Center for Food Safety & Applied Nutrition FISH AND FISHERIES PRODUCTS HAZARDS AND CONTROLS GUIDANCE: Third Edition June 2001 |
This appendix contains a listing of FDA and EPA levels relating to safety attributes of fish and fishery products published in regulations and guidance. In many cases, these levels represent the point at or above which the agency will take legal action to remove products from the market. Consequently, the levels contained in this table may not always be suitable for critical limits.
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 (80![]() |
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). |
See also:
Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book)
Seafood Information and Resources
Hypertext updated by dav/dms/kwg 2002-JUN-17