Table #A-5. FDA & EPA safety levels in regulations and guidance.
Updated: 07/18/07

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 Staphylococcus aureus - 1. 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 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, and mussels, fresh or frozen - imports Microbiological - 1. E. coli - MPN of 230/100 grams (average of subs or 3 more of 5 subs); or 2. APC - 500,000/gram (average of subs or 3 more of 5 subs). Sec 560.600 Compliance Policy Guide
Clams and oysters, and mussels, fresh or frozen - domestic Microbiological - 1. E. coli or fecal coliform - 1 or more of 5 subs exceeding MPN of 330/100grams or 2 or more exceeding 230/100 grams; or 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, less than 5 inches in length (e.g., anchovies and herring sprats), that are processed in a manner that prevents toxin formation, and that reach a water phase salt content of 10% in refrigerated products, or a water activity  of below 0.85 or a pH of 4.6 or less, in shelf-stable products are exempt from the evisceration requirement) 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, if 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)1. 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 in 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 ppm1. 40 CFR 180.226
Fin fish and crayfish Fluridone - 0.5 ppm1. 40 CFR 180.420
Fin fish Glyphosate - 0.25 ppm1. 40 CFR 180.364
Shellfish Glyphosate 3.0 ppm1. 40 CFR 180.364
Fin fish Simazine - 12 ppm1. 40 CFR 180.213a
All fish 2,4-D - 1.0 ppm1. 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 drugs2 - 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 Document
Clams, oysters, and mussels Toxic elements: 86 ppm arsenic; 4 ppm cadmium; 13 ppm chromium; 1.7 ppm lead; 80 ppm nickel. FDA Guidance Document
All fish Methyl mercury - 1.0 ppm3 Sec 540.600 Compliance Policy Guide
All fish Paralytic shellfish poison - 0.8 ppm (80µg/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 inches [7 mm] to 1.0 inches [25 mm] in length Sec 555.425 Compliance Policy Guide

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).

1 These values are tolerances.
2 Sanctioned drugs are approved drugs and drugs used under an INAD.
3 See Chapter 25 for additional information.

References 

FDA. 2001. Table #A-5: FDA & EPA Safety Levels in Regulations and Guidance. Appendix 5. In Fish and Fishery Products Hazards and Controls Guide, 3rd ed., p. 286. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.

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