农业部发布对《欧盟动物和动物产品残留评估团赴中国考察报告》（草案）的评价报告（English）
Comments by the Ministry of Agriculture of P.R. China
on the "Draft Report for the Residue control in Live Animals and
Animal Products by EC Inspection Mission to China"
Comments by the Ministry of Agriculture of P.R. China on the "Draft Report for the Residue control in Live Animals and Animal Products by EC Inspection Mission to China"
From the 8th to 22nd November 2001, a Veterinary inspection mission sent by the European Union Commission carried out an evaluation in China on the residue control work for food-commodities of animal origin. And a Draft Report of the mission (hereafter referred to as the Draft Report) was submitted to the Chinese side on the 22nd January 2002. It also requested that the Chinese side should present their comments on the Draft Report within 10 working days. The Chinese side attached great importance to the Draft Report and immediately organised the relevant experts to make a scrutiny into the contents of the Draft Report. Therefore, scientific comments were made and they are as follows:
1. Background
1.1 The EC has provided great support and technical assistance towards the residue control programme for food-commodities of animal origin in China. In 1999, with the assistance of EU experts and in reference to the relevant directives of EC 96/22/EC and 96/23/EC, China established a residue control system for food-commodities of animal origin, which was approved by the Mission on residue inspection sent by the EC in October 1999. The EC also made a positive confirmation on the Report of residue control in the year 2000 presented by the Chinese side.
After efforts of more than two years, China has already established a network of systems which are suitable to the reality in China for the residue control for food-commodities of animal origin with the level of control improving year by year. However, the Draft Report submitted by the EC this time has in fact denied the positive comments of the previous two missions on residue control programme in China.
1.2 At present, China has linked the residue control work with the export examination in order to ensure the safety and hygiene of food commodities of animal origin. From the 1970s, China has already started taking samples for testing on every batch of export goods and forcefully ensured the continuous development of the trade for food commodities of animal origin between China and Europe. In recent years, China carried out the residue control programme and intensified the work for nation-wide residue control of food commodities of animal origin. Some problems brought up during the course of implementation of residue control programme in China and the issue of "chloramphenical residues" tested out during the import examination, came only from the limited areas they had visited and they do not reveal the true and overall situation of the residue control for food commodities of animal origin in China.
1.3 The Chinese side is endeavouring to fulfil their commitments to the EC. With regard to the establishment of relevant laws and regulations and quality control of laboratories, the Chinese side has always been making great efforts in this regards, but the goal can not be reached in one step. For example, at the end of 2001, China had already revised " Administration Regulations for the Veterinary Drug ", " Administration Regulations for the Medicated Feed Additives " and "Administration Measures for the Veterinary Drug Used in Raising Animals and Poultry for Meat Export"; the relevant departments have also organised training courses for testing methods on residues and laboratory quality control so as to improve the residue control management and the capacity building as well as professional level of the technical staff on .
2. Untrue facts contained in the Draft Report
According to the findings of the study made by the Chinese exports, the Chinese side believes that the Draft Report consists of many points that do not reflect the true facts in an objective manner. They are mainly contained in the following aspects:
2.1 Regarding "the issue of chloramphenicol residues"
2.1.1 In the Draft Report, a large sections were devoted to describing the harmful effects of chloramphenicol residues and the positive results for chloramphenicol residues found in the testing of shrimps/prawns. However, from the perspective of actual facts, the level of chloramphenicol residues found in the tests was generally very low. Within the EC official methods, the limit of detection for Sg3.3 and Cy3.7 tests is 1μg/kg. When using Cy3.6 for confirmation, it is 10μg/kg, and only by using the Cy3.5 method can 0.1μg/kg be detected. The Cy3.5 method also involves very complicated operation procedures and requires very delicate instruments, therefore it is not widely used even in developed countries, let alone having it applied in developing countries. The MRL required by many countries is 0-10μg/kg while the standards and requirements by the EC as mentioned above are too rigorous, with an obvious nature of technical barriers.
2.1.2 Having received the notification from the EC, the Chinese competent authorities took a series of active measures for adjustment and changes (which are mentioned in the EC Draft Report). In order to avoid the appearance of chloramphenicol residues , the MOA of China deleted chloromycetin from the "Chinese Veterinary Pharmarcopoeia" of the year 2000 edition and this drug has been again entered into the system for safety evaluation, thus the allegations made in the Draft Report are not based on the true facts. Meanwhile, the relevant departments also carried out an all-round investigation regarding the situation of the chloramphenicol residue pollution; the CIQ in Zhejiang Province not only took further samples from the finished products, half-finished products and raw material prawns (sea-caught prawns) for further examinations, but also took samples of the water used for processing and the disinfectants used for disinfecting the processing equipments for examination. The cause of the pollution was then found out. The prawn peeling workers had not worn protective gloves in the past, causing an itchy symptoms on their hands, so some of the workers used chloromycetin to treat their hands in order to avoid the itching, and as a result, the prawns were polluted. The Chinese side made an explicit explanation to the EC. The other exporting provinces, such as the CIQ of Shandong, also carried out tests for more than 100 samples. Chloramphenicol residues tests have been made compulsory for routine export examination. Any products that fail the test will be completely banned for export.
