FDA_&_EPA_Safety_Levels_in_Regulations_and_Guidance.doc

求美国食品方面法规，各方面的，有关水产品的更好，谢谢各位了！
FDA & EPA Safety Levels in Regulations and Guidance
Product Level Reference
Ready to eat fishery products (minimal cooking by consumer) Enterotoxigenic Escherichia coli (ETEC) - 1 x 103 ETEC/g, LT or ST positive. Compliance Program 7303.842
Ready to eat fishery products (minimal cooking by consumer) Listeria monocytogenes-presence of organism. Compliance Program 7303.842
All fish Salmonella species- presence of organism. Sec 555.300
Compliance Policy Guide
All fish 1.Staphylococcus aureus - positive for staphylococcal enterotoxin, or
2. Staphylococcus aureus level is equal to or greater than 104/g (MPN). Compliance Program 7303.842
Ready to eat fishery products (minimal cooking by consumer) Vibrio cholerae - presence of toxigenic 01 or non-01. Compliance Program 7303.842
Ready to eat fishery products (minimal cooking by consumer) Vibrio parahaemolyticus-levels equal to or greater than 1 x 104/g (Kanagawa positive or negative). Compliance Program 7303.842
Ready to eat fishery products (minimal cooking by consumer) Vibrio vulnificus - presence of pathogenic organism. Compliance Program 7303.842
All fish Clostridium botulinum -
1. Presence of viable spores or vegetative cells in products that will support their growth; or,
2. Presence of toxin. Compliance Program 7303.842
Clams and oysters, fresh or frozen - imports Microbiological -
1. E. coli - MPN of 230/100 grams (average of subs or 3 or more of 5 subs);
2. APC - 500,000/gram (average of subs or 3 or more of 5 subs). Sec 560.600
Compliance Policy Guide
Clams, oysters, and mussels, fresh or frozen - domestic Microbiological -
1. E. coli or fecal coliform - 1 or more of 5 subs exceeding MPN of 330/100 grams or 2 or more exceeding 230/100 grams;
2. APC - 1 or more of 5 subs exceeding 1,500,000/gram or 2 or more exceeding 500,000/gram. Compliance Program 7303.842
Salt-cured, air-dried uneviscerated fish Not permitted in commerce (Note: small fish exemption). Sec 540.650
Compliance Policy Guide
Tuna, mahi mahi, and related fish Histamine - 500 ppm based on toxicity. 50 ppm defect action level, because histamine is generally not uniformly distributed in a decomposed fish. Therefore, 50 ppm is found in one section, there is the possibility that other units may exceed 500 ppm. Sec 540.525
Compliance Policy Guide
All fish Polychlorinated Biphenyls (PCBs) - 2.0 ppm (edible portion)*. 21 CFR 109.30
Fin fish and shellfish Aldrin and dieldrin - 0.3 ppm (edible portion). Sec 575.100
Compliance Policy Guide
Frog legs Benzene Hexachloride - 0.3 ppm (edible portion). Sec 575.100
Compliance Policy Guide
All fish Chlordane - 0.3 ppm (edible portion). Sec 575.100
Compliance Policy Guide
All fish Chlordecone - 0.4 ppm crabmeat and 0.3 ppm in other fish (edible portion). Sec 575.100
Compliance Policy Guide
All fish DDT, TDE and DDE - 5.0 ppm (edible portion). Sec 575.100
Compliance Policy Guide
All fish Heptachlor and heptachlor epoxide - 0.3 ppm (edible portion). Sec 575.100
Compliance Policy Guide
All fish Mirex - 0.1 ppm (edible portion). Sec 575.100
Compliance Policy Guide
All fish Diquat - 0.1 ppm*. 40 CFR 180.226
Fin fish and crayfish Fluridone - 0.5 ppm*. 40 CFR 180.420
Fin fish Glyphosate - 0.25 ppm*. 40 CFR 180.364
Shellfish Glyphosate - 3.0 ppm*. 40 CFR 180.364
Fin fish Simazine - 12 ppm*. 40 CFR 180.213a
All fish 2,4-D - 1.0 ppm*. 40 CFR 180.142
Salmonids, catfish and lobster Oxytetracycline - 2.0 ppm. 21 CFR 556.500
All fish Sulfamerazine - no residue permitted. 21 CFR 556.660
Salmonids and catfish Sulfadimethoxine/ormetoprim combination - 0.1 ppm. 21 CFR 556.640
All fish Unsanctioned drugs ** - no residue permitted Sec 615.200
Compliance Policy Guide
Crustacea Toxic elements: 76 ppm arsenic; 3 ppm cadmium; 12 ppm chromium; 1.5 ppm lead; 70 ppm nickel. FDA Guidance Documents
Clams, oysters, and mussels Toxic elements: 86 ppm arsenic; 4 ppm cadmium; 13 ppm chromium; 1.7 ppm lead; 80 ppm nickel. FDA Guidance Documents
All fish Methyl mercury - 1.0 ppm *** Sec 540.600
Compliance Policy Guide
All fish Paralytic shellfish poison - 0.8 ppm (80g/100g) saxitoxin equivalent. Sec 540.250
Compliance Policy Guide, and
Compliance Program 7303.842
Clams, mussels and oysters, fresh, frozen or canned Neurotoxic shellfish poison - 0.8 ppm (20 mouse units/100 gram) brevetoxin-2 equivalent. National Shellfish Sanitation Program Manual of Operations
All fish Amnesic shellfish poison - 20 ppm domoic acid, except in the viscera of dungeness crab, where 30 ppm is permitted. Compliance Program 7303.842
All fish Hard or sharp foreign object - generally 0.3 (7mm) to 1.0 (25mm) in length Sec 555.425 Compliance Policy Guide
* These values are tolerances.
** Sanctioned drugs are approved drugs and drugs used under an INAD. See Chapter 11 for additional information.
*** See Chapter 10 for additional information.
Note: the term "fish" refers to fresh or saltwater fin fish, crustaceans, other forms of aquatic animal life other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d).
鱿鱼丝
 监控
副溶血性弧菌
<1×104/g(神奈川试验阳性或阴性者)
SN 0173-92
Compliance Program 7303.842

