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为了确保我国生产和进出口的动物源性食品安全，保护国内外广大消费者的身体健康，促进我国食品的对外贸易，农业部和国家质量监督检验检疫总局(以下简称质检总局)于1999年制定了《中华人民共和国动物及动物源食品中残留物质监控计划》(以下简称《残留监控计划》)。根据残留监控计划和2001年残留监控结果，农业部和质检总局制定了《2002年度中华人民共和国动物及动物源性食品残留监控抽样和检测计划》(以下简称《2002年度残留监控计划》)。现将《残留监控计划》和《2002年度残留监控计划》予以发布。
请各省、自治区、直辖市畜牧(农牧、农业)厅(局、办)，有关渔业主管部门、农业部各任务承担单位和各直属出入境检验检疫局严格按照规定实施2002年度的残留监控计划。请各有关单位积极配合。
二○○二年六月十日
中华人民共和国动物及动物源食品中残留物质监控计划
1.总论
中华人民共和国政府认识到动物源性产品及其他食品中的某些物质及其残留对消费者有害，并影响动物源性产品的质量，同时不当地使用某些兽药将严重影响人体健康。
鉴于我国已经制定了多部有关涉及安全卫生和进出口商品检验、动物防疫等方面的法律和有关兽药使用和管理、出口肉品加工企业注册管理等方面的专业性法规，但仍需在原有的法律框架下对有关残留监控的重点环节制定明确的专门条款，对出口动物及其产品的生产尤为必要。政府有关部门对有关物质进行监控是残留监控体系是的必要措施。
中国政府制定了动物源食品中农药、兽药及其他有害化学物质的最高残留限量。
中国政府于禁止使用某些具有激素或甲状腺素样作用的物质，并于1999年1月1日起禁止使用诸如已烯雌酚或类固醇内物质(如具有促蛋白合成作用的β-受体激动剂)。
残留监控体系对农、兽药生产、分销、零售及使用进行监控，并对动物饲养和动物源性初级产品的生产过程进行监控。中华人民共和国有关主管部门通过监管和检验来全面、系统地对对禁用物质及其残留进行监控。为保证该监控系统有效的运行，以达到在全国范围内对残留问题进行有效的控制和检测，有必要制定专门的条款来协调检验检疫部门、农牧兽医部门等主管部门之间的合作；
鉴于为迅速、有效的统一实施控制，需将有关各项监控的规则和措施集中于一单独文本，特制定本监控规划。
该文件主要包括：
1).与残留监控的有关法律、法规以及有关受监控物质的禁用或允许使用、销售管理规定；
2).监控体系中主管部门和有关部门的组织结构；
3).实验室检测网络及其检测能力；
4).企业自控和官方控制措施；
5).官方抽样细则；
6).准备检测的物质，分析方法，准备抽取的样品数量及理由；抽样水平和频率以及准备抽取的官方样品的数量；
7).对违规的动物或产品的处理措施。
中华人民共和国的管理体系明确区分了用于内销和出口的动物及动物产品的生产。通过采取监控措施确保只有在符合出口标准的饲养场饲养的动物及上述动物在符合出口标准的加工厂中加工后的动物源性产品才允许出口。
本残留监控计划是结合中国国情并参考了96/22/EC理事会指令和96/23/EC理事会指令而制定，适用于出口动物及动物源性产品的生产。
2.范围和概念
2.1本监控规划在于制定措施以监控附件所列的物质和各组残留
2.2有关概念
2.2.1动物源性食品(Animal Derived Food)：全部可食用的动物组织以及蛋和奶。
2.2.2禽类(Poultry)：系指包括鸡、鸭、火鸡、鹅、鸽等在内的家养的禽。
2.2.3饲养动物(Farm Animal)：指牛、猪、绵羊和山羊、家养奇蹄兽、骆驼和养殖鱼类；
2.2.4家养及野生野味：兔、家养及野生野味，如野鸡和珍珠鸡等；
2.2.5治疗处理(Therapeutic Treatment)：根据兽药使用，管理规定，经兽医诊断后，对单个饲养动物施用经许可的物质以处理繁殖方面的问题，包括中止不需要的妊娠，对于β-受体激动剂， 用于引起因牛和非肉用饲养马的分娩以及治疗呼吸方面的问题；
2.2.6动物技术处理(Animal technical Treatment)：指对单个家养动物施用根据兽药使用管理规定许可的物质，在兽医检查后，用于同期发情以及为胚胎移植，准备移植体和受体；对于水产养殖动物，在兽医指导和监督下，对一群育种动物进行性别转化；
2.2.7非法处理(Illegal Treatment)：指使用未经许可的物质或产品或虽经有关法规许可， 但不是用于许可的用途或不是在许可的条件下施用。
2.2.8禁用的物质或制品(Unauthorized Substances or Products)：指我国兽药使用管理规定和有关贸易国法规禁止施用于动物的物质或制品；
2.2.9残留(Residue)：指具有药物作用的物质及其代谢产物和其他传播至动物制品并可能危害人类健康的物质的残留；
2.2.10主管当局(Competent Authority)：指国务院授权机构；
2.2.11官方样品(Official Sample)：指为检测违禁物质或残留由主管当局指定检测机构抽取的标明品种类型、有关数量、抽样方法和动物性别以及动物或动物制品来源等具体识别特性的样品；
2.2.12批准的实验室(Approved Laboratory)：指为检测官方样品中的残留，经我国主管当局批准的实验室；
2.2.13一批动物(Batch of Animals)：指一组在同一饲养场、同时期、相同条件下饲养、同一年龄段、同一品种的动物；
2.2.14β-受体激动剂(Beta-agonist)：指一种β肾上腺素受体兴奋药。
3.法律和法规(Law and Regulations)
3．1有关法律、法规
《兽药管理条例》
《饲料管理条例》
《中华人民共和国食品卫生法》
《中华人民共和国动物防疫法》
《中华人民共和国进出口商品检验法》
《中华人民共和国产品质量法》
3．2有关规定
《允许作饲料药物添加剂的兽药品种及使用规定》
《饲料添加剂允许使用品种目录》
《动物性食品中兽药最高残留限量》
《出口食品生产企业向国外卫生注册管理规定》
《进出口商品检验实验室认可管理办法》
《进出口商品抽查检验管理办法》
《出口畜禽肉及其制品加工企业注册卫生规范》
《出口水产品加工企业注册卫生规范》
《出口鳗鱼养殖场登记管理方法》
本监控规划的建立与实施除以我国的有关法律、法规和兽药使用规定为依据外，也尽量符合进口国法规要求，并通过相应的行政指令予以保证。
4.管理与组织机构
我国的动物及动物源食品残留物监控工作由农业部及所属机构承担，国家出入境检验检疫局及其分支机构承担进出口动物源性食品的残留的检测工作。其年度报告将于次年7月1日前发表。
农业部和国家出入境检验检疫局成立专家协调工作组，负责全国有害物质残留监控规划及年度监控计划，并负责有关监控信息的交流，根据监控结果准备并起草年度监控报告。
农业部邀请其他有关部门专家，成立全国药物残留监控专家委员会。
4.1全国药物残留监控专家委员会职责
全国药物残留监控专家委员会根据
(1)国内药品使用情况及有关环保监控信息；
