Competent Authority comments on the draft report received 2 March 2018

Competent Authority comments on the draft report received 2 March 2018 1. (p6) After Paragraph No.1, we would like to add a paragraph about National Institute of Animal Health (NIAH), shown below, because it is shown in following several paragraphs (83-85, 87, 128, 132, 151, 153-154, 156-158). Please note that NIAH is neither a part of MAFF nor MHLW but it is a part of National Agriculture and Food Research Organization.: National Institute of Animal Health conducts several disease confirmation tests such as BSE, FMD and HPAI. It includes OIE reference laboratories for BSE, equine infectious anaemia, classical swine fever, swine influenza, and rinderpest. It also provides several diagnosis training courses to Livestock Hygiene Service Centres (LHSCs). 22: 35: 121: Japan has no legal framework to determine the disease-free status by the unit of cattle holding / herd with respect to bovine tuberculosis and bovine brucellosis Rather, Japan has the policy to acquire freedom of those diseases as a whole country through the detection and culling of all milking cows tested positive for those diseases over a certain period of time. If a positive cow is confirmed in the diagnosis tests, every cow in the same farm will be examined and any positive animal is culled. 27. The official veterinarians at both slaughterhouses for pig and poultry conduct ante- and post-mortem inspections, record the result of the inspection every day, and keep the records at Meat Inspection Centre s (MIC) office according to the Abattoir Act (see attachment (41) for the records of ante-mortem inspection). In Japan, the company employee is not allowed to perform the ante- and post- mortem inspections. At the both establishments visited, official veterinarians conducted the ante- and post- mortem inspections at the dates of EU s audit. Furthermore, the ante- and post-mortem inspection procedure guideline (Japanese only) was issued by MHLW and the official veterinarian of MIC conduct the ante- and post-mortem inspection according to the guideline. For this reason, we would like to revise the paragraph No. 27 shown below. 27. The ante-mortem inspections in the visited slaughterhouses were not properly documented. Often, the inspections had been done by company's staff and not by the official veterinarian, which is not in compliance with national Page: 1

provisions. There were records on that activity, but they were vague and uninformative, and reflected very few findings. According to the official veterinarians of both slaughterhouses, the animals were always healthy at the time of arrival. 42: In Japan, farmers with integrated management (Farrow-to-finishing type farm) are 72% (Table 1: 4,510 units vs. 3,260 units), and pigs traded in livestock markets are 0.2% or less compared with the number of slaughtered animals yearly (Tables 2 and 3: 16,392,000 vs. 25,508 head). Table 1. Number of Pigs Farms - Types of Farming (as of February 1 2017) Total Type Breeding farm Fattening farm Farrow-to-finishing type Unit: Farm 4510 379 876 3260 Note:this table does not include non-profitable farms, such as school and testing farms Source: MAFF Livestock Product Marketing Statistic Table 2 Number of Pigs sold at Livestock Markets Unit: head Number of Pigs Sold at livestock markets 2014 2015 2016 Total 31,844 27,121 25,508 Source: Livestock Market Database of NBAFA Table 3 Page: 2

Number of Pigs slaughtered Unit: head 46: 49: 56: Number of Slaughtered Pig 2014 2015 2016 Total 16,202,855 16,104,466 16,392,000 Source: MAFF Livestock Product Marketing Statistic Article 12-4 of the Act on Domestic Animal Infectious Diseases Control describes that owners of pig must report to the prefectural governor once a year about the location of the farm, the number of livestock, the number of pig pens, etc. According to the report, each prefecture can perceive all pig farms in the jurisdiction area. This reporting obligation is once a year, not necessarily reported in accordance with the establishment of the farm. Meanwhile, the number of domestic pig farms in Japan has been decreasing in recent years. On February 2007, there were 7,550 farms, but as of February 2017, it is only 4,510. Among them, small farmers with less than 100 pigs, including backyard holdings, are as few as 560 farms (12%), decreasing year by year (654 farm holds in February 2015, 600 in February 2016). Therefore, even if a new farm is established in a certain area, its jurisdictional LHSC can notice the farm through shipment of swine, purchase of feed etc. as an actual fact. Even the OIE Terrestrial Animal Health Code (Chapter 4.1) describes The equivalent outcomes based on performance criteria rather than identical systems based on design criteria should be the basis for comparison of animal identification systems and animal traceability. Paragraph No. 56 describes that the uncertainty of trace-back survey will not eliminate at the time of disease occurrence due to absence of a public traceability system. However, for example, in the case of foot and mouth disease (FMD), livestock which has contacted to the affected one within 7 days from the date of the FMD confirmation will be slaughtered, and those that have contacted with the affected animal within 8 to 21 days will be subject to movement restrictions until examination tests are confirmed as negative. The jurisdictional LHSC immediately conducts on-site inspection of the suspected farm after receiving a report of suspicious cases and conducts tracing study by scrutinising the documents related with purchase/sales, hearing from people involved in the farm. In order to confirm the reliability of the tracing study, Japan verifies the information of the Page: 3