沙门氏菌
不得检出
SN 0170-92
Sec 555.300 Compliance Policy Guide

霍乱弧菌
产毒性01群或非01群不得检出
SN/T1022-2001
Compliance Program 7303.842

大肠菌群
<230MPN/100克（5组的平均值或5组中3组或以上）
SN 0169-92
Sec 560.600 Compliance Policy Guide

金黄色葡萄球菌
<104/g（MPN）
SN 0172-92
Compliance Program 7303.842

单胞增生李氏特菌
不得检出
SN 0184-93
Compliance Program 7303.842

细菌总数
<500000/克（5组的平均值或5组中3组或以上）
SN 0168-92
Sec 560.600 Compliance Policy Guide

山梨酸

HPLC
GB/T5009.29-1996

苯甲酸

HPLC
GB/T5009.29-1996

FDA & EPA Safety Levels in Regulations and Guidance
Product Level Reference
产品水平参考
1、即食渔业产品（消费者）最小的烹饪肠产毒性大肠杆菌（ETEC） - 1×103 ETEC /克，LT或ST阳性。符合程序7303.842
即食水产品（消费者）的最小的烹饪李斯特菌存在有机体。符合程序7303.842
所有的鱼沙门氏菌的生物物种存在。 符合政策导向。
2、所有鱼 ①staphylococcus金黄色葡萄球菌 - 金黄色葡萄球菌肠毒素阳性，或
②金黄色葡萄球菌的电平是否等于或大于104克/（MPN）。符合程序7303.842
即食水产品（最小消费者烹饪）01或01非产毒霍乱弧菌 - 存在。符合程序7303.842
即食水产品（最小消费者烹饪）副溶血性弧菌水平等于或大于1×104 /克（神奈川县正或负）。符合程序7303.842
即食渔业产品（消费者）最小的烹饪创伤弧菌 - 病原体的存在。符合程序7303.842
3、所有的鱼肉毒杆菌 - ①存在可行的孢子或植物细胞产品，将支持他们的成长;②毒素的存在。符合程序7303.842
4、蛤和牡蛎，新鲜或冷冻 - 进口微生物 - ① Ë。大肠杆菌 - MPN的百分之二百三十零克;② APC - 500,000 /克，符合政策导向
蛤，牡蛎和贻贝，新鲜或冷冻 - 国内微生物 - ① Ë。大肠杆菌或粪大肠菌群 - 1个或多个5超过MPN百分之三百三十○克或2个或更多超过百分之二百三十〇克;② APC - 1个或多个5超过1,500,000 /克或2或以上的超过50万/克。符合程序7303.842
5、金枪鱼，鲯鳅鱼，以及相关的鱼类组胺 - 500 PPM基于毒性。 50 ppm的缺陷行动水平，因为组胺一般不会均匀地分布在一具腐烂的鱼。因此，50ppm的一个段中的发现，有其它单元的可能性，可能会超过500 ppm的。
6、所有鱼类中的多氯联苯（PCB） - 2.0 PPM（可食部分）*。 21 CFR 109.30
鳍鱼类和贝类艾氏剂，狄氏剂 - 0.3 PPM（可食部分）。
鲑鱼，鲶鱼和龙虾土霉素 - 2.0 PPM。 21 CFR 556.500
所有的鱼磺胺甲基嘧啶 - 无残留允许。 21 CFR 556.660
鲑鱼和鲶鱼磺胺二甲氧嘧啶/奥美普林组合 - 百万分之0.1。 21 CFR 556.640
所有鱼类未经批准的药物** - 允许无残留秒615.200
7、甲壳类动物的有毒元素：76 ppm的砷，镉为3 ppm，12 ppm的铬，1.5 ppm的铅70 ppm的镍。 FDA的指导文件
蛤，牡蛎，淡菜有毒元素：86 ppm的砷，镉百万分之4; 13 ppm的铬，1.7 ppm的铅80 ppm的镍。 FDA的指导文件
所有的鱼甲基汞 - 1.0 PPM
蛤，贻贝和牡蛎，新鲜，冷冻或罐装神经性贝毒 - 0.8 PPM（20鼠标units/100克）短裸甲藻毒素-2相当于。国家贝类卫生计划操作手册
**批准的药物被批准INAD下使用的药物和药物。了解更多信息，请参见第11章。