(2)地方残留监控机构的数据及农、兽药销售和使用等方面信息；评估残留监控计划的效果及效率，进行必要调整；
该委员会同时负责与相关国际专业组织进行对话，并负责拟订、审议和修改全国残留年度监控计划。
4.2农业部负责全国兽药在动物性食品中的残留控制工作；制定、修订有关兽药残留法规、规定；发布兽药残留限量标准、检验方法等技术规定；发布兽药残留监控计划和年度监控计划；负责兽药残留工作的组织、协调、监督等管理工作。
4.3国家出入境检验检疫局负责制定国家进出口动物产品的药物残留检测方法的标准、进出口动物产品的检测和监督管理。制订国家残留监控计划中针对进出口动物及动物产品的残留监控计划，并负责对进出口动物产品检验和监管工作。
4.4地方残留监控机构
4.4.1地方畜牧部门
1)、各省(市)、自治区农牧厅(局)负责协调本辖区内残留监控计划的实施；
2)、各省(市)、自治区兽药监察所及动物防疫部门负责：
至执行国内消费的动物和动物产品中残留检测任务；
至对本地兽药和饲料药物添加剂生产厂进行检查和监督；
至在当地农场进行残留监控和检查；
至采集国内市场的农场和屠宰厂样品。
4.4.2地方检验检疫部门(地方CIQ)
经国家出入境检验检商局批准，地方检验检疫机构执行残留监控计划的以下方面：
至从出口屠宰厂中采集官方样品；
至对出口动物产品进行残留检查；
至对进口动物产品进行检验和监管；
至对出口动物产品进行检验，并对出口屠宰厂进行监管；
至对动物源性食品中的残留进行对比检验；
至对当地出口屠宰厂使用的动物用药情况进行检查和监管，并向国家局提供有关监控数据。
4.5实验室分析能力
包括农业系统和检验检疫系统实验室，以及农业部和国家出入境检验检疫局认可的学术机构的实验室。
实验室按ISO/IEC导则25-1990等标准，编制了体系文件，并进行规范化管理，实验室定期参加国际水平测试，并组织国内协同试验，比对实验等活动。
所有检验人员需按实验室管理要求，经考核获得上岗证书，才能从事有关的检验。所有认可实验室都具备从事其检验工作的大型精密仪器等资源。
5.企业的协同责任
5.1任何从事动物产品生产和/或动物饲养的企业(个人或法人) 必须遵守国内的有关管理规定，对生产出口产品的企业，遵守有关贸易国的规则。
5.2最初加工动物源性初级产品的企业，应采取必要的措施， 确保加工生产者，能够保证只接受停药期的动物；通过检验或检查，使自己确信进厂的动物或产品，残留不超过最高限量；不含有禁用物质或制品。
5.3所有出口企业(个人或法人)应确保生产和出口，未使用过未经认可的物质或制品的动物，或未接受非法处理的动物；使用过认可物质或制品，但其停药期得以遵守的动物；及其以上动物的制品。
5.4经农业部认可的官方兽医应负责对饲养条件以及用药情况进行监控和认可。兽医应在养殖场记录上处理或投药日期和种类，接受治疗的动物身份和相应停药期。
5.5动物产品加工企业应设立相对独立的质量管理部门和一定规模的实验室，配备必要的检测仪器、设备和相应检测试剂，应建立相应的监控制度，并制定当某环节失控时的纠正措施。
5.6动物产品加工企业应具有供药、防疫和技术监控的资料，每一个环节都应建立相应的质量文件并保持记录。
5.7有关企业生产出口动物源性食品的出口产品必须接受检验检疫部门的监督检查，厂方有责任向主管当局提供有关信息。
5.8检验检疫部门的驻厂人员应加强对商标和卫生标识的监控。
5.9饲料厂必须向主管部门申报饲料添加剂和添加的药物以及各种营养成份配方，应详细记录饲料添加剂和药物成份的来源。
5.10商品畜禽养殖场在饲养过程中使用的药品必须是有关法规允许使用的药物，并认真填写“用药登记”内容至少包括用药名称、用药方式、剂量、停药日期。并将处方保留五年以作证据。严防使用违禁药物。
5.11商品畜禽养殖场饲养的商品动物应按规定停药期出栏，屠宰厂应认真检查动物的用药卡与检疫证明。
6.官方控制措施(Official control measures)
6.1控制的范围和内容
6.1.1地方残留监控机构在实施年度监控计划过程中， 可以在下列情形下随机进行官方检查：
(1)属于A组(具有合成作用的物质和未经许可的物质)的生产、搬运、储存、运输、分发、销售或购买过程中；
(2)在动物饲料生产和分发的各个环节；
(3)在本指令涉及的动物源性原料和动物的整个生产过程中。
(4)对关键控制的违禁药物进行宰前检测，扣留可疑动物以便确定，并立即向有关部门报告阳性结果。
6.1.2以上检查或检测是针对是否拥有或出现准备用于动物育肥或非法处理的违禁物质或制品而进行的。
6.1.3 如果有迹象表明，或怀疑有欺诈行为，并且在检查中出现阳性结果的情况下，则对检测出残留的组织或动物按国家有关规定处理。
6.1.4主管部门执行的所有检查必须在不预先通知的情况下进行。所有被检单位有义务为宰前检验提供方便，协助进行必要的操作。
6.1.5在发现问题时，应采取以下措施：
(1)在怀疑有非法处理时，要求饲养场负责人或兽医提供材料，以证明处理的性质；
(2) 如果经质询证实确有非法处理或使用了未经许可的物质或制品或有理由怀疑这种使用应进行：
至对原生产场进行抽样检查，主要是检测由于非法使用而导致的残留；
至必要时对饮用水和饲料进行官方抽样；
至必要时对水产养殖动物的捕获水源或水源进行抽样检查；
至对违禁药物的生产、搬运、储存、运输、分发、销售或购买过程进行检查；
至为确定违禁物质或制品的来源或被处理动物的来源所需的任何检查；
(3)如果超出进口贸易国制定的最高限量或国内法规制定的限量， 可采取任何必要的措施或进行任何必要的调查。
6.2基准实验室
6.2.1农业部在中国兽药监察所和中国农业大学设立基准实验室， 国家出入境检验检疫局在中国进出口商品检验技术研究所等单位设立残留物监控的基准实验室。每一试验室及其他拟建立的实验室应专门针对某一物质或某一组物质进行检验。
6.2.1.1基准实验室职责：
(1)基准实验室负责协调残留分析实验室的工作，尤其是协调每种残留或残留组分析方法和标准；
(2)协助主管当局制定残留监控计划和组织实施；
(3)定期有针对性的组织进行比对试验；
(4)保证国内实验室遵守制定的限量；
(5)普及国际有关残留量监控信息；
(6)保证有关检验监督人员能够参加国际有关组织的进一步培训，以利有关人员专业水平的发展。
6.2.2国家在各省(市)兽药残留检测机构和有关单位设立残留检测认可实验室，实施国家残留检测计划。
6.3化合物评价和分类方法
肉食动物在生长周期中可能接触并被摄入残留在其家畜、家禽产品中的化合物主要包括：
6.3.1化学杀虫剂。被允许直接用于家畜或家禽或农作物， 或用于饲养场的环境消毒，灭蝇虫的一些化学杀虫剂。
6.3.2兽药，指用于预防、治疗、诊断、畜禽等动物疾病，有目的地调节其生理机能并规定作用、用途、用法、用量的物质(含饲料药物添加剂)。包括：
1).血清、菌(疫)苗诊断液等生物制品；
2).兽用的中药材、中成药、化学原料及其制剂；
3).抗生素、生化药品、放射性药品。
