Appendix 5: FDA & EPA Safety Levels in Regulations and ...

1 Appendix 5: FDA & EPA Safety Levels in Regulations and GuidanceContinuedThis Appendix contains a listing of FDA and EPA Levels relating to Safety attributes of fish and fishery productspublished in Regulations and guidance. In many cases, these Levels represent the point at or above which theagency will take legal action to remove products from the market. Consequently, the Levels contained in thistable may not always be suitable for critical 5: Guidance Levels285 Table #A-5 FDA & EPA Safety Levels in Regulations and GuidanceProductReady to eat fishery products(minimal cooking by consumer)Ready to eat fishery products(minimal cooking by consumer)All fishAll fishReady to eat fishery products(minimal cooking by consumer)Ready to eat fishery products(minimal cooking by consumer)Ready to eat fishery products(minimal cooking by consumer)

2 All fishClams and oysters, and musselsfresh or frozen - importsClams, oysters, and mussels,fresh or frozen - domesticSalt-cured, air-drieduneviscerated fishTuna, mahi mahi,and related fishLevelEnterotoxigenic Escherichia coli(ETEC) - 1 x 103 ETEC/g, LT or ST monocytogenes - presence of species- presence of aureus - 1. positive forstaphylococcal enterotoxin, or2. Staphylococcus aureus level is equal to orgreater than 104/g (MPN).Vibrio cholerae - presence of toxigenic 01or parahaemolyticus - Levels equal to or greaterthan 1 x 104/g (Kanagawa positive or negative).Vibrio vulnificus - presence of pathogenic botulinum - 1.

3 Presence of viable sporesor vegetative cells in products that will support theirgrowth; or2. Presence of - 1. E. coli - MPN of 230/100 grams(average of subs or 3 or more of 5 subs); or2. APC - 500,000/gram (average of subs or 3 or moreof 5 subs).Microbiological - 1. E. coli or fecal coliform - 1 or moreof 5 subs exceeding MPN of 330/100 grams or 2 or moreexceeding 230/100 grams; or2. APC - 1 or more of 5 subs exceeding 1,500,000/gramor 2 or more exceeding 500,000 permitted in commerce(Note: small fish exemption).Histamine - 500 ppm based on toxicity. 50 ppmdefect action level, because histamine is generallynot uniformly distributed in a decomposed fish.

4 Therefore, if50 ppm is found in one section, there is the possibilitythat other units may exceed 500 Program Program policy GuideCompliance Program Program Program Program Program policy GuideCompliance Program policy GuideSec policy GuideNote: 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 (d). Appendix 5: Guidance Levels286 Reference21 CFR policy GuideSec policy GuideSec policy GuideSec policy GuideSec policy GuideSec policy GuideSec policy Guide40 CFR CFR CFR CFR CFR CFR CFR CFR CFR policy GuideFDA Guidance DocumentLevelPolychlorinated Biphenyls (PCBs) - ppm(edible portion)*.

5 Aldrin and dieldrin - ppm (edible portion).Benzene Hexachloride - ppm (edible portion).Chlordane - ppm (edible portion).Chlordecone - ppm in crabmeat and ppmin other fish (edible portion).DDT, TDE and DDE - ppm (edible portion).Heptachlor and heptachlor epoxide - ppm(edible portion).Mirex - ppm (edible portion).Diquat - ppm*.Fluridone - ppm*.Glyphosate - ppm*.Glyphosate - ppm*.Simazine - 12 ppm*.2,4-D - ppm*.Oxytetracycline - ppmSulfamerazine - no residue combination - drugs** no residue permittedToxic elements: 76 ppm arsenic; 3 ppm cadmium;12 ppm chromium; ppm lead; 70 ppm fishFin fish and shellfishFrog legsAll fishAll fishAll fishAll fishAll fishAll fishFin fish and crayfishFin fishShellfishFin fishAll fishSalmonids, catfish and lobsterAll fishSalmonids and catfishAll fishCrustacea* These values are tolerances.

6 ** Sanctioned drugs are approved drugs and drugs used under an INAD. See Chapter 11 for additional : 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 (d). Appendix 5: Guidance Levels287** See Chapter 10 for additional informationNote: 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 (d).ProductClams, oysters, and musselsAll fishAll fishClams, mussels and oysters,fresh, frozen or cannedAll fishAll fishLevelToxic elements: 86 ppm arsenic; 4 ppm cadmium; 13 ppmchromium; ppm lead.

7 80 ppm mercury ppm**Paralytic shellfish poison - ppm (80ug/100g)saxitoxin shellfish poison - ppm (20 mouse units/100 gram) brevetoxin-2 shellfish poison - 20 ppm domoic acid,except in the viscera of dungeness crab,where 30 ppm is or sharp foreign object - generally [7mm]to [25mm] in lengthReferenceFDA Guidance DocumentsSec policy GuideSec compliance PolicyGuide, and compliance Shellfish SanitationProgram Manual of OperationsCompliance Program compliance PolicyGuideAppendix 5: Guidance Levels288