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Fluoride150ppm ICP/MS Food and Drug Regulation,Devertion 15 FOOD SAFETY AND INSPECTION SERVICE,National Residue Program Scheduled Sampling Plans,p156-157 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Lead0.5ppm ICP/MS Food and Drug Regulation,Devertion 15 FOOD SAFETY AND INSPECTION SERVICE,National Residue Program Scheduled Sampling Plans,p156-157 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Tin250ppm ICP/MS Food and Drug Regulation,Devertion 15 FOOD SAFETY AND INSPECTION SERVICE,National Residue Program Scheduled Sampling Plans,p156-157 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Methyl mercury:1ppm Methods for the Determination of Metals in Environmental Samples No.200.2, 200.3, 245.1,245.3, 245.5, 245.6 http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.epa.gov/nerlcwww/methmans.html Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
FD&C Blue  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.10128Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Cochineal extract  GMPAcceptability determination 21 CFR Section73.1008,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Toasted partially defatted cooked cottonseed flour  GMPAcceptability determination 21 CFR Section73.1401,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Fruit juice  GMPAcceptability determination 21 CFR Section73.25016,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Vegetable juice  GMPAcceptability determination 21 CFR Section73.26017,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Sulfamerazine:  no residue permittedTLC/GC/ESI-MS 21 CFR 556.660 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFis 2005 National Residue Program Data - Red Book/Appendix IV FSIS Laboratory Analytical Methods Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Unsanctioned drugs*:  no residue permittedTLC/GC/ESI-MS Compliance Policy Guide Section 615.200 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDoc 2005 National Residue Program Data - Red Book/Appendix IV FSIS Laboratory Analytical Methods Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
2,4-D0.1ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Carfentrazone-ethyl0.3ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Penoxsulam0.01ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Spinosad4ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Triclopyr3ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
DIURON2ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Penoxsulam0.01ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Carrot oil  GMPIn-house validated method 21 CFR Section73.30018,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Paprika  GMPIn-house validated method 21 CFR Section73.34019,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Paprika oleoresin  GMPIn-house validated method 21 CFR Section73.3452,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Riboflavin  GMPAOAC 970.65 21 CFR Section73.45022,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Saffron  GMPAcceptability determination 21 CFR Section73.50023,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Blue  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.10229Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Green  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.20330Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Red  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.34034Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Yellow  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.70535Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Yellow  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.70636Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Paralytic shellfish poison:0.8ppm(80m g/100 g)saxitoxin equivalentGuidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Se http://fn.cfs.purdue.edu/fish4health/HealthRisks/EPAFCA100.pdf Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Amnesic shellfish poison:20ppmdomoic acid, except in the viscera of Dungeness crab, where 30 ppm is permittedbioassay/HPLC Compliance Policy Guide Section 540.525 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDo http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/ucm070795.htm Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Histamine500ppmset based on toxicity; 50 ppm set as defect action level, because histamine is generally not uniformly distributed in a decomposed fish; therefore, if 50 ppm is found possibility that other units may exceed 500 ppmalcoholic extraction and quantitation by fluorescence spectroscopy Compliance Policy Guide Section 540.525 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDoc http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/ucm070823.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
CHLORDANE0.3ppm(edible portion)Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Chlordecone0.3ppmin other fish (edible portion)Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
DDT, TDE and DDE:5ppm(edible portion)Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
DIQUAT2ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Spinosad4ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Penoxsulam0.02ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Spinosad4ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Polychlorinated biphenyls:2ppm Pesticide Analytical Manual (PAM) vol.I (section 304) 21 CFR 109.30 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFi Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Enterotoxigenic Escherichia coli1x 10³ ETEC/g, LT or ST positive presence of pathogenic organismBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 4. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Listeria monocytogenes  presence of pathogenic organismBacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 10 and 11. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Annatto extract  GMP  21 CFR Section73.302,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Salmonella species  presence of pathogenic organismBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 5. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Staphylococcus aureus  positive for staphylococcal enterotoxin, or level ³ 104/g (MPN)Bacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 12. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Clostridium botulinum  Presence of viable spores or vegetative cells in products that will support their growth; or Presence of toxinBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 17. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Arsenic3.5ppm ICP/MS Food and Drug Regulation,Devertion 15 FOOD SAFETY AND INSPECTION SERVICE,National Residue Program Scheduled Sampling Plans,p156-157 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6 Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 1 Fish Sampling and AnalysisThird Edition, Charpter6
Dehydrated beets (beet powder)  GMP  21 CFR Section73.403,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Canthaxanthin30mg/lbof solid or semisolid food or per pint of liquid foodOFFICIAL ANALYTICAL PROTOCOL p. 20 21 CFR Section73.754,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0237-07-Tab-E-vol172.pdf OFFICIAL ANALYTICAL PROTOCOL p. 20 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Caramel  GMP  21 CFR Section73.855,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
B-Apo-8'-carotenal15 mg/lb of solid , 15 mg/pt liquid  AOAC 941.15 21 CFR Section73.906,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
B-Carotene  GMPAOAC 941.15 21 CFR Section73.957,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Vibrio cholearae  presence of toxigenic 01 or non-01Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. Compliance Programme 7303.842(Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seaf http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Vibrio parahaemolyticuslevel ³ 1 x 104/g (Kanagawa positive or negative)Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Vibrio vulnificus  presence of pathogenic organismBacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Titanium dioxide≤ 1.0%by wt. of foodIn-house validated method 21 CFR Section73.57524,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Tomato lycopene extract; tomato lycopene concentrate  GMPAcceptability determination 21 CFR Section73.58525,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Turmeric  GMPIn-house validated method 21 CFR Section73.60026,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Turmeric oleoresin  GMPIn-house validated method 21 CFR Section73.61527,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Endothall (endothal)0.1ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Glyphosate0.25ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Heptachlor and heptachlor epoxide:0.3ppm(edible portion)Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
IMAZAPYR1ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Mirex:0.1ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Aldrin and dieldrin:0.3ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Sec 575.100 Compliance Policy Guide (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
SIMAZINE12ppm Pesticide Analytical Manual (PAM) vol.I (section 304) 40 CFR 180.213a (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFi Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
FLURIDONE0.5ppm Pesticide Analytical Manual (PAM) vol.I (section 304) 40 CFR 180.420 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFis Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
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