6.3.3环境污染物。包括不可避免的污染物，不当使用农药和兽药，所产生环境污染在屠宰动物的可食组织中产生的不可接受的残留量。重点监控的违禁药物见附表1。
6.3.4对残留物进行监控的判断标准
某一类残留物往往包括多种残留，根据中国的国情，对所有的化合物残留均进行检验，是行不通也是不必要的。因此，与本文本规定有关抽样细则不相抵触，根据在不同的地区的环境条件下，各类化合物的生产、销售、使用等有关信息，以确定这些化合物可能产生的残留及其危害的程度，并在此基础上，选择适当的方法，对当前具有最大潜在危险的化合物实施检验。
6.3.5分类方法：
根据以下因素对每种化合物进行综合评价，以判断动物接触化合物后，产生的潜在危险对人类健康的影响。
(1)是否使用有关化合物；
(2)实际使用量或大概使用量；
(3)有无滥用及其产生有害残留的潜在危险；
(4)在动物、植物体内和外界中吸收、分布、代谢、 排泄情况包括代谢物残留的生物效力和持续性；
(5)残留物的化学性质及其毒性。
综合这些因素进行评价，将这些化合物划分为A、B、C、D四个种类，以A、B、C、D来表示在动物屠宰时发生潜在的有害残留量的递降顺序(A、B、C表示化合物承担作用的最大或最小的价值，“D ”表示“无关紧要”或“还未被列入”)。
6.4抽样方法和抽样细则
残留物控制计划旨在调查发现饲养场，屠宰场、奶场、水产品加工厂、蛋类收购站等动物源性食品中残留危害的原因。
我国官方抽样方法将参照国际通行的抽样水平和抽样频率，制定并执行；出口动物产品的官方抽样参照贸易国的规定，如欧盟96/23/EC和96/23/EC指令。
6.5检验方法：
建立检验方法的执行标准，任何达到该标准的方面均可用于检验。
6.5.1AOAC法定方法：
(1)可直接采用；
(2)由三位化验师(二个或三个实验室)研究至验证，可将方法，扩大到其他分析物、组织、种类和产品；
(3)扩大到早期研究的分析物相同基质的其它类似的分析物。
6.5.2中华人民共和国农业部兽药残留检测方法
6.5.3国家出入境检验检疫局制定的出口动物产品兽药残留检测方法
6.5.4有关贸易国认可的常规方法和标准方法。
6.5.5美国《联邦注册》中发表并收编在美国联邦法规中的分析方法。FDA方法。FSIS方法。
6.6标准物质
采用国际认可的标准物质。
6.7官方样品
官方样品必须按本文本抽样方针和抽样水平和频率的要求抽取以在认可实验室检测。
当批准允许销售某种兽药用于拟供人类食用的动物时，农业部应同时发布相应的常规分析方法以进行残留检测。
如果对分析结果有异议，其结果必须由指定的该物质或残留的有关监测实验室进行验证。
6.8发现违规时所应采取的措施
6.8.1如果官方抽样检查出现阳性结果，表明有非法处理，农业部等有关部门应及时采取必要的措施
(1)获取所有必要的信息以验明有关动物的原始饲养场或输出场；
(2)检查全部详情及其结果，如果一个省(市) 采取的控制措施表明需要在一个或多个省(市)进行调查，或需要在其它相关部门(系统)进行调查，如果证明调查有必要，国家出入境检验检疫局与农业部，应协调在其他省(市)部门采取适当的措施；
6.8.2有关机构应：
(1)适当时对原始或输出场进行调查，以找出残留出现的原因；
(2)对于出现非法处理，适当时在生产、加工、储存、运输、 施用分发或销售等环节，对有关物质或制品的来源进行调查；
(3)该机构认为必要的任何其他的进一步调查；
对于出口加工生产厂
1).当有关调查涉及授权出口的加工厂时，主管部门应立即对该出口加工厂的其他动物或动物产品进行取样。对样品所采集的动物群要进行识别并立即通知有关农牧部门。在此情况下，检查结果未出来之前，任何动物都不能离开养殖场。如果证实进行了非法处理，应立即将检验结果为阳性的动物群置于官方监控，并立即停止出口的生产、吊销其加工许可证。国家检验检疫局将尽力识别和追回收可能受到影响的其它动物或动物制品。
2).如果证明出现滥用许可药物的现象或未遵守停药期规定，应要求相关企业采取适当的预防措施改正其错误。该养殖场交受到更为严格的相关残留的检查。如果再次违规将吊销其出口注册许可证。
对国内产品
1).如果有证据表明允许使用的药物或制品的残留量超出最高限量，主管部门应适当地对原始养殖场或输出口场进行调查，以确定超出限量的原因，根据调查结果，采取一切必要的措施以保证公共卫生，禁止动物离开饲养场一段时间。如果确实进行了非法处理，主管部门必须保证将有关家畜禽立即置于官方控制之下，并进行官方标识，并依据动物性产品抽样细则抽取具有代表性的样品数量。
2).如有关动物性产品多次超出最高限量，农业部等有关部门必须至少在六个月内国强对有关养殖场/企业的动物和制品的检查，在对样品的分析结果出来之前扣留有关制品或胴体，只要有结果表明残留超出最高限量，对有关制品或胴体必须宣布为不适于人类食用。
3).凡涉及出现阳性结果或非法处理的一切检查分析和调查费用应由生产者或动物所有者承担。
6.8.3对违规企业的处罚措施
当未被授权的个人发现拥有非授权物质或产品，或该文件附录中所列的A组及B组(1)、(2)类产品，这些非授权物质或产品应由官方控制直至有关主管采取相应措施，不管将对违规者采取任何处罚。
如果发现任何农场使用任何违禁药品，除在官方监控下，涉案农场的动物不能离开所其原产农场或转交给任何个人。主管部门应根据所发现的物质的特性采取适当的预防措施。
如果主管部门怀疑或有证据表明相关动物接受过允许的处理方法，但不符合停药期规定，主管部门应推迟对上述动物的屠宰直至确认残留量未超过允许值，特别是对按许可方式接受过β-受体激动剂治疗的动物，其停药期应不低于28天。
根据国家残留监控计划的要求实施检查和抽样工作中，并按本计划规定进行调查和核查过程中，如不配合或阻扰主管部门的工作将导致有关政府主管部门对此采取适当的刑事或行政处罚。
对持有或提供有在规定禁止的药物或产品的个人，或对动物使用此类药物或产品的个人，将采取合适政府行政处罚措施。
对外贸易经济合作部欧洲司
农业部畜牧局
国家出入境检验检疫局认证监管司
(translation for reference)
Monitoring Plan for Certain Substances and Residues in Live Animals and Products of Animal Origin， the Peoples Republic of China (PRC)
1. Outline
The PRC recognises that residues and certain substances in animal products and other foods may be hazardous to the consumer and affect the quality of animal products and that the improper use of certain veterinary medicines shall seriously affect human health，
