中国与欧盟和美国禽肉、禽蛋中兽药残留限量标准的对比研究

【目的】 为推进中国食品安全监控体系建设及完善相关的法规标准提供参考,保障食品安全的同时提升中国禽肉、禽蛋产品在国际市场的竞争力,打破国际技术性贸易壁垒,促进国际禽产品贸易繁荣发展。【方法】 首先对比分析中国新发布的食品安全国家标准GB 31650－2019《食品安全国家标准食品中兽药最大残留限量》及已废除的农业部公告第235号《动物性食品中兽药最高残留限量》中有关禽肉、禽蛋的兽药残留种类和兽药最大残留限量（MRLs）标准;然后对中国新国家标准与欧盟和美国在禽肉、禽蛋的兽药残留种类区别和MRLs标准的严宽程度等几项内容进行了对比分析。【结果】 中国新国家标准对旧标准进行了一定程度上的补充与修改,大部分有关禽肉、禽蛋的MRLs标准与欧盟和美国的标准相同甚至更加严格,这标志着中国兽药残留标准体系进入了新阶段,但部分兽药的MRLs标准仍与欧盟和美国的标准存在一定差异,其中共有包括双氯西林在内的33种兽药的MRLs标准缺失或宽于欧盟和美国。【结论】 未来中国仍需结合禽肉、禽蛋的生产情况、兽药实际使用情况及人民消费升级的需求,进一步完善禽肉、禽蛋产品中兽药残留限量的相关标准,使其向国际标准靠拢,提高中国禽肉、禽蛋产品在国际市场上的竞争力,并对进出口产品中兽药的残留情况进行严格监控,防止其影响消费者的健康安全和禽肉、禽蛋的国际贸易发展。     

中国与美国、欧盟、日本和CAC猪组织中兽药残留限量标准的对比研究

为便于中国兽药残留标准的改进和相关法规体系的建立提供参考,同时为中国畜产品贸易提供数据参考,保障人们的饮食安全,促进中国畜产品经济的更好发展,本研究首先对中国新国标GB 31650-2019《食品安全国家标准食品中兽药最大残留限量》中规定的猪组织中兽药残留种类和兽药最大残留限量（MRLs）标准进行了简单分析;然后对美国、欧盟、日本和食品法典委员会（CAC）规定的猪组织中兽药残留种类和兽药MRLs标准与中国新国标进行对比,通过对规定兽药总数、中国没有规定而其他标准有规定的兽药种类、其他标准严于中国标准的兽药种类等几项内容的比较,找出差异。结果显示,中国新国标做出了更加详细的补充和修改;从整体上来看,中国规定的猪组织中兽药MRLs标准越来越完善,大部分标准与欧盟、美国、日本和CAC规定标准的差距也越来越小,然而在部分种类兽药MRLs标准的规定方面和这些国家或组织仍有一定的差距。中国需加强与各个发达国家和组织的交流与合作,推进中国的兽药残留标准的发展,加快对动物产品质量安全标准的更新。     

Residues of veterinary drugs at injection sites

Residues of veterinary drugs have potential implications for human food safety and international trade in animal-derived food commodities. A particular concern is the slow depletion of residues of some injectable formulations from the site of administration. Licensing authorities have adopted different approaches to the human food safety assessment of injection site residues. European agencies apply the maximum residue limit (MRL) for muscle to muscle at the injection site and specify a withdrawal period sufficient to ensure the ingestion of a 300 g portion of muscle, if comprised entirely of injection site tissue, does not exceed the acceptable daily intake. The agencies in Australia, Canada and the USA also exclude injection site residues from the MRL-setting process. These agencies evaluate the risk to consumers posed by potential acute manifestations resulting from the infrequent ingestion of injection site residues based on acute dietary exposure considerations. While all of these approaches protect the safety of consumers, the adoption of different approaches has potential implications for residue surveillance programs in the international trade in meat. In particular, when an exporting country establishes standards for residues at injection sites based on acute dietary exposure considerations and the importing country assesses these residues against the MRL for muscle, the unnecessary condemnation of meat and disruption to market access may result. The latter may represent a potential economical impost to the exporting country. An internationally harmonized approach to the risk analysis of residues of veterinary drugs at injection sites, which protects the safety of consumers and facilitates the international trade in meat, is needed.     

