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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
39.2°F
4°C
86°F
30°C
50°F
10°C
37.9°F
3.3°C
50°F
10°C
44.6°F
7.0°C
131°F
55°C
113°F
45°C
118.4°F Anaerobeb
48°C
113°F
45°C
125.6°F
52°C
120.9°F
49.4°C
Aerobe
Microaerophilica
Anaerobeb
Anaerobeb
Facultative
anaerobeC
31.3°F 113°F
-0.4°C 45°C
41.4°F 115.2°F
5.2°C 46.2°C
43°F 116.8°F
6.1°C 47.1°C
44.6°F 122°F
7°C 50°C
50°F 118°F
10°C 48°C
50°F 109.4°F Facultative
10°C 43°C anaerobeC
41 °F 111 °F Facultative
5°C 44°C anaerobeC
46.4°F 109.4°F Facultative
8°C 43°C anaerobeC
29.7°F 107.6°F Facultative
-1.3°C 42°C 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 86-93°F (30-34°C) 48 hours
Above 93°F (above 34°C) 12 hours
Germination, growth, and toxin formation by 50-70°F (10-21°C) 12 hoursa
Clostridium botulinum type A, and Above 70°F (above 21°C) 4 hoursa
proteolytic B and F
Germination, growth, and toxin formation 37.9-50°F (3.3-10°C) 24 hours
by C. botulinum type E, and 51-70°F (11-21°C) 12 hours
nonproteolytic B and F Above 70°F (above 21°C) 4 hoursa
Growth of pathogenic strains of 44.6-50°F (7-10°C) 14 days
Escherichia cold 51-70°F (11-21 °C) 6 hours
Above 70°F (above 21°C) 3 hours
Growth of Listeria monocytogenes 31.3-50°F (-0.4-10°C) 2 days
51 -70°F (11 -21 °C) 12 hoursa
Above 70°F (above 21°C) 3 hoursa
Growth of Salmonella spp. 41.4-50°F (5.2-10°C) 14 days
51-70°F (11-21 °C) 6 hours
Above 70°F (above 21°C) 3 hours
Growth of Shigella spp. 43-50°F (6.1-10°C) 14 daysa
51-70°F (11-21 °C) 6 hoursa
Above 70°F (above 21°C) 3 hoursa
Growth and toxin formation by 44.6-50°F (7-10°C) 14 days
Staphylococcus aureus 51-70°F (11-21°C) 12 hoursa
Above 70°F (above 21°C) 3 hours
Growth of Vibrio cholerae 50°F (10°C) 21 days
51-70°F (11-21 °C) 6 hoursa
Above 70°F (above 21°C) 2 hoursa
Growth of V. parahaemolyticus 41-50°F (5-10°C) 21 days
51-70°F (11-21 °C) 6 hoursa
Above 70°F (above 21°C) 2 hoursa
Growth of V. vulnificus 46.4-50°F (8-10°C) 21 days
51-70°F (11-21 °C) 6 hours
Above 70°F (above 21°C) 2 hours
Growth of Yersinia enterocolitica 29.7-50°F (-1.3-10°C) 1 day
51-70°F (11-21 °C) 6 hours
Above 70°F (above 21°C) 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.
Representative terms from entire chapter:
policy guide