farms which were recognised in trace forward or trace back investigation, by scrutinising the documents related to purchase/sale and hearing from the people related to the farm. After the confirmation of the information, Japan takes necessary control measures against the disease. 72: In order to conduct this follow-up survey, LHSCs visit livestock farms more than once a year to confirm the compliance status of the Biosecurity Standards, and also record the ordinary number of livestock at the farms, and its epidemiology-related farms by checking people and vehicles entering and leaving the farm. According to the information, LHSCs make disease control plans in case of an outbreak. Taking into the mentioned above, Japan believes that no public traceability system and no database information make it impossible to perform rapid and accurate tracing study. (Even if there is a public traceability system and also there is database information, you cannot track quickly and accurately unless you visit farms and implement a thorough investigation in case of disease outbreaks.) Paragraph No. 72 is incorrect. By amendment of Act on Domestic Animal Infectious Diseases Control in 2011, Act allows pre-emptive culling in a case of FMD. [abstract from Article 17-2 of Act on Domestic Animal Infectious Diseases Control] Article 17-2 (1) In cases where foot-and-mouth disease is spreading or is likely to spread, when it is difficult to prevent the spread solely through the steps prescribed under the provisions of this chapter (excluding the portion prescribed in this article), and it is deemed necessary to slaughter domestic animals other than animals affected or suspected of footand-mouth disease (hereinafter referred to as "affected animals, etc.") to prevent the rapid and large-scale spread thereof, the Minister of Agriculture, Forestry and Fisheries may specify the area in which it is necessary to slaughter domestic animals other than affected animals, etc. as a specified area, and the domestic animals that must be slaughtered (excluding affected animals, etc.) in the specified area as specified domestic animals. (omission of (2)-(4) ) (5) In the event specified areas and specified domestic animals have been specified, the prefectural governors with jurisdiction over said specified areas shall order owners of specified domestic animals in the specified areas to Page: 4

slaughter the specified domestic animals within a set period. 113: 116: 115: 129: Paragraph No. 113 describes "There is an annual surveillance program for bovine tuberculosis since 1998." in the 1st sentence, but it is not correct because, before 1997, all the milking cows were examined every two years. As for milking cows in Japan, they are less than 900,000 heads, and now they are going to be inspected every five years, so it is reasonable that the actual number of testing is around 200,000. The dairy period of Japanese dairy cows is from 5 to 6 years, and theoretically all milking cows will be examined at least once in their lifetime. In the surveillance program of tuberculosis, Japan devises to evenly examine the cattle to be examined, for example, a LHSCs the jurisdictional area into five, and inspects one area every year; after five years, it is supposed to make a round of all dairy herds in the jurisdiction area. The disease-free status of Japanese dairy herds is as follows: As for cattle tuberculosis, in 1901, Japan enacted the Act on Cattle Tuberculosis Disease Prevention. According to the Act, Japan has commenced active surveillance programme to examine all dairy cows and bulls at least once a year, and slaughtered the disease positive cattle based on the survey. In 1956, bovine brucellosis also became the subject of this active surveillance. At the most extensive years, more than one thousands of cattle were slaughtered due to tuberculosis each year, and hundreds over the cattle with brucellosis were also slaughtered every year. The cases of both diseases have dramatically decreased in incidence, and since 1975 active surveillance programme was amended to the one which perform examinations all dairy cows and bulls at least every two years In 1998, considering the subsequent situation of disease occurrence, the active surveillance programmes of both diseases were revised to the ones in which all dairy cows and bulls are examined at least once every five years Therefore Paragraph No. 118 saying "There is an annual surveillance program for bovine tuberculosis since 1998." only refers to the current active surveillance. Whereas Japan has been implementing active surveillance programmes, and culling the disease affected cattle for a longer period of time. Article 8.11.4. of the OIE Terrestrial Animal Health Code describes that at least three years this testing has demonstrated that infection with M. tuberculosis complex was not present in at least 99.8% of the herds for the free Page: 5

status of the disease. Prior to 1997, active surveillance programmes was for whole dairy cattle every two years which is shorter than the OIE. In 1996 and 1997, about 40,000 dairy herds (1.5 million in number of heads) were examined, and the number of positive cattle was 10 heads (at most 10 groups). It means that the positive ratio of the group base is about only 0.025%. 118: 120: 119: For bovine brucellosis, Article 8.4.4 of the OIE Terrestrial Animal Health Code mentions that for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the herds representing at least 99.9% of bovids in the country or zone for the free status of the disease. During 1996 and 1997, active surveillance programmes were performed and 40 thousands dairy whole dairy herds (over 1.5 million in number of heads) were examined. No positive cattle were found in the programmes. The first bullet of Paragraph 118 describes that the OIE Terrestrial Manual recommends 2000 IU administration. It is true but the same Chapter 2.4.6 of the OIE Terrestrial Manual also recommends doses of up to 5000 IU in national eradication campaigns. Administration of over 5000 IU might introduce non-specific reaction; however, Japan inoculates 10000 IU to cattle in order to get clear result at the first reaction under the policy that Japan culls every cattle showing positive as well as non-specific reaction. Currently, the titre of tuberculin used in Japan is 500,000 IU (400,000 to 625,000 IU) per 5 ml. Given that 0.1 ml is inoculated at a time, the antigen titre of Mycobacterium tuberculosis complex is 10,000 IU (8,000 to 12,500 IU / dose). Regarding tuberculin for test, the effectiveness of tuberculin has been confirmed by National Veterinary Assay Laboratory. For examination at slaughterhouses, Japan will conduct testing in collaboration with LHSCs through education for MIC staff at slaughterhouses. As mentioned in the comments for Paragraph Nos. 115 and 129 above, Japan had extremely low positive rate at the year of 1997 as the result of promoting detection and culling positive cattle at farms. As a consequence, the number of suspected cattle of bovine tuberculosis has become also very few at slaughterhouses. MIC, if the abnormality is visually confirmed in lymph nodes, incise them to confirm. If MIC determines it as suspicious one, the following process of the sampled carcass is suspended and a precise examination will be performed. In 1999, Mycobacterium tuberculosis complex was isolated from beef cattle by a slaughterhouse s inspection. Page: 6