Acrylamide, antiparasitic agents, dioxins and more: how dangerous are contaminants and residues in food?

Within the European Union, food safety and consumer protection are topics of highest priority. The evaluation of the safety of contaminants and residues in food is usually based on the determination of the acceptable daily intake (ADI), which in turn is the basis for maximum residue levels (MRLs). As this procedure depends on animal testing, a safety factor of 100 is usually applied to provide a margin of safety. This paper discusses the occurrence of relevant contaminants (e.g. dioxins, acrylamide) and residues (e.g. antibiotics, antiparasitic agents) in food and provides a brief assessment of the risks resulting from the consumption of food containing these substances.     

Development of Risk Warning Method of Veterinary Drug Residues in Raw Milk Based on Shewhart Control Chart

The aim of this study was to develop a dynamic risk warning method of veterinary drug residues in raw milk because of dynamic changes of raw milk. Risk warning methods of veterinary drug concentration above MRLs, abnormal detection rates and average-standard deviation were developed based on theory of Shewhart control chart. Veterinary drug residues data of 1000 milk samples collected from a large dairy company were analyzed with Shewhart control charts and no risk warning were found. Abnormality of detection rate and average were assumed and also analyzed in this study.     

兽药新化药的临床前安全评价与人用药物的差别

兽药的使用不但要保障靶动物的安全,更要保障人的食品消费安全,因此,兽药新化药研发的临床前安全评价与人用药物相比,有其独特的特点.每日允许摄入量、兽药最高残留限量和休药期的制定是兽药独有的内容.本文比较了兽药和人用药物在临床前安全评价内容的差异,为从事新药研发的毒理学工作者提供参考.     

New food safety initiatives in the Food and Drug Administration

Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has been to achieve international agreement on veterinary drugs issues. CVM is an active participant on this committee. The CC/RVDF has established a list of priority veterinary drugs that are, or that have the potential to cause trade problems as the result of public health concerns. Included in this list are anabolic hormones, chloramphenicol, sulfonamides, nitrofurans, nitroimidazoles, somatotropins, benzimidazoles and trypanocides. In the upcoming years, the CC/RVDF will work toward developing international maximum residue levels for these compounds. The evaluation of the toxicity of veterinary drug-bound residues is another area of international concern. In conjunction with the Bureau of Veterinary Medicine, Health and Welfare Canada, CVM is developing guidelines on biological models to demonstrate the safety of veterinary drug-bound residues. In working with veterinary drug regulators from other countries, CVM has new solutions to human food safety problems.     

动物源性食品中多种兽药残留种类及检测方法

动物源食品中多种兽药残留主要是动物在生长和加工中额外添加。该种残留现象具有水平低、种类多、机制效应复杂的特点。针对该种动物制品在进行兽药残留检测中应综合运用新技术新方。目前在动物源食品中多种兽药残留检测中常用的技术为高效液相色谱质谱联合使用技术,该项技术具有检测灵敏度高,数据获取精准的特点,能对多种兽药残留情况进行定性定量的分析,在动物源食品多种兽药残留检测过程中应用较为广泛。该文主要论述动物源食品中多种兽药残留的种类及兽药残留检测技术。     

鸡蛋药物残留研究进展

国内外鸡蛋药物残留主要包括合成抗菌药物（磺胺类药物、喹诺酮类药物和硝基咪唑类药物）、抗生素类药物（四环素类、大环内酯类、氯霉素类及其他抗生素类药物）、抗球虫药物（聚醚类药物）及农药等。这些药物都是常见的家禽用药,由于其效果好、价格低廉、抗菌谱广等被广泛应用。但药物残留直接危害人体健康,且细菌对该类药物较易产生耐药性,耐药菌株可通过食物链向人类传递,此外鸡蛋药物的残留也可导致人体内敏感细菌产生耐药性,该现象已引起了全世界的关注。目前对动物性食品药物残留进行监测是确保食品安全和人类健康的最后一道防线。因此鸡蛋常见药物残留的监测技术的研究,可确保鸡蛋食用安全性,提高鸡蛋的质量,保障人体健康,增强国际贸易竞争力。     