Special regulations concerning hygiene， import and export commodity inspection， epidemic prevention， using and control of veterinary medicines， and registration administration of factories of food for export are promulgated in the PRC. However， more detailed and clear special stipulations on certain key points under the existing laws are necessary to be made in respect of the production of animals and animal products intended for export. The enforcement of monitoring by the governmental authorities are essential measures in this control system.
The PRC has established maximum residue limits(MRLs) for pesticides， veterinary drugs and other hazardous chemicals in animal originated foods.
Chinese government prohibits the use of hormonal substances such as diethylstilboesterol or steroid substances (anabolic or β-adrenoceptor agonists) from January 1， 1999.
The monitoring system is carried out in the manufacturing， distributing， selling and using of veterinary medicines and in the animal raising and animal product manufacturing. This monitoring over unauthorized substances and its residues is carried out entirely and systematically by the supervision and inspection of the competent authorities of the PRC. However， further to ensure the effective performance of this monitoring system so as to effectively control and inspect residues in the whole country， special stipulations are necessary to be established for harmonizing the cooperation of competent authorities such as inspection and quarantine authorities， husbandry and veterinary authorities，
To ensure that uniform controls shall be effectively and swiftly performed， every monitoring rule and measure must be collected in one document， therefore this plan of monitoring system is issued.
This plan mainly consists of：
A. Laws and special rules concerning residue monitoring， the prohibition and permission of substances under monitoring， detailed rules of distribution and sale of substances under monitoring;
B. The organisation of competent authorities and authorities concerned in the monitoring system.
C. Laboratory testing net and its testing ability.
D. Self-control measures by the processing plants and official-control measures.
E. Rules of official sampling.
F. Substances to be tested， method of analysis， number of sampling and its reason， sampling criteria and frequency and number of sampling to be taken by officials.
G. Measures to be taken on contaminated animal or animal products.
The system of control in the PRC is such that the production of animals and animal products is clearly separated between the domestic and export markets. Controls exist to ensure that only animals reared on farms and processed in establishments of export standards are allowed to be exported.
The following residues surveillance plan is based on the actual situation in the PRC and， with reference to Council Directives 96/22/EC and 96/23/EC， applies to the production for export of animals and animal products.
