Customs clearance (Ministry of Finance customs) Domestic distribution *MHLW = Ministry of Health, Labour & Welfare