中美兽药产业内贸易研究

文章根据2000-2017年中美兽药产品贸易的进口额和出口额，计算了中美两国兽药产品产业内贸易G-L指数及B指数，分析两国兽药产业内贸易情况。经研究认为，中美兽药产业内贸易整体水平不高，但是呈近年来上升趋势，且中美兽药贸易增加的原因以产业内贸易为主。另外，中美兽药产业的产业内贸易可能是受到市场需求差异、产品差异、规模经济等因素的影响。最后，针对研究结果提出促进中美产业内贸易发展的建议,包括继续充分利用两国资源禀赋的互补性，加大技术引进、技术创新的力度，加强中美兽药产业贸易更进一步向产业内贸易的转化。     

利用表面等离子谐振免疫生物传感器检测动物组织中的兽药残留

表面等离子谐振免疫生物传感器已成为分析生物分子特异性相互作用的有效工具.20世纪90年代已来,有几家实验室进行了应用该技术筛选检测动物组织及体液中兽药残留的研究,结果表明该方法具有快速、准确、灵敏度高和实时检测的特点,有可能作为筛选方法用于大批量样品的兽药残留检测.本文简要介绍了这种生物传感器检测动物组织及体液中兽药残留的原理及检测某些兽药残留的性能.     

Approaches in the safety evaluations of veterinary antimicrobial agents in food to determine the effects on the human intestinal microflora

The administration of antimicrobial agents to livestock creates potential for antibiotic residues to enter the food supply and be consumed by humans. Therefore, as a process of food animal drug registration, national regulatory agencies and international committees evaluate data regarding the chemical, microbiologic, pharmacokinetic, pharmacodynamic, pharmacologic, toxicologic, and antimicrobial properties of veterinary drugs to assess the safety of ingested antimicrobial residues to consumers. Currently, European, Australian and United States guidelines for veterinary drug registration require a safety assessment of microbiologic hazards from consumption of antimicrobial residues taking into account the potentially adverse effects on human intestinal microflora. The main concerns addressed are selection of resistant bacteria in the gastrointestinal tract and disruption of the colonization barrier of the resident intestinal microflora. Current requirements differ among national agencies. Efforts are ongoing internationally to review and harmonize approaches and test methods and protocols for application to these microbiologic safety evaluations of antimicrobial drug residues in food. This review describes the background to current regulatory approaches used in applying in vitro and in vivo methods to set a microbiologic acceptable daily intake for residues in food derived from animals treated with an antimicrobial agent. This paper also examines the current research needs to support these evaluations.     

Estimates of genetic parameters associated with lactation feed intake and reproductive performance in purebred and F1 sows

Daily feed intake during lactation was recorded in parity records from purebred Yorkshire (n = 1587), Landrace (n = 2197) and reciprocal cross F1 (n = 6932) females, and lactation feed intake (LFI) curves were predicted using a mixed model. Evaluation of the difference in feed intake between two consecutive days of lactation resulted in the following classifications: three periods for purebreds, days 1–6, days 7–10 and days 11–18, and two periods for F1 sows, days 1–5 and days 6–18. Average rate of change in intake (ARC), average daily intake (ADI) and variation from predicted LFI values (VAR) were computed for each period of lactation. Gibbs sampling was used to estimate genetic (co)variance components for LFI metrics and reproductive performance traits. Genetic variance estimates for each LFI metric were obtained with univariate animal models, and covariance estimates were estimated with bivariate models. Heritability estimates for ADI, ARC and VAR metrics computed over the duration of lactation were 0.37, 0.24, and 0.16, respectively. Heritability estimates were highly variable across periods of lactation for ARC (0.03–0.17), ADI (0.09–0.36) and VAR (0.04–0.18) metrics in purebred and F1 populations. Genetic correlations between LFI metrics and reproductive traits were relatively low, although LFI metrics later in lactation were more highly correlated with reproductive performance.     