2. Scope and Definition
2.1 This monitoring measures are promulgated to control every groups of residues listed in the attachment(Annex 1).
2.2 Related definition
2.2.1 Foods of animal origin (animal derived food)
All kinds of products of animal origin for human consumption including egg， milk and honey.
2.2.2 Poultry
Farmed birds including chicken， duck， turkey， goose， pigeon and etc.
2.2.3 Farmed animals
Farmed animals such as cattle， swine， sheep， goat， farmed solipeds and camels， and finned fishes.
2.2.4 Farmed and Wild Animals
Rabbit， farmed and wild game， including pheasant and guinea-fowl..
2.2.5 Veterinary medicine
Substances for therapeutic use， disease diagnosis and deliberately adjustment of Physiological function， whose function， purpose， usage and dose are regulated.
2.2.6 Therapeutic treatment
After diagnosis by veterinarians， hormonal substances can be used， according to the rules governing the usage and administration of veterinary drugs， on individual farmed animals for the purpose of treating reproduction problems， such as the termination of unwanted pregnancy. Beta-agonists may be used for therapeutic purposes for horses not intended for human consumption and cows at the time of calving and for diseases of the respiratory system.
2.2.7 Animal treatment
After veterinary examination， the application of substances authorised for use by rules governing the use and administration of veterinary drugs to individual farmed animals for the synchronisation of oestrus， preparation of the insemination implantation donor and recipient; to farmed aquatic animals to change the sex of a group under the guidance and supervision of veterinarians.
2.2.8 Illegal treatment
The use of unauthorised substances or products， or of authorised substances or products for forbidden purposes or under unauthorised conditions.
2.2.9 Unauthorised substances or products
Hormonal growth promoters and beta-agonists used for growth promoting purposes. Substances or products forbidden to be used on animals by rules governing the use and administration of veterinary drugs and the legislation of importing countries.
2.2.10 Residue
Residue of any substance having medicated action and its ester and metabolites， and the residue of any other substance which， when remaining in a product of animal origin， proves to be hazardous to human health.
2.2.11 Competent authority
Institutions authorised by the State Council of the PRC.
2.2.12 Official sample
Samples taken for the purpose of testing illegal substances or residue by testing agencies appointed by competent authorities which are labelled with specification， number， sampling methods， sex of animals and the origin of animal or animal products
2.2.13 Approved laboratory
Laboratory approved by competent authorities for the purposes of testing residues in official samples
2.2.14 Batch of animal
A group of animals of the same age and species， reared on the same farm at the same period， under the same conditions
2.2.15 Beta-agonist
A beta- adrenoceptor agonist
3. Legislation
3.1 Related laws and regulations
the Product Quality Law of P. R. China
the Law of the P. R. China on Food Hygiene
the Epidemic Prevention Law of the P. R. China
the Law of the P. R. China on the Import and Export Commodity Inspection
the Provisions on the Administration of Veterinary Drugs
the Provisions on the Administration of Animal Feed
3.2 Related rules
the Rules on Authorising Certain Veterinary Drugs to be Used as Feed Additives and Their Uses
the List of Additives Allowed to be Used in Animal Feed
the Maximum Residue Limit in Food of Animal Origin
the Administration Stipulation for the Sanitation Registration of Food Manufacturers for Export
the Administration Provisions for Licensing Laboratories for Import and Export Commodity Inspection
the Administrative Provisions for Spot Inspection of Import and Export Commodities
the Sanitary Registration Standards for Export-Oriented Processing Plants of Livestock and Poultry Meat and their Products
the Sanitary Registration Standards for Export-Oriented Processing Plants of Aquatic Products
the Administrative Provisions on the Registration of Export -oriented Eel Farm
The formulation and implementation of the PRC Residue Monitoring Plan follow the related domestic legislation， while taking into account of requirements of importing countries. The enforcement of the plan is guaranteed by administrative orders.
4. Institutions of administration and organization
The Ministry of Agriculture (MOA) and its subsidiary agents is responsible for the surveillance of residues in animals and food of animal origin. The State Administration for Entry-Exit Commodity Inspection and Quarantine (SAIQ) and its subsidiary organization is responsible for the surveillance over residues in imported and exported foods of animal origin. The annual reports will be published before July 1 in the next year.
An expert co-ordination group between MOA and SAIQ is set up for the purposing of formulating the national residue surveillance programme and annual plan， exchanging related information， preparing and drafting the annual report on the results of residue monitoring.
MOA sets up the National Residues Monitoring Expert Committee， inviting experts from other competent authorities.
4.1 National Residue Monitoring Expert Committee
The National Residue Monitoring Expert Committee should formulate the National Residue Monitoring Plan.
The National Residue Monitoring Expert Committee assesses the efficiency and effect of the monitoring plan and make necessary amendments according to (1). The use of veterinary medicines and information about environmental protection， (2). The statistics from local residue monitoring organisations and the information of selling and using of pesticides and veterinary medicines.
The Committee is also responsible to have dialogues with related international professional organisations， formulate and review the annual residue monitoring plan.
4.2 MOA is responsible for controlling the residues of veterinary medicines in animal products in the country， setting up and amending the laws and regulations on the residues of veterinary medicines， promulgating technical standards such as MRL and standards for testing methods and etc.， promulgating the residue surveillance plan and its annual surveillance programme， and the administration of organizing， harmonizing and supervising the residue monitoring work.
4.3 SAIQ is responsible for controlling and measuring residues in animal products of import and export; setting up performance criteria for testing methods and standard methods for determination of residues and toxic substances on import and export products of animal origin; formulating a residue surveillance programme over import and export animals and products of animal origin as part of the national surveillance plan， conducting inspection and administration over imported and exported animal and animal products.
4.4 Local Residue Monitoring Organization
4.4.1 Local Agricultural and Animal Husbandry Authorities
(1). The provincial， municipal and autonomous regional Bureau of Animal Husbandry is responsible for co-ordination of local residue monitoring and control.
