U.S. Food & Drug Administration
Center for Food Safety & Applied Nutrition
FISH AND FISHERIES PRODUCTS
HAZARDS AND CONTROLS GUIDANCE:
Third Edition June 2001

APPENDIX 5

FDA & EPA Safety Levels in Regulations and Guidance

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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.


Table A-5

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 (80ug/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).


See also:

FDA Seafood List

Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book)

Seafood Information and Resources

Seafood HACCP   |   Fish & Fisheries Products Hazards & Controls Guidance: 3rd Edition (2001)

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