Dr. Yuan Wen-Ze, 袁文泽 Director, Animal Inspection and Quarantine Division, Liaoning Entry-Exit Inspection and Quarantine

1. 贝类及其产品的食用安全 法律法规和卫生监控体系 The edible safety, laws and regulations, sanitary supervision of the shellfish and their products Dr. Yuan Wen-Ze, 袁文泽 Director, Animal Inspection and Quarantine Division, Liaoning Entry-Exit Inspection and Quarantine Bureau, PRC 中國遼寧出入境檢驗檢疫局 動物檢驗檢疫處

2. 主要内容 Main Topics 一、中国贝类概况 Outline of the shellfish in China 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish

3. 一、中国贝类概况Outline of the shellfish in China ■中国是世界上最大的贝类生产国，年产量1000万吨以上，占世界贝类生产总量的60%。 China is largest shellfish producer in the world, annual output of more than 10 million tons, accounting for 60% of the world's total production of shellfish. ■中国有700多个贝类品种，主要为海水贝类，包括扇贝、牡蛎、鲍鱼、蛤蜊等，主要分布在辽宁、山东、广东等东部沿海地区。养殖与生长方式包括吊笼、底播、滩涂、礁岩、池塘等 China has more than 700 varieties of shellfish, mainly seawater shellfish, including scallops, oysters, abalone, clams, etc. which are mainly distributed in the eastern coastal regions such as Liaoning, Shandong, Guangdong.

4. 一、中国贝类概况Outline of the shellfish in China 中国地图Map of China

5. 一、中国贝类概况Outline of the shellfish in China 虾夷扇贝 （Patinopecten yessoensis） 贻贝 （Mytilus coruscus） 牡蛎 （Ostreidar ） 杂色蛤 （Ruditapes philippinarum） 文蛤 （Meretrix lusoria） 魁魽 （Scapharca broughtonii）

6. 一、中国贝类概况Outline of the shellfish in China ■中国是贝类消费大国，全球出产的贝类产品有半数以上在中国消费。少量中国贝类还出口到其他国家和地区，包括日本、韩国、美国、澳大利亚、新西兰等。 China is a big country of shellfish consuming, more than half of the world‘s shellfish products are consumed in China. China also exports a small amount of shellfish to other countries and regions, including Japan, South Korea, the United States, Australia and New Zealand, etc.. ■中国养殖和出口贝类主要是双壳贝类，而双壳贝类是贝类中引起食源性疾病的主要品种，卫生学意义重大，因此，本文着重讨论双壳贝类有关问题。 The main species of shellfish cultured and exported in China are bivalve molluscs which are the major species causing food-borne diseases and has great hygienic significance, therefore, this presentation focuses on the issues related to bivalve shellfish.

7. 一、中国贝类概况Outline of the shellfish in China ■双壳贝类的生理结构：主要由贝柱（闭合肌）、中肠腺、生殖腺、外套膜、消化腺、腮等部分组成。 The physiological structure of bivalves molluscs mainly consist of Pui-chu (closing muscle), midgut gland, gonad, mantle, digestive gland, gills and other components.

8. 一、中国贝类概况Outline of the shellfish in China 不同规格虾夷扇贝的各部位重量(g) The weight (g) of various parts of patinopecten yessoensiswith different specifications 规格（cm） 全贝 贝肉 中肠腺 Specifications Full shell Flesh midgut gland 小small（8-9 ） 75.5 31.6 3.6 中medium(9-10） 91.5 39 4.5 大Large（10以上） 122 52.5 6.3 注(remarks)： 全贝：带壳扇贝 Full shell: Scallop with shell 贝肉：去壳后的全部贝肉（未包括体液） Flesh: The flesh after shelling (not including body fluids) 重量：分别为8只扇贝的平均值 Weight: an average weight of eight scallopsrespectively, 贝肉的重量大体为全贝的1/2，而中肠腺为贝肉重量的11-12%。 The weight of the flesh in general is 1 / 2 of the whole shellfish weight, the weight of the mid-gut gland is 11-12% of the flesh weight.

9. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products ■双壳贝类系无选择性滤食动物，个体移动范围不大。食物主要为有机碎屑、硅藻、原生动物和单鞭藻类等。双壳贝类通过过滤大量海水摄食，因此受污染的机率非常高。尤其是生活在近海及河口的贝类风险性更大。良好的养殖环境与水质质量是双壳贝类食用安全的先决条件。 Bivalve molluscs are non-selective filter feeders, individual movement limited in a small scope, their food is mainly organic detritus, diatoms, protozoa, and single-whip algae. Bivalve molluscs intake feed through filtering a large amount of seawater, so the chances of contamination is very high. Particularly those living in offing and estuaries have greater risk. A good aquaculturing environment and water quality are the prerequisites for edible safety of bivalve molluscs.

10. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products ■贝类及其产品的食用安全性危害因素： （一）物理危害：贝壳杂质、金属异物 （二）微生物污染：细菌、病毒 （三）生物毒素：麻痹性贝类毒素、腹泻性贝类毒素等 （四）化学危害：化学污染物、重金属污染 Hazard factors of edible safety for the shellfish and their products: (A) Physical hazards: shell impurities, external metals(B) microbial contamination: bacteria, viruses (C) Biotoxins: PSP, DSP, etc.(D) Chemical hazards: chemical pollutants, heavy metal pollution

11. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （一）物理危害 Physical hazards ■物理危害：贝壳杂质、金属异物 问题来源:养殖、捕捞、流通、加工、制作各环节，预防较容易。 Physical hazards: shell impurities, external metalThe problems are sourced from the links of culturing, catching, circulating, processing, manufacturing, etc., which are easier to prevent.

12. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （二）微生物污染 Microbiological contamination ■微生物污染：细菌、病毒 问题主要来自养殖环节，其他环节如不能很好控制，也存在一定风险。 Microbiological contamination: bacteria, virus Hazards are mainly from culturing links, other links also exist risks if not well controlled .

13. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （二）微生物污染 Microbiological contamination 1、细菌：大肠杆菌、沙门氏菌、副溶血弧菌 Bacteria: E.coli,Salmonella, Vibrio parahaemolyticus 大肠杆菌作为贝类生长海域水质环境的主要监测指标广泛被采用。 E coli. has been widely adopted as a main monitoring indicator for water quality environment of the growing area of bivalve molluscs 标准 Standards ： 微生物： - 捕捞区域的分级和操作标准： - A : <230 大肠杆菌/100gm 肉质和水质; - B : 230 – 4,600; - C : 4,600 – 46,000 - 禁止 : >46,000 Microbiology : - Classification of Harvesting Areas and standards for operation: - A : <230 E.coli/100gm flesh & liquid; - B : 230 – 4,600; - C : 4,600 – 46,000 - Prohibited : >46,000 野生扇贝除外，还适用于被囊类和腹足类动物 Exception for wild caught scallop, but also applies to tunicates and gastropods

14. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （二）微生物污染 Microbiological contamination 1、细菌：大肠杆菌、沙门氏菌、副溶血弧菌 Bacteria: E.coli,Salmonella, Vibrio parahaemolyticus 沙门氏菌、副溶血弧菌：对海水贝类而言，生物危害主要是沙门氏菌、副溶血型弧菌，可以引起食用者腹泻等临床问题。在没有交叉污染和重复污染的前提下，只要保证较短的捕捞、运输时间和必要的冷链设施，沙门氏菌不存在大的风险。尽管副溶血型弧菌是嗜盐菌，在海水中分布很广，但是一般也不会超过100/g的限量，不足于造成食物中毒的风险。 Salmonella, Vibrio parahaemolyticus: for seawater shellfish, the biological hazards are mainly Salmonella, Vibrio parahaemolyticus which can cause clinical problems of consumer such as diarrhea etc.. In the absence of cross-contamination and repeat contamination, so long as ensure a shorter catching, transporting time and the necessary cold-chain facilities, there will not occur a great risk of Salmonella . Although Vibrio parahaemolyticus is widely distributed in seawater as a halophilic bacteria, but it generally does not exceed the limit of 100 / g which is not insufficient to cause the risks of food poisoning.

15. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （二）微生物污染 Microbiological contamination 2、病毒 Virus 诺瓦克病毒、甲型肝炎病毒 Norovirus, Hepatitis A

16. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 1、河豚毒素 TTX;tetrodotoxin 氰化钾毒力的1000倍，0.2mg的河豚毒素可使人发生中毒症状，1-2mg可使人致死。 The toxicity of TTX is 1000 times of that of Potassium cyanide, 0.2mg of TTX can makes people develop symptoms of poisoning ,1-2mg of TTXenable people to death.

17. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 2、鱼肉毒(ciguatera)： 热带或亚热带珊瑚礁回游的有毒鱼类，毒力是河豚毒素的20倍。 ciguaterais from the toxic migration fish in tropical or subtropical coral reef, its toxicity is 20 times of that of tetrodotoxin.

18. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■麻痹贝毒（PSP：Paralytic shellfish poison) 毒素成份主要是石房蛤毒素（saxitoxin）等20余种 结构相似的组分，与河豚毒素的毒力相当。 麻痹贝毒是由于双壳贝类在中肠腺蓄积A.tamarense 以及A.catenella等十几种有毒藻形成。 麻痹贝毒的限量为4MU/g The PSP consists of more than 20 kinds of structurally similar components, mainly Saxitoxin, its toxicity is equivalent to that of tetrodotoxin. The reason of PSP formation is that bivalve molluscs accumulate A.tamarense, A.catenella as well as more than 10 kinds of other toxic algae in the mid-gut gland. The maximum limit of PSP is 4MU / g. A.tamarense

19. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■腹泻贝毒（DSP：Diarrhetic shellfish poison) 毒素的成份主要是大田脂肪酸、扇贝毒、虾夷扇贝毒。 毒力相当于河豚毒素的1/16，1976年在日本的宫城县由 紫贻贝引起的食物中毒发现。 由于双壳贝类在中肠腺蓄积了D.fortii、D.acuminata等 有毒藻而形成。 腹泻贝毒的限量为0.05MU/g。 The main ingredient of DSP are daejeon fatty acids, scallop poison, patinopecten yessoensis poison. The  toxicity of DSP is  equivalent to 1 / 16 that of Tetrodotoxin, this was found by food poisoning caused by Mytilus edulis in Miyagi Prefecture,Japan, 1976. The reason is that bivalve molluscs accumulate the toxic algae such as D.fortii, D.acuminata, etc. in the mid-gut gland The maximum limit of DSP is 0.05MU / g. D.fortii

20. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■神经性贝毒（NSP：Neurotoxic shellfish poison) 毒素的主要成份是短裸甲藻毒素（Breveroxin、BTX），贝类滤食了短裸甲藻（Gymnodinium breve）蓄积了毒素。 NSP的限量是不得检出。 The main ingredient of NSP is Breveroxin, shellfish accumulates the toxin through filter- feeding Gymnodinium breve.      The maximum limit of NSP is zero tolerance.

21. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■记忆丧失性贝毒（ASP：Amnesix shellfish poison) 毒素的主要成份是软骨藻酸（Domoic acid），贝类滤食了拟菱形藻（Diatom Pseudo-nitzschia）蓄积了毒素。 ASP的限量是DA不超过20mg/kg。 The main ingredient of ASP is Domoic acid, The shellfish accumulate the toxin through filtering the Diatom Pseudo-nitzschia.      The maximum limit of ASP is that DA do’nt exceed 20mg/kg.

22. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP 虾夷扇贝不同部位的PSP毒性（MU/g）the PSP toxicity of different parts of Scapharca broughtonii NO. 性别 贝柱 中肠腺 外套膜 肠 腹足 腮 生殖腺 (sex) (adductor) (mid-gut gland ) (mantle) (intestine) (pleopod) (gills) (gonad) 1 M 2 110 39 83 40 9 10 2 M 2 48 24 32 33 11 13 3 M 2 44 22 32 33 11 13 4 M 2 19 11 12 21 3 3 5 F 2 50 30 20 26 13 13 6 F 2 100 33 22 56 13 13 7 F 2 100 33 22 56 13 13 8 F 3 85 17 56 36 12 2 ————————————————————————————————————— 平均(mean) 2.13 69.5 26.13 34.88 37.63 10.63 10 —————————————————————————————————————— 各批次各10个扇贝, 从表中可见，PSP在贝类体内的分布是不均匀的。贝柱的PSP为2-3MU/g，小于 限量值4MU/g，而中肠腺PSP在19-110MU/g之间，其它部位含有的PSP不等，大多超过限值。 10 scallops each batch respectively. The distribution of PSP in shellfish body is uneven. The PSP concentration in adductor is 2-3MU / g which is less than the maximal limit of 4MU / g, PSP concentration in mid-gut gland is between 19-110MU / g, the PSP concentrations in other parts are different but all of them exceed maximal limit.

23. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■麻痹性贝毒的致死量(The lethal dose of PSP) （1）贝类毒素的鼠单位（MU）：目前国际上PSP的限量值是4MU/g（相当于80μg/100g）。1MU/g为1g双壳贝类的可食贝肉15分钟致死20g体重老鼠的毒性； Mouse units (MU) of Shellfish poison: the current international PSP limits is 4MU / g (equivalent to 80μg/100g), 1MU / g means that the toxicity of 1g edible bivalve molluscs can cause a rat of 20g body weight to death within 15 minutes; （2）麻痹贝毒对人的致死量：以体重60㎏计， PSP的致死量为3，000 MU。 The lethal dose of PSP: The lethal dose of PSPis 3,000 MU calculated by 60 kg body weight.

24. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■麻痹性贝毒的致死量(The lethal dose of paralytic shellfish poison) （3）如果3g的杂色蛤去壳贝肉含有16.9MU的PSP，则食用大约60个杂色蛤可达到致死量； If 3g of shelling short-necked clam flesh contains PSP 16.9MU, then consuming about 60 short-necked clam can be up to the lethal dose; （4）如按2007年5月份香港食环署报告的扇贝中的麻痹贝毒为1922μg/100g，则换算为鼠单位为96.1MU/g.。其致死量为31.22g, 也就是相当于一个小贝的去壳贝肉重量；According to the report of Food and Environmental Hygiene Departmentof Hong Kong in May 2007, the concentration of PSP in scallop is 1922μg/100g, which is equivalent to mouse units 96.1MU / g, its lethal dose is 31.22g which is equivalent to the weight of a small shelling clam;

25. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■麻痹性贝毒的致死量 (The lethal dose of paralytic shellfish poison) （5）表3中NO.4样品各部位的PSP合计为71MU/g，如按照PSP的致死量，则食用42g去壳贝肉即可致死，相当于1个中型扇贝（39g）；如果食用时去除了中肠腺，可食用其它部位贝肉52克，不能超过57克，相当于1个大型扇贝；NO.1样品各部位的PSP合计为291MU/g，如按照PSP的致死量，则食用10克的去壳贝肉可致死亡；如果食用时去除了中肠腺，其它部位贝肉的PSP为181克，则不能食用超过16克的贝肉，相当于半个小型扇贝；The total PSP of various parts of NO.4 sample in table 3 amount to 71MU / g, in accordance with the lethal dose of PSP, it will be lethal for consuming 42g shelling flesh which is equivalent to a medium-sized scallops (39g); if mid-gut gland was removed before consuming, it will be safe to consume 52g but not exceed 57g of other parts of shellfish flesh which are equivalent to a large scallops; The total PSP of various parts of NO.1 sample amount to 291MU / g,in accordance with the lethal dose of PSP,it will be lethal of consuming 10g shelling flesh ; if mid-gut gland was removed before consuming, other parts of shellfish flesh is 181g, it will be safe to consume not exceeding 16g of shellfish flesh which are equivalent to a half small scallop;

26. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （三）生物毒素 Biotoxin 3、贝类毒素：麻痹贝毒、腹泻贝毒、神经贝毒、失忆贝毒 Shellfish poison: PSP, DSP, NSP, ASP ■麻痹性贝毒的致死量 (The lethal dose of paralytic shellfish poison) （6）如仅仅食用PSP毒化期的的裙边（表3）26.13MU/g，可食用114.8g；有一定风险，尤其是老幼病弱人群； If only consuming 26.13MU / g of scallop skirts during the period of PSP poisoning (Table 3), consuming 114.8g is safe; but also there exists a certain risk, especially for the young and old, sick people; （7）如食用毒化期的贝柱（表3）2.13MU/g，可食用1408.5g，几乎无风险。 If consuming 26.13MU / g of scallopadductor during the period of PSP poisoning, consuming 1408.5g is safe, there almost not exists risks.

27. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （四）化学危害 Chemical hazard 化学污染物：海洋石油污染 陆地农药污染 入海口排污污染 Chemical contaminants: Marine Oil Pollution                        Pesticide pollution on land                        sewage into the sea

28. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （四）化学危害 Chemical hazard 重金属污染：铅、汞、镉、铜等 来源：海洋污染、陆地污染、船舶作业污染 Heavy metal pollution: lead, mercury, cadmium,copper, etc. Source: marine pollution, land-based pollution, ship operatingpollution 重金属镉的最大摄入量(The maximum intake of cadmium): FAO/WHO食品添加剂专家委员会（JEFCA）评价镉的每周耐受摄入量（Provisional tolerable weekly intakes,PTWI）维持在7μg /kg.BW。 以体重60Kg计，每人每周镉允许摄入量为420μg，每人每日镉允许摄入量为60μg。 一般认为正常膳食不会超过摄入量。FAO / WHO Expert Committee on Food Additives (JEFCA) evaluated provisional tolerable weekly intakes ( PTWI) of cadmium maintained at 7μg / kg.BW.       Taking 60Kg body weight into account, the provisional tolerable weekly intakes of cadmium foreach person is 420μg, the provisional tolerable daily intakes of cadmium is 60μg.      It is generally believed that normal diet will not exceed tolerableintake.

29. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （四）化学危害 Chemical hazard 镉的限量(The maximum limit of cadmium)： CAC （Codex Stan 193-1995,Rev 2007）关于双壳贝类中镉的最大限量为2mg/Kg(牡蛎和扇贝除外)。 The maximum limit of cadmium in bivalve molluscs of CAC (Codex Stan 193-1995, Rev 2007) is 2mg/Kg (except for oysters and scallops). 欧盟（1881/2006/EC）关于双壳贝类中镉的最大限量为1mg/Kg。 The maximum limit of cadmium in bivalve molluscs of EU(1881/2006/EC) is 1mg/Kg.

30. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （四）化学危害 Chemical hazard 虾夷扇贝不同部位中的镉（ mg/kg ）Cadium in different parts of scallop 全贝（56） 去藏（32） 贝柱（18） 卵（4） 柱连籽（11） 内藏（5） Full-shellevisceration adductor roe adductor with roegut 6.80 2.52 0.097 0.65 0.90 33.35 注：（ ）内数字为样品数 重金属主要积聚在肝脏和生殖腺，带生殖腺的双壳贝类和不带生殖腺的重金属含量不同 （1881/2006/EC）。对虾夷扇贝中不同部位的镉含量进行了调查，结果显示内脏中的 镉含量最高为33.35mg/kg，贝柱、卵、柱连籽中的含量较低，分别为0.097、0.65、 0.90mg/kg，可符合EU（1881/2006）污染物限量标准规定。 Note: The figures in ( ) stand for the number of samples Heavy metals mainly accumulate in the liver and gonads, the content of heavy metals are different from bivalve molluscs with gonads to without gonads (1881/2006/EC). The survey for the cadmium content in different parts of Patinopecten yessoensis showed that the gut contain the highest concentrations of cadium (33.35mg/kg), the adductors, roes, adductor with roe contain a lower cadium content which are 0.097,0.65,0.90 mg / kg respectively, which are in line with EU (1881/2006) requirements on Pollutant maximum limit standard.

31. 二、贝类及其产品的食用安全性 The edible safety of the shellfish and their products （五）贝类及其产品的食用安全性防范 ■来源良好的海域环境，实施有效监测 ■减少中肠腺等高危部位食用 ■熟食或半熟食 ■保持完善的冷链运输，变质勿食 Prevention of edible safety for shellfish and their products: ■ sourcing from a good the marine environment and implementing effective monitoring    ■ reducing the consumption of mid-gut gland and other high-risk parts ■ cooked or semi-cooked ■ maintaining a complete cold-chain transport and the rotten and metamorphic shellfish are not used for consuming.

32. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （一）法律和法规Laws and regulations 《中华人民共和国食品安全法》及其实施条例 Food Safety Law of the People's Republic of China and its Implementation Regulations 《中华人民共和国进出口商品检验法》及其实施条例 Law of the People’s Republic of China on Import and Export Commodity Inspection and its Implementation Regulations 《中华人民共和国进出境动植物检疫法》及其实施条例 Law of the People's Republic of China on the Entry and Exit Animal and Plant Quarantine and its Implementation Regulations 《中华人民共和国渔业法》Fishery Law of the People's Republic of China 《中华人民共和国产品质量法》 Product Quality Law of the People's Republic of China 《中华人民共和国农产品质量安全法》 Quality Safety Law for Agricultural Product of the People's Republic of China 《中华人民共和国海洋环境保护法》 Marine Environmental Protection Law of the People’s Republic of China

33. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （二）行政规章、规定Administrational rules and provisions 《出口食品生产企业卫生注册登记管理规定》 Administrative Regulation of Sanitary Registration for Food Processing Establishment for Export 《进出境水产品检验检疫管理办法》 Administrative Measures of Inspection and Quarantine of Aquatic Products for Import and Export 《进境水生动物检验检疫监督管理办法》 Administrative Measures of Inspection and Quarantine of Aquatic Animals for Import 《出境水生动物检验检疫监督管理办法》 Administrative Measures of Inspection and Quarantine of Aquatic Animalts for Export 《供港澳食用水生动物检验检疫监督管理办法》 Administrative Measures of Inspection and Quarantine of Aquatic Animals for Food to Hongkong and Macol 《进出境水生动物质量安全监控工作规范》 National monitoring standard for the Quality Safety of Aquatic Animals for Importand Export

34. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （二）行政规章、规定Administrational rules and provisions 《食品生产企业危害分析与关键控制点（HACCP）管理体系认证管理规定》 Management Rules of HACCP for Food Processing Establishment 《出口食品生产企业申请国外卫生注册管理办法》 Administrative Measures of Application for Registration Abroad for the Export Food Processing Establishment 《出境水产品追溯规程（试行）》 The tracing procedure for export aquatic products (trial edition) 《水产养殖质量安全管理规定》 Administrative Regulation of Quality Safety for Aquiculture 《贝类生产环境监督管理暂行规定》 Temporary Regulation of Supervision and Management of Shellfish Producing Environment 《水产养殖质量安全管理办法》Management Regulation of Quality Safety of Aquaculture

35. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （三）有关标准 Relevant standards 国际标准 International standards 《国际水生动物法典(OIE)》 Aquatic Animal Health Code by OIE 《国际水生动物疾病诊断手册》 Manual of Diagnostic Tests for Aquatic Animals 食品法典委员会（CAC）有关标准 Relevant Standards by CAC

36. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （三）有关标准 Relevant standards 国内标准 Domestic standards GB 11607-89 《渔业水质标准》National standard for water quality standard for fisheries GB 3097-1997《海水水质标准》National standard for sea water quality standard GB 2762-2005 《食品中污染物的限量》 National standard for Maximum levels of contaminants in foods GB 2733-2005 《鲜、冻动物性水产品卫生标准》 National Standard for Hygienic standard for fresh and frozen marine products of animal origin SN/T 1347-2004 《水产品生产企业注册卫生规范》 Professional standard for Code of hygienic practice for registration on fish and fishery products establishment SN/T 0376-1995《出口水产品检验抽样方法》 Professional standard for Method of sampling of inspection in fishery products for export

37. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （三）有关标准 Relevant standards 国内标准 Domestic standards GB 17378-1998 海洋监测规范National standard for the specification for marine monitoring SC/T3002-98 船上渔获物加冰保鲜操作技术规程Professional standard for Operation code for preserving the catch on the boat by using ice SC/T3003-98 渔获物装卸操作技术规程Professional standard for Operation code for loading and unloading the catch 贝类产品质量认证有关的标准 Standards of Quality Certification of Shellfish Products

38. 三、中国贝类相关法律法规标准 Relevent laws, regulations and standards of the shellfish in China （三）有关标准 Relevant standards 国内检测标准 GB/T4789.38-2008 食品卫生微生物学检验－大肠杆菌计数 Microbiological examination of food hygiene Enumeration of E.coli GB/T5009.213-2008 贝类中麻痹性贝类毒素的测定 Determination of paralytic shellfish poison in shellfish GB/T5009.212-2008 贝类中腹泻性贝类毒素的测定 Determination of diarrheic shellfish poison in shellfish

39. 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China 负责出口贝类安全卫生主管部门主要有： ■农业部及其各地渔业部门：负责贝类养殖区环境的评估、养殖区监测、管理； ■质检总局及各地检验检疫部门：负责鲜活贝类产品出口口岸查验、贝类产品加工过程的质量安全监督及出口查验； Competent Authorities responsible for the export shellfish safety and health: ■ Ministry of Agriculture and local fishery administration are responsible for the assessment, monitoring and management on the environment of shellfish aquaculturing areas; ■ AQSIQ and local departments of inspection and quarantine are responsible for the port check of the export live and fresh shellfish, quality and safety supervision for the processing of shellfish products, export inspection;