According to the examination report by the MIC, the LHSC performed an epidemiological survey and found the other 34 cattle affected with bovine tuberculosis at a farm. 142: 144: 143: 144: 150: As an example shown in above, Japan has implemented thorough surveillance by examinations by LHSCs at farm level as well as those in respond to examination reports by MICs. It is true that For instance, no visit, inspection or sampling is carried out in in any holding keeping less than 100 poultry... mentioned in Paragraph No. 142. However, movement restrictions within a radius of 3 kilo meters of the affected farm and shipment restrictions within radii between 3 and 10 kilometres are also imposed on farms with less than 100 birds. In addition, in restricted zones within 10 kilometres of radius, every farmer must notify any abnormal signs and the number of dead poultry to a LHSC in accordance with Article 52 of Act on Domestic Animal Infectious Diseases Control. If the LHSC acknowledges the abnormal report, it performs several required examination. These are required notification stipulated in the Act, if a farmer does not notify any report or it does false report; the farmer is imposed legal penalties. As described in the draft report, in Japan, the setting period of the shipment restricted zone is approximately 15 days, and that of the movement restricted zone (MRZ) is 21 days when a highly pathogenic avian influenza occurs. The movement restriction will be lift 21 days after implementing the required inspections in the movement restricted zone, where the risk is higher than others, and confirming that there are no reports of abnormalities as stipulated in the Act. The OIE Terrestrial Animal Health Code mentions the incubation period for avian influenza shall be 21 days and Japan does not think it is scientifically insufficient. In Japan, 12 HPAI cases for domestic poultry were confirmed during the fiscal years of 2016 17. There was no additional HPAI positive case confirmed during 9 days after the date of lifting MRZ within the same MRZ, thus there was no case that Japan needed to re-establish MRZ in the same area. ( 9 days stands for the time difference of the maximum duration of the restriction zones between EU (i.e. 30 days) and Japan (i.e. 21 days).)japan considers that our HPAI control measures are functioning well, such as the policy on completion of culling within 24 hours after a confirmation of HPAI affected or suspected poultry. However, if Japan undergoes a situation that prevention of spreading HPAI was not possible with 21days of MRZ, we might consider expanding the period up to 30 days. Page: 7

146: Paragraph No.146 describes There was no assessment of the epidemiological circumstances ; however, Japan 150: conducts epidemiological surveys for investigation of infectious paths including environmental sampling and publishes them on each case. Therefore it is not a correct description: no assessment. 158: 159: 160: 162: 163: Furthermore, when a suspicious bird is found, Japan commences an epidemiological survey to identify movement of poultry, humans, and objects from the suspected farm. This pre-survey contributes to the control measures taken after confirmation of the HPAI such as immediate culling and additional active surveillance points. As an example, in an HPAI case determined in 2018, the pre-survey found a farm which had an epidemiological relation; some employees also worked in the suspected farm. After confirming HPAI case, all poultry in this farm were also culled. In the fiscal years of 2016-17, the outbreak farms showed that they were significantly more farms closer to waterside in the surrounded area. In Japan, fixed-point monitoring is carried out by selecting farms which are located in the area at higher risk of infection compared with others, such as farms located around the stopovers of wild birds. This selection criterion of target farms in the monitoring programme is proved by the above-mentioned result. As Paragraph No.158 describes, the national external quality assurance scheme for Livestock Hygiene Service Centres in the whole country is developing at this time. However, in order for the development, Japan has implemented the three-year-project since FY 2015, and through the project, Japan will distribute manuals on external quality control and internal accuracy control to all Livestock Hygiene Service Centres by April 2018. The project will be continued for further 3 years from FY 2018; in the project, Japan plans to perform proficiency tests to the laboratories based on the National Institute of Animal Health already acquiring ISO 17025. Based on the programmes and projects so far, Japan deems that momentum for quality control at the Livestock Hygiene Service Centres have been mature enough to proceed, Japan decides to amend the government ordinance for the Livestock Hygiene Service Centres Law by revising to make it compulsory to implement quality controls at Livestock Hygiene Service Centres from April 2019; and in February 2018, MAFF informed and guided all prefectural governments to prepare and test out quality controls at the laboratories since April 2018. Page: 8