(2).The provincial institute for the supervision over veterinary pharmaceutics and animal disease control departments
n performing the task of residue detection in animal and animal products for domestic consumption
n Inspect and supervise the local animal drug and medicated feed manufacturing facilities
n conduct residue surveillance and inspection on local animal farms
n collect samples from animal farms and slaughterhouses for domestic market
4.4.2 Subsidiary Branches of Inspection and Quarantine System(Local CIQ)
Local CIQ is approved by SAIQ to carry out residue monitoring and control in aspects of
l take official samples from slaughterhouses oriented for export;
l implementation of residue inspection on animal products for export;
l carry out inspection and supervision on imported animal products;
l inspection over animal products for export and supervision on export-oriented slaughterhouse
l conduct comparative testing on residues in products of animal origin;
l investigation on the usage of veterinary medicines in local slaughterhouses for export， provide the data of residue monitoring and relative information to SAIQ.
4.5 Analyzing Ability of Laboratories
This will include laboratories of MOA system and SAIQ， academic laboratories accredited by MOA and SAIQ.
Laboratories have set up systematic regulations according to ISO/IEC 25-1990 and have standardised administration. They will take part in regular tests at the international level and organise co-operative and comparison experiments between themselves.
Only after taking examinations and obtaining qualification certificates according to the administration requirements of laboratories shall the inspectors make their relative inspections. All the approved laboratories are equipped with sufficient precision instruments and the necessary facilities for their inspection work.
5. Co-responsibility on the part of enterprises.
5.1 ny enterprise (natural or legal person) who operates the production and/or animal farm must follow the relative administration regulations of the state. All the export-oriented enterprises must operate to the requirements of the importing countries.
5.2 roducers of animal products must take all necessary measures to ensure that they accept for slaughter only those animals which have observed the withdrawal periods for any medicines administered to them. Through inspection or examination they must ensure that residues in the animal or material are below the prescribed limits. Animals or animal products must be free from unauthorised substances.
5.3 All export operators (natural or legal persons) must ensure that any animals or animal products which are exported
1) have observed the withdrawal periods for any medicines used
2) do not contain any residues of authorised substances above the MRL.
3) do not contain any illegal or unauthorised substances.
4) do not contain residues of any substances which may be harmful to human health.
5.4 Farming situations and the use of any veterinary medicines must be supervised by veterinarians approved by MOA. The veterinarians shall write down the date of using the medicine， the name of the medicine， the identification and status of the animal which is treated and the date of withdrawing the medicine.
5.5 Animal product processors must establish independent quality control sections and laboratories equipped with necessary inspection instruments， equipment and testing reagents， set up relative monitoring systems and corrective measures in case of violation.
5.6 Animal product processors must possess the records on medicine usage， vaccination and technical supervision. Quality control records must be kept for each point.
5.7 Producers of animal originated products for export should be supervised and checked by inspection and quarantine authorities. These producers have the responsibility to supply relative information to competent authorities.
5.8 The CIQ (the former CCIB) inspectors should strengthen the control over the health markings and labels for the products processed by the plants in their charge.
5.9 Feed mills should apply to and get approval from competent authorities for their feed additives， medicated additives and the formulation of nutrition contents， record in detail the origin of feed additives and added drugs.
5.10 The drugs used in stockfarms should be approved according to the relative regulations. The stockfarmers should record drug usage， at least including the name of the drug， style of use， dosage and withdrawal time. The animals treated and their status must also be identified. Prescriptions issued by a veterinarian should be kept for 5 years.
5.11 Stockfarmers should guarantee their animals are not sold within the withdrawal times. The slaughterhouse should carefully examine and checke the drug usage card and quarantine certificate.
6. Official control measures
6.1 Scope and content
6.1.1 Local authorities shall make checks to implement the annual plan in the following aspects：
(1). The production， handling， storage， transport， distribution and sale of substances in Group A (anabolic and/or unauthorised substances);
(2). At any point in the production and distribution of feed;
(3). The production of animals and products of animal origin;
(4). The detection for the presence of unauthorised drugs before slaughter， detaining the suspected animals for confirmation， immediate notification of any positive results.
6.1.2 The checks provided for in paragraph 6.1.1 must conducted with a view in particular to detecting the use or presence of banned substances or products administered to animals for the purposes of fattening or illegal treatment.
6.1.3 Where fraudulence is suspected， and in the case of positive results from any of the checks referred to in paragraph 6.1.1， positive tissues and animals will be dealt with according to relative regulations.
6.1.4 The checks must be carried out by competent authorities without prior notice. The owner， the person empowered to dispose of the animals， or their representative， shall be obliged to facilitate pre-slaughter inspection operations， and in particular to assist the official veterinarian or the authorised staff in any manipulation judged necessary.
6.1.5 Authorities shall take appropriate measures where abuse is suspected
(1). Where illegal treatment is suspected， they must ask the owner or person having charge of the animals or the veterinarian in charge of the farm to provide any documentation justifying the nature of the treatment;
(2). Where this inquiry confirms illegal use of prohibited substances or products， or where there are grounds for suspecting their use， the following measures should be taken：
一spot check on the residues of banned substances;
一if necessary， spot check on animals feed and drinking water;
一if necessary， spot check on the water of the farm for aquarcultural products;
一check on the production， handling， storage， transport， distribution and sale of any drugs which may be authorised for domestic production but may not be administered to animals intended for export;
一checks on the source of any prohibited substances and products;
(3). Where the maximum residue levels laid down by domestic regulations or the importing country have been exceeded， carry out any measures or investigations may be deemed appropriate in relation to finding the reason for the residue in question.
6.2 Reference laboratory
6.2.1 The MOA has set up reference laboratories in the Veterinary Drug Monitoring and Supervision Institute and in the University of Agriculture of PRC， and SAIQ has set up reference laboratories in China Import and Export Commodity Inspection Technology Institute. Each laboratory， and others which are to be established， will specialise in detecting the residues of a particular group or groups of substances.
