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Appendix C Food and Drug Administration and Environmental Protection Agency Guidance Levels for Seafood TABLE C-1 Microbiological and Chemical Guidelines/Tolerances in Seafood Product Guideline/Tolerance Reference Ready to eat Enterotoxigenic Escherichia cold Compliance Program 7303.842 fishery products (ETEC): 1 x 103 ETEC/g, LT or (minimal cooking ST positive by consumer) Listeria monocytogenes: Compliance Program 7303.842 presence of organism Vibrio cholerae: presence of Compliance Program 7303.842 toxigenic 01 or non-01 V. parahaemolyticus: level Compliance Program 7303.842 2 1 x 104/g (Kanagawa positive or negative) V. vulnificus: presence of Compliance Program 7303.842 pathogenic organism All fish Salmonella species: presence of Compliance Policy Guide organism Section 555.300 1. Staphylococcus aureus: Compliance Program 7303.842 positive for staphylococcal enterotoxin, or 2. S. aureus level 2 104/g (most probable number [MPN]) 303 continued

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304 TABLE C-1 Continued APPENDIX C Product Guideline/Tolerance Reference All fish Clostridium botulinum: Compliance Program 7303.842 (continued) 1. Presence of viable spores or vegetative cells in products that will support their growth; or, 2. Presence of toxin Polychlorinated biphenyl s: 21 CFR 109.30 2.0 ppm (edible portion)a Chlordane: 0.3 ppm Compliance Policy Guide (edible portion) Section 575.100 Chlordecone: 0.4 ppm crabmeat Compliance Policy Guide and 0.3 ppm in other fish Section 575.100 (edible portion) DDT, TDE and DDE: 5.0 ppm Compliance Policy Guide (edible portion) Section 575.100 Heptachlor and heptachlor epoxide: Compliance Policy Guide 0.3 ppm (edible portion) Section 575.100 Mirex: 0.1 ppm (edible portion) Compliance Policy Guide Section 575.100 Diquat: 0.1 ppma 40 CFR 180.226 2,4-D: 1.0 ppma 40 CFR 180.142 Sulfamerazine: 21 CFR 556.660 no residue permitted Unsanctioned drugsb: Compliance Policy Guide no residue permitted Section 615.200 Methyl mercury: 1.0 ppm Compliance Policy Guide Section 540.600 Paralytic shellfish poison: Compliance Policy Guide 0.8 ppm (80 ,ug/100 g) Section 540.250 and saxitoxin equivalent Compliance Program 7303.842 Amnesic shellfish poison: Compliance Program 7303.842 20 ppm domoic acid, except in the viscera of dungeness crab, where 30 ppm is permitted Salt-cured, air-dried Not permitted in commerce Compliance Policy Guide uneviscerated fish (small fish exemption) Section 540.650 Tuna, mahi mahi, Histamine: 500 ppm set based Compliance Policy Guide and related fish on toxicity; 50 ppm set as Section 540.525 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

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FDA AND EPA GUIDANCE LEVELS FOR SEAFOOD TABLE C-1 Continued 305 Product Guideline/Tolerance Reference Fin fish Glyphosate: 0.25 ppma 40 CFR 180.364 Simazine: 12 ppma 40 CFR 180.213a Fin fish and shellfish Aldrin and dieldrin: 0.3 ppm Compliance Policy Guide (edible portion) Section 575.100 Fin fish and crayfish Fluridone: 0.5 ppma 40 CFR 180.420 Frog legs Benzene hexachloride: 0.3 ppm Compliance Policy Guide (edible portion) Section 575.100 Shellfish Glyphosate: 3.0 ppma 40 CFR 180.364 Salmonids, catfish Oxytetracycline: 2.0 ppm 21 CFR 556.500 and lobster Salmonids and catfish Sulfadimethoxine/ormetoprim 21 CFR 556.640 combination: 0.1 ppm Toxic elements: 76 ppm arsenic, 3 ppm cadmium, 12 ppm chromium, 1.5 ppm lead, 70 ppm nickel Food and Drug Administration Guidance Documents Clams and oysters, Microbiological: Compliance Policy Guide fresh or frozen, 1. E. coli: MPN of 230/100 g Section 560.600 imports (average of subs or 3 or more of 5 subs) 2. Aerobic plate count (APC): 500,000/g (average of subs or 3 or more of 5 subs) Clams, oysters, and Microbiological: Compliance Program 7303.842 mussels, fresh or 1. E. cold or fecal coliform: frozen, domestic 1 or more of 5 subs exceeding MPN of 330/100 g or 2 or more exceeding 230/100 g 2. APC: 1 or more of 5 subs exceeding 1,500,000/g or 2 or more exceeding 500,000/g Clams, oysters, and Toxic elements: 86 ppm arsenic, FDA Guidance Documents mussels 4 ppm cadmium, 13 ppm chromium, 1.7 ppm lead, 80 ppm nickel continued

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306 TABLE C-1 Continued APPENDIX C Product Guideline/Tolerance Reference Clams, mussels and Neurotoxic shellfish poison: oysters, fresh, frozen, 0.8 ppm (20 mouse units/100 g) or canned brevetoxin-2 equivalent National Shellfish Sanitation Program Manual of Operations 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 C.F.R. 123.3(d). a These values are tolerances. b Sanctioned drugs are approved drugs, low regulatory priority drugs, and drugs used under an investigational new drug application. SOURCE: CFSAN (2001).