2.1.3 The Draft Report mentioned in 5.2.5 that "we cannot be convinced of the fact that the Chinese side believes that the prawns processed in EC-approved processing plants and exported from Zhejiang Province are only caught from the sea", such a conclusion is too arbitrary. Firstly, the Chinese side examines every batch of export prawns and the technicians can easily tell from the appearance of the prawns whether they are caught from the sea water or fresh water; secondly, the price of farmed prawns is much more higher than that of sea water caught prawns, and the processing plant will not process farmed prawns to replace sea caught prawns for export; thirdly, according to the results of monitoring in the year 2000, chloramphenicol residues were never found in farmed prawns.
2.2 Legal basis for the Chinese residue control programme
The Draft Report from the EC cannot approve the relevant Chinese regulations concerning the control of veterinary drug residue in food commodities of animal origin published at the ministerial level; they also believe that China has no mandatory laws and regulations concerning the residue control programme, follow-up treatment after positive results, punishment for the abuse of drugs, management of veterinary drug labels, management of prescribed and non-prescribed drugs, maximum residue limit, list of drugs banned for food producing animals, etc., and the Chinese side does not believe this is in accordance with the facts.
2.2.1 Section 5.2.1 of the Draft Report repeatedly mentioned that there is no legal basis for the Chinese residue control programme for animals and food commodities of animal origin and its implementation. This shows that the EC side still does not know about the Chinese legal system. Differing from the laws of EC, the Chinese legal system consists of Laws, Administrative Regulations, Local Laws and Regulations at the ministerial level as well as Local Regulations. Apart from the relevant laws and regulations listed in the residue control programme in the year of 1999, all the administrative documents and regulations at the ministerial level which were published by the relevant competent authorities are parts of the Chinese legal system and all have the equal binding force.
2.2.2 All of the annual residue control programmes in China are published in the form of administrative documents. The residue control programme in 1999 contained an explicit regulation regarding the procedure of taking samples and follow-up investigations, as well as the measures to be taken for rectifying errors.
With regard to the punishment for violations, the Criminal Law of China will play its role. For instance, Nantong City in Jiangsu Province severely punished, as a criminal case, the persons responsible for the illegal production of Clenbuterol.
2.3 Laboratory capacities
The Draft Report points out that all the CIQ laboratories they had visited were obviously insufficient, with serious deficiencies in terms of capacities for quality control, testing and analysis etc. This does not reflect the true situation.
2.3.1 The EC side"s suspicion regarding the capacities of laboratories in China lacks of sound basis. At present, there are as many as eight national level base laboratories in China for testing the residues of veterinary drug and many local laboratories for the residue control of veterinary drug have been awarded the national measurement standard, which are equipped with various kinds of large or medium testing equipments and instruments at the advanced level. All laboratories are subject to quality criteria and some have passed ISO guide25 and are moving toward ISO17025. The relevant management and technical personnel have all received strict trainings in management and operational techniques.
2.3.2 Section 5.2.2 of the Draft Report mentions problems at the Bee Research Institute of the Chinese Academy of Agricultural Sciences. In fact, this institute completed the testing of over 100 samples by using gas chromatography and other precision instruments; meanwhile, some other tasks were also completed, albeit that the filing procedure for the test documents is not ideal.
2.3.3 The issues of confirmation and quality control mentioned in Section 5.6 of the Draft Report do not reflect the true facts.
2.3.3.1 The large mass spectrophotometer of the Chinese side has always been used for testing residues and for confirmation of the samples with positive results, such as the testing and confirmation of β- agonists, zeranol and malachite green, etc. In addition, the laboratories are also able to adopt confirmation methods equivalent to or with equal effects of those used by EC, FDA and AOAC.
AQSIQ has already carried out the testing and training of these methods.
2.3.3.2 The Chinese side has always paid attention to the laboratory quality control and the new training materials have been delivered to the visiting mission. The mission should have observed that some of the laboratories have started to carry out the new quality control standards. If any real problems with criteria still exist, they are being improved step by step. Besides, the EC"s "Criteria for Laboratory Quality Control" has just been put into practice. It is unrealistic to expect the Chinese to immediately and completely implement these criteria. The fact that EC mission had found a few of instances that are not conformed with the new criteria, can not be considered as a betrayal of commitment on the part of the Chinese.