6.2.1.1 Responsibility of reference laboratories：
(1).Coordinating the work of the other national laboratories responsible for residue analysis， in particular by coordinating the standards and methods of analysis for each residue or residue group concerned;
(2).Assisting the competent authorities in organising the plan for monitoring residues;
(3).Periodically organising comparative tests for each residue or residue group assigned to them;
(4).Ensuring that national laboratories observe the limits laid down;
(5).Disseminating information of residue control supplied by related countries;
(6).Ensuring that their staff are able to take part in further training courses organised by international organisation so as to maintain their continued professional development.
6.2.2 Local competent authorities shall set up approved routine laboratories for the implementation of the national residue control plan.
6.3 Substances review and classification
6.3.1 Chemical pesticides
6.3.2 Veterinary drugs
6.3.3 Environmental contaminants
6.3.4 Residues monitoring priorities
There are a lot of residual substances in a group and， considering the actual situation in China， I.e. the production， sale， use of a substance， the competent authorities shall assess the degree of the danger of certain residue， and make a priority list of residual substances to be monitored. With respect to exporting products， they will respect the requirements laid down in the legislation of the importing countries.
6.3.5 Method of Classification on Compounds
The potential hazardous effect of each compound to which animal exposed on human health shall be evaluated by the following criteria：
1) the use of relevant compounds;
2) exact dosage or approximate dosage;
3) if there is abuse and its potency of producing hazardous residues;
4) the absorption， distribution， metabolism， and excretion in animal， plant and environment， including the biological effects and consistence of the metabolised residues;
5) the chemicals characteristics and toxicity of residues.
Based upon the criteria above mentioned， for the purposes of domestic production compounds can be classified into 4 categories， A， B， C and D. The alphabet A， B， C， and D represent the degrade sequence of the potential residue occurrence at the time of slaughtering. (A，B，C represent the maximum/minimum potency a compound bear， D represents “not listed yet”). In respect of importing countries they will respect the requirements of their legislation.
6.4 Sampling strategy
The residue control plan is aimed at surveying and revealing the reasons for residue hazardous in foods of animal origin on farms， slaughterhouses， dairies， honey farms， fish farms， fish processing plants and egg collecting and packing stations.
The official sampling strategy for domestic production in China will be worked out and enacted by reference to the general international Sampling Levels and Frequency. Official samples for export testing are to be taken in accordance with the legislation of the importing country， e.g. the Council Directive 96/23/EC and Commission Decision 98/179/EC.
6.5 Method of Testing
Performance criteria for testing methods will be set up. Any methods reach the requirements of the criteria may be used in testing.
6.5.1 Official Method of AOAC
1) it could be applied directly;
2) after retesting by 3 analyst (in 2 or 3 laboratories) ， it could be extended to apply for other analysis， tissues， species and products;
3) it could also be extended to apply for other relevant analysis with same matrix as that in the early studies.
6.5.2 The Methods for Detecting the Presence of Residues of the Ministry of Agriculture， the People’s Republic of China.
6.5.3 The SAIQ Methods for Detecting the Presence of Residues in Products of Animal Origin for Export.
6.5.4 Where appropriate， the regulatory method and performance standards approved by the relevant importing country.
6.5.5 The analytical methods published in Federal Register and collected in the Federal Code of Regulations， USA， FDA approved methods， and FSIS methods.
6.6 Standard Substances
The internationally recognised reference materials will be accepted.
6.7 Official samples must be taken in accordance with the rules on Sampling Strategy and Sampling Level and Frequency in order to be examined in approved laboratories.
Whenever an authorisation is issued for the placing the market of a veterinary drug intended for administration to a species， the meat or product of which is intended for human consumption， the Ministry of Agriculture shall concurrently issue the routine analysis method for detection of residues.
If challenged on the basis of a contradictory analysis， those results must be confirmed by the reference laboratory designated for the substance or residue in question.
6.8 Measures to be taken in the event of infringement.
6.8.1 If official samples examined have positive results， it shows a case of illegal treatment. The competent authorities such as the Ministry of Agriculture and SAIQ shall take necessary measures to obtain：
1) all the information required to identify the animal and farm of origin or departure;
2) full details of the examination and its results. If the controls carried out in a province demonstrate the need for an investigation or other action in one or more provinces， or in other appropriate authority (system)， The MOA and SAIQ shall coordinate the appropriate measures taken in another province where an investigation or other action proves necessary.
6.8.2 The appropriate authority shall carry out：
1) an investigation on the farm of origin or departure， as appropriate， to determine the reasons for the presence of residues;
2) in the case of illegal treatment， an investigation of the source or sources of the substances or products concerned at the stage of manufacture， handling， storage， transport， administration， distribution or sale， as appropriate;
3) any other further investigation which the authority considers necessary.
In respect of export establishments
a) Where the investigation concerns an establishment authorised to export， the authority shall immediately sample other animals or animal products from the same establishment. They will identify animals from which samples have been taken and immediately notify the animal husbandry authority concerned. No animals should in any circumstances leave the farm until the results of the checks are available. If there is confirmation of a case of illegal treatment， the flock where animal or animals found to be positive shall be put under official control immediately and the export production and processing permits of the enterprises shall be immediately suspended. SAIQ will make all efforts to identify and recall any other animals or animal products which may be affected.
B) Where it is indicated that authorised drugs have been abused or withdrawal times have not be observed， the enterprise shall be required to take appropriate and preventive measures to correct its practice. The farms shall be subject to more stringent checks for residues in question. The registration of export permit may be deleted if the enterprises repeatedly break the regulations or laws.
In respect of domestic production
c) If there is any evidence showing that the residues of substances or products exceed the maximum limit， the competent authority shall appropriately take an investigation on the farm of origin to find out the cause for the failure， and take all necessary measures to safeguard public health which may include prohibiting animals from leaving the farm or establishment concerned for a set period. Where illegal treatment is established， authorities shall ensure that the livestock in the investigation is immediately placed under official control， all the animals concerned should bear an official mark or identification， as a first step， and an official sample must be taken from a statistically representative sample.