Determination of trimethoprim and sulphadoxine residues in porcine tissues and plasma.

Healthy gilts and market-ready hogs were administered a single intramuscular (IM) injection of Borgal, a commercial formulation of trimethoprim-sulfadoxine (TMP-SDX), once or twice daily. The objectives were to determine if a newly-developed high-performance liquid chromatographic (HPLC) method would be suitable for measuring the residual concentrations of TMP in the plasma of these live animals, and to determine if the administration of this veterinary drug would leave measurable residues in their plasma and tissues at slaughter. Plasma and tissue concentrations of SDX and TMP from these animals were determined over a period of 14 d using thin-layer chromatography/densitometry (TLCD), and the newly-developed HPLC method, respectively. The lowest detectable limit (LDL) for SDX in plasma and tissue was 20 ppb by TLCD. The HPLC method had a LDL of 5 ppb for TMP in plasma and tissue. Both methods were then used to provide baseline data on the absorption and depletion of TMP and SDX from these healthy animals. It was observed that both TMP and SDX were readily absorbed into the blood and tissues, but TMP was eliminated much faster than SDX. No TMP residues were detected in the plasma of any of the gilts at and beyond 21 h after drug administration. Also, no TMP residues were detected in the plasma of any of the market-ready hogs 24 h after drug administration at either the label dose or twice the label dose. Sulfadoxine residues at concentrations above the maximum residue limit (MRL) of 100 ppb were, however, detected in the plasma, muscle, kidney, liver, and injection sites of hogs slaughtered 1 and 3 d after a single IM administration at the label dose. Although SDX residues were still detectable in the lungs, kidney, liver and plasma of some hogs 10 d after administration of the label dose and twice the label dose, these were below the MRL. Postmortem examination revealed necrosis and inflammation at the injection sites, but no visible deposits of the injected drug.     

Substances with pharmacological effects including hormonally active substances in the environment: identification of tetracyclines in soil fertilized with animal slurry

Many drugs used in human medicine are detectable in surface waters from the low to the very low microgram/L concentration range. In drinking waters only some of these substances were detected, the concentrations are usually an order of magnitude below the concentrations found in surface waters. A risk assessment of long time effects caused by a permanent intake of these low concentrations of drug residues cannot be done at this time. Hormonally active substances in surface waters may present an ecotoxicological risk, there are many investigations currently under way to assess this problem. Our investigations show for the first time that residues of the commonly used veterinary drugs tetracycline and chlortetracycline can be detected in the surface of soil (0-40 cm) fertilized with animal slurry. The maximum concentrations found were 32.3 micrograms/kg and 26.4 micrograms/kg respectively. Leaching of these compounds into seeping water sampled at a depth of 80-140 cm could not be detected with the methods employed. The significance of the detected antibiotic residues in soil samples for the quality of food of animal origin or any ecotoxicological consequences needs further investigations. The knowledge about the concentrations of veterinary drug residues resulting from animal husbandry in the environment is the first step for such a risk assessment.     

我国食品中兽药最大残留限量标准现状分析与建议

通过梳理我国兽药最大残留限量标准发展概况,对比分析了我国目前的限量需求和现行标准《食品安全国家标准兽药最大残留限量》(GB 31650-2019)的不足,提出兽药最大残留限量标准研究与制定的合理化建议与对策。     

The role of veterinary epidemiology and veterinary services in complying with the World Trade Organization SPS agreement