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FDA AND EPA GUIDANCE LEVELS FOR SEAFOOD TABLE C-2 Limiting Conditions for Pathogen Growth in Seafood 307 Pathogen Min Min Max Max % Min pH pH Salt Temp Max Oxygen Temp Requirement Bacillus cereus 0.92 Campylobacter 0.987 . . . JeJunl Clostridium botulinum, type A, and proteolytic B end F C. botulinum, type E, and nonproteolytic B end F C. perfringens Pathogenic strains of Escherichia cold Listeria monocytogenes Salmonella spp. Shigella spp. Staphylococcus aureus growth S. aureus toxin Vibrio cholerae V. parahaemolyticus V. vulnificus Yersinia enterocolitica 4.3 9.3 18 4.9 9.5 1.5 0.935 4.6 0.97 5 0.93 0.95 9 10 9 5 5 9 7 4 9 6.5 0.92 4.4 9.4 10 0.94 3.7 9.5 8 4.8 9.3 5.2 0.83 4 10 25 0.85 4 9.8 10 0.97 5 10 6 0.94 4.8 11 10 0.96 5 10 5 0.945 4.2 10 7 39.2F 4C 86F 30C 50F 10C 37.9F 3.3C 50F 10C 44.6F 7.0C 131F 55C 113F 45C 118.4F Anaerobeb 48C 113F 45C 125.6F 52C 120.9F 49.4C Aerobe Microaerophilica Anaerobeb Anaerobeb Facultative anaerobeC 31.3F 113F -0.4C 45C 41.4F 115.2F 5.2C 46.2C 43F 116.8F 6.1C 47.1C 44.6F 122F 7C 50C 50F 118F 10C 48C 50F 109.4F Facultative 10C 43C anaerobeC 41 F 111 F Facultative 5C 44C anaerobeC 46.4F 109.4F Facultative 8C 43C anaerobeC 29.7F 107.6F Facultative -1.3C 42C anaerobeC Facultative anaerobeC Facultative anaerobeC Facultative anaerobeC Facultative anaerobeC a Requires limited levels of oxygen. b Requires the absence of oxygen. c Grows either with or without oxygen. SOURCE: CFSAN (2001).

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308 APPENDIX C TABLE C-3 Time and Temperature Guidance for Controlling Pathogen Growth and Toxin Formation in Seafood Maximum Cumulative Exposure Potentially Hazardous Condition Product Temperature Time Growth of Campylobacter jejuni 86-93F (30-34C) 48 hours Above 93F (above 34C) 12 hours Germination, growth, and toxin formation by 50-70F (10-21C) 12 hoursa Clostridium botulinum type A, and Above 70F (above 21C) 4 hoursa proteolytic B and F Germination, growth, and toxin formation 37.9-50F (3.3-10C) 24 hours by C. botulinum type E, and 51-70F (11-21C) 12 hours nonproteolytic B and F Above 70F (above 21C) 4 hoursa Growth of pathogenic strains of 44.6-50F (7-10C) 14 days Escherichia cold 51-70F (11-21 C) 6 hours Above 70F (above 21C) 3 hours Growth of Listeria monocytogenes 31.3-50F (-0.4-10C) 2 days 51 -70F (11 -21 C) 12 hoursa Above 70F (above 21C) 3 hoursa Growth of Salmonella spp. 41.4-50F (5.2-10C) 14 days 51-70F (11-21 C) 6 hours Above 70F (above 21C) 3 hours Growth of Shigella spp. 43-50F (6.1-10C) 14 daysa 51-70F (11-21 C) 6 hoursa Above 70F (above 21C) 3 hoursa Growth and toxin formation by 44.6-50F (7-10C) 14 days Staphylococcus aureus 51-70F (11-21C) 12 hoursa Above 70F (above 21C) 3 hours Growth of Vibrio cholerae 50F (10C) 21 days 51-70F (11-21 C) 6 hoursa Above 70F (above 21C) 2 hoursa Growth of V. parahaemolyticus 41-50F (5-10C) 21 days 51-70F (11-21 C) 6 hoursa Above 70F (above 21C) 2 hoursa Growth of V. vulnificus 46.4-50F (8-10C) 21 days 51-70F (11-21 C) 6 hours Above 70F (above 21C) 2 hours Growth of Yersinia enterocolitica 29.7-50F (-1.3-10C) 1 day 51-70F (11-21 C) 6 hours Above 70F (above 21C) 2.5 hours a Additional data needed. SOURCE: CFSAN (2001). REFERENCE CFSAN (Center for Food Safety and Applied Nutrition). 2001. Fish and Fishery Products Hazards and Controls Guidance, 3rd ed. Online. Food and Drug Administration. Available at http:// www.cfsan.fda.gov/~comm/haccp4.html. Accessed December 27, 2002.