D) In the event of repeated infringements of maximum residue limits intensified checks on the animals and products from the farm and /or establishment in question must be carried out by the MOA and other government departments concerned for a period at least 6 months， and the products and animal carcases being impounded pending the result of analysis of the samples. Any result showing that the maximum residue limit has been exceeded must lead to the carcases or products concerned being declared unfit for human consumption
e) Where the investigation confirms that suspicion was justified， products are found positive or illegal treatment of the products， the cost of analysis shall be borne by the producer or person having charge of the animal.
6.8.3 Measures Taken on the Enterprises Who Break the Regulations
Where unauthorised substances or products or substances listed in Groups A and B (1) and (2) of Annex I to this Document are discovered in the possession of non-authorized persons， those unauthorised substances or products must be placed under official control until appropriate measures are taken by the competent authorities， without prejudice to the possible imposition of penalties on the offenders.
Where any prohibited drugs are found to be used in any animal farms， the animals from the farm in question may not leave the farm of origin or be handed over to any other person except under official control. The competent authorities shall take appropriate precautionary measures in accordance with the nature of the substance or substances identified.
If the authorities suspects or has evidence that the animals concerned have been subject to an authorised treatment， but that withdrawal periods have not been compiled with， it may postpone slaughter of the animals until it is satisfied that the quantity of residues does not exceed the permitted levels， specifically for Beta-agonists used for authorised therapeutic purposes not less than 28 days.
Any failure to cooperate with the competent authorities and any obstruction during inspection and sampling as required for the implementation of National Plan for monitoring residues and during the investigations and checks provided for in this Regulation， shall result in the appropriate criminal and /or administrative penalty being posed by the competent national authorities.
Proper government administrative measures of penalties shall be taken against persons who possess or supply substance or products which are not allowed by the regulations， or persons who administer the substance or products to animals.
European Affairs Department， Ministry of Foreign Trade and Economic Co-operation
Bureau of Animal Husbandry and Veterinary Affairs， Ministry of Agriculture
Department of Certification Supervision， the State Administration of Exit-Entry Inspection and Quarantine
2002年度中国动物及动物源性食品残留物质监控计划
(2002.1-2002.12)
中华人民共和国农业部和国家质量监督检验检疫总局，按照《中国动物及动物源食品残留监控计划》的要求，结合中国畜牧业和渔业生产的发展和国内外市场的需求，制订、发布本计划。
一、残留监控计划的执行时间
2002年度残留监控计划的实施时间为2002年1月至12月。
二、残留监控抽样计划修订的依据和原则
1、根据2001年残留监控结果，尤其是阳性结果的检出以及出口检出情况，适当增加对应监测地区、检测项目的动物、动物产品的抽样数量。
2、采纳欧盟等进口国或地区的合理建议。
3、优先考虑禁用药物，并增加了进口国有新限量要求，且在我国法定兽药标准中规定了停药期的药物。
4、推动中西部地区的残留监控工作。
三、主要修订内容的说明
1、牛：增加了乙二烯雌酚、己烷雌酚、苄青霉素、邻氯青霉素、双氯青霉素、卡那霉素、强力霉素、环丙沙星等项目的检测；
2、马：增加了乙二烯雌酚、己烷雌酚、苄青霉素、邻氯青霉素、双氯青霉素、强力霉素、依维菌素等项目的检测；
3、猪：增加了乙二烯雌酚、己烷雌酚、苄青霉素、邻氯青霉素、双氯青霉素、强力霉素、卡那霉素、左旋咪唑、依维菌素、卡巴多、甲硝咪唑、二甲硝咪唑等项目的检测；对活猪的检测可取尿样进行检测；
4、羊：增加了乙二烯雌酚、己烷雌酚、邻氯青霉素、双氯青霉素、强力霉素、卡那霉素、左旋咪唑、四环素、土霉素、金霉素、氯霉素、磺胺嘧啶等项目的检测；
5、兔：增加了乙二烯雌酚、己烷雌酚、卡那霉素、环丙沙星、噻苯哒唑、莫能菌素、氯霉素、呋喃西林等项目的检测；
6、禽类：其中鸡类增加了乙二烯雌酚、己烷雌酚、青霉素、苄青霉素、卡那霉素、红霉素、螺旋霉素、链霉素、环丙沙星、噻苯哒唑；鸭增加了氯霉素、呋喃西林等项目的检测。
7、水产品(除小龙虾外)：增加了乙二烯雌酚、己烷雌酚、喹乙醇、氯霉素、呋喃西林等项目的检测；
8、小龙虾：为淡水野生产品，除对环境污染物进行监控外，增加了氯霉素的检测；
9、蜂蜜：增加了氯霉素的检测；
10、肠衣：增加了氯霉素的检测；
11、牛奶：增加了氯霉素的检测；
2002年度动物及动物源食品监控的残留物质及动物种类详见附录1
四、抽样地区和数量
抽样地区以畜牧业、养殖业发达，且动物源性食品消费或出口量较大的省(市)为主，适当增加了对中、西部地区的抽样数量。2002年计划抽取样品27621份，分布于34个省、市或地区。
各类动物、动物产品的具体抽样地区及数量见附录2
五、实施残留监控抽样和检测计划的部门
在农业部负责的残留监控任务中，由地方畜牧兽医部门指派的官方兽医进行抽样，由农业部指定的兽药残留检测实验室承担相关检测工作。
在质检总局承担的残留监控任务中，各直属出入境检验检疫局根据各自的监控任务制订残留监控计划实施方案，确定被抽样的出口企业，并将抽样和检测任务落实到具体的抽样和检测人员。
抽样工作应保证随机性和不确定性。
六、参加残留监控检测的实验室
2002年度共有8个基准实验室、63个批准实验室参加残留检测。其中农业部系统有2个基准实验室和32个批准实验室；检验检疫系统有6个基准实验室、31个批准实验室。
实验室的名单见附录3
中华人民共和国农业部畜牧兽医局
中华人民共和国国家质量监督检验检疫总局进出口食品安全局
二○○二年四月二十四日