The agreement on the application of sanitary and phytosanitary measures (SPS agreement) was one of the major products of the GATT's Uruguay round of multilateral trade negotiations, signed in Marrakesh on 15 April 1994. This agreement and others are part of the treaty that established the World Trade Organization (WTO). The WTO superseded the GATT as the umbrella organization for international trade (WTO, 1998a). The SPS agreement's main intent is to provide guidelines and provisions to member countries to facilitate trade while taking measures to protect human, animal or plant life or health. The agreement dictates that all sanitary measures must be scientifically based and not more restrictive than required to avoid the risk identified. The agreement recommends the use of international standards from the World Organization for Animal Health (OIE), Codex Alimentarius (CAC) and the International Plant Protection Convention (IPPC) as the basis for import requirements. If a country chooses to apply more restrictive measures than those in the international standards, it has to justify its position through a risk analysis, thus avoiding the use of sanitary and phytosanitary measures as unjustified barriers to trade. More than ever, veterinary services worldwide are faced with having to fulfill a crucial role in protecting their country's animal health status, provide sound surveillance information on the occurrence of diseases within their territories, and conduct scientifically valid risk analyses to establish justified import requirements. During the past two decades, most countries have experienced resource reduction in their veterinary services. The effect of these policies has been severe, in many cases leading to an inability of veterinary services to conduct their disease prevention and control duties. There is a clear inconsistency between the demands placed on veterinary services and the current level of funding and support they are receiving, particularly in the developing world. This paper analyzes the implications in complying with the SPS agreement and explores the role of veterinary epidemiology in developing viable alternatives that can enhance the veterinary services' ability to perform under the current economic reality. The key provisions of the SPS agreement are regionalization, risk analysis, harmonization, equivalence and transparency. The paper focuses on the contribution of epidemiology in each of these areas in the effective implementation of the SPS agreement.     

中草药复配物对奶牛子宫内膜炎致病菌的体外抑菌试验

细菌感染是引起奶牛子宫内膜炎发生的主要病因,兽医临床多采用抗菌药物疗法对其进行治疗。但该治疗方法易造成耐药菌株的产生和兽药残留等问题,因此,研制高效、低毒、低残留的中草药制剂将为治疗奶牛子宫内膜炎提供新的治疗手段。设计了8种单提复配中草药配方、6种共煎中草药配方以及12种中西药复合配方,通过药物敏感性试验,分别测定了上述配方对金黄色葡萄球菌、大肠杆菌和链球菌3种奶牛子宫内膜炎主要致病菌的抑菌活性,从中优选出了最佳配方7A(中西药复合配方)。该配方对3种致病菌均有良好的抑制效果,有望作为治疗奶牛子宫内膜炎的药物应用于兽医临床。     

液相色谱-串联质谱法在兽药残留检测中的应用

 随着兽药和药物添加剂在畜禽饲养过程中长期不合理的使用,残留在动物体内的兽药及其添加剂随着食物链进入人体,对人类的健康构成潜在威胁。加强对兽药残留的检测,对保护生态环境和人类的身体健康有着极其重要的现实意义。近年来,液相色谱—串联质谱技术以其良好的适用性、定性定量功能及高灵敏度等优点,在兽药残留的检测方面已得到了广泛应用。论文概述了液相色谱—串联质谱技术在饲料、畜产品和尿液中兽药残留以及违禁药物和有害添加剂检测的应用现状。     

中国与美国及新西兰牛奶兽药残留监测计划的比较

目的：比较中国与美国及新西兰牛奶兽药残留监测计划的差异和不足,为完善我国牛奶兽药残留监测计划提供参考。方法：收集2008-2011年中国、美国及新西兰的牛奶兽药残留监测计划的数据,比较各个国家实施监测计划的药物种类、样本量以及实施结果。结果：我国与美国及新西兰牛奶兽药残留监测计划相比,监测药物种类与美国及新西兰相近,但检测量少,难以覆盖所有牧场;2011年度的中国与美国及新西兰牛奶抗生素残留监测的检测结果为：中国的检出率高于美国和新西兰（P〈0．05）,有统计学意义。建议在监测计划中扩大监测范围,增加检测量,使监测计划能覆盖更多地区和牧场。