2.3.3.3 All methods used in the CIQ testing laboratories are completed either via common confirmation or through joint experiments. All have been subject to rigorous verification and the ensured quality control system has been established, so that test precision can be guaranteed.
2.3.4 Section 5.6 of the Draft Report mentions that the laboratories are "often unable to provide the original data for sample analysis and the rectifying experiment ". This does not reflect the true situation. Apart from the fact that some individual standard curve operations could not meet the criteria, all samples analysed by CIQ laboratories have the original data. As for the claim that they were "missing important standard substances", the truth is that one of the laboratories was unable to find out one of the isomers on time, in such a short while, from the hundreds of standard substances.
2.3.5 The numbers of internationally organised tests for the level of testing veterinary drug residue are few, however, many CIQ laboratories have in recent years actively taken part in international level tests and joint experiments. 35 CIQ laboratories have passed tests for the level of residues of veterinary drug, thus receiving approval from the Japanese Ministry of Health. 9 laboratories in Zhejiang and Shanghai took part in the tests of the level of pesticide residues in tea by the British TPA and acquired approval from the Tea Commission of the EC. Liaoning Province, Shanghai and Zhejiang Province took part in the tests of APLAC for the level of food testing. Qinhuangdao, Dalian and the Commodities testing Institute took part in the joint experiment for AOAC analysis methods (such as 克球酚 and pyrethroids, etc.).
2.3.6 With regard to the issues of operator"s experience for analysing the residues of veterinary drug as mentioned in the Draft Report, it is obvious that the EC side does not have a sufficient understanding of the Chinese laboratories. The CIQ laboratories started testing for residues in the 1970s and vast experience has been accumulated throughout the long period of practice. The mission only relied upon their personal impressions after they had only spoken to a few operators and concluded that the operators lacked experience in analysing residues of veterinary drug. This conclusion is extremely partial. All our tests are carried out under the guidance of highly experienced management staff and technical specialists, and all test results must be checked and approved by technical experts.
2.4 The residue control programme
The work of the residue control in China has been carried out with the assistance of the EC. Each year, China has provided the EC with plans for the control and these have always been approved by the EC. The criticism as raised in the Draft Report, concerning the residue control in China, may be quite different from the actual facts.
2.4.1 After more than two years" efforts, the Chinese residue control programme has been continuously improved and perfected. As regards the varieties of drugs under control and testing, new items have been added each year; and there has also been a great increase in the total number of samples taken; the number of species controlled also increases year by year.
2.4.2 In the Draft Report, the claim that "during control of the residues, there is no effective screening method for the screening of antibiotics" is not correct. The programme for residue control in China is purposely aimed at controlling a certain category of drug, such as sulfanilamide, and the methods used for the tests - the High Performance Liquid Chromatography method can completely satisfy the needs of the tested samples, thus there is no need for screening. Other antibiotics such as penicillin, streptomycin, terramycin and aureomycin, etc. are the same. As far as hormones are concerned, the CIQ laboratories have actually already used the screening method. The Draft Report claims that "in the laboratories we visited, we found there to be no analytical methods among the specified test items". This conclusion is partial. In actual fact, all the laboratories have the requisite standard methods to cope with the specified test items. Some individual items may use expanded, identical or similar standard analytical methods, and all these methods were confirmed before being used in practice.
2.4.3 In the Draft Report, it is claimed that "in the control programme, the same sample is often used for different tests". This is not entirely correct. Apart from the bee honey, all export samples are one sample for one test item. When the bee honey control programme was constituted, it was permitted to use the same sample for different tests and this was decided based upon the special nature of the bee honey samples.
2.4.4 With regard to "samples were taken within a certain period of time", this is due to the fact that sampling is affected by the different seasons for processing products of export and it"s very difficult to conduct a balanced sampling all year round. In the circular for the implementation of " The programme for residue control sampling and test for animals and food commodities of animal origin in the year of 2001 in China", the various local inspection and quarantine services are requested to take into consideration of different seasons demanded by production and its distribution as well as the features of industry structures, so as to ensure that the samples for residue control can have the nature of representation.
2.4.5 The claim that "in the domestic sampling plan of the year 2001, there had been no sampling of prawns and king prawns" is due to the fact that the Chinese domestic farming of king prawns has declined since 1994, thus even the domestic market was short of supply, the farmed king prawns were all consumed by the domestic markets and there had basically been no exports - we even had to import large qu