40. 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China 农业部（MOA） Ministry of Agriculture 农业部渔业局 Fishery Bureau of MOA 农业部渔业局（中华人民共和国渔政渔港监督管理局）负责全国水产品的养殖、捕捞、加工、流通、渔用船舶、渔港、渔船检验、远洋渔业和渔业水域生态环境等渔业生产和行业的监督管理，制订水产品生产的有关行业法规、标准，开展有关水产品生产的安全质量控制、认证工作。 Fishery Bureau of MOA (Supervision and Management Bureau for Fishery Administration and Fishery Port of People’s Republic of China) is responsible for supervision and management of fishery production and the whole industry including culturing, catching, processing, distribution, fishery boat, fishery port, inspection of fishery boat, oceanic fishery and environment of fishery water area, for stipulating the related departmental regulations and standards concerning aquatic products, for carrying out safety quality control and certification of fishery production.

41. 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China 国家质检站总局（AQSIQ） 国家质检总局（AQSIQ）主管全国质量、计量、出入境商品检验、出入境卫生检疫、出入境动植物检疫、进出口食品安全和认证认可、标准化等工作，负责全国进出境动物、动物产品的检验、检疫，及与进出境动物及其产品有关的动物卫生和兽医公共卫生等工作，主管所有进出口商品包括进出口贝类产品检验检疫监管。 AQSIQ is in charge of national quality, metrology, entry-exit commodity inspection, entry-exit health quarantine, entry-exit animal and plant quarantine, import-export food safety, certification and accreditation, standardization, responsible for inspection and quarantine of animals and animal products for import and export, responsible for animal sanitary and veterinary public health concerning import and export animals and animal products, and responsible for supervision on inspection and quarantine of all types of import and export commodities including shellfish products.

42. 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China 国家质检站总局（AQSIQ）

43. 四、中国出口贝类卫生管理机构 Sanitary competent authorities of the export shellfish in China AQSIQ 近300个检验检疫分支局和200多个办事处 more than 300 branches and near 200 offices 35个直属局3万余人 35 provincial CIQs and 30,000 staffs 452个实验室452 Labs 检疫出证及监督管理6000人 6000 staffs for quarantine and supervision 国家质检站总局（AQSIQ） 直属检验检疫局和分支机构（CIQ）Provincial CIQs and Branches

44. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 1、养殖区选择与确定Selection and determination of aquaculture zone 养殖区的环境与水质的卫生质量，决定了双壳贝类的食用安全性，因此世界发达国家对双壳贝类的养殖区实施分类管理。对未经分类的养殖区一概不得进行采捕作业。The sanitary quality of water in aquaculture areadetermines edible safety of bivalve molluscs, so the world's developed countries enforces classified management on aquaculture area of bivalve molluscs, harvesting operations are prohibited in unclassified aquaculture area.

45. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 1、养殖区选择与确定Selection and determination of aquaculture area 在进行养殖区的分类之前，美国和欧盟都强调要进行养殖区环境的卫生评估： ●要进行人类或动物污染源的识别与控制评估； ●要对季节变化、降雨量、废水治理等有机物的污染程度进行评估； ●要依据海洋动力学和生产区的潮汐循环进行污染物循环特点的评估； ●要建立科学的取样计划，取样数量、取样地点的地理学分布和取样频率要有充分的代表性。 Before classifying the aquaculture areas, U.S. and EU have stressed the sanitary assessment on the environment of aquaculture areas :   ● To conduct assessments on the identification and control of pollution sources of human or animal ;   ● To conduct assessments on organicpollution related to seasonal changes, rainfall, and wastewater treatment;   ● To conduct assessments on the characteristics of pollutants cycling based on ocean dynamics and tidal cycle;   ● To establish a scientific sampling plan. The sampling quantity, geographic distribution of sampling locations and sampling frequency should be adequately representative.

46. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 1、养殖区选择与确定Selection and determination of aquaculture zone 按照FAO“水产养殖认证指南”的要求，养殖区的评估还应考虑到双壳贝类的生态养殖、动物健康和福利方面的问题，如是否满足贝类对不同地理条件、自然环境、饵料等的需求等。通过健康最优化、压力最小化、减少水产动物疾病风险，保持生产周期各阶段的健康的养殖环境。生态和健康的养殖环境对贝类的食用安全性是至关重要的。解决了贝类的生态养殖和健康养殖，使得贝类在环境清洁、饵料丰富的条件下愉悦生长，方可使人类得到营养、丰满的安全美食。 According to FAO “ Guide of Aquaculture Certification ” , the assessment of aquaculture zoneshould also take into account the ecological culturing, animal health and welfare issues of bivalve molluscs, such as whether meeting the requirement about the shellfish on different geographical conditions, the natural environment, bait, etc. To reduce the risk of aquatic animal diseases through health optimization, pressure minimization and maintain healthy aquaculture environment of the various stages of production cycle. Ecological and healthy aquacultureenvironment is essential for the edible safety of shellfish. Only the ecological and healthy culturing are the shellfish grown under the pleasant conditions of clean and feed rich, can the mankind acquire nutrient, rich and safe food.

47. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 2、养殖区分类 Classification of aquaculture area 养殖区的分类是以养殖区的水体或者贝肉中是否有粪便污染以及粪便污染的程度进行分类，以粪大肠菌群或大肠杆菌做为粪便直接或近期污染的指示菌。由于大肠菌群仅能指示粪便的间接或远期污染，因而近年不再以该菌做为指示菌。 Classification of aquaculturing zoneis based on if there is faecal contamination and the extent of fecal contamination of shellfish flesh in waterbody of aquaculture zone, the fecal coliform or E. coli are used as indicator bacteria of direct or lately fecal pollution. As the fecal coliform only indicate indirect or long-term pollution, and therefore it was no longer used as the indicator bacteria in recent years.

48. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture are of bivalve molluscs 2、养殖区分类Classification of aquaculture area ■美国（国家贝类卫生计划， National shellfish sanitation program, NSSP） 按照NSSP的规定，将双壳贝类养殖区划分为五类： 许可区：水样的粪大肠菌群 的MPN值为每100ml不超过14； 限制区：水样粪大肠菌群的MPN值为每100ml不超过88； 禁止区：未调查鉴定或污染严重区域，通过暂养或净化达不到人类安全消费的水平； 条件性许可区：有条件许可采捕时，应符合许可区的卫生条件； 条件性限制区：有条件限制采捕时，应符合限制区的卫生条件。 In accordance with NSSP, the aquaculture areas of bivalve molluscs are divided into five categories: Approved Area: The fecal coliform MPN of the water sample results shall not exceed 14 per 100 ml. Restricted Area: The fecal coliform MPN of the water sample results shall not exceed 88 per 100 ml. Prohibited Area: No sanitary survey or seriously polluted areas where the shellfish can not reach the level of human safety consumption even through holding or purifying; Conditionally Approved Area: it is in line with sanitary conditions of approved area while permittingharvest; Conditionally Restricted Area: it is in line with sanitary conditions of Restricted Area while permitingharvest;

49. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 2、养殖区分类Classification of aquaculture area ■欧盟 （EU 854/2006/EC） 按照854/2006/EC指令的规定，将双壳贝类养殖区划分为以下三类： A类：贝类体内的大肠杆菌MPN值为每100克不超过230的，可以供人类直接生食； B类：贝类体内的大肠杆菌MPN值为每100克不超过4600的，需经过净化达到A类限值后方可供人类生食；(净化) C类：贝类体内的大肠杆菌MPN值为每100克不超过 46000的，需经过暂养和净 化达到A类限值后方可生食；(暂养) In accordance with Directive 854/2006/EC, the aquaculture area ofbivalve molluscs are divided into 3 categories:         A: E. coli MPN of shellfish shall not exceed 230 per 100g, the flesh can be eaten raw.         B: E. coli MPN of shellfish shall not exceed 4600 per 100 g, the flesh can be eaten raw only if the shellfish were purified and reached the standard of class A;         C: E. coli MPN of shellfish shall not exceed 46000 per 100 g, the flesh can be eaten raw only if the shellfishwere purified or hold and reached the standard of class A;       

50. 五、出口贝类检验检疫监督管理 Supervision management of inspection and quarantine for the export shellfish （一）双壳贝类养殖区管理 Management on theaquaculture area of bivalve molluscs 2、养殖区分类Classification of aquaculture area ■欧盟 （EU 854/2006/EC） 对贝类体内的大肠杆菌MPN值每100克超过 46000的区域，不得进行采捕作业。 对来自B类和C类区域的、未经过净化或者暂养处理的贝类，需按照规定的工艺进行加热处理。 Harvestiong operations will not permitted in the areas where E. coli MPN exceeds 46000 per 100 g, the shellfish from B and C area and without holding and purifying shall be heat- processed in accordance with prescribedtechnology before eating.